Regenerative Technology Innovations in the Medical Market

Tuesday, April 4, 2017 Corporate News
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NEW YORK, April 4, 2017 /PRNewswire/ -- News Commentary


to a report by Mordor Intelligence, the global regenerative market is estimated to reach USD 102.2 billion by 2021, from USD 24.8 billion in 2016 or growing at a CAGR of 23.2 %. Thanks to scientific
and technological advancements made in recent years, small molecules and biologics are showing potential in the market. These sectors are estimated to grow at a CAGR of 18.9% and contributing to the regenerative market as a whole. Regenerative medicines have the ability to restore the lost functionalities in tissues or organs, unlike conventional medicines which are palliative. RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX-V: RP), Allergan plc (NYSE: AGN), BioTime, Inc. (NYSE: BTX), Athersys, Inc. (NASDAQ: ATHX), NuVasive, Inc. (NASDAQ: NUVA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB) explains that the Regenerative medicine is a broad field that includes tissue engineering but also incorporates research on self-healing - where the body uses its own systems, sometimes with help from foreign biological material to recreate cells and rebuild tissues and organs. The field hopes to focus on cures instead of treatments for complex, often chronic, diseases. In addition to medical applications, non-therapeutic applications include using tissues as biosensors to detect biological or chemical threat agents, and tissue chips that can be used to test the toxicity of an experimental medication.

RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX-V: RP) earlier today reported, 'statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.'

The primary objective of this trial was to establish a complete safety profile for intradermal injections of RCS-01 (RepliCel's type 1 collagen-expressing, hair follicle-derived fibroblasts "NBDS cells") at six months post-injection. Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product's potential for skin rejuvenation.

The study was neither powered for, nor was expected to show statistically significant results of efficacy. However, the nearly two-fold increase in gene expression of collagen-related biomarkers in the skin after a single injection of RCS-01 was so profound that the results are considered statistically significant. The study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. Notably, gene expression markers, such as tissue inhibitor of metalloproteinases (TIMP), showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin.

"This type of positive effect on TIMP gene expression, which is related to protection against collagen degeneration, is rarely observed. In my experience, after decades of performing these tests, this is an exceptional finding, particularly for a safety trial with a small sample size," stated Prof. Dr. med Jean Krutmann, Scientific Manager of the IUF Leibniz Research Institute for Environmental Medicine where the study was conducted. "The promising results demonstrate the potential of RCS-01 to promote skin rejuvenation. An increase in collagen markers of this nature would be expected to translate into clinically measurable and aesthetically visible effects."

"This is the most compelling data we have announced to date," stated RepliCel CEO and President, R. Lee Buckler. "Longer term, this data is very complementary to our focus on commercializing a next-generation dermal injector and its targeted application not only with RCS-01, but also with other aesthetic products on the market today. We look forward to discussing these findings and the potential of our products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in our programs."

Allergan plc (NYSE: AGN) is a global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. On February 1st, 2017, Allergan announced the completed acquisition of LifeCell Corporation, a leading regenerative medicine company for approximately $2.9 billion in cash. This acquisition creates world-class aesthetic and regenerative medicine business in plastic surgery as well as including immediate accretive revenues from leading acellular dermal matrix and fat grafting products.

BioTime, Inc. (NYSE: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, on March 13th, 2017 announced the expansion of its ongoing Phase I/IIa clinical trial for OpRegen® in the advanced dry form age-related macular degeneration (dry-AMD) by naming the first two sites that will treat patients in the U.S. OpRegen® is a therapy in development for the dry form of Age-related Macular Degeneration (dry AMD). OpRegen® cells are introduced into the subretinal space where they are expected to replace missing RPE cells.

Athersys, Inc. (NASDAQ: ATHX) an international biotechnology company engaged in the discovery and development of therapeutic product, candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived 'off-the-shelf' stem cell product, initially for disease indications in the neurological, cardiovascular, inflammatory and immune disease areas, and has several ongoing clinical trials evaluating this potential regenerative medicine product. On March 20th, 2017 the company announced that clinical investigators have published results from Athersys' Phase 2 trial of MultiStem cell therapy for treating ischemic stroke patients in the peer-reviewed journal, The Lancet Neurology. The article highlights the feasibility and safety of intravenous MultiStem treatment for patients who have suffered a moderate to severe stroke, the increased benefit for those patients receiving MultiStem treatment within 36 hours of their stroke, include all the way up to one year.

NuVasive, Inc. (NASDAQ: NUVA) is a leader in minimally invasive, procedurally-integrated spine solutions. NuVasive's highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. The company announced that the U.S. Food and Drug Administration provided (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. "This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons," said Jason Hannon, NuVasive's President and Chief Operating Officer.

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