Archive for the ‘Cardiac Stem Cells’ Category

Three-dimensional printers have now assembled candy, clothing, and even mouse ovaries. But in the next decade, specialized bioprinters could begin to build functioning human organs in space. It turns out, the minimal gravity conditions in space may provide a more ideal environment for building organs than gravity-heavy Earth.

If successful, space-printed organs could help to shorten transplant waitlists and even eliminate organ rejection. Though they still have a long way to go, researchers at the International Space Station (ISS) hope to eventually assemble organs from adult human cells, including stem cells.

The medical field has only recently embraced 3D printing in general, particularly in biomedical fields like regenerative medicine and prosthetics. So far, these printers have produced early versions of blood vessels, bones, and different types of living tissue by churning out repeated layers of bioinka substance comprised of living human cells and other tissue thats meant to mimic the natural environment that surrounds growing organs.

Recently, researchers are finding that Earth might not be the best environment for growing freestanding organs. Because gravity is constantly pushing down on these delicate structures as they grow, researchers must surround the tissues in scaffolding, which can often debilitate the delicate veins and blood vessels and prevent the soon-to-be organs from growing and functioning properly. Within microgravity, however, soft tissues hold their shape naturally, without the need for surrounding supportan observation thats driven researchers to space.

And one manufacturing lab based in Indiana thinks its tech could play a key role in space. The 3D BioFabrication Facility (BFF) is a specialized 3D printer that uses bioink to build layers several times thinner than human hair. It cost about $7 million to build and employs the smallest print tips in existence.

The brainchild of spaceflight equipment developer Techshot and 3D printer manufacturer nScrypt, the BFF headed to the ISS in July 2019 aboard the SpaceX CRS-18.

Currently, the project focuses on building increasingly thick artificial cardiac tissue and delivering it back to Earth. Once the printed cardiac tissue reaches a certain thickness, it gets harder for researchers to ensure that a printed structures layers effectively grow into one another. Ultimately, though, theyd like the organs to arrive here fully formed.

Printed organs would eventually require vasculature and nerve endings to work properly, though that technology doesnt yet exist.

The next stagetesting heart patches under microscopes and within animalscould span over the next four years. As for whole organs, Techshot claims it plans to begin production after 2025. For now, the project is still in its infancy.

If you were to look at what we printed, it looks very modest, says Techshot vice president of corporate advancement Rich Boling. Its just a cuboid-type shape, this rectangular box. Were just trying to get cells to grow one layer into the next.

Cooking organs like pancakes

Compare the manufacturing process to cooking pancakes, Boling says. The space crew first creates a custom bioink pancake mix with the cells sent from Earth, which they load with syringe-like tools into the BFF.

Researchers then insert a cassette into the BFF containing a bioreactora system that mimics the normal bodily functions essential for growing healthy tissue, like providing nutrients and flushing out waste.

Approximately 200 miles below in Greenville, Indiana, Techshot engineers connect with ISS astronauts on a NASA-enabled secure digital pathway. The linkup allows Techshot to remotely command BFF functions like pump pressure, internal temperature, lighting, and print speed.

Next, the actual printing process occurs within the bioreactor and can take anywhere from moments to hours, depending on the shapes complexity. In the final production step, the cell-culturing ADvanced Space Experiment Processor (ADSEP) cooks the theoretical pancake; essentially, the ADSEP toughens up the printed tissue for its journey back to earth. This step could take anywhere from 12 to 45 days for different tissue types. When completed and hardened, the structure heads home.

The researchers have gone through three testing processes so far, each one getting more exact. This March, theyll begin the third round of experiments.

The bioprinter space race

The BFF lab is the sole team developing this specific type of microgravity bioprinter, Boling says. Theyre not the only ones looking to print human organs in space, though.

A Russian project has also entered the bioprinting space race, however their technique highly differs. Unlike the BFFs bioink layering method, Russian biotechnology laboratory 3D Bioprinting Solutions uses magnetic nanoparticles to produce tissue. An electromagnet creates a magnetic field in which levitating tissue forms the desired structuretechnology that appears ripped from the pages of a sci-fi novel.

After their bioprinter fell victim to an October 2018 spacecraft crash, 3D Bioprinting Solutions rebounded; the team now collaborates with US and Israeli researchers at the ISS. Last month, their crew created the first space-bioprinted bone tissue. Similar to the US project, 3D Bioprinting Solutions aims to manufacture functioning human tissues and organs for transplantation and general repair.

Just because we have the technology to do it, should we do it?

If the 3D BioFabrication Facility prospers in printing working human organs, theyd be subject to thorough regulation here on Earth. The US approval process is stringent for any drug, Rich Boling says, posing a challenge for this unprecedented invention. Techshot predicts at least 10 years for space-printed organs to achieve legal approval, though its an inexact estimate.

Along with regulatory acceptance, human tissue printed in microgravity may encounter societal pushback.

Each country maintains varying laws related to medical transplants. Yet as bioengineering advances into the the final frontier, the international scientific research community may need to shape new guidelines for collaboration among the stars.

As the commercialization of low-Earth orbit continues to ramp up in the next few years, it is certainly true that were going to have to take a very close look at the regulations that apply to that, says International Space Station U.S. National Laboratory interim chief scientist Michael Roberts. And some of those regulations are going to stray into questions related to ethics: Just because we have the technology to do it, should we do it?

Niki Vermeulen, a University of Edinburgh science technology and innovation studies lecturer, has researched the social implications of 3D bioprinting experiments. Like any Earth-bound project, she urges scientists not to get peoples hopes up too early in the process; individuals seeking organ transplants could read about the BFF online and think it could soon be ready to meet their needs.

The most important thing now, I think, is expectation management, Vermeulen says. Because its really quite difficult to do this, and of course we really dont know if its going to work. If it did, it would be amazing.

Another main issue is cost. Like other cutting-edge biotechnology innovations, the organs could also pose a major affordability challenge, she says. Techshot claims that a single space-printed organ could actually cost less than one from a human donor, since some people must pay for a lifetime of anti-rejection meds and/or multiple transplants. Theres currently no telling how long the BFF process would actually take, however, compared to the conventional donor route.

Plus, theres potential health risks for recipients: Techshot chief scientist Eugene Boland says cell manipulation always presents a possibility of genetic mutation. Modified stem cells can potentially cause cancer in recipients, for example.

The team is now working to define and minimize any dangers, he says. The BFF experiment adheres to the FDAs specific regulations for human cells, tissues, and cellular and tissue-based products.

Researchers on the ground now hope to perfect human cell manipulation: Over 100 US clinical trials presently test cultured autologous human cells, and several hundred test cultured stem cells with multiple origins.

What comes next

After the next round of printing tests this March, Techshot will share the bioprinter with companies and research institutions looking to print materials like cartilage, bone, and liver tissue. Theyre currently preparing the bioprinter for these additional uses, Boling says, which could advance health care as a whole.

To speed things up for space crews, Techshot is now building a cell factory that produces multiple cell types in orbit. This technology could cut down the number of cell deliveries between Earth and space.

The ISS has taken in plenty of commercial ventures in recent years, Michael Roberts says, and its getting crowded up there. Space-based experiments ramped up between 40 and 50 years ago, though until recently they mostly prioritized satellite communications and remote observation technology. Since then, satellites have shrunk from bus-sized to smaller than a shoebox.

Roberts has witnessed the scientific areas of interest broaden over the past decade to include medicine. Organizations like the National Institutes of Health are now looking to space to improve treatments, and everything from large pharmaceutical companies to small-scale startups want in.

Theyve got something stuck on every surface up there, he says.

As the ISS runs out of space and exterior attachment points, Roberts predicts that commercial ventures will build new facilities built for specific activities like manufacturing and plant growth. He sees it as a good opportunity for further innovation, since the ISS was originally designed for far more general purposes.

Space, as a whole, may start to look quite different from the first exploration age.

Baby boomers may remember glimpsing at a grainy, black-and-white moon landing five decades ago. Within the same lifetime, they could potentially observe the introduction of space-printed organs.

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Space might be the perfect place to grow human organs - Popular Science

Biomedical researchers from Texas Tech University Health Sciences Center El Paso and the University of Texas at El Paso are working on a joint project to send miniature 3D bioprinted hearts to space. The research project, which has received backing from the National Science Foundation (NSF), seeks to understand how a microgravity environment affects the function of the human heart.

Bioprinting in space is a growing venture. The microgravity environment found aboard the International Space Station (ISS) provides a unique setting for bioprinted tissues and cellular structures to culture and grow. Bioprinting specialists like CELLINK and 3D Bioprinting Solutions are showcasing the potential of bioprinting in space, both for the advancement of bioprinting technologies and to understand the impact of zero-gravity on the human body.

The three-year research project conducted by the Texas-based research team falls into the latter category. The team, led by Munmun Chattopadhyay, Ph.D., TTUHSC El Paso faculty scientist, and Binata Joddar, Ph.D., UTEP biomedical engineer, wants to understand how the human heart is impacted by microgravity by testing bioprinted cardiac organoids aboard the ISS.

The cardiac organoids consist of heart-tissue structures measuring less than 1 mm in thickness which are bioprinted using human stem cells. The organoids will be sent to the ISS, where they will exposed to microgravity environments. This will provide vital insights into a condition commonly experienced by astronauts.

The condition in question is cardiac atrophy and it is caused by a weakening of heart tissue. The condition can lead to other problems, like fainting, irregular heartbeats and even heart failure. Because astronauts often suffer from cardiac atrophy after spending long stints in space, the researchers want to better understand the link.

Cardiac atrophy and a related condition, cardiac fibrosis, is a very big problem in our community, said Dr. Chattopadhyay. People suffering from diseases such as diabetes, muscular dystrophy and cancer, and conditions such as sepsis and congestive heart failure, often experience cardiac dysfunction and tissue damage.

The project, which officially started in September, is currently focused on research design. In this stage of the research, the team is developing bioprinted cardiac organoids and exploring different material compositions using cardiac cells to create heart-like tissue. The second stage of the research will be focused on preparing to launch to organoid to space. The final stage will consist of analyzing data collected during the organoids time in space, once they have returned to Earth.

Dr. Chattopadhyay expressed excitement about the ongoing research project, saying: Knowledge gathered from this study could be used to develop technologies and therapeutic strategies to better combat tissue atrophy experienced by astronauts, as well as open the doorforimproved treatmentsforpeople who suffer from serious heart issues due to illness.

The researchers also hope to engage the community with their research by offering a workshop for K-12 students about their experiments aboard the ISS. The team will also host a seminar for medical students, interns and residents about conducting research in space and on Earth.

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El Paso researchers sending bioprinted mini hearts to ISS - 3DPMN

Ncardia and BlueRock Therapeutics today announced an agreement covering process development technologies for the manufacture of induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Under the terms of the agreement, Bluerock gains access to Ncardias large-scale production processes and intellectual property for the production of iPSC-derived cardiomyocytes for therapeutic use.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200121005200/en/

"BlueRock is a leader in the field of cell therapy and our collaboration is a perfect match of mission and capabilities. This relationship allows us to utilize our experience in iPSC process development to help advance potential cell therapies for cardiac diseases," said Stefan Braam, CEO of Ncardia.

"There are hundreds of millions of people worldwide that suffer from degenerative cardiovascular disease where the root cause is the loss of healthy heart muscle cells, and where medical treatment options are limited. BlueRocks authentic cellular therapy is a novel approach that has the potential to transform the lives of patients, but will require the manufacture of our cell therapies at unprecedented scale. The Ncardia team has developed key technologies related to this scale-up challenge, and we are pleased to work with them as we advance BlueRocks novel CELL+GENE platform towards the clinic and those patients in need," said Emile Nuwaysir, President and CEO, BlueRock Therapeutics.

About BlueRock Therapeutics

BlueRock Therapeutics, a wholly owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics CELL+GENE platform harnesses the power of cells for new medicines across neurology, cardiology and immunology indications. BlueRock Therapeutics cell differentiation technology recapitulates the cells developmental biology to produce authentic cell therapies, which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function. BlueRocks culture is defined by scientific innovation, highest ethical standards and an urgency to bring transformative treatments to all who would benefit. For more information, visit http://www.bluerocktx.com.

About Ncardia

Ncardia believes that stem cell technology can deliver better therapies to patients faster. We bring cell manufacturing and process development expertise to cell therapy by designing and delivering human induced pluripotent stem cell (iPSC) solutions to specification. Our offerings extend from concept development to pre-clinical studies, including custom manufacturing of a range of cell types, as well as discovery services such as disease modelling, screening, and safety assays. For more information, visit http://www.ncardia.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200121005200/en/

Contacts

BlueRock:media@bluerocktx.com

Ncardia:Steven Dublinmedia@ncardia.com

Excerpt from:
Ncardia and BlueRock Therapeutics Announce Collaboration Agreement and Licensing of Process Development Technologies for the Manufacture of...

Theres a team of scientists who basically discovered live robots. You read that right. They found a new purpose for living cells, which they took from frog embryos, and they constructed new life forms. These life forms were named Xenobots, and they can move in small places and carry stuff, too. They also want to try to see if they are useful in medicine.

Apparently, they can heal themselves after theyre cut, which gives them a longer life span. They are not a species of animals, and they are not robots in a real way. As Joshua Bongard states, Its a new class of artifact: a living, programmable organism. He is a computer scientist at the University of Vermont.

A supercomputer developed these live robots at UVM. The idea behind this creation is not a new one. But it is the first time they actually improved it from scratch. The team was led by doctoral student Sam Kriegman, who used an evolutionary algorithm to develop thousands of designs for these new life forms.

They gave the program the basic rules about biophysics about the frog skin and the cardiac cells. They tested about a hundred algorithms to find the best design. Then, the team worked with microsurgeons to transfer the silicon designs into life. They took the stem cells from Xenopus lavevis, an African frog. Then the embryos were assembled in body forms, so the cells began to work.

Almost everything we see today is made out of steel, silicon, or plastic. While its true that the material is durable, it also creates human health problems. Bongard stated that the living tissues degrade quickly. Also, these living robots made with frog cells could help us live a healthier life. More research will be conducted.

Tanya is an expert in reddit and health subjects. She finds good stories where no one ever thinks to look.

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The Living Robots Made With Frog Cells Could Boost Our Health - Dual Dove

Transparency Market Research (TMR)has published a new report on the globalcell separation technology marketfor the forecast period of 20192027. According to the report, the global cell separation technology market was valued at ~US$ 5 Bnin 2018, and is projected to expand at a double-digit CAGR during the forecast period.

Overview

Cell separation, also known as cell sorting or cell isolation, is the process of removing cells from biological samples such as tissue or whole blood. Cell separation is a powerful technology that assists biological research. Rising incidences of chronic illnesses across the globe are likely to boost the development of regenerative medicines or tissue engineering, which further boosts the adoption of cell separation technologies by researchers.

Expansion of the global cell separation technology market is attributed to an increase in technological advancements and surge in investments in research & development, such asstem cellresearch and cancer research. The rising geriatric population is another factor boosting the need for cell separation technologies Moreover, the geriatric population, globally, is more prone to long-term neurological and other chronic illnesses, which, in turn, is driving research to develop treatment for chronic illnesses. Furthermore, increase in the awareness about innovative technologies, such as microfluidics, fluorescent-activated cells sorting, and magnetic activated cells sorting is expected to propel the global cell separation technology market.

Request PDF Sample of Cell Separation Technology Market Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=1925

North America dominated the global cell separation technology market in 2018, and the trend is anticipated to continue during the forecast period. This is attributed to technological advancements in offering cell separation solutions, presence of key players, and increased initiatives by governments for advancing the cell separation process. However, insufficient funding for the development of cell separation technologies is likely to hamper the global cell separation technology market during the forecast period. Asia Pacific is expected to be a highly lucrative market for cell separation technology during the forecast period, owing to improving healthcare infrastructure along with rising investments in research & development in the region.

Rising Incidences of Chronic Diseases, Worldwide, Boosting the Demand for Cell Therapy

Incidences of chronic diseases such as diabetes, obesity, arthritis, cardiac diseases, and cancer are increasing due to sedentary lifestyles, aging population, and increased alcohol consumption and cigarette smoking. According to the World Health Organization (WHO), by 2020, the mortality rate from chronic diseases is expected to reach73%, and in developing counties,70%deaths are estimated to be caused by chronic diseases.

Southeast Asia, Eastern Mediterranean, and Africa are expected to be greatly affected by chronic diseases. Thus, the increasing burden of chronic diseases around the world is fuelling the demand for cellular therapies to treat chronic diseases. This, in turn, is driving focus and investments on research to develop effective treatments. Thus, increase in cellular research activities is boosting the global cell separation technology market.

Increase in Geriatric Population Boosting the Demand for Surgeries

The geriatric population is likely to suffer from chronic diseases such as cancer and neurological disorders more than the younger population. Moreover, the geriatric population is increasing at a rapid pace as compared to that of the younger population. Increase in the geriatric population aged above 65 years is projected to drive the incidences of Alzheimers, dementia, cancer, and immune diseases, which, in turn, is anticipated to boost the need for corrective treatment of these disorders. This is estimated to further drive the demand for clinical trials and research that require cell separation products. These factors are likely to boost the global cell separation technology market.

According to the United Nations, the geriatric population aged above 60 is expected to double by 2050 and triple by 2100, an increase from962 millionin 2017 to2.1 billionin 2050 and3.1 billionby 2100.

Enquiry for Discount on Cell Separation Technology Market Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=D&rep_id=1925

Productive Partnerships in Microfluidics Likely to Boost the Cell Separation Technology Market

Technological advancements are prompting companies to innovate in microfluidics cell separation technology. Strategic partnerships and collaborations is an ongoing trend, which is boosting the innovation and development of microfluidics-based products. Governments and stakeholders look upon the potential in single cell separation technology and its analysis, which drives them to invest in the development ofmicrofluidics. Companies are striving to build a platform by utilizing their expertise and experience to further offer enhanced solutions to end users.

Stem Cell Research to Account for a Prominent Share

Stem cell is a prominent cell therapy utilized in the development of regenerative medicine, which is employed in the replacement of tissues or organs, rather than treating them. Thus, stem cell accounted for a prominent share of the global market. The geriatric population is likely to increase at a rapid pace as compared to the adult population, by 2030, which is likely to attract the use of stem cell therapy for treatment. Stem cells require considerably higher number of clinical trials, which is likely to drive the demand for cell separation technology, globally. Rising stem cell research is likely to attract government and private funding, which, in turn, is estimated to offer significant opportunity for stem cell therapies.

Biotechnology & Pharmaceuticals Companies to Dominate the Market

The number of biotechnology companies operating across the globe is rising, especially in developing countries. Pharmaceutical companies are likely to use cells separation techniques to develop drugs and continue contributing through innovation. Growing research in stem cell has prompted companies to own large separate units to boost the same. Thus, advancements in developing drugs and treatments, such as CAR-T through cell separation technologies, are likely to drive the segment.

As per research, 449 public biotech companies operate in the U.S., which is expected to boost the biotechnology & pharmaceutical companies segment. In developing countries such as China, China Food and Drug Administration(CFDA) reforms pave the way for innovation to further boost biotechnology & pharmaceutical companies in the country.

Global Cell Separation Technology Market: Prominent Regions

North America to Dominate Global Market, While Asia Pacific to Offer Significant Opportunity

In terms of region, the global cell separation technology market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the global market in 2018, followed by Europe. North America accounted for a major share of the global cell separation technology market in 2018, owing to the development of cell separation advanced technologies, well-defined regulatory framework, and initiatives by governments in the region to further encourage the research industry. The U.S. is a major investor in stem cell research, which accelerates the development of regenerative medicines for the treatment of various long-term illnesses.

The cell separation technology market in Asia Pacific is projected to expand at a high CAGR from 2019 to 2027. This can be attributed to an increase in healthcare expenditure and large patient population, especially in countries such as India and China. Rising medical tourism in the region and technological advancements are likely to drive the cell separation technology market in the region.

Launching Innovative Products, and Acquisitions & Collaborations by Key Players Driving Global Cell Separation Technology Market

The global cell separation technology market is highly competitive in terms of number of players. Key players operating in the global cell separation technology market include Akadeum Life Sciences, STEMCELL Technologies, Inc., BD, Bio-Rad Laboratories, Inc., Miltenyi Biotech, 10X Genomics, Thermo Fisher Scientific, Inc., Zeiss, GE Healthcare Life Sciences, PerkinElmer, Inc., and QIAGEN.

These players have adopted various strategies such as expanding their product portfolios by launching new cell separation kits and devices, and participation in acquisitions, establishing strong distribution networks. Companies are expanding their geographic presence in order sustain in the global cell separation technology market. For instance, in May 2019, Akadeum Life Sciences launched seven new microbubble-based products at a conference. In July 2017, BD received the U.S. FDAs clearance for its BD FACS Lyric flow cytometer system, which is used in the diagnosis of immunological disorders.

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Cell Separation Technology Market Statistics, Demand and Forecasts to 2027 Examined in New Research Report - Dagoretti News

US Stem Cell (OTCMKTS:USRM) and National Research (NASDAQ:NRC) are both small-cap medical companies, but which is the superior investment? We will compare the two companies based on the strength of their earnings, risk, valuation, dividends, profitability, analyst recommendations and institutional ownership.

Institutional & Insider Ownership

39.7% of National Research shares are owned by institutional investors. 16.7% of US Stem Cell shares are owned by insiders. Comparatively, 4.5% of National Research shares are owned by insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a stock will outperform the market over the long term.

Analyst Recommendations

This is a breakdown of current ratings and price targets for US Stem Cell and National Research, as provided by MarketBeat.com.

Volatility & Risk

US Stem Cell has a beta of 4.87, meaning that its stock price is 387% more volatile than the S&P 500. Comparatively, National Research has a beta of 0.78, meaning that its stock price is 22% less volatile than the S&P 500.

Valuation and Earnings

This table compares US Stem Cell and National Researchs gross revenue, earnings per share (EPS) and valuation.

National Research has higher revenue and earnings than US Stem Cell.

Profitability

This table compares US Stem Cell and National Researchs net margins, return on equity and return on assets.

Summary

National Research beats US Stem Cell on 7 of the 9 factors compared between the two stocks.

US Stem Cell Company Profile

U.S. Stem Cell, Inc., a biotechnology company, focuses on the discovery, development, and commercialization of autologous cellular therapies for the treatment of chronic and acute heart damage, and vascular and autoimmune diseases in the United States and internationally. Its lead product candidates include MyoCell, a clinical therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells or cells from a patient's body for enhancing cardiac function in chronic heart failure patients; and AdipoCell, a patient-derived cell therapy for the treatment of acute myocardial infarction, chronic heart ischemia, and lower limb ischemia. The company's product development pipeline includes MyoCell SDF-1, an autologous muscle-derived cellular therapy for improving cardiac function in chronic heart failure patients. It is also developing MyoCath, a deflecting tip needle injection catheter that is used to inject cells into cardiac tissue in therapeutic procedures to treat chronic heart ischemia and congestive heart failure. In addition, the company provides physician and patient based regenerative medicine/cell therapy training, cell collection, and cell storage services; and cell collection and treatment kits for humans and animals, as well operates a cell therapy clinic. The company was formerly known as Bioheart, Inc. and changed its name to U.S. Stem Cell, Inc. in October 2015. U.S. Stem Cell, Inc. was founded in 1999 and is headquartered in Sunrise, Florida.

National Research Company Profile

National Research Corporation (NRC) is a provider of analytics and insights that facilitate revenue growth, patient, employee and customer retention and patient engagement for healthcare providers, payers and other healthcare organizations. The Companys portfolio of subscription-based solutions provides information and analysis to healthcare organizations and payers across a range of mission-critical, constituent-related elements, including patient experience and satisfaction, community population health risks, workforce engagement, community perceptions, and physician engagement. The Companys clients range from acute care hospitals and post-acute providers, such as home health, long term care and hospice, to numerous payer organizations. The Company derives its revenue from its annually renewable services, which include performance measurement and improvement services, healthcare analytics and governance education services.

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National Research (NASDAQ:NRC) versus US Stem Cell (NASDAQ:USRM) Head-To-Head Review - Riverton Roll

The following are the top rated Healthcare stocks according to Validea's Small-Cap Growth Investor model based on the published strategy of Motley Fool. This strategy looks for small cap growth stocks with solid fundamentals and strong price performance.

ZYNEX INC. (ZYXI) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 83% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: Zynex, Inc. operates through the Electrotherapy and Pain Management Products segment. The Company conducts its business through its subsidiaries and the operating subsidiary is Zynex Medical, Inc. (ZMI). Its other subsidiaries include Zynex Monitoring Solutions, Inc. (ZMS) and Zynex Europe, ApS (ZEU). ZMI designs, manufactures and markets medical devices that treat chronic and acute pain, as well as activate and exercise muscles for rehabilitative purposes with electrical stimulation. ZMS is in the process of developing its blood volume monitoring product for non-invasive cardiac monitoring. ZEU intends to focus on sales and marketing its products within the international marketplace, upon receipt of necessary regulatory approvals. It markets and sells Zynex-manufactured products and distributes private labeled products. Its products include NexWave, NeuroMove, InWave, Electrodes and Batteries. ZMI devices are intended for pain management to reduce reliance on drugs and medications.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

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LEMAITRE VASCULAR INC (LMAT) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 80% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: LeMaitre Vascular, Inc. is a provider of medical devices for the treatment of peripheral vascular disease. The Company develops, manufactures and markets medical devices and implants used primarily in the field of vascular surgery. It is engaged in the design, marketing, sales and technical support of medical devices and implants for the treatment of peripheral vascular disease industry segment. The Company's product lines include valvulotomes, balloon catheters, carotid shunts, biologic vascular patches, radiopaque marking tape, anastomotic clips, remote endarterectomy devices, laparoscopic cholecystectomy devices, prosthetic vascular grafts, biologic vascular grafts and powered phlebectomy devices. Its portfolio of peripheral vascular devices consists of brand name products that are used in arteries and veins outside of the heart, including the Expandable LeMaitre Valvulotome, the Pruitt F3 Carotid Shunt, VascuTape Radiopaque Tape and the XenoSure biologic patch.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

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INMODE LTD (INMD) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 79% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: Inmode Ltd is an Israel-based company. It designs, develops, manufactures and commercializes energy-based, minimally-invasive surgical aesthetic and medical treatment solutions. The Company's proprietary technologies are used by physicians to remodel subdermal adipose, or fatty, tissue in a variety of procedures including fat reduction with simultaneous skin tightening, face and body contouring and ablative skin rejuvenation treatments. Its products target a wide array of procedures including simultaneous fat killing and skin tightening, permanent hair reduction, skin appearance and texture, among others. The Company's products may be used on a variety of body parts, including the face, neck, abdomen, upper arms, thighs and intimate feminine regions. It owns six product platforms: BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF. All are market and sell traditionally to plastic and facial surgeons, aesthetic surgeons and dermatologists, among others.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

For a full detailed analysis using NASDAQ's Guru Analysis tool, click here

BIOLIFE SOLUTIONS INC (BLFS) is a small-cap growth stock in the Medical Equipment & Supplies industry. The rating according to our strategy based on Motley Fool is 76% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: BioLife Solutions, Inc. (BioLife) is engaged in the developing, manufacturing and marketing a portfolio of biopreservation tools and services for cells, tissues and organs, including clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management application for shippers. The Company's product offerings include hypothermic storage and cryopreservation freeze media products for cells, tissues, and organs; generic blood stem cell freezing and cell thawing media products; custom product formulation and custom packaging services; cold chain logistics services incorporating precision thermal packaging products and cloud-hosted Web applications, and contract aseptic manufacturing formulation, fill and finish services of liquid media products. Its products include HypoThermosol FRS, CryoStor, BloodStor, Cell Thawing Media, PrepaStor and biologistex cold-chain management service.

The following table summarizes whether the stock meets each of this strategy's tests. Not all criteria in the below table receive equal weighting or are independent, but the table provides a brief overview of the strong and weak points of the security in the context of the strategy's criteria.

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MEDPACE HOLDINGS INC (MEDP) is a mid-cap growth stock in the Biotechnology & Drugs industry. The rating according to our strategy based on Motley Fool is 76% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

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Validea's Top Five Healthcare Stocks Based On Motley Fool - 1/19/2020 - Nasdaq

Stem Cell Therapy Market Insights 2019, is a professional and in-depth study on the current state of the global Stem Cell Therapy industry with a focus on the Global market. The report provides key statistics on the market status of the Stem Cell Therapy manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. Overall, the report provides an in-depth insight of 2019-2025 global Stem Cell Therapy market covering all important parameters.

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The key points of the Stem Cell Therapy Market report:

The report provides a basic overview of the Stem Cell Therapy industry including its definition, applications and manufacturing technology.

The report explores the international and Chinese major industry players in detail. In this part, the report presents the company profile, product specifications, capacity, production value, and 2019-2025 market shares for each company.

Through the statistical analysis, the report depicts the global total market of Stem Cell Therapy industry including capacity, production, production value, cost/profit, supply/demand and Chinese import/export.

The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.

The report then estimates 2019-2025 market development trends of Stem Cell Therapy industry. Analysis of upstream raw materials, downstream demand, and current market dynamics is also carried out.

The report makes some important proposals for a new project of Stem Cell Therapy Industry before evaluating its feasibility.

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There are 3 key segments covered in this report: competitor segment, product type segment, end use/application segment.

For competitor segment, the report includes global key players of Stem Cell Therapy are included:

Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Reasons to Purchase this Report:

* Estimates 2019-2025 Stem Cell Therapy market development trends with the recent trends and SWOT analysis

* Market dynamics scenario, along with growth opportunities of the market in the years to come

* Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects

* Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.

* Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years

* Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

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Stem Cell Therapy Market is Anticipated to Attain a Market Value of US$XX by the End of 2017 2025 - Fusion Science Academy

In a recent study published by MRInsights.biz, titled, Global Fish Skinning Machine Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2024, analysts offer a comprehensive overview of the industry for the forecast period 20192024.The report is based on complete research of the entire market, covering all its sub-segments through comprehensively thorough classifications. The report comprises of an in-depth investigation into the geographical landscape, industry size, demand, market share, technological advancements, regional gamut, and revenue estimations for the forecast duration. Further, it sheds light on the challenges impeding market growth and expansion strategies employed by leading companies in the market.

The Report At A Glance:

The report offers profound knowledge and extensive examination of the trends from the yesteryear and future. It provides the stakeholders, product owners, and marketing personnel a competitive edge in the market for the forecast period, 2019-2024. It focuses on economic developments and consumer spending trends across different countries. The report makes projections on which countries and regions will have a better standing in the years to come. The research study takes a closer look at the key driving forces, restraints, and opportunities responsible for determining the future of the market for the forecast period 2019-2024.

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Firstly, the report aims to find out why customers need a certain product or service. The report looks at what problems a certain product and service can solve. The industry experts focus on the factors including audience type, target demographics, as well as other vital attributes about the target customer segment.

Global Fish Skinning Machine market competition by top manufacturers, with production, price, revenue (value) and each manufacturer including VMK Fish Machinery, , Uni-Food Technic, , Trio Machinery, , Baader, , NOCK Maschinenbau, , Cabinplant, , Maja-Maschinenfabrik Hermann Schill, , AGK Kronawitter, , Grupo Josmar, , Varlet,

On the basis of product, this report displays the production, revenue, price, market share, and growth rate of each type, primarily split into Automatic Fish Skinning Machine, Manual Fish Skinning Machine

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including: Canned, Seafood Processing, Frozen Food, Other

This report studies the top producers and consumers, focuses on product capacity, production, value, consumption, market share and growth opportunity in these key regions, covering: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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Autologous Stem Cell Based Therapies Market Report Analysis, Share, Revenue, Growth Rate With Forecast Overview To 2024 - Fusion Science Academy

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

To know Untapped Opportunities in the MarketCLICK HERE NOW

One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Request TOC of the Reportfor more Industry Insights @CLICK HERE NOW

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

About TMR Research:

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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This post was originally published on Food and Beverage Herald

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Stem Cell Therapy Market Detailed Analysis and Forecast 2017-2025 - Food & Beverage Herald

As humans continue to pump more and more carbon dioxide into the atmosphere, concerns about global warming and climate change continue to grow. But what if that CO2 could be turned into a source of energy? One startup in Kyoto has developed cutting-edge nano-materials that could trap atmospheric CO2 and harness it as a power source. Its one way that Japans ancient capital is harnessing its large scientific and biomedical potential to address environmental and social problems.

Panning for invisible gold

Porous coordination polymers can be a form of carbon-capture technology, says discoverer Susumu Kitagawa, second from left, with (left to right) Atomis CTO Masakazu Higuchi, CEO Daisuke Asari, R&D officer Kenji Sumida, and COO Dai Kataoka.

Atomis is a new materials company that was spun off from Kyoto University Institute for Integrated Cell-Material Sciences (iCeMS). Founded in 2015 following government-supported research, its business is based on studies led by Susumu Kitagawa, a professor and the director of iCeMS.

Its core technology is the production of materials comprising extremely small void spaces that can trap gases, including CO2. A breakthrough discovery in 1997 by Kitagawa, who has been considered a contender for the Nobel Prize in Chemistry, these porous coordination polymers (PCPs, aka metal-organic frameworks) have enormous potential as tools to precisely control gases.

Humans have used the principle behind PCPs for thousands of years. They work the same way that a hunk of charcoal traps ambient odor molecules in its large surface area, but PCPs are many times more powerful. To the naked eye, PCPs look like powders, pellets or granules of various colors, shapes and sizes. But if you were to zoom in, you would see that PCPs are sponge-like materials with pores the size of a nanometer, or one billionth of a meter. They can be designed as scaffoldlike 3D structures from metals and organic ligands, and can be used for storage, separation and conversion of molecules.

These materials are unique in that we can design the shapes and chemical properties of the pores to suit specific applications, and some of the materials have flexible structures, which can potentially provide them with even more advanced features, says Daisuke Asari, president and CEO of Atomis. The company is basically the only business in Japan working with these materials in an industrial context. Collaborating with Kitagawa is a big advantage over foreign rivals, adds Kenji Sumida, executive officer for R&D.

One challenge related to these nanomaterials is that its difficult and costly to produce more than a few kilograms per day. Massively scaling production so that PCPs can be used to fight climate change is one reason that Atomis was founded, says Atomis founder and CTO Masakazu Higuchi, one of Kitagawas collaborators. The firm is developing solid-state techniques and making capital investments to increase PCP production capacity. Meanwhile, Atomis has developed products that harness the groundbreaking potential of PCPs, including Cubitan, a compact and lightweight gas cylinder for industrial and consumer use packed with smart features, such as the ability to notify users when the amount of reserve gas becomes low.

When viewed without special equipment, PCPs look like powders, pellets or granules of various colors, shapes and sizes, but they are sponge-like materials with countless pores the size of a nanometer.

Kitagawa has his sights on the bigger picture. He believes PCPs can be used as a form of carbon-capture technology, allowing the synthesis of methanol, an energy source. Thats why he calls CO2 invisible gold.

In ancient China, Taoist mystics were said to live in the mountains and survive simply on mist, which consists of water, oxygen and CO2, says Kitagawa. They were taking something valueless and using it for energy. Similarly, PCPs can control gases that humans cannot use and turn them into something beneficial, for instance absorbing CO2 in the air and turning into methanol and other hydrocarbon materials.

Building a regenerative medicine Silicon Valley

Atomis is one of many science startups in Kyoto that have benefitted from collaborative research between industry and government. Its part of a growing startup industry in Japan, where total funding for new companies reached a record high of 388 billion yen in 2018, up from 64.5 billion yen in 2012, according to Japan Venture Research. One driver for this expansion is science and technology discoveries.

While it may be known for its traditional culture, Kyoto has a strong pedigree in scientific research. It is home to 38 universities and about 150,000 students, which form a large pool of institutional knowledge, experience and talent. Many recent Nobel laureates either graduated from or taught at Kyoto University, including professors Tasuku Honjo and Shinya Yamanaka, who won the Nobel Prize for Physiology or Medicine in 2018 and 2012, respectively. Working on discoveries by Yamanaka, Megakaryon has become a world leader in creating artificial blood platelets made from synthetic stem cells.Theres also a large group of high-tech companies that have carved out niches for themselves internationally.

Kyoto is a unique city in that it has an independent spirit that is similar to the U.S. West Coast, says Eiichi Yamaguchi, a professor at Kyoto University who has founded four companies.

Kyoto companies like Murata Manufacturing, Horiba, Shimadzu, and Kyocera have a global market and theyre competing with China, says Eiichi Yamaguchi, a professor at Kyoto University who has founded four companies. Thats the difference with companies in Tokyo, which are more domestically oriented.

Yamaguchi has authored several books on innovation, and says there is a growing awareness of the importance of collaborative research and entrepreneurship in Kyoto. He cites a recently formed cooperative group of seven university chairpersons and presidents from leading materials and biosciences companies that meets to discuss issues such as fostering new technologies, for instance building high-speed hydrogen fueling systems.

Kyoto is a unique city in that it has an independent spirit that is similar to the U.S. West Coast, says Yamaguchi. Kyoto is only a fraction of the size of Tokyo, but if you take a stand here, people will pay attention.

Another group that is promoting local high-tech business is Innovation Hub Kyoto. Its an open innovation facility based in the Kyoto University Graduate School of Medicine aimed at commercializing research from the university. Steps away from Kyotos historic Kamo River, its geared to researchers, investors, startups, and established companies working in the field of medical innovation including device development and drug discovery. This is where Japanese researchers are trying to build a Silicon Valley of regenerative medicine.

Tenants at Innovation Hub Kyoto can use this wet lab for research.

Part of the Kyoto University Medical Science and Business Liaison Organization, the hub was established about 15 years ago and opened a new building in 2017 with the support of the Ministry of Education, Culture, Sports, Science and Technology. The structure has a variety of labs, including ones meeting biosafety level P2 and for animal experiments.

Its tough for startups in Japan to access to animal laboratories like the one we have, says hub leader Yutaka Teranishi, a professor in the Graduate School of Medicine who estimates that some 50% of university researchers want to work with industry, up from 10% a few years ago. Were focused on university startups because its very difficult for them to develop drugs from just an alliance between companies and universities.

About 28 companies are tenants at Innovation Hub Kyoto. They include major brands such as Shimadzu and Nippon Boehringer Ingelheim as well as younger businesses. One is AFI, founded in 2013 and focused on fluid, electric filtering and sorting (FES) technology that can be used for applications ranging from food safety inspections to rapid diagnosis of disease to regenerative medicine.

Tomoko Bylund heads the Japan office of CELLINK, a Swedish bioprinting and bioink company that is a tenant at Innovation Hub Kyoto.

Another tenant is CELLINK, a Swedish bioprinting and bioink company headed in the Japan by Tomoko Bylund. Using its products, researchers can print body parts with human cells for drug and cosmetics testing. In 2019, the first 3D print of a human cornea in the U.S. was accomplished with the companys BIO X Bioprinter.

iHeart Japan is also a tenant. It was established in 2013 as a regenerative medicine business and is aiming to address a major shortage in the Japanese medical system: only about 40 out of 200,000 people on national waiting lists can receive donor hearts every year. The company is developing innovative medical products such as multi-layered cardiac cell sheets derived from synthetic stem cells. The Hub basis its success in fostering companies on its diversity and the business environment in Kyoto.

We have people from different backgrounds here who are exchanging cultures and experimental results, and this diversity is powering innovation here, says Teranishi. There are many traditional industries in Kyoto, and though people say its a conservative city, these companies have survived because theyre open to new technologies and have taken the time to choose which ones can help them. Thats how this city and its businesses have lasted for more than 1,000 years.

Diversity is powering innovation here, says Yutaka Teranishi, center, head of Innovation Hub Kyoto, with Kyoto University professor Hirokazu Yamamoto, left, and Graduate School of Medicine lecturer Taro Yamaguchi, right.

To learn more about Atomis, click here.

To learn more about Innovation Hub Kyoto, click here.

Link:
How Kyoto Is Rebuilding Itself As A Nanotech And Regenerative Medicine Powerhouse - Forbes

LOS ANGELES (PRWEB) January 09, 2020

DOXYVA is a validated circulatory and nerve stimulant. The system was used by Prof. Puruhito for CO transdermal delivery, which has been shown to produce higher oxygen unloading by hemoglobin, thereby increasing oxygen-rich blood flow in the local microcirculatory system. This improved dermal microcirculation leads, in turn, to enhanced wound healing.

The American Diabetes Association standards of care for DFUs refer to microvascular complications and their treatment via improvements in microcirculation; therefore, Prof. Puruhitos team set out to test CO transdermal delivery via DOXYVA in their patients. They have been gathering data since 2015, which led to the following results.

During the course of a 5-day treatment, O saturation increased in patients treated with transdermal CO in comparison to controls (15 patients/group) over the whole measurement range (up to 120 minutes post application). Moreover, a consistent heart rate decrease was found in patients undergoing transdermal CO treatment. Furthermore, the perfusion index (PI) showed an upwards tendency in the treatment group, whereas it remained stable for untreated controls. See figure 1.

Figure 1: Changes observed after a 5-day transdermal CO treatment with DOXYVA. H1-H5: pre-treatment, 10, 30, 60, 90, and 120 minutes after; blue trace: control, orange trace: treatment. (A) Changes in O saturation (B) Decrease in heart rate due to treatment (C) Masimo measurements of PI.

In light of these results, Prof. Puruhitos team performed extra measurements of transcutaneous carbon dioxide (TcPCO), O saturation, and PI in the 15 patients treated with DOXYVA for transdermal CO delivery. This data show that the oxygen saturation reached almost 100% in some patients, whereas the TcPCO remained relatively stable throughout the treatment time (120 minutes). For more detailed information, see figure 2.

Figure 2: Transcutaneous CO pressure (TcPCO), O saturation, and PI assessment in the 15 patients subjected to transdermal CO. (A) SENTEC TcPCO measurements for all patients at various time points after DOXYVA application (pre-treatment, 5, 60, 90, and 120 minutes after) (B) O saturation (C) PI.

Finally, Prof. Puruhitos team demonstrated the positive effects of transdermal CO delivery via DOXYVA on the healing of DFUs (fig. 3), proving the clinical potential of this intervention to improve the quality of life of people suffering from this common complication of diabetes.

In conclusion, the use of a DOXYVA device for transdermal CO delivery improves the outcomes of DFUs by enhancing dermal microcirculation and increasing perfusion rates and tissue oxygenation, therefore assisting in the healing process of the ulcers typical of diabetes neuropathy.

About DOXYVADOXYVA (deoxyhemoglobin vasodilator) is a novel, clinically validated blood flow and nerve stimulant for people suffering from neuropathy. In various clinical trials, DOXYVA has validated leading independent research results and demonstrated above-average results in improving a host of physiological functions.

Subjects suffering from high blood sugar have reported neuropathy pain relief minutes after DOXYVA was administered and long-term blood sugar level improvements after just a few weeks.

Rapid and gentle skin delivery (over-the-skin) with the DOXYVA lightweight, handheld device has prompted improvements in blood microcirculation or PI by 33%* on average in all participants. Lasting results have been measured at 5-60 minutes and up to 4 hours after a single 5-minute DOXYVA delivery on the skin surface without reduction in PI levels.

About Prof. PuruhitoIto Puruhito, MD is professor in the Department of Thoracic and Cardiovascular Surgery at Dr. Soetomo General Hospital as well as a senior lecturer in the Faculty of Medicine at Universitas Airlangga (Indonesia). From 2001 to 2016, he was the rector of the aforementioned university. Prof. Puruhito finished his medicine studies at Universitas Airlangga in 1967, and in 1972 he received a doctorate degree, graduating cum laude from Frederich-Alexander University (Erlangen-Nrnberg, Germany). In his native country, he developed the Department of Thoracic-Cardiovascular Surgery at his former university, Universitas Airlangga, Surabaya. In 1978, he co-founded the Indonesian Association of Thoracic, Cardiac and Vascular Surgery. Prof. Puruhito has authored numerous indexed research articles in Scopus, ISI-Thompson or PUBMED, and scientific presentations and written several books in Indonesian, English, and German. He acted as reviewer for peer-reviewed journals such as Medical Tribune, Annals of Thoracic and Cardiovascular Surgery, Asian Annals of Surgery, Medicinus, and many more Indonesian medical-surgical journals. Currently, apart from lecturing, Prof. Puruhito actively researches stem cells, cardiovascular medicine, and surgery at the Institute of Tropical Disease as well as some work in microcirculation. Further, he acts as coordinator of research affairs at the Department of TCV-Surgery at Dr. Soetomo General Hospital Surabaya. Since 2014, he has been the chairman of the Council of Research in the Ministry of Research Technology and Higher Education of the Republic of Indonesia.

About Circularity Healthcare, LLCCircularity Healthcare, LLC, located in Los Angeles, CA, is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes, and licenses its patented and patent-pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, DOXYVA. One of the main mechanisms underlying DOXYVAs science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products in large and small clinics and hospitals to help enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital, and patient financing at industry-leading terms and speed.

For more information, please visit http://www.circularityhealthcare.com or http://doxyva.com; doctors (Rx only) visit http://wound.doxyva.com and send your general inquiries via the Contact Us page. For specific inquiries, contact Circularity Customer Care at info(at)doxyva(dot)com, info(at)circularityhealthcare(dot)com, or by phone (toll free) at 1-855-5DOXYVA or 1-626-240-0956.

References:

1.Rogers, L. C., Muller-Delp, J. M. & Mudde, T. A. Transdermal delivery of carbon dioxide boosts microcirculation in subjects with and without diabetes, Information summary for healthcare professionals. Circularity Healthcare, LLC2.Puruhito, I. et al. DOXYVA Medical Device, a Potentially Cost-Efficient and Safe Adjuvant Therapy for Diabetic Ulcers: A Pilot Study. J Vasc Surg (2019).3.Puruhito, I., Soebroto, H., Sembiring, Y. & Nur Rahmi, C. Observation of O2 Saturation after transdermal CO2 delivery using Doxyva apparatus.4.Jayarasti, K. & Puruhito, I. Preliminary study of measurement of TcPCO2 using SENTEC device.5.Nur Rahmi, C. Pengaruh Pemberian Transdermal CO2 terhadap Output Perawatan Luka Kaki Diabetik Wagner I dan II. (2018).6.D`OXYVA Relief from neuropathic pain. D`OXYVA https://doxyva.com/complete-fast-advanced-painless-relief-from-neuropathic-pain/.

Forward-Looking InformationThis press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to managements expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

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D'OXYVA improves dermal microcirculation and promotes wound healing in the diabetic foot - PR Web

This weeks Cardio Round-up features a look back at what you may have missed during the holidays, as well as some of the big 2019 cardiology stories.

The past year saw some big stories like the Apple Heart study, presented at ACC.19, which essentially validated the ability of a wearable device (an Apple iWatch) equipped with a tachogram-tracking algorithm was able to detect pulse irregularities associated with atrial fibrillation. Icosapent ethyl also featured prominently, gaining an FDA approval for the reduction of cardiovascular disease risk as an add-on to statin therapy in high-risk patients with hypertriglyceridemia. Dapagliflozin (highlighted in the DAPA-HF study) also was shown to be an effective treatment for heart failure in both diabetic and non-diabetic patients.

2019 In Cardiology: Apple Heart Study Lands; Icosapent Ethyl Gets FDA Nod for New Indication; Dapagliflozin For Nondiabetics; and More

A new observational study published inEuropacesuggests it is possible to monitor and predict individual progression ofatrial fibrillation (AFib) using pacemakers or defibrillators.We aimed to study the progression of AER in individual patients with implantable devices and AFib episodes, the paper authors wrote. The study results indicated that the slope of AAR changes during the progression of AFib showed patient-specific patterns correlating with the time-to-completion of AER (R2 = 0.85). This technology opens up enormous possibilities in personalized medicine for AFib patients because it allows us to determine the progression rate of the arrhythmia in each individual and to optimize the timing of medical intervention with current treatment options, one of the researchers said in a press release.

Personalized Medicine for AFib: How Electric Activity in the Heart Can Predict Individual Progression of Atrial Fibrillation

A research team, publishing the study in the Journal of Molecular and Cellular Cardiology, worked on converting adipogenic mesenchymal stem cells, which reside within fat cells, into cardiac progenitor cells. The ensuing cardiac progenitor cells can be programmed to aid heartbeats as a sinoatrial node (SAN), which is part of the electrical cardiac conduction system.We are reprogramming the cardiac progenitor cell and guiding it to become a conducting cell of the heart to conduct electrical current, said study co-author Bradley McConnell, associate professor of pharmacology, in a press release. Results of this study show that the SHT5 combination of transcription factors can reprogram CPCs into Pacemaker-like cells.

The Next Generation of Biologic Pacemakers? New Discovery in Stem Cells from Fat Creates Another Alternative Treatment

Diabetes mellitus is an independent predictor for heart failure, according to the findings of a study published inMayo Clinic Proceedings. In this study, using the Rochester Epidemiology Project, researchers assessed the long-term impact ofdiabeteson the development of heart failure by including 116 study subjects with diabetes, who were matched 1:2 based on age, hypertension, sex, coronary artery disease and diastolic with 232 participants without diabetes. The results showed that that diabetes is an independent risk factor for the development of heart failure. Over the duration of 10 years, 21% of participants with diabetes developed heart failure, independent of other causes. The researchers observed that by comparison, only 12% of patients without diabetes developed heart failure. The key takeaway is that diabetes mellitus alone is an independent risk factor for the development of heart failure, wrote one of the authors.

Diabetes is an Independent Predictor for Heart Failure

A new study suggests that regularly getting a good nights sleep isnt just a helpful overall health recommendation but is also an essential way to keep risk for heart disease and stroke down. The paper, published in theEuropean Journal of Cardiology, included more than 300,000 participants initially free of cardiovascular disease (CVD) from UK Biobank. According to the results, there were 7,280 documented cases of incident CVD (4,667 coronary heart disease and 2,650 stroke) cases. Participants with a sleep score of 5 had a 35% reduced risk for CVD, a 34% reduced risk for coronary heart disease, and a 34% reduced risk for stroke when compared to participants with a score of 0-1.As with other findings from observational studies, our results indicate an association, not a causal relation, one of the authors said in a press release. However, these findings may motivate other investigations and, at least, suggest that it is essential to consider overall sleep behaviors when considering a persons risk of heart disease or stroke.

Getting Quality Sleep, and the Right Amount, Can Offset Genetic Susceptibility for Heart Disease and Stroke Risk

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Cardio Round-up: Look Back at 2019, The Importance of Sleep, and More - DocWire News

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues and tumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successful stem cell therapy treatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market Expected to Witness a Sustainable Growth over 2025 - Filmi Baba

Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases.

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Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market. Some of the major companies operating in the global cardiac rhythm management market are

Other companies with significant presence in the global cardiac rhythm management market include

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Key geographies evaluated in this report are:

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Cardiac Rhythm Management Market Development, Key Opportunity and Analysis of Leading Players to 2015 To 2021 - Info Street Wire

Stem Cells Market AnalysisAccording to Market Research, the Global Stem Cells Market was valued at USD 5.88 Billion in 2018 and is expected to witness a growth of 10.32% from 2019-2026 and reach USD 12.96 Billion by 2026.

What is Stem Cells Market?Stem cellscan be defined as unspecialized cells that develop into the specialized cells and make up different types of tissue in the human body. Since stem cells are unspecialized type of cells and are capable of renewing themselves through cell division. Stem cells can be Pluripotent as well as Multipotent.

Pluripotent stem cells are stem cells usually found in embryos which give rise to all the cells found in the human body, while multipotent stem cells, which are found in adults or in babies umbilical cords, have a more restricted ability. Their development is limited to cells that form the organ system that they are originated from. When a stem cell undergoes division, each new cell possess a potential either to remain a stem cell or develop into another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

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Stem Cells Market OutlookStem cell research is considered as one of the most intriguing areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells stimulates scientific queries as rapidly as it produces new discoveries. Until recently, scientists used to primarily work with two types of stem cells from animals and humans: embryonic stem cells and non-embryonic somatic or adult stem cells.

Since the advent of stem cells, one of the crucial benefits of stem cell research is the accessibility of cell lines and that they can be acquired ethically. The demands for pluripotent stem cells are increasing owing to the fact that it differentiates in various cell types in the human body. Pluripotent stem cells tend to have various applications in the medical treatment. Growing awareness regarding the stem cells and establishment of stem cell banks is expected to fuel the market growth rate.

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Ethical issues related to pluripotent stem cells could hamper the growth of stems cells in the global market as research with these cells require disrupting an artificially-fertilized embryo at the 5-14 day stage. Another factor which is limiting the growth of stem cells market is unknown long-term consequences.

Global Stem Cells Market SegmentationThe Global Stem Cells Market is classified on the basis of Product, Treatment Type, Therapeutic Application and Region. The gist of breaking down the market into various segments is to gather the information about various aspects of the market.

On the basis of Products, the market is bifurcated on the basis of Adult Stem Cells, Human Embryonic Cells, and Induced Pluripotent Stem Cell. Adult stem cells accounts for a major share in the global stem cells market. Even though embryonic stem cells have a wide range of applications, the market growth rate for this sub-segment is substantial owing to the ethical issues faced by this sub-segment in the global market.

In terms of Therapeutic Application, the market study encompasses various aspects such ca Regenerative Medicine, Neurological Disorders, Orthopedic Treatments, Oncology Disorders, Diabetes, Injuries & Wounds and Cardiovascular Disorders. Growing awareness regarding regenerative medicine is expected to make this sub-segment hold a potential market share globally. Growing healthcare expenditure and presence of major industry players makes North America hold major share in the global market.

Stem Cells Market Competitive LandscapeThe Stem Cells Market study report offers a valuable insight with an emphasis on global market including some of the major players such asBioTime Inc., Cytori Therapeutics, Inc., STEMCELL Technologies Inc., Astellas Pharma Inc., U.S. Stem Cell, Inc., Osiris Therapeutics, Inc., Takara Bio Inc., Caladrius Biosciences, Inc., Cellular Engineering Technologies Inc., and BrainStorm Cell Therapeutics Inc. Our market analysis also entails a section solely dedicated for such major players wherein our analysts provide an insight to the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share and market ranking analysis of the above mentioned players globally.

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Stem Cells MarketCar Rental MarketThermoelectric Modules MarketCar Audio MarketQuantum Computing MarketInternet of Things (IoT) MarketIndustrial Cybersecurity Market

Analyst View:As per our sources following trends were observed in terms of most popular sources of stem cells:

Stem cells from adult bone marrow were observed to be the most popular source. Scope of stem cell therapy is increasing with growing number of applications. Clinical research has advanced to a great magnitude towards preventing, identifying and handling devastating diseases. Various applications of stem cells in regeneration such as Cardiac Regeneration, Hepatic Regeneration, Regeneration of Neural Tissue, etc. have come up lately. This suggests that the market for stem cells will grow significantly over the forecast period.

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A research team from the University of Houston has found a way to use the stem cells found in fat and guide it to become a pacemaker-like cell, according to a new study.

We are reprogramming the cardiac progenitor cell and guiding it to become a conducting cell of the heart to conduct electrical current, said study co-author Bradley McConnell, associate professor of pharmacology, in a press release

The team, publishing the study in the Journal of Molecular and Cellular Cardiology, worked on converting adipogenic mesenchymal stem cells, which reside within fat cells, into cardia progenitor cells. The ensuing cardiac progenitor cells can be programmed to aid heartbeats as a sinoatrial node (SAN), which is part of the electrical cardiac conduction system.

The researchers used what they called a standard screening strategy to test for reprogramming factors for converting human cardiac progenitor cells into pacemaker-like cells. According to their study results, the authors observed expressions of many pacemaker-specific genes, including CX30.2, KCNN4, HCN4, HCN3, HCN1, and SCN3b. The authors wrote that SHOX2, HCN2, and TBX5 (SHT5) combinations of transcription factors were much better candidate(s) in driving cardiac progenitor cells into pacemaker-like cells than other combinations and single transcription factors.

Results of this study show that the SHT5 combination of transcription factors can reprogram CPCs into Pacemaker-like cells, they wrote in their conclusion. SHT5 may be used as a potential stem cell therapy for sick sinus syndrome (SSS) and for other cardiac conduction diseases.

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The Next Generation of Biologic Pacemakers? New Discovery in Stem Cells from Fat Creates Another Alternative Treatment - DocWire News

University of Houston's C.T. Bauer College of Business has received its second largest donation to benefit its entrepreneurship program.

The Cyvia and Melvyn Wolff Center for Entrepreneurship, which was recently ranked the top undergraduate entrepreneurship program in the country, received the $13 million gift from its namesake foundation The Cyvia and Melvyn Wolff Family Foundation and the state of Texas is expected to match an additional $2 million, bringing the total impact to $15 million.

"Our family is deeply committed to the ideals of entrepreneurship," says Cyvia Wolff in a news release. "Our business personified everything that it means to be an entrepreneur. The skills, the thinking, the mindset are fundamental to success for business leaders today and in the future. On behalf of my late husband, we are truly honored to ensure the entrepreneurial legacy not only endures but remains accessible for students. We are truly honored to be part of this program and university."

The money will be used to create three endowments for the program. The Dave Cook Leadership Endowment, named for the center's director, Dave Cook, will be created and funded with $7 million of the donation to support leadership within the organization. For $4 million, the center will create the Wolff Legacy Endowment, which aims to increase students involved in the center, as well as the companies coming out of the program. The last $2 million will be used to create the Cyvia and Melvyn Wolff Endowed Chair(s)/Professorship(s) in Entrepreneurship. This initiative will support research and community outreach.

"We are passionate about entrepreneurship and how it can forever change students' lives," says Bauer Dean Paul A. Pavlou in the release. "We seek to further promote entrepreneurship as a university-wide, even citywide effort, by collaborating within and across the university in a multitude of areas, such as technology, health care, arts and sports."

The program was created in the mid '90s and was later renamed after Cyvia and Melvyn Wolff in 2007, and has seen great success over the past decade. In that time, Wolff students have created 1,270 businesses, with identified funding of just over $268 million. According to the release, the program has been ranked in the top two spots of the Princeton Review's top undergraduate entrepreneurship programs for nine of the past 12 years.

"Entrepreneurship is crucial for the future of our country, as well as our city and state," says UH President Renu Khator in the release. "We are proud to be at the forefront of work around entrepreneurial training and research. The uniqueness of our program has and continues to make it the model program. This extraordinary gift ensures our leadership in this space will continue and will support the creation of businesses, change communities and impact our students' lives."

At UH, 2,500 students take at least one entrepreneurship course a year, and more than 700 students complete certificate programs.

"What we are doing is transformative in the lives of students, mentors and stakeholders in a way that elevates everyone towards excellence," Cook, who was named the director of the program in 2017, says in the release. "The impact of this gift allows us to remain the leader and to move forward with confidence, purpose and permanence."

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3 innovative research projects coming out of the University of Houston - InnovationMap

The report covers the forecast and analysis of the gene therapy market on a global and regional level. The study provides historical data from 2015 to 2018 along with a forecast from 2019 to 2027 based on revenue (USD Million). The study includes drivers and restraints of the gene therapy market along with the impact they have on the demand over the forecast period. Additionally, the report includes the study of opportunities available in the gene therapy market on a global level.

In order to give the users of this report a comprehensive view of the gene therapy market, we have included a competitive landscape and an analysis of Porters Five Forces model for the market. The study encompasses a market attractiveness analysis, wherein all the segments are bench marked based on their market size, growth rate, and general attractiveness.

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The report provides company market share analysis to give a broader overview of the key players in the market. In addition, the report also covers key strategic developments of the market including acquisitions & mergers, new service launches, agreements, partnerships, collaborations & joint ventures, research & development, and regional expansion of major participants involved in the market on a global and regional basis.

The study provides a decisive view of the gene therapy market by segmenting the market based on the type, vector type, therapy area, and regions. All the segments have been analyzed based on present and future trends and the market is estimated from 2019 to 2027. The regional segmentation includes the current and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

Gene therapy is utilized for treating neurodegenerative disorders like Alzheimer, amyotrophic lateral sclerosis, and spinal muscular atrophy. Gene therapy is one of the key treatment kinds that will propel the market growth over the forecast period. Moreover, gene therapy also finds lucrative applications in precision medicine. In addition to this, a rise in the occurrence of cancer is prompting the demand to treat the disease through gene therapy.

Based on the type, the market can be segregated into Germ Line Gene Therapy and Somatic Gene Therapy. In terms of vector type, the gene therapy industry can be divided into Viral Vectors, Non-Viral Vectors, and Human Artificial Chromosome. On the basis of therapy area, the market for gene therapy can be classified into Cancer, Neurological Diseases, Infectious Diseases, Genetic Disorders, Rheumatoid Arthritis, and Others.

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The key players included in this market are Advanced Cell & Gene Therapy, Audentes Therapeutics, Benitec Biopharma, Biogen, Blubird Bio, Inc., Bristol-Myers Squibb Company, CHIESI Farmaceutici SPA, Eurofins Scientific, Geneta Science, Genzyme Corporation, Gilead, GlaxoSmithKline PLC, Human Stem Cells institute, Novartis AG, Orchard Therapeutics, Pfizer Inc., Sangamo therapeutics, Spark therapeutics, and Voyager Therapeutics.

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market,By Applications (Eurodegenerative Disorders, Autoimmune Diseases, Cancer & Tumors, Cardiovascular Diseases), By Product (Blood Pressure (BP) Monitoring Devices, Pulmonary Pressure Monitoring Devices, Intracranial Pressure (ICP) Monitoring Devices), By End User (Hospitals And Ambulatory Surgical Center), By Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2025

The Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market is expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

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In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease. According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

Major Market Drivers and Restraints:

Introduction of novel autologous stem cell based therapies in regenerative medicine

Reduction in transplant associated risks

Prevalence of cancer and diabetes in all age groups

High cost of autologous cellular therapies

Lack of skilled professionals

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The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

Some of the major players operating in the global autologous stem cell and non-stem cell based therapies market are Antria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analysed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more pleaseRequest an Analyst Callor can drop down your inquiry.

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market Industry Trends and Forecast to 2025 - News Distribute

Dec 23, 2019 05:03 AM EST

Origami's new role in the field of science and technology has definitely taken a turn for the better in the recent decade. Better known as origami engineering, the practice is used to reduce structures or maximize space and function.

Origami engineering has made great strides in the medical field in particular. The same principles used in origami, when applied to medical devices, allows implants to be folded to minuscule sizes and then unfolded to its actual size. The reverse is also applicable, where like toothpaste tubes, can be fully de-compressed.

Folding techniques could transform flat objects with wrinkles to increase resilience, shock-absorbance, strength, or rigidity. Origami provides a unique insight into how single pieces could sustainably be packaged without cutting, welding, or riveting, allowing for cheaper manufacturing costs and easier assembly.

The utility of origami engineering has captured the attention of people such as Rebecca Taylor, assistant professor at Carnegie Mellon University's Department of Mechanical Engineering. Taylor specializes in microfabrication and biomechanics, a study that has helped her fabricate microscale sensors to reliably assess cardiomyocytes derived from stem cells. A natural inclination to similar practice, Dr. Taylor has developed an origami-based DNA synthetic cardiac contractile protein, which allowed her to observe merging mechanics in multiprotein, acto-myosinc contractile systems.

As a professor, Taylor expands on the utilization of DNA origami in medicine. This technique (also referred to by Dr. Taylor as "bottom-up manufacturing"), allows improvement in nanomanufacturing and nanomechanics of multiprotein systems, paving the way for heart stents that could unfold in a very precise location.

The problem, however, is on how to deploy these structures in a 100% fault-free way. To illustrate this, a common problem that impedes the creation of pop-up tents that could self-assemble at the press of the button is when the folds of the tent get stuck during the folding process on occasion.

Understandably, this raises some concern among those who are keen to use self-folding nanomachines in medicine.

So this is where origami comes in.

According to University of Chicago scientists, the limits of self-folding structures could be intrinsic in that so-called "sticking points" seem to be unavoidable.

Previously thought possible to engineer around, the researchers observed the capacity of foldable structures by creating mathematical models. During the experiment, the team had designed structures capable of self-folding, such as paper origami and nanobots, and creating creases in them beforehand. The result was that when more pre-creases were added to the folds, the more branches in the next folding process could form and the more likely the self-folding mechanism is to get stuck.

Origami engineering is a relatively new innovation. Its application is vast and can be of use to not only technology but to medicine as well. The development of the field itself, then, needs to pick up at a faster pace in order to cater to the intelligent design of foldable structures and materials. But while there are creases in the field that needs to be smoothed out, the greater promise of origami engineering has brought about several research papers in its wake.

RELATED ARTICLE: Swallowed a Battery? Ingestible Origami Robot Made from Pig Gut Can Remove It,Stop Stomach Bleeding

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The Art of Origami is Now A Key Tool That Helps Doctors Save Lives - Nature World News

SAN FRANCISCO, Dec. 17, 2019 /PRNewswire/ -- The genome of human cells looks a lot like a tangled ball of yarn, with tightly wound clumps from which myriad loose strands escape and loop out. But there is order to this tangleand growing evidence that the genome's 3D architecture influences the activity of its genes. Understanding the rules that control gene activity has been the object of a long collaboration between Gladstone investigators Deepak Srivastava, Benoit Bruneau, Katherine Pollard, Bruce Conklin, and Nevan Krogan, and their UC San Francisco (UCSF) partner Brian Black. Together, they have already found many key regulators of gene activity in the heart.

Now, their collaboration has received a strong shot in the arm from the National Institute of Health with the recent award of a Program Project Grant totaling $13 million between the labs for the next five years.

With this new support, the researchers will carry out a comprehensive probe into gene activity in heart cells and its intersection with the genome's 3D organization during heart formation.

"It is truly gratifying to see our long collaboration supported in this way by the National Institute of Health,"says Srivastava, president of Gladstone Institutes and project leader on this multi-investigator grant. "This funding will allow us to dig deep into processes that are fundamental to heart cell biology, but that will also directly inform our efforts to design therapies for congenital heart disease, heart failure, and other heart diseases."

Heart failure is the most common cause of death in adults, and congenital heart defects the most common form of birth defects. These defects have been traced to mutations in a number of proteins that regulate gene activity in heart cells, including the proteins at the core of the researchers' new proposal.

"However, the investigation of the 3D organization of the genome is a relatively new area, particularly in the heart," says Srivastava, who is also a pediatric cardiologist and has devoted much of his career to understanding heart formation and congenital heart defects.

The work outlined in this grant is therefore expected to yield novel insight into heart disease and spur the design of new therapies. It will also help the researchers improve their ability to coax human cells into becoming various types of heart cells. This technology could eventually be used to regenerate failing heart tissue.

Gladstone Senior InvestigatorBruce Conklinwill lend his expertise in cardiac stem cell biology and CRISPR gene-editing technology to the project.

The researchers' plan is to correlate gene activity and genome organization at the whole-genome scale and during multiple stages of heart formation. This will require enormous technological power. It will also require massive computing power and statistical analysis to store and sift through the large data sets the group will generate.

But the team is well-positioned to take on this challenge.

"Our studies are facilitated by extraordinary new technology,"says Bruneau, also a cardiovascular development specialist and the director of the Gladstone Institute of Cardiovascular Disease.

The $13 million proposal will leverage Srivastava, Bruneau, and Black's deep understanding of heart development and disease, and enlist the state-of-the-art technologies and analytic tools that Pollard and Krogan have developed to collect and analyze information about biological networks on a grand scale.

"Our team combines a remarkable array of expertise and technologies," says Srivastava, who is also director of the Roddenberry Stem Cell Center at Gladstone. "It would be impossible for any one or two labs in isolation to pursue the complex goals we set out to achieve with this project."

Dynamic Protein Networks

The project focuses on a small set of proteins the team has previously shown to be crucial for the formation of a functional heart. These proteins, known as transcription factors, activate or silence genes by binding to specific DNA sequences in the genes' vicinity.

The scientists have shown that cardiac transcription factors can associate with each other and with other proteins. "Depending on the associations they form, they turn genes on, off, or somewhere in between, and different types of heart cells may form," says Black.

But for a transcription factor to turn a gene on or off, it needs to access the gene's DNA sequence. That's not as easy as it sounds, as much of the genome is wound up in tight coils that give no foothold to transcription factors.

Bruneau's team studies proteins that modulate the accessibility of DNA sequences along the genome, a process known as chromatin remodeling. These proteins unspool segments of the genome from the tightly wound coils, opening up stretches of DNA that transcription factors can bind.

Like transcription factors, chromatin remodeling proteins associate with each other and with other proteins, forming associations that vary depending on the cell type or the stage of heart formation.

Interestingly, Srivastava's group recently discovered that cardiac transcription factors may have long-range effects on the 3D organization of the genome. The genome is housed in a separate compartment of the cell, a spherical structure called the nucleus. Srivastava's team found that cardiac transcription factors may pull genome loops all the way to proteins lining the edges of the nucleus.

The picture that emerges from these findings is that of a vast network of proteins that coordinate gene activity and genome architecture, and change as the heart forms.

Now the researchers want to know how these networks form, how many proteins they entail, and what genes they affect.

Dynamic Lab Partnerships

To answer these questions, the team will analyze the associations between cardiac transcription factors, chromatin remodeling proteins, and their various partners during heart development. They will pair this analysis with a genome-wide survey of the genes these proteins target and of these genes' activity.

"Our overarching goal is to understand all the levels of gene regulation in developing hearts, from genes and transcription factors to chromatin remodeling and to genome organization within the nucleus," says Bruneau, who is also a professor of pediatrics at UCSF.

The researchers will use a battery of sophisticated techniques to capture the complexes that proteins form with each other or with DNA sequences and to record which genes are active or inactive in different types of heart cells.

They will leverage various models of heart development, including human induced pluripotent stem cells (hiPS cells) that can give rise to heart tissue in the dish, or cells from the developing heart of mouse embryos. They will also use CRISPR technology and other genetic tools to insert mutations in heart cells and evaluate the impact of these mutations on the protein-genome networks.

Their success will depend on high-throughput data collection and analysis, and powerful statistics to guarantee the validity of the findings. That's where Krogan and Pollard come in.

Krogan's labwill contribute technology his lab developed to determine how proteins interact with one another in the celland how those interactions affect the interaction of proteins with DNA.

Pollard's groupwill devise statistical methods to rigorously analyze the protein networks and gene activity profiles the researchers uncover through the lens of genetic causes of heart disease.

"The biggest challenge will be to develop novel computational methods, including artificial intelligence tools," says Pollard, who directs the Gladstone Institute for Data Science and Biotechnology. "This is the first time that scientists will integrate such diverse kinds of data to understand a disease."

Together, these tools will allow the researchers to reliably identify connections between protein networks and gene activity at all stages of heart formation, in the context of disease or healthy heart formation.

"This project crystallizes a more than a decade-long collaboration across our labs, with a laser focus on fundamental concepts of gene regulation," says Bruneau.

"We will learn how these concepts apply to the heart and to heart diseases," he adds, "but we think they will also be relevant to other organs and sets of diseases."

Media Contact:Megan McDevittmegan.mcdevitt@Gladstone.ucsf.edu

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team-of-researchers-who-received.jpg Team of Researchers who Received the Grant New funding from the NIH fuels collaboration between UCSF's Brian Black and Gladstone's Deepak Srivastava, Benoit Bruneau (front row, left to right), Katie Pollard, Bruce Conklin (back row, left to right), and Nevan Krogan (not shown).

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$13 Million Grant to Probe the Genome of Heart Cells - PRNewswire

Company closes $5.6 million in funding and secures distinguished board of directors as it seeks to empower individual health ownership with personalized biological analysis and storage

GoodCell ("LifeVault Bio"), the personal biobanking company with the health indicators to inform actionable next steps in your health journey, today announced it has secured a $2.6 million price round under LifeVault Bio and a $3 million convertible note, and brought on renowned technology executive Anthony Bay as its newest board member. The capital will be used to expand GoodCell Diagnostics, the companys commercial application, as it pioneers a cell quality test to measure the DNA damage to somatic cells over time, as well as fuel the formation of strategic partnerships across the healthcare and life sciences sectors, and grow the team at its headquarters in Waltham, Mass.

GoodCell helps individuals take control of their health through personalized biobanking of cells, DNA and blood plasma, with the belief that medical science will continue to progress, bringing forth new ways of preventing, detecting and treating diseases. Research continues to prove that cells are an essential starting material for the treatments of tomorrow. DNA and plasma are widely validated as critical information sources for monitoring and tracking health risk and informing lifestyle decisions. GoodCell aims to empower individuals with personal health information and storage resources to take full advantage of breakthrough medical science as it emerges.

"Stem cells are among the most promising areas of medical research because they are the starting materials from which all other cells originate," said Brad Hamilton, co-founder and chief science officer at GoodCell. "Some of these cells, specifically induced pluripotent stem (iPS) cells which can be derived from a persons own skin or blood, can be programmed to produce virtually any type of cell in the human body. This versatility has made them an instrumental tool, helping scientists understand and fight some of the biggest health threats of our time, such as Parkinsons disease, Type 1 diabetes and heart disease. GoodCell exists to help people preserve their access to these potentially lifesaving cells."

After GoodCell sends members a sample collection kit to their doorstep, they are prompted to schedule a convenient blood-draw with a certified phlebotomist, who then safely packages and ships the sample for processing. Once received, GoodCell isolates and preserves three components of the blood sample: cells, DNA and blood plasma. The DNA sample is then tested to inform genetic predisposition to disease, such as metabolic, neurologic and cardiac disorders, as well as certain cancers. Armed with deep insight into a members biology, the GoodCell Dashboard displays their health information as a comprehensive overview, designed to inform the next best action in their health journey. Samples are stored in a state-of-the-art, FDA-registered CLIA/CAP certified lab and biorepository that is trusted by larger biotechnology companies and the National Institutes of Health. Since it is the change in health indicators that indicates risk, recurrent sampling is possible to enable measuring the trajectory of change in plasma components or DNA. Since the samples belong to GoodCell members, they can decide whether or not to share their information with their doctor or allow researchers to use it in clinical studies.

Story continues

"To me, GoodCell represents the ultimate in personalized medicine. Individuals can now have their own biobank and their own biodata. These wont be owned by a hospital or in the case of your cells, by no one at all. These will be stored for you, accessible only on your instruction. As new tests come online or as cells become a broader therapy source, you will be able to tap into your own earlier, preserved self in the form of your blood," said David Scadden, MD, co-founder and chair of the Scientific Advisory Board at GoodCell. "Imagine two scenarios. First, a new blood test becomes available for Alzheimers disease. You get the test, but just like current tests for things like prostate cancer, it is only meaningful in light of how it is changing. Your doctor will likely advise waiting months or a year to re-test. With a GoodCell sample, we envision the test can be done on your blood from a previous time. Then you can know how things are changing without the prolonged wait and the anxiety it engenders. Second, lets say the stem cell field delivers on the therapies it is currently testing for diabetes, heart failure, Parkinsons disease and macular degeneration. Those therapies will likely be as cells derived from you. Would you want those to be from you at a younger age since we know our cells accumulate genetic damage with age? I think most people would, and would want cells from their blood, which the bones have shielded from radiation, rather than their skin as is currently done. GoodCell will have those blood cells for you and has shown they can be made into stem cells (iPSC) with high efficiency."

GoodCell is focused on continuing to grow its customer base and building up its talent pool at its new headquarters in Waltham, Mass. The company, which is poised to expand its headcount in early 2020, will also be exploring strategic partnerships with cell and gene therapy companies and interest groups that could benefit from GoodCell members deciding whether to opt-in to allow access to stored cells, DNA and plasma. GoodCell will also continue to recruit pioneers in business, science and technology to its board positions. Most recently, it welcomed Anthony Bay, former Global Head of Digital Video for Amazon and a veteran senior executive at other technology powerhouses, including Apple and Microsoft.

"Ive devoted my career to creating scalable and differentiated technology platforms and unique digital experiences in many industries, and am excited to lend my expertise and perspectives to GoodCell," said Bay. "I am delighted to play a role in helping the GoodCell team scale and expand to match the size of our opportunity to change peoples lives."

Bay joins an already robust and diverse group of consumer technology and life science leaders, including John Goscha, Lucidity Lights founder and Chairman of the Board of Directors, Finally Light Bulb Company founder and entrepreneur; David Scadden, MD, professor of medicine at Harvard Universitys Department of Stem Cell and Regenerative Biology; Daniel Marshak, principal consultant in therapeutics, diagnostics and medical devices; Avi Ellman, managing partner of Delta Global Investment Services; and Trevor Perry, co-founder and chief executive officer at GoodCell.

"Up until now, existing genetics offerings can only go so far as to inform your genetic makeup. GoodCell is taking that a step further today by combining genetics, health indicator testing and personal biobanking into one solution, and then turning this information right back to the individual so they can understand the story of their health and leverage actionable data at any age," said Perry. "We are taking advantage of leading scientific innovation to help people take control of their health through personalized biobanking of cells, DNA, and blood plasma, and we believe the tremendous amount of support we received during this initial funding round will further allow us to be a true enabler of and partner in this process. Our goal is to set a new standard for personal biobanking as an individual health milestone, and our mission is to ensure our members feel confident and prepared to own their aging experience, and we look forward to accelerating our efforts in the months ahead."

For more information about GoodCell, visit https://www.goodcell.com. To order your starter kit, visit https://www.goodcell.com/shop/.

About GoodCell

GoodCell helps you take control of your health through personalized biobanking of cells, DNA and blood plasma. Leveraging the best science, the technology provides health indicators for a comprehensive and proactive approach to self-care. Through the GoodCell Dashboard, the company informs the next best action in your health journey, offering access for you and for your doctor to actionable data and insights that relate to all aspects of your health through genetic reporting and blood analysis. Driven by mounting evidence in support of cellular therapy and united in the belief that you should be empowered to take control of your health, GoodCell is led by a founding team of scientific advisors with a diverse set of medical research and clinical expertise. By backing up your starting materials, GoodCell is setting a new standard of personal biobanking today for a healthier future. Learn more at: https://www.goodcell.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191217005485/en/

Contacts

PAN CommunicationsStaci Didner407 734 7325Goodcell@pancomm.com

Read more:
GoodCell Oversubscribes Upon Debut, Fueling Expansion of Health Tracking and Personal Biobanking Services; Adds Former Amazon and Microsoft Executive...

The ODAC discussions were based on the supplemental Biologics License Application (sBLA), currently under priority review at the FDA, seeking approval of KEYTRUDA monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). This application is based on results from the Phase 2 KEYNOTE-057 trial.

The positive vote from todays ODAC meeting supports the potential for KEYTRUDA in certain patients with high-risk, non-muscle invasive bladder cancer, who currently have limited non-surgical treatment options approved by the FDA, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. We are encouraged by todays productive discussion and look forward to working with the FDA as they continue their review of our supplemental application for KEYTRUDA in this patient population.

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committees guidance but takes its advice into consideration. Merck anticipates a Prescription Drug User Fee Act (PDUFA), or target action date, in January 2020, based on priority review.

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumor and spread to other areas of the body. Bladder cancers are described based on how far they have invaded into the wall of the bladder. NMIBC occurs when the cancer has not grown into the main muscle layer of the bladder. It is estimated that more than 80,000 new cases of bladder cancer will be diagnosed in 2019 in the United States. Approximately 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC patients who are BCG-unresponsive with persistent or recurrent disease, treatment guidelines recommend radical cystectomy, a surgery to remove the entire bladder that often requires removal of other surrounding organs and tissues. In men, removal of the prostate is common, and in women, surgeons may also remove the uterus, fallopian tubes, ovaries and cervix, and occasionally a portion of the vagina.

About KEYNOTE-057

The filing was based on data from KEYNOTE-057 (NCT02625961), a Phase 2, multicenter, open-label, single-arm trial in 102 patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who were ineligible for or had elected not to undergo cystectomy (Cohort A). In this study, BCG-unresponsive high-risk NMIBC is defined as persistent disease despite adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG. Patients received KEYTRUDA 200 mg every three weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease. Assessment of tumor status was performed every 12 weeks, and patients without disease progression could be treated for up to 24 months. The major efficacy outcome measures were complete response (as defined by negative results for cystoscopy [with transurethral resection of bladder tumor (TURBT)/biopsies as applicable], urine cytology, and computed tomography urography [CTU] imaging) and duration of response.

About KEYTRUDA (pembrolizumab) Injection, 100mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle...

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