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Archive for the ‘Regenerative Medicine’ Category

CIRM Bridges to Stem Cell Research & Therapy The Bridge to Everywhere (in biomedicine) OP-ED – The Silicon Valley Voice

Sunday, October 18th, 2020

In a recent clinical trial for an immune cell therapy for lymphoma, 62% of patients experienced complete cancer clearance in spite of the fact that some of them were on their 5th line of treatment. Stem cell therapies have the potential to enact more of these paradigm-shifting treatments. Proposition 14 will continue to advance these therapies and bring them to full development as available cures.

The vision of stem cell therapy is that a physician can just as easily grab an IV bag full of therapeutic cells as they might draw a drug into a syringe. Conceived through Proposition 71 in 2004, the California Institute for Regenerative Medicine (CIRM) serves as a vehicle to support all aspects of stem cell research. Medical progress requires not just well-designed clinical studies but also a well-trained workforce, educated at the intersection of stem cell biology, engineering, and chemistry.

Since 2008, CIRM has supported the training of nearly 1300 Community College and California State University students for the emerging field of Regenerative Medicine through the Bridges to Stem Cell Research and Therapy Program. The Bridges Training Program has functioned as a pathway for first-generation and underrepresented students from Humboldt to San Diego, to all of the biomedical sectors startup and cell therapy companies, academic research institutes, graduate and medical school, and more. Exposure to hands-on labs, advanced seminar discussions, and a required paid internship fully prepares these students for entering the stem cell workforce. Over 80% of Bridges alumni have either advanced to graduate school or joined the biomedical workforce in industry or academic institutions. These Programs bring a greater return than the initial cost of training.

SPONSORED

Consider Vahid Hamzeinejad, a bright high school student, headed to UC Berkeley to begin his college career. Enter the Great Recession; Vahid found himself back at home, working non-stop to help keep his parents restaurant afloat. Not giving up on his commitment to an education, he enrolled at the College of the Canyons. After completing an Associates degree, Vahid transferred to Cal Poly, hoping to join the Bridges Program. After receiving the Bridges core training, Vahid started his internship at ViaCyte, where he continues to work today, as a critical member of the team supporting ViaCytes clinical development of a functional cure for diabetes. The nearly $30 billion that California currently spends on diabetes treatments could be significantly reduced, in no small part due to the efforts of a student that cost taxpayers $36,000 to educate. That is before considering the benefit to patients quality of life that would occur by replacing insulin pumps, glucose monitors, and constant vigilance with a stem-cell-derived tissue that regulates blood sugar levels biologically making and secreting its own insulin.

Passing Proposition 14 will enable this and other unparalleled treatments for diabetes, heart disease, cancer, and neurological disorders.

Signed,

Robert Kam and the CIRM Bridges Program

SPONSORED

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CIRM Bridges to Stem Cell Research & Therapy The Bridge to Everywhere (in biomedicine) OP-ED - The Silicon Valley Voice

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Former NFL Players Show Interest in Regenerative Medicine and Cell Therapies – Yahoo Finance

Sunday, October 18th, 2020

InvestorPlace

In late September, a U.S. House vote to remove marijuana from the federal Controlled Substances Act was delayed until after the presidential election. If the House remains controlled by Democrats, industry analysts expect the Marijuana Opportunity Reinvestment and Expungement (MORE) Act to potentially pass before the end of 2020. Then, it would be up to the Senate to possibly take a similar action. Today, we will look at three marijuana stocks to buy with decriminalization in the agenda.Canada is the first and only G7 nation to have legalized cannabis nationwide. In the U.S., at the federal level, marijuana is illegal and remains a Schedule I drug. Legal status varies at the state level. However, Democratic vice president nominee Kamala Harris has recently said marijuana would be decriminalized at the federal level under a Biden administration.2018 saw excessive speculation in marijuana stocks. Yet since 2019, a wide range of issues have affected the cannabis industry. Recreational cannabis sales in Canada hit significant headwinds and never reached the levels investors hoped. Although revenue improved for some companies, they have yet to become profitable. And cash burn remains concerning. As a result, most marijuana stocks have been on a roller coaster ride and hit new lows. Put another way, the bubble has burst.InvestorPlace - Stock Market News, Stock Advice & Trading TipsAccording to recent research led by Douglas Berman of Ohio State University, the COVID-19 pandemic has both introduced tremendous new challenges for the cannabis industry and exacerbated long-standing difficulties for businesses in this arena.7 Value Stocks to Buy in an Overvalued MarketNonetheless, with difficulties usually come new opportunities while industry leaders and innovations may appear. With that information, here are three marijuana stocks that could benefit from U.S. developments at the federal level:Constellation Brands(NYSE:STZ)ETFMG Alternative Harvest ETF(NYSEARCA:MJ)GW Pharma(NASDAQ:GWPH)Marijuana Stocks: Constellation Brands(STZ)Source: ShinoStock / Shutterstock.comConstellation Brands is best known as a leading producer and marketer of alcoholic beverages. It holds a large portfolio of beer, wine and distilled spirits brands. Several of those well-recognized brands include Corona, Modelo, Robert Mondavi, Svedka vodka, Casa Noble tequila and High West whiskey. It is one the fastest-growing large consumer packaged goods companies stateside. Outside the U.S., it has operations in Italy, Mexico and New Zealand.The Victor, New York-based group is on our list of marijuana stocks because in 2018, it took a large stake in Ontario, Canada-based Canopy Growth(NYSE:CGC), one of the leading Canadian marijuana producers. STZs 38%-stake in CGC means the latter now has considerable managerial and financial backing.So far, this equity stake in Canopy Growth has been an earnings drag for Constellation Brands, and it will likely remain so in the near future. However, any potential improvement in the outlook of the pot sector in Canada and the U.S. could easily benefit STZ stock. Therefore, this indirect play on CGC could be a less risky approach for many investors.Year-to-date, STZ stock is down about 1.5%. However, that metric tells only half the story. Since the lows hit in early spring, the stock is up about 80%. The current forward price-earnings and price-sales ratios stand at at 20.88 and 4.78 respectively. Wed look to buy the the dips in price, especially if there is a decline toward the $175 level.ETFMG Alternative Harvest ETF (MJ)Source: ShutterstockThe ETFMG Alternative Harvest ETF offers exposure to Canadian cannabis producers as well as a number of firms with exposure to the industry, albeit indirectly. Thus the fund could be appropriate for long-term investors who are interested in the pot sector, but would like to have access to a diverse range of companies.MJ, which has 37 holdings, tracks the Prime Alternative Harvest index. Canopy Growth, Cronos (NASDAQ:CRON), and Tilray (NASDAQ:TLRY) top the list of holdings. Top-10 names make up around half of net assets, which stand around $550 million. The ETF was launched in 2015.7 Value Stocks to Buy in an Overvalued MarketSo far this year, the fund is down more than 30% and hit an all-time low in March. Since 2019, MJ has lost considerable value, driven by the industrys weakness and poor earnings by most pot companies. These stocks tend to be very choppy when their quarterly earnings are due. Given the volatility in the sector, long-term investors should be ready for large short-term price fluctuations in the fund. The sector is risky, but MJs diversification makes it safer than many alternatives.GW Pharma (GWPH)Source: ShutterstockOur final marijuana stock is the cannabis-focused biotech GW Pharma. According to a recent report by the United Nations, Britain is the biggest producer and exporter of legal cannabis in the world. And almost all of the exports are in a single drug, i.e., Sativex, produced by the UK-based GW Pharma. It is used to treat spasms in multiple sclerosis patients.Earlier in the year, the U.S. Drug Enforcement Administration also descheduled Epidiolex, another one of the companys products. As a result, it is no longer listed as a controlled substance stateside. In August, the U.S. Food and Drug Administration approved it to treat seizures in tuberous sclerosis complex.GW is also one of MJs largest holding, accounting for 6.41% of its assets. GWPH stock could be an alternative way to get exposure to the cannabis industry. Year-to-date, the shares are down around 8%. A potential decline toward $90 or below would improve the safety margin for long-term investors.On the date of publication, Tezcan Gecgil did not have (either directly or indirectly) any positions in the securities mentioned in this article.TezcanGecgil has worked in investment management for over two decades in the U.S. and U.K. In addition to formal higher education in the field, she has also completed all 3 levels of the Chartered Market Technician (CMT) examination. Her passion is for options trading based on technical analysis of fundamentally strong companies. She especially enjoys setting up weekly covered calls for income generation. She also publisheseducationalarticles on long-term investing.More From InvestorPlaceForget The Election Pick These Stocks for the Win in 2021Why Everyone Is Investing in 5G All WRONGAmericas #1 Stock Picker Reveals His Next 1,000% WinnerRevolutionary Tech Behind 5G Rollout Is Being Pioneered By This 1 CompanyThe post 3 Marijuana Stocks to Buy With Decriminalization on the Table appeared first on InvestorPlace.

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Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By…

Sunday, October 18th, 2020

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Regenerative Medicine Market.

Trusted Business Insights presents an updated and Latest Study on Regenerative Medicine Market. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Regenerative Medicine Market during the forecast period.It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2020 2029 (Includes COVID-19 Business Impact)

We have updated Regenerative Medicine Market with respect to COVID-19 Business Impact.Inquire before buying

This report focuses on the Regenerative Medicine market and value at the global level, regional level, and company level. From a global perspective, this report represents the overall Regenerative Medicine market size by analyzing historical data and future prospects. Regionally, this report focuses on several key regions: North America, Europe, Japan, China, Southeast Asia, India, Latin America, and South America.

Global Regenerative Medicine Market: Segment Analysis

The research report includes specific segments by region (country), by Company, by Type, and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2019 to 2029. An in-depth analysis of the segments assists in identifying the different factors that will aid market growth.

Global Regenerative Medicine Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, Japan, China, Southeast Asia, India, Latin America, and South America. The report has been curated after observing and studying various factors that determine regional growth such as the economic, environmental, social, technological, and political status of the particular region. Researchers have studied the data of revenue, sales, and manufacturers of each mentioned region. This section analyses region-wise revenue and volume for the forecast period of 2019 to 2029.

Global Regenerative Medicine Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2019 to 2029.List of Companies Profiled

Report Coverage

The potential to directly alter human genes was first recognized nearly more than 50 years ago. Cell and gene therapy, represent overlapping fields of biomedical research with similar therapeutic goals. Regenerative medicine also comprises of therapeutic tissue engineering and biomaterials -engineered substances used in medical applications to supplement or replace a natural body function. The increased number of the clinical trials and the use of the regenerative medicine for the development of the medicine to treat chronic diseases are some of the factors propelling the regenerative medicine market trends.

The report provides qualitative and quantitative insights on the regenerative medicine industry trends and detailed analysis of market size and growth rate for all possible segments in the market. The market is segments include type, application, distribution channel, and geography. On the basis of the type, the market is segmented into cell therapy, gene therapy, tissue engineering and platelet rich plasma. On the basis of the application, the market is segmented into orthopedics, wound care, oncology and others. On the basis of distribution channel, the regenerative medicine market is segmented into hospitals, clinics and others. Geographically, the market is segmented into five major regions, which are North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The regions are further categorized into countries.

Along with this, the regenerative medicine market report comprises analysis of the industry dynamics and competitive landscape. Various key insights provided in the report are prevalence and incidence of diabetes by key countries, advancements in insulin delivery devices, recent industry developments such as mergers & acquisitions, pricing analysis, technological advancements, and key industry trends.

SEGMENTATION

By Product

By Application

By Distribution Channel

By Geography

Key Industry Developments

In September 2020, Takeda Pharmaceutical Company Limited announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takedas efforts to develop next-generation cell therapies, initially focused on oncology with the potential to expand into other therapeutic areas.

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U., and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world.

Takedas Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization. It provides bioengineering, chemistry, manufacturing, and control (CMC), data management, analytical, and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

In 2018, Novartis received EU approval for one-time gene therapy Luxturna, which has been developed to restore vision in people with rare and genetically-associated retinal disease.

In 2018, Novartis received EU approval for its CAR-T cell therapy, Kymriah.In 2017, Integra LifeSciences launched its product, Integra Dermal Regeneration Template Single Layer Thin for dermal repair defects reconstruction in a one-step procedure.

 

Looking for more? Check out our repository for all available reports on Regenerative Medicine Market in related sectors.

Quick Read Table of Contents of this Report @ Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2020 2029 (Includes COVID-19 Business Impact)

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Bone Therapeutics to present at 2020 Virtual Cell & Gene Meeting on the Mesa – GlobeNewswire

Sunday, October 18th, 2020

Gosselies, Belgium, 12 October 2020, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announce that CEO, Miguel Forte, MD, PhD will present at the annual Cell & Gene Meeting on the Mesa to be held virtually October 12-16. Miguel Forte will also chair the session The European Regulatory Environment for ATMPs Should we expect more or less regulation? with the participation of panelists from the European Organization for Rare Diseases (EURORDIS), the European Medicines Agency (EMA) and the European Commission.

Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a five-day virtual conference featuring more than 120 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies. The meeting also includes over 100 panelists and featured speakers taking part in 20 in-depth sessions covering all aspects of cell and gene therapy commercialization. Companies presentations will be available to view on-demand throughout the entirety of the conference

Please visit http://www.meetingonthemesa.com for full information including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at lstringham@alliancerm.org and interested media should contact Kaitlyn Dupont at kdupont@alliancerm.org.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

For US Media and Investor Enquiries:LHA Investor RelationsYvonne BriggsTel: +1 310 691 7100ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation – BioSpace

Sunday, October 18th, 2020

Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed. Specifically, that entails improving manufacturing to control variables and thus ensure product consistency, and maturing the regulatory environment to improve predictability.

Manufacturing cells is not like manufacturing small molecules, Brian Culley, CEO of Lineage Cell Therapeutics, told BioSpace. For cell therapy products to mature into real products that deliver on the promises of 10 years ago, they must be scalable which drives affordability and they must solve their purity issues.

On the clinical side, cell and gene therapies must find places where small molecules, antibodies or other traditional approaches may not be the best option.

For example, The era of transplant medicine is unfolding before us, Culley said. Because of the transplant component, cell therapy may enable changes the body never could do alone.

Lineage is addressing dry AMD and spinal cord injuries with two of its therapeutics.

Our approach is fundamentally different from traditional approaches. We replace the entire cell rather than modulate a pathway. There is a rational hypothesis where cell therapy can win, but first we need to fix the operational hurdles, Culley said.

To address the manufacturing challenges, Culley said, We work only with allogeneic approaches. For us, not being patient-specific is a huge advantage.

Not long ago, the industry was focused on 3D manufacturing in bioreactors.

Were beyond that, Culley said. For our dry AMD product, we can manufacture 5 billion retinal cells in a three liter bioreactor. The advantage is that the cells exist in a very homogenous space and are 99% pure.

As a result, they are more affordable and can be harvested with little manipulation.

Manual manipulation affects gene expression, he pointed out, so minimizing that, as well as the vast quantities of plastics typically required, results in a more controlled process and a more consistent product.

Additionally, Lineage introduced a thaw and inject formulation, so the cell therapy can be thawed in a water bath, loaded into a chamber and injected, all within a few minutes. Traditional dose administration requires washing, plating and reconstituting the cells the before they are administered to a patient.

Getting rid of the prior day dose prep is one example of the maturation of the field, which we are deploying today to help usher in a new branch of medicine, Culley said.

At Lineage, were tackling problems that largely were intractable. For dry AMD, theres nothing approved by the FDA. No one know why the retinal cells die off, so we manufacture brand new retinal cells (OpRegen) and implant them, Culley said. Were seeing very encouraging clinical signs, including the first-ever case of retinal restoration.

Retinal cells compose a thin layer in the back of the eye, Culley explained.

They start to die off in one spot, and that area grows outward. When we inject our manufactured cells where the old ones died, weve seen the damaged area shrink and the architecture in previously damage areas completely restored, Culley said. Weve treated 20 patients for dry AMD in, ostensibly, safety trials, but you cant help but notice efficacy when a patient reads five more lines on an eye chart. Its hard to imagine our intervention wasnt responsible for that, especially when humans cant regenerate retinal tissue.

The spinal injury program (OPC1) may represent an even greater breakthrough. As with dry AMD, there is no FDA-approved therapy.

We manufacture oligodendrocytes and transport them into the spinal cord, to help produce the myelin coating for axons, he told BioSpace. Because of the oligodendrocytes, the axons grow, become myelinated, and begin to function. Small molecule and antibody therapies havent been able to do that.

So far, 25 people have been treated in a Phase I/II trial. Culley reported cases in which a quadriplegic man, after OPC1 therapy, is now typing 30 to 40 words per minute, and another who now can throw a baseball. Its not unusual for patients who initially were completely paralyzed to now schedule their treatments around college classes, Culley said.

Humans can have varying degrees of recovery from spinal cord injury, but these are higher than we would expect, Culley said.

Other cell and gene companies are advancing solutions, too.

Many companies with induced pluripotent stem cells (iPSCs) are trying to figure out how to get scalability, purity, and reproducibility to work for them. Its not a quick fix, he said.

One of the challenges is balancing the clinical and manufacturing aspects of development.

If you have a technology thats not yet commercially viable, but you have clinical evidence, its tempting to focus on the clinical side, Culley said.

Too many companies do that, and then find their candidate must be reworked for scale up. Therefore, consider scale up and manufacturing early.

Theres a need for balance at a more granular level, too. For example, he asked, How many release criteria do you need? Just because you know a cell expresses a certain surface marker, does that add to your process? Ive seen companies ruined by trying to be perfect, and others by rushing headlong, seeing evidence where evidence doesnt exist.

As Lineage matures its processes to support larger clinical trials, the greatest challenges have been time It takes 30 to 40 days to grow cells, Culley said and regulatory uncertainty. Often, there is no regulatory precedence so there are holes to be addressed. For example, cell and gene therapies sometimes have a delivery component such as a scaffold or delivery encapsulation technology that also must be considered. Real-time regulatory feedback isnt available, so you proceed, presuming that what youre doing will be acceptable to regulators.

The FDA recognizes that new, disruptive technologies and approaches are being used, and must be used, for cell and gene therapy to reach patients.

The FDA is responsive and is trying to push guidance out, Culley said, but it takes time.

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Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation - BioSpace

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Woolly worm race champion to predict winter weather this upcoming season – WJHL-TV News Channel 11

Sunday, October 18th, 2020

Woolly worm race champion to predict winter weather this upcoming seasonNews / 8 hours ago

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Hundreds attend 'Trump Train Parade' in Sullivan County SaturdayNews / 8 hours ago

60th annual Southeastern Autorama returns to ErwinNews / 8 hours ago

Medical cannabis processor Dharma Pharma opens to patients in Bristol, VirginiaNews / 8 hours ago

The Volunteer Bus: Give back, Go Vols!News / 2 days ago

UPDATE: Police identify 3 dead after Saturday morning shootingNews / 8 hours ago

Trump Train Parade to go from Bristol to KingsportNews / 1 day ago

Hard Rock executives hold event for women and young professionals ahead of Bristol casino referendumNews / 1 day ago

Court TV interviewed Anslee Daniel regarding Evelyn Boswell case Friday nightNews / 1 day ago

Ballad leader: Fresh spike in COVID deaths likely four to six weeks awayNews / 1 day ago

Tennessee leaders to make adjustments to teacher accountabilityNews / 2 days ago

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Woolly worm race champion to predict winter weather this upcoming season - WJHL-TV News Channel 11

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Crowdfunding campaigns seeking donations supporting the use of investigational medical products provided via expanded access or ‘right-to-try’…

Sunday, October 18th, 2020

As health sciences researchers conduct clinical trials to develop safe and effective therapies and vaccines for COVID-19, two nontrial pre-approval access pathways expanded access and right-to-try are becoming more widely-known to the general public.

A study published in Regenerative Medicine written by University of Minnesota Associate Professor Leigh Turner, Simon Fraser University Professor Jeremy Snyder, and New York University Assistant Professor Alison Bateman-House suggests thatmost patients engaged in online crowdfunding and seeking nontrial preapproval access to investigational medical products obtain them using the expanded access regulatory pathway rather than through what is known as the right-to-try.

The federal Right To Try (RTT) Act became law in 2018. It allows for individuals with life-threatening diseases to access investigational medical products if they:

Supporters, including President Trump, promote the right-to-try option as an important pathway for obtaining access to investigational medical products, said Turner, who is with the U of Ms Center for Bioethics. To date, however, few individuals appear to be obtaining access to such products on a right-to-try basis. Right-to-try has been promoted as a faster and less bureaucratic alternative to expanded access.

However, our research findings suggest that when it comes to crowdfunding campaigns on GoFundMe, references to right-to-try often reflect a poor understanding of nontrial preapproval access. In reality, at least according to the crowdfunding campaigns we examined, expanded access is the route by which individuals more commonly access investigational products outside clinical trials.

Expanded access, while also providing access to investigational medical products provided outside clinical trial context, differs significantly from the right-to-try pathway in that it requires FDA and institutional review board (IRB)oversight. The FDA and the IRB review submitted requests and decide if an investigational medical product should be provided on an expanded access basis. President Trump, for example, recently obtained access to an investigational product for COVID-19 a monoclonal antibody cocktail on an expanded access basis.

The experimental interventions allowed under the RTT Act and through an expanded access basis are not commonly covered by insurers. As a result, many individuals engage in online crowdfunding activity to cover the often substantial costs associated with accessing investigational interventions provided outside clinical trials.

Turner and his co-authors identified 79 GoFundMe campaigns referencing right-to-try and 115 campaigns referencing expanded access between April 2019 and April 2020. These campaigns also discussed seeking experimental medical interventions in the U.S.

When restricting analysis to campaigns initiated in 2018 and later, which is around the time the RTT Act was made into law, the researchers identified:

Through this study, researchers found that:

It is important to note that the campaigns on GoFundMe list donation goals and funds received but they may not accurately reflect costs associated with seeking access to investigational medical products pursued via expanded access pathway or a right-to-try option. Furthermore, data collected on crowdfunding sites does not necessarily reflect experiences of individuals who seek access to investigational medical products administered outside clinical trials but do not engage in crowdfunding activities.

Acknowledging these limitations, the study does suggest that, in practice, expanded access provides meaningful access to investigational medical products whereas right-to-try is more rhetorical slogan than practical option.

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Research report covers the Japan Regenerative Medicine Products Market Forecasts and Growth, 2019-2025 – Eurowire

Sunday, October 18th, 2020

This report also researches and evaluates the impact of Covid-19 outbreak on the Japan Regenerative Medicine Products industry, involving potential opportunity and challenges, drivers and risks. We present the impact assessment of Covid-19 effects on Japan Regenerative Medicine Products and market growth forecast based on different scenario (optimistic, pessimistic, very optimistic, most likely etc.).

Global Japan Regenerative Medicine Products Market Overview:

The research report, titled [Global Japan Regenerative Medicine Products Market 2020 by Company, Regions, Type and Application, Forecast to 2025], presents a detailed analysis of the drivers and restraints impacting the overall market. Analysts have studied the key trends defining the trajectory of the market. The research report also includes an assessment of the achievements made by the players in the global Japan Regenerative Medicine Products market so far. It also notes the key trends in the market that are likely to be lucrative. The research report aims to provide an unbiased and a comprehensive outlook of the global Japan Regenerative Medicine Products market to the readers.

Get PDF Sample Copy of this Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2785605&source=atm

Global Japan Regenerative Medicine Products Market: Segmentation

For clearer understanding of the global Japan Regenerative Medicine Products market, analysts have segmented the market. The segmentation has been done on the basis of application, technology, and users. Each segment has been further explained with the help of graphs figures. This breakdown of the market gives the readers an objective view of the global Japan Regenerative Medicine Products market, which is essential to make sound investments.

Segment by Type, the Regenerative Medicine Products market is segmented intoCell TherapyTissue EngineeringBiomaterialOthers

Segment by Application, the Regenerative Medicine Products market is segmented intoDermatologyCardiovascularCNSOrthopedicOthers

Regional and Country-level AnalysisThe Regenerative Medicine Products market is analysed and market size information is provided by regions (countries).The key regions covered in the Regenerative Medicine Products market report are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. It also covers key regions (countries), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, U.A.E, etc.The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of sales and revenue for the period 2015-2026.

To understand the changing political scenario, analysts have regionally segmented the market. This gives an overview of the political and socio-economic status of the regions that is expected to impact the market dynamic.

Global Japan Regenerative Medicine Products Market: Research Methodology

To begin with, the analysis has been put together using primary and secondary research methodologies. The information has been authenticated by market expert through valuable commentary. Research analysts have also conducted exhaustive interviews with market-relevant questions to collate this research report.

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Global Japan Regenerative Medicine Products Market: Competitive Rivalry

The research report also studied the key players operating in the global Japan Regenerative Medicine Products market. It has evaluated and elucidated the research and development statuses of these companies, their financial outlooks, and their expansion plans for the forecast period. In addition, the research report also includes the list of strategic initiatives that clearly explain the achievements of the companies in the recent past.

Competitive Landscape and Regenerative Medicine Products Market Share AnalysisRegenerative Medicine Products market competitive landscape provides details and data information by players. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by players for the period 2015-2020. Details included are company description, major business, company total revenue and the sales, revenue generated in Regenerative Medicine Products business, the date to enter into the Regenerative Medicine Products market, Regenerative Medicine Products product introduction, recent developments, etc.The major vendors covered:AcelityDePuy SynthesMedtronicZimmerBiometStrykerMiMedx GroupOrganogenesisUniQureCellular Dynamics InternationalOsiris TherapeuticsVcanbioGamida CellGolden MeditechCytori TherapeuticsCelgeneVericel CorporationGuanhao BiotechMesoblastStemcell TechnologesBellicum Pharmaceuticals

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Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Japan Regenerative Medicine Products market

Chapter 2: Evaluating the leading manufacturers of the global Japan Regenerative Medicine Products market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Japan Regenerative Medicine Products market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

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Geistlich Derma-Gide Added to the General Services Administration’s Federal Supply Schedule – BioSpace

Sunday, October 18th, 2020

Oct. 16, 2020 13:00 UTC

PRINCETON, N.J.--(BUSINESS WIRE)-- The Geistlich Medical business unit of Geistlich Pharma AG, a family owned, Swiss based global leader in regenerative solutions is proud to announce that the General Services Administration (GSA) has added Geistlich Derma-Gide Advanced Wound Matrix to the Federal Supply Schedule (FSS). Geistlich Pharma focuses on a wide variety of clinical indications.

The GSA award will pave the way for physicians and staff of Veterans Administration facilities to utilize Geistlich Derma-Gide for the management of hard to heal wounds. The product is FDA cleared for a wide variety of indications, including diabetic foot ulcers, venous leg ulcers, surgical wounds, and first/second degree burns (among others).

Advanced wound care for those in need

Geistlich Medical has partnered with Recon-Supply, a Service-Disabled Veteran-Owned Small Business owned by Marine Corps veteran Stephen Clark and his wife Katy Clark. It was important to Geistlich Medical to partner with a SDVOSB in order to support and honor those that have served in the US Military, says Geistlich CEO Paul Note. We found a great organization in Recon-Supply and look forward to serving the Veterans Administration facilities as they treat those in need of advanced wound care. All nine of the Geistlich Derma-Gide sizes are a part of the FSS so that physicians and their staff have full access to the portfolio of products available to the broader healthcare market.

Novel second-generation xenograft

Geistlich Derma-Gide Advanced Wound Matrix is a novel second generation xenograft product that features an advanced 4D design: Dual-sourced, highly refined, bi-layered, and structurally optimized. It has demonstrated a 90% closure rate in its first 10 patient observational study recently published in International Wound Journal1. A larger prospective, randomized clinical trial is currently underway, with interim results to be published in late 2020.

1 Armstrong, DG, Orgill, DP, Galiano, RD, et al. An observational pilot study using a purified reconstituted bilayer matrix to treat nonhealing diabetic foot ulcers. Int Wound J. 2020; 17: 966 973.

About Geistlich Pharma

Geistlich Pharma has existed since 1851 and is family-owned. It specializes in the regeneration of bone, cartilage and tissue. More than 700 employees worldwide work for Geistlich in the area of regenerative medicine. With its twelve affiliates and 60 distribution partners, Geistlichs medical devices and medicinal products reach around 90 markets worldwide.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201016005406/en/

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Regenerative Medicine Market to Witness a Pronounce Growth During 2020 to 2025 – TechnoWeekly

Sunday, October 18th, 2020

Market Study Report, LLC recently added a report on Regenerative Medicine market that delivers a holistic view on industry valuations, market size, profit estimations, SWOT analysis and regional landscape of the market. In addition, the report points out key challenges and growth opportunities, while examining the current competitive standings of key players in during the forecasted timeline.

The research report on Regenerative Medicine market report provides a detailed analysis of this business landscape. The document analyses various market dynamics such as the opportunities and factors which drive the market growth. The market is poised to generate notable revenue and display a remunerative growth rate during the analysis timeframe, cites the report.

Request a sample Report of Regenerative Medicine Market at:https://www.marketstudyreport.com/request-a-sample/2440816?utm_source=technoweekly.com&utm_medium=SK

Additionally, the report assesses the existing market competition trends and elaborates on various risk factors which may hamper the growth of the Regenerative Medicine market during the analysis timeframe.

The document also highlights the impact of COVID-19 pandemic on the growth of Regenerative Medicine market.

Additional takeaways of the Regenerative Medicine market report:

Details of the regional analysis of the Regenerative Medicine market:

Ask for Discount on Regenerative Medicine Market Report at:https://www.marketstudyreport.com/check-for-discount/2440816?utm_source=technoweekly.com&utm_medium=SK

Table of Contents:

The key questions answered in the report:

For More Details On this Report: https://www.marketstudyreport.com/reports/global-regenerative-medicine-market-2020-by-company-regions-type-and-application-forecast-to-2025

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Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease…

Sunday, October 18th, 2020

HAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.

GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient's body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.

Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3-month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.

Prof. Ram of Ichilov Hospital commented, From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses."

Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication, stated Pluristem CEO and President, Yaky Yanay.

About cGvHDChronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT). The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is 30% to 40% by National Institutes of Health criteria1. The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipients body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints. Long term immunosuppression is given to try to prevent or treat cGvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX-PAD cells may potentially treat chronic GvHD patients and mitigate symptoms. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana RubinDirector of Investor Relations972-74-7107194danar@pluristem.com

_________________________________

1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/

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FDA officials, experts discuss impact of COVID-19 on cell and gene therapies – Regulatory Focus

Sunday, October 18th, 2020

While the US Food and Drug Administration (FDA) is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the COVID-19 pandemic on clinical trials.Its clear that COVID-19 has adversely affected all aspects of development of cell and gene therapies, said Peter Marks, director of FDAs Center for Biologics Evaluation and Research (CBER), said at the Alliance for Regenerative Medicines Meeting on the Mesa. For some of the studies that are ongoing there are some real challenges to overcome in terms of endpoints that may have been missed.The pandemic also has disrupted global harmonization efforts around gene therapies, Marks said.We were on the cusp, in fact, working with global regulators trying to get towards more harmonization of gene therapy programs in different countries, he said. Were trying to keep it moving but its a challenge to do.Marks noted that before COVID-19 he spent about 75% of his time on cell and gene therapies, but the pandemic has forced him to shift priorities. Some things have less policy demands at this point in time. At this point in time its very much reversed and its probably 80% of my time on COVID-related activities.Marks also noted that CBERs Office of Tissues and Advanced Therapies (OTAT) has been struggling to keep up with its workload even before the pandemic. With the influx of applications for cell and gene therapies over the last five years, Marks said the office, Should have doubled in size and its only modestly larger, 15-20% larger in size.Marks said he is not satisfied with the level of dialogue the agency has been able to have with gene therapy developers. Especially early on, we should be able to have this dialogue that really facilitates setting things up well so that our knowledge of the entire fieldwe help leverage that for every sponsor.Weve been so strapped in terms of personnel that its hard to do that, Marks said, noting that COVID-19 has exacerbated things even further. Because the number of gene therapy applications hasnt fallen off dramatically, some of the trials may not be moving as quickly, but the applications keep coming in. Marks said that OTAT has also had to shift priorities during the pandemic and that he hopes the next user fee cycle will bring in the resources necessary to staff up further.Speaking on a separate panel with members of industry, OTAT Director Wilson Bryan echoed Marks sentiment.We were stretched thin before the pandemic, and with the flood of work that came in, it really had an impact, he said. Sometimes folks dont like to admit this, but we all know weve had delayed meetings, weve had to delay review of some applications because of giving priority to the pandemic.However, Bryan said the office is getting its balance and is working to catch up on some of its delayed activities.Bryan expressed some worry about the financial well-being of some of the smaller companies his office works with. Were hearing a lot about their struggles to stay afloat and continue and finish off their development programs and whether or not those development programs are going to be sufficient to meet regulatory standards, he said.One of the challenges, said Timothy Schroeder, CEO of CTI Clinical Trial & Consulting, will be dealing with gaps in data from clinical trials. The question is going to be how do sponsors, how do regulatory authorities and how do companies such as ourselves fill those gaps?On the regulator side, Bryan said his office is working with companies on an individual basis to sort out those issues, which differ from one indication to the next.Bryan added that one positive to come of the pandemic is greater interest in remote outcome assessments in clinical trials. If we have an energy now to develop outcome measures and validate outcome measures that allow us to reliably capture information from patients in remote locations, that will ultimately facilitate development, he said.The pandemic also has significantly disrupted FDAs ability to conduct surveillance and preapproval inspections. While the agency has resumed some domestic inspections and mission-critical foreign inspections, it also is leveraging other sources of information, including inspection reports from other regulators, and requesting documents from applicants and facilities in lieu of on-site inspections where possible. (RELATED: FDA issues pandemic inspections FAQ guidance, Regulatory Focus 19 August 2020).Were considering virtual inspections, particularly for companies where the site has a track record, but if its a site that is brand new with no track record or if its a site with that has a bad track record, were hesitant to do that, Bryan said.Bryan also raised the prospect of FDA inspectors tagging along remotely for an inspection being conducted by other regulators. Is it possible that we could have an inspection by European inspectors and have US regulators going along for a virtual inspection at the same time? We think about those things, I dont know that weve done them yet, Bryan said, adding that he is not sure whether FDA inspectors would be comfortable with the information they would get.Curran Simpson, chief operations and technology officer at REGENXBIO, said he sees promise in virtual audits and believes the level of documentation a site provides can be indicative of its compliance.How often have I walked into a manufacturing facility thats well-run but has terrible documentation? Almost never. I think virtual audits, if you do a risk-based approach and the audit partner has the ability to send documentation in an efficient way and you have experienced people doing this, I think youre going to get the same flavor of an audit very quickly from the level of the documentation, he said.Of course, youll want to accompany that to the extent possible with imaging of the facility, Curran said, To see if those practices are being followed, the overall cleanliness of the facility and the management of material movement If you dont get a good impression from the documentation that youre working through, its probably a bigger issue that you want to escalate.Amy DuRoss, co-founder and CEO of Vineti, an enterprise software company specializing in advanced therapies, expressed some doubts about the current potential for fully remote audits.Certainly our piece of the chain because were enterprise software is readily auditable remotely, but I would say that the overall system and in manufacturing, Im not sure weve evolved as a species yet to adapt our remote techniques to get a full picture I dont think were there yet, she said.

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Orgenesis in deal to acquire regenerative medicine company Koligo Therapeutics – Proactive Investors USA & Canada

Tuesday, October 6th, 2020

The agreed consideration terms include $15 million in shares of Orgenesis stock valued at $7 share which will be issued to Koligos accredited investors

Inc () announced Tuesday that it will acquire Koligo Therapeutics Inc, a regenerative medicine company, before year-end.

According to a statement, Koligo is a leader in developing personalized cell therapies utilizing the patients own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a Phase 2 trial of KT-PC-301 for COVID-19-related acute respiratory distress syndrome (ARDS).

Koligos development stage technology utilizes 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer-term applications for neural, liver, and other cell/tissue transplants.

Following the closing of the transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the US and in international markets as well.

Also after closing and eventual clearance by the US Food and Drug Administration, Orgenesis expects to start patient recruitment for a Phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Koligo already has completed a pre-Investigational New Drug consultation with the FDA to start clinical trials of KT-PC-301 in COVID-19-related ARDS. Orgenesis also plans to leverage Koligos 3D-V bioprinting technology across its POCare platform.

Under the deal, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders. The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis common stock valued at $7 share, which will be issued to Koligos accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligos liabilities, estimated to be substantially all of Koligos liabilities.

Koligos management team will be joining Orgenesis to continue commercial and development activities. Koligo CEO Matthew Lehman is an accomplished executive in the biotech and regenerative medicine fields.

We are pleased to announce this transformative acquisition, which we expect will add broad capabilities to our therapeutic and technology platform, and will further our leadership in the cell and gene therapy field, said Orgenesis CEO Vered Caplan.

Based on several phase 1 studies, Koligos KT-PC-301, using a patients own cells, has demonstrated safety and tolerability, and has shown signs of efficacy to support continued development in COVID-19-related ARDS. If successful for the treatment of COVID-19-related ARDS, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent significant unmet medical need.

Koligo CEO Lehman added: The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligos goals. Orgenesis intellectual property is highly complementary to Koligos technology and the combined companies will work to advance a robust commercial and development product portfolio.

Contact the author: [emailprotected]

Follow him on Twitter @PatrickMGraham

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Orgenesis in deal to acquire regenerative medicine company Koligo Therapeutics - Proactive Investors USA & Canada

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What Is Medical 3D Printingand How Is it Regulated? – The Pew Charitable Trusts

Tuesday, October 6th, 2020

Overview

Advances in 3D printing, also called additive manufacturing, are capturing attention in the health care field because of their potential to improve treatment for certain medical conditions. A radiologist, for instance, might create an exact replica of a patients spine to help plan a surgery; a dentist could scan a broken tooth to make a crown that fits precisely into the patients mouth. In both instances, the doctors can use 3D printing to make products that specifically match a patients anatomy.

And the technology is not limited to planning surgeries or producing customized dental restorations such as crowns; 3D printing has enabled the production of customized prosthetic limbs, cranial implants, or orthopedic implants such as hips and knees. At the same time, its potential to change the manufacturing of medical productsparticularly high-risk devices such as implantscould affect patient safety, creating new challenges for Food and Drug Administration (FDA) oversight.

This issue brief explains how medical 3D printing is used in health care, how FDA regulates the products that are made, and what regulatory questions the agency faces.

Unlike traditional methods, in which products are created by shaping raw material into a final form through carving, grinding, or molding, 3D printing is an additive manufacturing technique that creates three-dimensional objects by building successive layers of raw material such as metals, plastics, and ceramics. The objects are produced from a digital file, rendered from a magnetic resonance image (MRI) or a computer-aided design (CAD) drawing, which allows the manufacturer to easily make changes or adapt the product as desired.1 3D printing approaches can differ in terms of how the layers are deposited and in the type of materials used.2 A variety of 3D printers are available on the market, ranging from inexpensive models aimed at consumers and capable of printing small, simple parts, to commercial grade printers that produce significantly larger and more complex products.

To date, most FDA-reviewed products developed via 3D printing have been medical devices such as orthopedic implants; more than 100 have been reviewed.3 Such a manufacturing approach offers several clinical advantages. For example, manufacturers have used 3D printing technologies to create devices with complex geometries such as knee replacements with a porous structure, which can facilitate tissue growth and integration.4 3D printing also provides the ability to create a whole product or device component at once while other manufacturing techniques may require several parts to be fabricated separately and screwed or welded together.

Because this type of manufacturing does not rely on molds or multiple pieces of specialized equipment and designs can rapidly be modified, 3D printing can also be used for creating patient-matched products based on the patients anatomy. Examples include joint replacements, cranial implants, and dental restorations.5 While some large-scale manufacturers are creating and marketing these products, this level of customization is also being used at the site of patient care in what is called point-of-care manufacturing. This on-demand creation of 3D-printed medical products is based on a patients imaging data. Medical devices that are printed at the point of care include patient-matched anatomical models, prosthetics, and surgical guides, which are tools that help guide surgeons on where to cut during an operation. The number of U.S. hospitals with a centralized 3D printing facility has grown rapidly in the past decade, from just three in 2010 to more than 100 by 2019.6 As the technology evolves, this point-of-care model may become even more widespread.

3D printing also has potential applications in other product areas. For example, research is underway to use 3D printing to manufacture pharmaceuticals with the potential for unique dosage forms or formulations, including those that might enable slower or faster absorption. FDA approved one such 3D-printed drug in 2015, an epilepsy treatment formulated to deliver a large dose of the active ingredient that can disintegrate quickly in water.7 3D printing could also one day be used to make personalized treatments that combine multiple drugs into one pill, or a polypill.8 Additionally, researchers are using bioprinters to create cellular and tissue constructs, such as skin grafts9and organs,10 but these applications are still in experimental phases.11

FDA does not regulate 3D printers themselves; instead, FDA regulates the medical products made via 3D printing. The type of regulatory review required depends on the kind of product being made, the intended use of the product, and the potential risks posed to patients. Devicesthe most common type of product made using 3D printing at this timeare regulated by FDAs Center for Devices and Radiological Health and are classified into one of three regulatory categories, or classes. (The agency may also regulate the imaging devices and software components involved in the production of these devices, but these are reviewed separately.)

FDA classifies devices based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.12 Class I devices are low risk and include products such as bandages and handheld surgical instruments. Class II devices are considered moderate risk and include items such as infusion pumps, while Class III devices, which are considered high risk, include products that are life-supporting or life-sustaining, substantially important in preventing impairment of human health, or present an unreasonable risk of illness or injury. A pacemaker is an example of a Class III device.13

Regulatory scrutiny increases with each corresponding class. Most Class I and some Class II devices are exempt from undergoing FDA review prior to entering the market, known as premarket review; however, they must comply with manufacturing and quality control standards. Most Class II devices undergo what is known as a 510(k) review (named for the relevant section of the Federal Food, Drug, and Cosmetic Act), in which a manufacturer demonstrates that its device is substantially equivalent to an existing device on the market, reducing the need for extensive clinical research. Class III devices must submit a full application for premarket approval that includes data from clinical trials.14 FDA then determines whether sufficient scientific evidence exists to demonstrate that the new device is safe and effective for its intended use.15

FDA also maintains an exemption for custom devices. A custom device may be exempt from 510(k) or premarket approval submissions if it meets certain requirements articulated under Section 520(b) of the Federal Food, Drug, and Cosmetic Act. These requirements include, for example, that the manufacturer makes no more than five units of the device per year, and that it is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat.16 In addition, FDA has the option to issue emergency use authorizations as it did in response to the COVID-19 pandemic for certain 3D-printed ventilator devices.17

All devices, unless specifically exempted, are expected by FDA to adhere to current good manufacturing practices, known as the quality system regulations that are intended to ensure a finished device meets required specifications and is produced to an adequate level of quality.18

In 2017, FDA released guidance on the type of information that should be included for 3D-printed device application submissions, including for patient-matched devices such as joint replacements and cranial implants. The document represents FDAs initial thinking, and provides information on device and manufacturing process and testing considerations.19 However, the guidance does not specifically address point-of-care manufacturing, which is a potentially significant gap given the rapid uptake of 3D printers by hospitals over the past few years. FDA has also cleared software programs that are specifically intended to generate 3D models of a patients anatomy;20 however, it is up to the actual medical facility to use that software within the scope of its intended useand to use it correctly.

Although specific guidance from FDA does not yet exist for 3D printing in the drug or biologic domains, these products are subject to regulation under existing pathways through FDAs Center for Drug Evaluation and Research (CDER) or FDAs Center for Biologics Evaluation and Research (CBER). Each product type is associated with unique regulatory challenges that both centers are evaluating. CDERs Office of Pharmaceutical Quality is conducting its own research to understand the potential role of 3D printing in developing drugs and has been coordinating with pharmaceutical manufacturers to utilize this technology.21 CBER has also interacted with stakeholders who are researching the use of 3D printing for biological materials, such as human tissue. In 2017, former FDA Commissioner Scott Gottlieb said that FDA planned to review the regulatory issues associated with bioprinting to see whether additional guidance would be necessary outside of the regulatory framework for regenerative medicine products.22 However, no subsequent updates on this review have emerged.

For medical 3D printing that occurs outside the scope of FDA regulation, little formal oversight exists. State medical boards may be able to exert some oversight if 3D printing by a particular provider is putting patients at risk; however, these boards typically react to filed complaints, rather than conduct proactive investigations. At least one medical professional organization, the Radiological Society of North America, has released guidelines for utilizing 3D printing at the point of care, which includes recommendations on how to consistently and safely produce 3D-printed anatomical models generated from medical imaging, as well as criteria for the clinical appropriateness of using 3D-printed anatomical models for diagnostic use.23 Other professional societies may follow suit as 3D printing becomes more frequent in clinical applications; however, such guidelines do not have the force of regulation.

3D printing presents unique opportunities for biomedical research and medical product development, but it also poses new risks and oversight challenges because it allows for the decentralized manufacturing of highly customized productseven high-risk products such as implantable devicesby organizations or individuals that may have limited experience with FDA regulations. The agency is responsible for ensuring that manufacturers comply with good manufacturing practices and that the products they create meet the statutory requirements for safety and effectiveness. When used by registered drug, biologic, or device manufacturers in centralized facilities subject to FDA inspection, 3D printing is not unlike other manufacturing techniques. With respect to 3D printing of medical devices in particular, FDA staff have stated that [t]he overarching view is that its a manufacturing technology, not something that exotic from what weve seen before.24

However, when 3D printing is used to manufacture a medical product at the point of care, oversight responsibility can become less clear. It is not yet apparent how the agency should adapt its regulatory requirements to ensure that these 3D-printed products are safe and effective for their intended use. FDA does not directly regulate the practice of medicine, which is overseen primarily by state medical boards. Rather, the agencys jurisdiction covers medical products. In some clinical scenarios where 3D printing might be used, such as the printing of an anatomical model that is used to plan surgery, or perhaps one day the printing of human tissue for transplantation, the distinction between product and practice is not always easy to discern.

In recognition of this complexity, FDAs Center for Devices and Radiological Health is developing a risk-based framework that includes five potential scenarios in which 3D printing can be used for point-of-care manufacturing of medical devices. (See Table 1.)25

Sources: U.S. Food and Drug Administration, Center for Devices and Radiological Health Additive Manufacturing Working Group; The American Society of Mechanical Engineers

Questions remain related to each regulatory scenario for point-of-care manufacturing. For example, it is unclear how minimal risk should be evaluated or determined. Should only Class I devices be considered minimal risk or is this determination independent of classification? Is off-label use considered minimal risk? Under the scenarios that involve a close collaboration between a device manufacturer and a health care facility, such as scenarios B and C, who assumes legal liability in cases in which patients may be harmed? Who ensures device quality, given that a specific 3D-printed device depends on many factors that will vary from one health care facility to another (including personnel, equipment, and materials)? Co-locating a manufacturer with a health care facility raises questions about the distinction between the manufacturer and the facility, in addition to liability concerns. Finally, many health care facilities may be ill-prepared to meet all the regulatory requirements necessary for device manufacturers, such as quality system regulations.26

More broadly, challenges will emerge in determining how FDA should deploy its limited inspection and enforcement resources, especially as these technologies become more widespread and manufacturing of 3D-printed devices becomes more decentralized. Furthermore, as the technology advances and potentially enables the development of customized treatments, including drugs and biological products, FDAs other centers will need to weigh in on 3D printing. The agency may need to define a new regulatory framework that ensures the safety and effectiveness of these individualized products.

3D printing offers significant promise in the health care field, particularly because of its ability to produce highly customized products at the point of care. However, this scenario also presents challenges for adequate oversight. As 3D printing is adopted more widely, regulatory oversight must adapt in order to keep pace and ensure that the benefits of this technology outweigh the potential risks.

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What Is Medical 3D Printingand How Is it Regulated? - The Pew Charitable Trusts

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Proposition 14 would authorize state to borrow $5.5 billon for stem cell research – KESQ

Tuesday, October 6th, 2020

California voters are once again considering the issue of stem cell research.

After approving spending $3 billion on the work in 2004, taxpayers are being asked for another $5.5 billion under Proposition 14.

Some of the initial funding was used to create the California Institute for Regenerative Medicine which would get more money if the measure passes.

"Prop 14 is targeted at treating and curing curable diseases that we all care about," said Dr. Larry Goldstein, a professor at UC San Diego, and the Scientific Director for the Sanford Consortium for Regenerative Medicine.

He a supporter of Prop 14, along with the California Democratic Party and the UC Board of Regents.

He says the funding is necessary to save lives.

"We lose family members prematurely to terrible diseases like cancer and Alzheimer's Disease," said Goldstein.

Proposition 14's total cost to tax payers, including interest on the general obligation bonds, is $7.8 billion according to the state legislate analyst.

That breaks down to $280 million a year over 30 years, with the money coming from the state general fund.

The highest profile opponent of Prop 14 points to what they call a "lack of legislative oversight" of the California Institute for Regenerative Medicine.

They also say the state budget deficit is already too high.

That opponent is the Oakland-based "Center for Genetics and Society".

Another opponent has close ties to the California Institute for Regenerative Medicine.

Jeff Sheehy is a member of the agency's Citizen's Oversight Committee.

"We have a lot of needs that are more pressing than stem cell research which is well funded by the federal government," said Sheehy.

Sheehy contends state funding for scientific research should be up to the state legislature.

"You don't vernally pay for programs like this with debt," said Sheehy.

ANALYSIS OF PROPOSITION 21 FROM BALLOTPEDIA:

https://ballotpedia.org/California_Proposition_14,_Stem_Cell_Research_Institute_Bond_Initiative_(2020)

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Proposition 14 would authorize state to borrow $5.5 billon for stem cell research - KESQ

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Election Guide: Here’s What You Need to Know About Proposition 14 – NBC Bay Area

Tuesday, October 6th, 2020

Proposition 14 on the November ballot asks voters to approve $5.5 billion to continue funding stem cell research in California.

Supporters said the research has already lead to important medical breakthroughs, including for COVID-19 victims. Opponents said the proposition is more "shameless overpromising" with money that could be better spent elsewhere.

California voters have been though this before.

In 2004, state voters approved Proposition 71, which meant $3 billion for stem cell research and to establish the California Institute of Regenerative Medicine, or CIRM. The group's chairman and Proposition 14's financial backer, Robert Klein, said that money has lead to significant medical breakthroughs.

But now, CIRM is almost out of money, and Proposition 14 asks voters for $5.5 more for stem cell research.

"If 70 different patient advocacy organizations, from the Michael J. Fox Foundation to the American Diabetes Foundation and the American Association of Cancer Researchers all endorse us -- could they all be wrong?" Klein asked.

Longtime AIDS activist Jeff Sheehy is on the CIRM board and said residents are still paying $325 million a year for Proposition 71.

"We're going to add another $300 million on top of that -- that's two-thirds of $1 billion for stem cell research," Sheehy said. "We don't have a single FDA approved product yet."

Sheehy said taxpayer funding of stem cell research was needed back in 2004 when California was on its own, but now the feds and private industry are spending billions on it every year.

"So we're just duplicating," Sheehy said.

Marcy Darnovsky, executive director of the Center for Genetics and Society, opposes Proposition 14 because of CIRM's quote "Shameless overpromising and hype set the stage for hundreds of underregulated commercial stem cell clinics now offering unapproved treatments that have caused tumors and blindness."

"All those people who survive COVID-19, they are finding up to 50% have heart damage and other organ damage," Darnovsky said. "How are you going to regenerate those tissues? Regenerative medicine is still cell therapy."

Dr. Michael Matthay professor of critical care medicine at UCSF, said CIRM has provided grant money to help research COVID-19 treatments.

"We are using cell based therapy to reduce injury to longs from COVID-19 and to accelerate the recovery process," Matthay said.

It should be pointed out everyone interviewed for this story are in favor of stem cell research -- Darnovsky and Sheehy believe that the billions of dollars being asked of taxpayers could be better spent on education, healthcare, housing and jobs.

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Election Guide: Here's What You Need to Know About Proposition 14 - NBC Bay Area

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Stem cell therapy for blood cancer patients at NIMS – The Hindu

Tuesday, October 6th, 2020

In a big blessing for blood cancer patients requiring stem cell therapy, the State government has established a Centre for Stem Cell and Regenerative Medicine in the Nizams Institute of Medical Sciences (NIMS). The facility will particularly help those from the lower strata of the society who cannot afford corporate medical care.

The centre was inaugurated on Friday by Health Minister Eatala Rajender in the presence of NIMS Director K. Manohar and Superintendent N. Satyanarayana. The centre will provide a ray of hope to blood cancer patients from poor families, those covered under Aarogyashri scheme, requiring stem cell therapy as they would be treated at the centre free of cost, the Minister saidafter dedicating the stem cell and molecular lab as part of the centre to the people.

With the opening of the stem cell therapy centre, NIMS has grown into one of the major hospitals in the country, Mr Rajender stated samples of blood cancer patients which were sent to Delhi for diagnosis earlier can now be done here itself. The success rate of NIMS in stem cell therapy among kidney and heart transplantation patients was very high, he said, but some services were stopped due to rise in COVID-19 cases. However, all services would be resumed within a week with the COVID spread now under control.

Stating that living with COVID-19 would be a new norm as the society was doing with dengue, viral fever, swine flu and malaria, the Minister said and asserted that as per ICMR statistics, about 40 lakh people in Telangana had developed antibodies to COVID and the fleecing of patients families by corporate hospitals in the name of plasma therapy and some costly injections was wrong.

Mr Rajender admitted that COVID treatment in NIMS had impacted the treatment of other patients, particularly those coming in emergency health conditions, and made it clear that outpatient services would be scaled up soon with OP and Critical Care blocks being set up with an investment of 250 crore. Chief Minister K. Chandrasekhar Rao would lay the foundation stone for the new blocks soon to scale up the outpatient services from 2,500 a day in the past to 5,000 a day.

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Winston-Salem trauma surgeon Dr. J. Wayne Meredith installed as the 101st President of the American College of Surgeons – Newswise

Tuesday, October 6th, 2020

Newswise CHICAGO: J. Wayne Meredith, MD, FACS, MCCM, an esteemed trauma, thoracic, and critical care surgeon from Winston-Salem, N.C., was installed this evening for a one-year term as the 101st President of the American College Surgeons (ACS). The installation occurred during the Convocation ceremony that is a highlight of the virtual ACS Clinical Congress 2020, one of the largest educational meetings of surgeons in the world.

Dr. Meredith is the Richard T. Myers Professor and Chairman, department of surgery, Wake Forest School of Medicine, Winston-Salem, and chair of surgery at Wake Forest School of Medicine since 1997. Dr. Meredith joined the faculty of Wake Forest University Health Sciences in 1987. In his years of service at Wake Forest School of Medicine, Dr. Meredith has taken on leadership roles: he served as director of surgical sciences through June 2014 and was appointed chief of clinical chairs of Wake Forest Baptist Medical Center in July 2019.

In addition to serving as the Richard T. Myers Professor and Chair, he has served 10 years as residency program director, department of surgery, Wake Forest School of Medicine. Along with serving as medical director of The Childress Institute for Pediatric Trauma, Dr. Meredith holds a cross-appointment at Wake Forest Institute for Regenerative Medicine, as well as a joint appointment as professor of pediatrics, department of pediatrics. He is chairman of the medical executive committee, a member of Wake Forests graduate medical education committee (1999present), the risk and insurance management advisory council (2002present), the faculty executive council (2002present), the cancer center oversight committee (2004present), the health system management council (2011present), and chairs the medical executive committee (2011present). He has served on the boards of North Carolina Baptist Hospital and Wake Forest Baptist Medical Center.

During his ACS presidential address, entitled Lessons Learned on the Way to this Podium, Dr. Meredith told more than 2,000 newly initiated Fellows of the American College of Surgeons numerous words of advice on having a successful and rewarding career in surgery.

A Fellow of the American College of Surgeons (FACS) since 1990, Dr. Meredith has devoted much of his expertise and energy to ACS trauma-related activities. He served as the Medical Director of ACS Trauma Programs (20062010) and Chair of the Committee on Trauma (COT) (20022006). He has chaired the COTs National Trauma Data Bank Ad Hoc Committee (19972002), the Trauma Registry Subcommittee (19942002), and continues to serve on the Verification, Review, and Consultation Committee (1996present). In addition, he has been a liaison member of the Program Committee (20022006), a member of the national faculty for Advanced Trauma Life Support (2002present), and the ACS COT representative to the American Board of Surgery (ABS) Trauma, Burns, and Critical Care Advisory Council (20052006).

Dr. Meredith is an ACS Governor at-Large (2017present) and serves on the Board of Governors Surgical Training Workgroup. He previously served on the Health Policy Advisory Council (2018).

Furthermore, Dr. Meredith has played a significant role in state-level ACS activities since joining the North Carolina Chapter of the ACS in 1991. He has served as a member of the chapters Board of Directors (1994present), as a member (1991present) and Chair (19911997) of the North Carolina COT, and North Carolina Chapter President (2005).

The College honored Dr. Meredith for his contributions to the ACS with the 2014 Distinguished Service Award (DSA), the Colleges highest honor. The Board of Regents of the ACS presented the DSA to Dr. Meredith in appreciation of his continuous and devoted service as a Fellow and in recognition of his distinctive scientific contributions in cardiovascular physiology during resuscitation, trauma registries, and trauma systems.

In addition to his previously noted service in leadership roles in ACS Trauma Programs, Dr. Meredith has been active in the field in various capacities both nationally and globally. He has been named a visiting professor or named lecturer at more than 20 institutions around the world, from Johannesburg, South Africa, to Quito, Ecuador. He serves on the editorial board of several journals, and is the author or coauthor of more than 170 scientific publications, more than 20 book chapters, and one textbook,Trauma: Contemporary Principles and Therapy.

Dr. Merediths research interests include thoracic trauma, the biomechanics of crash injury, injury severity measures, and trauma systems development. Over the course of his distinguished career, he has been awarded 10 grants for various trauma research studies. He is the principal investigator for a National Institutes of Health grant for Integrative Training in Trauma and Regenerative Medicine, as well as a joint project with Wake Forest School of Medicine and the National Highway Traffic Safety Administration that established a Crash Injury Research and Engineering Network Center of Wake Forest and Virginia Tech, Blacksburg.

Dr. Meredith has held leadership roles in many other professional organizations including president of many surgical professional societies: the Southeastern Surgical Congress, the Eastern Association for the Surgery on Trauma, the Halsted Society, the American Association for the Surgery of Trauma, and the Southern Surgical Association. He has held multiple other leadership positions, including service as director of the American Board of Surgery and the American Board of Thoracic Surgery.

Dr Meredith lives in Winston Salem with Gayle, his spouse of 46 years and constant source of inspiration and love. They have two wonderful children Russell and Amanda, aged 37 and 32.

Other ACS officers installed this evening include:

First Vice-President-Elect H. Randolph Bailey, MD, FACS, FASCRS, a respected colon and rectal surgeon who practices at the University of Texas (UT)/McGovern Medical School, Houston. Dr. Bailey is professor of surgery and emeritus program director of the UT colon and rectal surgery residency training program. He is chief, division of colon and rectal surgery, Memorial Hermann Hospital Texas Medical Center, and deputy chief of surgery, Houston Methodist Hospital.

Second Vice-President-Elect Lisa A. Newman, MD, MPH, FACS, FASCO, is director, interdisciplinary breast program; chief, division of breast surgery; and medical director, International Center for the Study of Breast Cancer Subtypes; Weill Cornell Medicine-New York Presbyterian Hospital Network, N.Y. She also is an adjunct professor of breast surgery at UT MD Anderson Cancer Center, Houston.

FACS designates that a surgeon is a Fellow of the American College of Surgeons.

# # #

About J. Wayne Meredith, MD, FACS, MCCM Dr. Meredith graduated from Emory University, Atlanta, Ga., with a bachelor of arts degree in physics. He earned his medical degree and completed his surgical training in general surgery and cardiothoracic surgery at what is now Wake Forest Baptist Medical Center, Winston-Salem, N.C. He completed his trauma/critical care fellowship as visiting assistant professor of surgery/trauma under the supervision of the late Donald D. Trunkey, MD, FACS, at Oregon Health Sciences University Hospital, Portland.

About the American College of Surgeons The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 82,000 members and is the largest organization of surgeons in the world. For more information, visitwww.facs.org.

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Winston-Salem trauma surgeon Dr. J. Wayne Meredith installed as the 101st President of the American College of Surgeons - Newswise

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Bone Therapeutics, Link Health and Pregene to develop and commercialize the ALLOB allogeneic bone cell therapy platform in China and Southeast Asia -…

Tuesday, October 6th, 2020

Gosselies, Belgium, 5 October 2020, 7am CEST BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, Link Health Pharma Co., Ltd (Link Health) and Shenzhen Pregene Biopharma Company, Ltd (Pregene) today announce the signing of an exclusive license agreement for the manufacturing, clinical development and commercialization of Bone Therapeutics allogeneic, off-the-shelf, bone cell therapy platform ALLOB in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea, and Thailand.

Under the agreement, Bone Therapeutics is eligible to receive up to 55 million in development, regulatory and commercial milestone payments including 10 million in upfront and milestone payments anticipated in the next 24 months. Bone Therapeutics is also entitled to receive tiered double-digit royalties on annual net sales of ALLOB. Bone Therapeutics retains development and commercialization rights to ALLOB in all other geographies outside of those covered by this agreement. As a result, Bone Therapeutics will continue to concentrate on its development and commercialization plans for ALLOB in the US and Europe and novel innovative cell-based products globally.

This collaboration between Bone Therapeutics, Link Health and Pregene expands our geographic reach and demonstrates the global commercial potential of ALLOB,said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. We already have operational experience in Asia with the Phase III clinical trial of our lead product JTA-004 in Hong Kong. We selected Link Health and Pregene to partner with us in Asia as a result of their expertise in advanced therapeutics and cell therapies, their proven track record of development and commercial implementation in Chinese and Asian markets, and Pregenes well established cell therapy manufacturing capacity. Bone Therapeutics will continue to develop the ALLOB cell therapy platform for other markets while exploring additional partnership opportunities in the U.S. and Europe.

The agreement grants Link Health and Pregene exclusive rights to clinically develop and commercialize ALLOB for the treatment of human bone disorders in Greater China, Taiwan, Singapore, South Korea, and Thailand. All rights for China will be transferred to Pregene and Link Health will gain rights for the remaining countries Bone Therapeutics will share its patented proprietary manufacturing expertise for the expansion and differentiation of bone-forming cells and has the option to sell clinical supplies to Link Health and Pregene in preparation for their clinical development of ALLOB.

This collaboration and license agreement for Bone Therapeutics ALLOB provides a strong addition to our pipeline. ALLOB has demonstrated the potential to reduce the recovery time and stimulate bone growth for a variety of bone conditions, and to have a considerable impact on patients lives,said Yan Song, PhD, Chief Executive Officer of Link Health. It is important for Link Health to collaborate with companies that have strong therapeutic product portfolios and entrepreneurial management. This partnership with Bone Therapeutics is a direct result of our shared commitment to appreciate the enormous potential of cell therapy and regenerative medicine.

Pregene now has a flourishing portfolio of CAR-T cell therapy-based cancer treatments. Bone Therapeutics ALLOB provides anallogeneic, off-the-shelf cell therapy that expands our portfolio of cell therapies to include the sizable commercial potential of orthopedics,said Hongjian Li, Co-founder and Chief Executive Officer of Pregene. We expect to be able to leverage our extensive international cell and gene therapy experience to develop Bone Therapeutics ALLOB platform and subsequently launch products in China and Southeast Asian markets.

ALLOB, an allogeneic and off-the-shelf cell therapy product manufactured through a proprietary, scalable production process, consists of human bone-forming cells derived from cultured bone marrow mesenchymal stem cells of healthy adult donors. In preclinical studies ALLOB has shown to reduce healing time in a delayed-union fracture model by half, and has demonstrated good tolerability and signs of efficacy in two Phase IIa studies for two separate indications. The Companys randomized, placebo-controlled, double-blind Phase IIb clinical trial in patients with difficult tibial fractures has received approval from regulatory authorities in six of the seven planned European countries to date, and is expected to enroll the first patient later this year.

About Link Health Pharma Co., Ltd

Link Health is a leading Chinese pharmaceutical company based in Guangzhou, Southern China, focusing on the development of innovative drugs for unmet medical needs.

Link Health has created a highly professional team with diverse expertise in drug development, medical affairs and regulatory affairs. Leveraging deep understanding of China market, regulatory environment and strong network with global biopharmaceutical companies, Link Health is well positioned to bring innovative drugs to the market efficiently. The company has a drug development pipeline of 5 clinical stage assets and 1 under NDA reviewing in China.

The company has also established a fully owned subsidiary in Amsterdam, the Netherlands. The Dutch office builds and further strengthen collaborations with global pharma/biotech partners and research institutes.

About Pregene Biopharma Co., Ltd

Shenzhen Pregene Biopharma Co. Ltd is a leading enterprise in the cell and gene therapy field with the core technology for industrialization. The companys core team comes from well-known institutions and companies including the Academy of Military Medical Sciences, the University of Toronto, and the US FDA.

Pregene has established the gene editing platform, viral vector and cell production platform, nanobody selection platform and other small to pilot trial manufacturing system, with total investment over 100 million CNY. It has the laboratories and GMP plants for cell and gene therapy of over 10,000 square meter.

The company focuses on the research and development of cell and gene therapy drugs, and participated in the drafting the national standard Considerations for CAR-T Cell Quality Study and Non-clinical Evaluation issued by the National Institutes for Food and Drug Control in June 2018. The CAR-T cell therapy for the treatment of multiple myeloma have obtained NMPA IND clearance as the Class I new drug, which is the first in China and fastest in the world using the humanized single domain antibody in CAR construct, and phase I clinical trials are now in progress. Other pipelines such as CAR-T, TCR-T and mRNA drugs for tumors, autoimmune diseases and other indications are in the development at different stages. The company has broad development prospects with the abundant backup technologies.

Looking forward to the future, the company will build the core capacity in one-stop solution for cell and gene therapy drugs, and fulfill the Express of innovative medicine development from drug discovery to clinical products.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available atwww.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

For US Media and Investor Enquiries:LHA Investor RelationsYvonne BriggsTel: +1 310 691 7100ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics, Link Health and Pregene to develop and commercialize the ALLOB allogeneic bone cell therapy platform in China and Southeast Asia -...

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Aziyo Biologics to price IPO on Oct. 7th; competitors include ABBV, MDT, SRGA and SYK – Seeking Alpha

Tuesday, October 6th, 2020

Aziyo Biologics, Inc. is slated to price its IPO on Wednesday, October 7th.

From the prospectus:

"We are a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, concentrating on patients receiving implantable medical devices. From our proprietary tissue processing platforms, we have developed a portfolio of advanced regenerative medical products that are designed to be very similar to natural biological material. Our proprietary products, which we refer to as our Core Products, are designed to address the implantable electronic device/cardiovascular, orthopedic/spinal repair and soft tissue reconstruction markets, which represented a combined $3 billion market opportunity in the United States in 2019. To expand our commercial reach, we have commercial relationships with major medical device companies, such as Boston Scientific and Medtronic, to promote and sell some of our Core Products. We believe our focus on our unique regenerative medicine platforms and our Core Products will ultimately maximize our probability of continued clinical and commercial success and will create a long-term competitive advantage for us."

"We estimate that more than two million patients were either implanted with medical devices, such as pacemakers, defibrillators, neuro-stimulators, spinal fusion and trauma fracture hardware or tissue expanders for breast reconstruction, in the United States in 2019. This number is driven by advances in medical device technologies and an aging population with a growing incidence of comorbidities, including diabetes, obesity and cardiovascular and peripheral vascular diseases. These comorbidities can exacerbate various immune responses and other complications that can be triggered by a device implant."

"Our Core Products are targeted to address unmet clinical needs with the goal of promoting healthy tissue formation and avoiding complications associated with medical device implants, such as scar-tissue formation, capsular contraction, erosion, migration, non-union of implants and implant rejection. We believe that we have developed the only biological envelope, which is covered by a number of patents, that forms a natural, systemically vascularized pocket for holding implanted electronic devices. We have a proprietary processing technology for manufacturing bone regenerative products for use in orthopedic/spinal repair that preserves a cells ability to regenerate bone and decelerates cell apoptosis, or programmed cell death. We have a patented cell removal technology that produces undamaged extracellular matrices for use in soft tissue reconstruction. In pre-clinical and clinical studies, our products have supported and, in some cases, accelerated tissue healing, and thereby improved patient outcomes."

"COMPETITION: Our Core Products compete primarily with implantable electronic device envelopes and other cardiovascular repair products, other orthobiologics and human-derived acellular dermis products. The CanGaroo envelope competes with the synthetic envelope TYRX from Medtronic (NYSE:MDT). ProxiCor, Tyke and VasCure compete with bovine pericardium produced by numerous companies, including Gores Goretex and Terumos (OTCPK:TRUMF) Vascutek. FiberCel, ViBone and OsteGro V compete with other viable bone matrices, such as Smith & Nephews (NYSE:SNN)Bio4, MTFs Trinity ELITE, NuVasives (NASDAQ:NUVA) OsteoCel, Vivex Biologics VIA Graft and LifeNet Healths ViviGen. SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including AbbVies (NYSE:ABBV)AlloDerm, Surgalign Holdings (NASDAQ:SRGA)Cortiva, Strykers (NYSE:SYK) DermACELL andEthicons FlexHD. SimpliDerm also competes against animal-derived biological mesh products, such as AbbVies Strattice and Integras (NASDAQ:IART) SurgiMend, as well as various synthetic mesh products."

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Aziyo Biologics to price IPO on Oct. 7th; competitors include ABBV, MDT, SRGA and SYK - Seeking Alpha

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