Stem Cell Clinic

Stemming the tide of stem-cell treatment scams – Houston Chronicle

Michael Roizen, M.D., and Mehmet Oz, M.D.

July 21, 2021Updated: July 21, 2021 1:56p.m.

Q: Im considering having my own stem cells injected into me to improve physical and mental problems that I am having post-COVID-19 infection. What do you think?

James D., Huntington, N.Y.

A: Theres been a lot of talk about using what are called autologous stem cells (your own) to fight off COVID-19 long-haul symptoms, as well as to treat everything from torn ligaments to Alzheimers disease. None is approved by the Food and Drug Administration. The only stem-cell-based products that are FDA-approved come from blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood and theyre for treating disorders involving production of blood (the hematopoietic system). A list is at fda.gov; search for Approved Cellular and Gene Therapy Products.

In fact, stem cell/regenerative medicine treatment scams are so prevalent that this spring the FDA finally told manufacturers and marketers that they had to comply with regulations on human cell and tissue products. Unfortunately, a June report from Pew Trust found compliance by the companies and enforcement from the FDA to be anemic.

What the report did find was that more than 700 clinics in the U.S. offer unapproved stem-cell and regenerative medicine interventions for conditions such as Alzheimers, muscular dystrophy, autism, spinal cord injuries and, most recently, COVID-19. They also found post-injection infection happens frequently and is likely because of sloppily manufactured products and failure to properly screen for diseases such as HIV and hepatitis B and C.

If youre considering stem-cell treatment, the FDA urges you to ask the clinic for the following info before getting it even if the stem cells are your own:

Proof the FDA has reviewed and approved the treatment. Have your primary care doc confirm the information.

If the clinic is claiming it has an FDA-issued Investigational New Drug application number, ask for it and ask to review the FDA communication acknowledging the IND.

Stem-cell treatment has great potential, but when used for unapproved therapies outside a clinical trial, its risky (and expensive). To search for a trial, go to clinicaltrials.gov.

Q: My doctor says my high blood pressure puts me at increased risk for dementia. I think hes just trying to get me on one more med. Is there really a connection?

Lacie R., Sacramento, Calif.

A: Dementia means that you have cognition problems that cause trouble with memory, thought and everyday tasks. That could result from mini- or regular strokes, and we know that high blood pressure increases your stroke risk. In fact, one Harvard study found that high blood pressure increases a mans risk of stroke by 220 percent; another found that each 10 mmHg rise in systolic pressure (the top number) boosts your risk of ischemic stroke by 28 percent and of hemorrhagic stroke by 38 percent.

Even if your high blood pressure doesnt trigger a stroke, it can lead to impaired cognition and dementia. The 2018 SPRINT-MIND trial found that intensive control of high blood pressure (getting the top number below 120) lowered the risk of mild cognitive impairment by 19 percent compared with standard blood pressure control. Now, a new study in the journal Hypertension indicates that certain antihypertensive medications ACE inhibitors and ARBs (and angiotensin II receptor blockers) can cross the blood-brain barrier and lower dementia risk. Tracking almost 13,000 people for three years, the researchers found that folks taking those meds showed less memory loss than folks taking other sorts of antihypertensive medications.

You dont indicate how high your blood pressure is, but if it is only slightly elevated you may be able to bring it down through changing your diet, losing weight if you need to and exercising for 30 to 60 minutes five days a week. If it is above 125 (top number) or above 85 (bottom number), a combo of those self-care techniques and medication may be the safest choice. But either way, bringing your blood pressure to around 115/75 will protect your brain, as well as your heart, kidneys and eyes.

Contact Drs. Oz and Roizen at sharecare.com.

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Stemming the tide of stem-cell treatment scams - Houston Chronicle

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy – – pharmaphorum

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinsons disease which is currently in early-stage clinical testing.

The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time.

Those are all considerations for the future as the first patients only started to be treated with DA01 in a phase 1 trial aimed primarily at showing the safety of the therapy, which is trying to replenish the dopaminergic neurons that progressively die away in Parkinsons and lead to slow, laboured movement, tremors and other symptoms.

The therapy involves implantation of dopamine-producing cells under general anaesthesia into a part of the brain called the putamen, which is particularly affected by neuron loss in Parkinsons and is responsible for regulating movement as well as some types of learning.

Patients take immune-suppressing drugs to prevent their body rejecting the transplanted cells, and the safety and tolerability of the procedure as well as the ability of the transplant to survive will be monitored for two years.

BlueRock is also hoping to demonstrate some evidence of efficacy, and will look at clinical measures such as motor function over the same time period. It is the first trial in the US to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinsons, according to the company.

The first patient in the trial, which will eventually enrol 10 subjects with advanced Parkinsons, was treated at Memorial Sloan Kettering Cancer Centre in June, and others will be recruited at Weill Cornell Medical Centre, the University of California, Irvine, and the University of Toronto.

Our objective is to use authentic cells, to have them integrate entirely into the brain and restore lost physiologic function, said BlueRock chief executive Emile Nuwaysir, as the first patient was treated.

If successful, this new therapeutic modality could have implications for the Parkinsons community and beyond, he added.

Bayer took control of BlueRock in 2019, three years after backing the formation of the company as joint venture with private equity group Versant, in a deal that valued the biotech at $1 billion.

DA01 is Bluerocks lead cell therapy programme, but the company is also working on treatments for other neurological disorders, degenerative heart disease, and autoimmune disorders.

Bayer is also developing a gene therapy for Parkinsons originated by Asklepios Bio (AskBio), which it acquired for $2 billion upfront last year with another $2 billion tied to milestones, and has pledged to make cell and gene therapies a pillar of its R&D strategy.

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FDA gives speedy review to Bayer's Parkinson's stem cell therapy - - pharmaphorum

Creative Medical Technology Holdings Announces MyeloCelz The Company’s Second Regenerative Immunotherapy Product – PRNewswire

PHOENIX, July 20, 2021 /PRNewswire/ -- (OTC CELZ)Creative Medical Technology Holdings Inc. announced today the launching of its second Regenerative Immunology product, MyeloCelz.

In contrast to the Company's ImmCelz product, which utilizes primarily T cells and B cells to induce activation of the body's own stem cells and healing processes, MyeloCelz utilizes the innate immune system, particularly cells of the monocyte/macrophage lineage.

"Immunotherapy is the future of medicine. In the field of oncology immunotherapy it has saved thousands of lives and resulted in the Nobel Prize in Medicine." Said Thomas Ichim, Ph.D, Chief Scientific Officer, and Co-Founder of the Company. "We believe that in using ImmCelz and MyeloCelz, we are in the position to advance immunotherapy for treatment of degenerative conditions, an approach that we term "Regenerative Immunotherapy". This is a first-in-class therapeutic direction that leverages the specificity, amplification, and memory of the immune system in order to accelerate the body to restore its function."

"The unique thing about MyeloCelz, like ImmCelz, is that the cellular product is personalized and the patient is receiving their own cells back into themselves. This not only significantly increases the safety of the procedure, but also conceptually may increase efficacy because the body's own cells know best how to interact with the body." Said Dr. Courtney Bartlett, Director of Clinical Development.

"Having recently joined the Scientific Advisory Board of the Company, I am astonished at the expedience, innovation, and productivity of the team assembled by Dr. Thomas Ichim, Chief Scientific Officer of the Company." Said Dr. Camillo Ricordi. "MyeloCelz, which is a parallel immunotherapy approach to ImmCelz, is another paradigm shifting product and to my knowledge, is covered by one of the most comprehensive patent applications in cell therapy."

The Company's first regenerative immunotherapy product, ImmCelz was demonstrated effective in numerous animal models of autoimmunity and is the subject of a filed and pending FDA IND for use in stroke. ImmCelz was featured at the international stem cell conference, The World Stem Cell Summit, with the presentation available at this link https://www.youtube.com/watch?v=LTHUxz_xN5w .

"I am grateful for our team of scientific advisors and collaborators, who have worked diligently and ingeniously to develop a cellular therapy that leverages aspects of the innate immune system in stimulating the body to heal itself naturally. The addition of MyeloCelzto our Regenerative Immunotherapy portfolio, which includes ImmCelz and multiple patent filings on the treatment of specific indications, clearly demonstrates our dedication to the immunotherapy space." Said Timothy Warbington, President and CEO of the Company.

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

Creativemedicaltechnology.com http://www.StemSpine.com http://www.Caverstem.com http://www.Femcelz.com http://www.MyeloCelz.com http://www.OvaStem.com http://www.ImmCelz.com

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

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Creative Medical Technology Holdings Announces MyeloCelz The Company's Second Regenerative Immunotherapy Product - PRNewswire

John Theurer Cancer Center Investigators Participated in ZUMA-7 Study Showing Value of CAR T-Cell Therapy as Second-Line Treatment for Relapsed Large…

July 19, 2021

A new study has found that using CAR T-cell therapy as the second line of treatment for diffusing large B-cell lymphoma (DLBCL) that has returned or continued to grow after initial treatment was more effective than the standard second-line regimen of care for improving event-free survival (EFS / defined as disease progression, needing to start a new lymphoma treatment, or death from any cause). Investigators from Hackensack Meridian/Hackensack University Medical Centers John Theurer Cancer Center (JTCC), a part of Georgetown Lombardi Comprehensive Cancer Center, participated in the multicenter international study, called ZUMA-7.

With a median follow-up of two years, the study showed that patients with DLBCL who received a one-time infusion of axicabtagene ciloleucel (Yescarta) experienced a 60% improvement in EFS compared with patients who received standard care with chemotherapy and autologous stem cell transplantation. Patients in the CAR T-cell therapy group also experienced a better overall response rate. The study is continuing with additional follow-up to assess the effect of the treatments on overall survival and other key endpoints.

Axicabtagene ciloleucel is currently approved by the U.S. Food and Drug Administration for the treatment of large B-cell lymphoma that relapses after or fails to respond to at least two prior regimens of therapy.

This is a very exciting paradigm shift for the treatment of large B-cell lymphoma, explained hematologist-oncologist Lori Leslie, M.D., who led JTCCs participation in the ZUMA-7 study. A 60% improvement in event-free survival is more dramatic than one would anticipate and suggests that early relapsers and some patients at high risk of relapse after initial treatment may benefit from proceeding directly to CAR T-cell therapy.

About 40% of patients with DLBCL will need a second regimen of treatment.

CAR T-cell therapy is a form of treatment which involves removing white blood cells called T cells from the patient, modifying them in the laboratory to train them to see a protein (called CD19) on lymphoma cells, and then multiplying them to much larger numbers. When given back to the patient intravenously, they expand further, ideally identifying and killing cancer cells anywhere in the body.CAR T-cell therapy is a form of immunotherapy and has been called a living therapy because the newly trained T cells continue to find and destroy cancer cells in the body.

As a leader in CAR T therapy, we are proud to be a part of this new development in research that will continue to reshape the landscape of relapsed/refractory aggressive lymphoma who fail standard regimens of chemoimmunotherapy, said Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center. The ZUMA-7 study began in 2017 and includes 359 patients with DLBCL at 77 medical centers around the world, 30% of whom were 65 years or older. Side effects observed in the study were consistent with or even more favorable than the safety profile previously established for axicabtagene ciloleucel. The use of CAR T-cell therapy as second-line treatment did not result in any new safety concerns. Yescarta has been instrumental in transforming outcomes for DLBCL patients in third line setting. It is likely the paradigm will continue to shift towards earlier timing in patients with early failures.

The contributions that the John Theurer Cancer Center made toward identifying a better therapy for the research and treatment of lymphoma further establishes its position as a leading center, said Ihor Sawczuk, MD, FACS, president, Northern Region, and chief research officer, Hackensack Meridian Health. Hackensack Meridian Health isproud to have been involved in this pivotal study.

We are dedicated to continuing to provide the latest research-based treatments to the members of our communities, added Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack MeridianHealth. John Theurer Cancer Center was the first center in New Jersey to be certified to offer CAR T-cell therapy and was active in research assessing its use long before its first FDA approval. We are very excited to see these promising results, which show how this powerful immunotherapy may benefit more people.

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John Theurer Cancer Center Investigators Participated in ZUMA-7 Study Showing Value of CAR T-Cell Therapy as Second-Line Treatment for Relapsed Large...

Kadimastem Patent for cell selection of beta cells to Treat and Potentially Cure Diabetes was Granted in Japan – Yahoo Eurosport UK

Kadimastem Ltd 21-Jul-2021 / 15:46 CET/CEST

Kadimastem Patent for cell selection of beta cells to Treat and Potentially Cure Diabeteswas Granted in Japan

NEWS RELEASE BY KADIMASTEM LTD

Ness Ziona, Israel | July 21, 2021 09:00 AM Eastern Daylight Time

Cell therapy company KadimastemLtd (TASE:KDST) has received its patent approval from the Japanese Patent Office for IsletRx, the company's innovative treatment for diabetes.

IsletRx comprises an expanded population of clinical grade pancreatic islet-like cluster (ILCs) cells, derived from human stem cells, that have the ability to secrete insulin when blood sugar is low and glucagon, a hormone secreted to prevent hypoglycemia, when blood sugar levels drop in response to varying sugar levels (glucose) in the blood. This particular function of IsletRX is similar to a "healthy" pancreas and functions to treat insulin-dependent diabetes, such as Type 1 diabetes also known as juvenile diabetes.

The patent announced today protects Kadimastem's cell selection and enrichment technology, that enables it to identify and fortify the best cells in the expanded population. The patent also covers the use of the company's special production process, where it can remove cells that are not necessary or may impair the efficiency of the transplanted cells. These capabilities are important in achieving the maximum therapeutic effect for potential future insulin-dependent diabetic patients.

In addition, this method of production and cell selection enables the ILCs to be transplanted using a variety of platforms, including very small devices that are more suitable and more convenient for patients.

Kadimastem CEO Asaf Shilonisaid, "Receiving the patent in Japan further strengthens our intellectual property position. The market, in Southeast Asia in general, and the Japanese market, are large and important for the company's future products. Registering the patent in Japan gives Kadimastem a much-welcomed priority status in this territory. We look forward to further developing business collaborations with key players in the pharmaceutical industry in Japan, both for our diabetes and ALS products."

The Japanese market is one of the most significant markets for stem cell-derived cell therapies. In Japan, 7.9% of the population is diabetic and there are more than 2.7 million insulin-dependent diabetic patients. Treatment of these patients is currently estimated at $ 29 billion.

Japan has strategic importance in the field of stem cell therapy, as it is one of the world's most prominent countries in promoting innovation and products in the field of cell therapy. In November 2014, the Japanese Parliament approved a special lawto facilitate clinical trials in the field of cellular medicine, with the aim of expediting approvals of intracellular therapies and quickly bringing them to market.

Social Media:LinkedIn,Twitter,Facebook

Company Contacts:

Asaf Shiloni

CEO

a.shiloni@kadimastem.com

Press Contact:

Marjie Hadad

General Manager

Must Have Communications

917-790-1178 marjie@mhc-pr.com

About Kadimastem:

Kadimastem is a clinical stage cell therapy company, developing and manufacturing "offthe-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. Kadimastem is focusing on two promising products, AstroRx(R) and IsletRX. AstroRx(R), the Company's clinically advanced product, is an astrocyte cell therapy in clinical development as a treatment for ALS and other neurodegenerative diseases. IsletRx, is comprised of functional Stem Cell derived pancreatic islet cells intended to cure patients with insulin dependent diabetes. IsletRx demonstrated safety and efficacy in preclinical studies. Kadimastem was founded by Professor Michel Revel, CSO of the Company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of

Science. Professor Revel received the Israel Prize for the invention and development of Rebif(R), a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).

Forward Looking Statement:

This document may include forward-looking information as defined in the Securities Law,

5728 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.

Asaf Shiloni

+972 73-797-1613

s.herzl@kadimastem.com

https://www.kadimastem.com/

Dissemination of a CORPORATE NEWS, transmitted by EQS Group. The issuer is solely responsible for the content of this announcement.

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Kadimastem Patent for cell selection of beta cells to Treat and Potentially Cure Diabetes was Granted in Japan - Yahoo Eurosport UK

Bluebird, with little fanfare, is first to bring a second gene therapy to market – BioPharma Dive

Dive Brief:

Bluebird is an important company in gene therapy's reemergence. The company's progress developing treatments for rare genetic diseases early last decade helped boost confidence in gene therapy at a time when the field was still recovering from setbacks. Now, gene therapy is a fast-growing field, with many publicly traded companies, a handful of approved products and dozens of startups raising record levels of investment from venture investors.

But Bluebird has had a bumpy ride since debuting as a public company in 2013. Shares swung wildly over the years amid various clinical delays and manufacturing setbacks, while competition from newer gene editing technologies dimmed the outlook for some of its treatments. At less than $30 per share, Bluebird's stock currently trades at levels not recorded for eight years.

The approval of Skysona reflects Bluebird's up-and-down story. It's a scientific achievement, making Bluebird the first company with two marketed gene replacement therapies. (The company also successfully developed an genetically engineered cell therapy called Abecma for the blood cancer multiple myeloma. Others have multiple cell therapies approved.)

Skysona also represents a medical advance for patients with CALD, more than 80% of whom are estimated to not have a matched sibling donor, according to Bluebird. The gene therapy is meant to be as effective as transplants, but safer. In clinical testing, 27 of 32 patients treated with Skysona hadn't experienced major function disabilities after two years of follow up. The company also hasn't observed instances of the potentially deadly immune responses associated with transplants.

Yet Skysona isn't expected to move the needle much for Bluebird's business. CALD is rare: About 80 patients are diagnosed with the disease in the U.S. and Europe combined each year, according to SVB Leerink analyst Mani Foroohar. Identifying those patients will be a challenge for Bluebird, particularly in Europe, as the Netherlands is currently the only country in the EU that screens newborns for the disease.

"The debate around Skysona is largely focused on the market opportunity and that it's commonly perceived as only incremental," Benjamin Burnett, an analyst at Stifel, wrote in June. He predicts $120 million in peak global sales based on an assumed price of $420,000 in Europe and $700,000 in the U.S.

What's more, Bluebird has already had trouble selling its other gene therapy, the beta thalassemia treatment Zynteglo, in Europe. Difficulty convincing EU member states to cover Zynteglo's $1.8 million price tag, combined with manufacturing issues and a temporarily suspended launch, have resulted in very little use of the product.

Bluebird didn't disclose a price for Skysona. A spokesperson told BioPharma Dive via email that the company will "share additional details at a later date."

Bluebird has said it will file for U.S. approval by mid-year, though the company hasn't yet submitted an application.

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Bluebird, with little fanfare, is first to bring a second gene therapy to market - BioPharma Dive

BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson’s Disease – Yahoo Finance

CAMBRIDGE, Mass., July 19, 2021 /PRNewswire/ -- BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly owned subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DA01 for advanced Parkinson's disease (PD). DA01, BlueRock's pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase 1 study.

BlueRock Therapeutics (PRNewsfoto/BlueRock Therapeutics)

The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for accelerated approval and priority review.

"Receiving Fast Track Designation from the FDA is an important step, which will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinson's disease," says Joachim Fruebis, Ph.D., BlueRock's Chief Development Officer. "This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition."

About the TrialThe trial will enroll ten patients in the United States and Canada. The primary objective of the Ph1 study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.

More information about this trial is available at clinicaltrials.gov (NCT#04802733).

About Parkinson's DiseaseParkinson's disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated that patients have already lost 60-80% of their dopaminergic neurons. Parkinson's disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and dyskinesias. Parkinson's disease is the second most common neurodegenerative disorder, impacting more than 7.5 million people, including 1.3 million people in North America.

Story continues

About BlueRock TherapeuticsBlueRock Therapeutics is an engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. The company's cell+gene platform enables the creation, manufacture, and delivery of authentic cell therapies with engineered functionality by simultaneously harnessing pluripotent cell biology and genome editing. This enables an approach where, in theory, any cell in the body can be manufactured and any gene in the genome can be engineered for therapeutic purposes. The platform is broadly applicable, but the company is focused today in neurology, cardiology, immunology, and ophthalmology. In August 2019, the company was acquired by Bayer Pharmaceuticals, for an enterprise value of $1B in upfront and milestone payments. For BlueRock this marks the next step in the journey to prove degenerative disease is reversible, and to bring our revolutionary new medicines to the patients who desperately need them. For more information, visit http://www.bluerocktx.com.

About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to http://www.bayer.com.

Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward-looking statements are based on BlueRock's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing of our clinical trial for DA01; our results regarding the safety, tolerance and efficacy of DA01 cell transplantation for patients with Parkinson's disease; and ongoing FDA and other regulatory requirements regarding the development of DA01. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

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BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson's Disease - Yahoo Finance

ViaCyte Appoints Dr. Jon Wilensky as Head of Surgery – PRNewswire

Dr. Wilensky is a board-certified plastic surgeon and joins ViaCyte after having functioned in an advisory capacity to the company since 2014. He formerly served as the lead surgeon for clinical trials involving both implantable continuous glucose monitors and ViaCyte's implantable cell therapy pipeline. In prior roles, Dr. Wilensky has consulted for numerous other early- and mid-stage companies developing related technologies. Previously, he served in teaching and practice positions with University of California-San Diego School of Medicine in both the Plastic Surgery and Endocrinology/Metabolism Divisions.

"Jon's substantial experience and expertise in plastic surgery, implantable biotechnologies, and cell-based therapeutics is a significant asset," said Howard Foyt, MD, PhD, FACP, Chief Medical Officer at ViaCyte. "We look forward to his contributions as we seek to optimize all aspects of the implantation procedure for patients with diabetes."

Dr. Wilensky received his MD from the University of Michigan Medical School and completed his residency in Plastic Surgery at the University of Michigan Health System. Designated as an Emerging Leader in Biotechnology, he received a fellowship to complete his MBA from the University of California-San Diego Rady School of Management, with an emphasis on Technology Commercialization, Disruptive Innovation & Entrepreneurship. He resides in San Diego and will be reporting directly to Dr. Foyt.

"ViaCyte is at the leading edge of the cell therapy field by combining state-of-the-art cell engineering and device integration technologies to provide cell replacement therapies as a functional cure for diabetes," said Dr. Wilensky. "I am excited to be part of this team focused on providing better outcomes for patients through first-in-class regenerative medicine therapies."

About ViaCyteViaCyte is a privately held clinical-stage regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use these technologies to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. The Company's first product candidates are being developed as potential long-term treatments for patients with type 1 diabetes to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the Company's efforts, ViaCyte has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. For more information, please visit http://www.viacyte.comand connect with ViaCyte on Twitter, Facebook, and LinkedIn.

SOURCE ViaCyte, Inc.

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ViaCyte Appoints Dr. Jon Wilensky as Head of Surgery - PRNewswire