Technological Advances in the Regenerative Medicine Markets

Tuesday, March 14, 2017 Drug News
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NEW YORK, March 14, 2017 /PRNewswire/ -- News Commentary


advancements play an important part in the development of biotech companies. The biotech field is very diverse, and therefore some segments stand out more than others, like the Regenerative medicine segment. According to a recent report by Markets and
Markets, the Regenerative medicine market reached a value at USD 13.41 Billion in 2016 and expected to reach USD 38.70 Billion by 2021, growing at a CAGR of 23.6%. The global market can be divided into two types - cell-based products and acellular products. Based on therapy, the market is segmented into cell therapy, gene therapy, tissue engineering, and immunotherapy. Currently, immunotherapy is the fastest growing segment in this industry. RepliCel Life Sciences Inc. (OTC: REPCF) (TSX-V: RP), Stryker Corporation (NYSE: SYK), Zimmer Biomet Holdings Inc. (NYSE: ZBH), Baxter International Inc. (NYSE: BAX), NuVasive Inc. (NASDAQ: NUVA).

The report also indicates that the Regenerative medicine market can be divided by application. The various medical fields where Regenerative medicine can be applied includes, orthopedic and musculoskeletal disorders, dermatology, cardiology, diabetes, central nervous system diseases, and other applications. Oncology is the fastest growing segment of all in this market. This is explained by the increasing cases of cancer around the world and the increasing demand for cancer therapeutics.

RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX-V: RP) is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of two recently completed clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation), as well as, its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries.

Earlier today, RepliCel Life Sciences Inc. announced that, the successful completion of its first-in-human clinical study of the Company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).

The Company reports that the trial successfully met its endpoints and sets the stage for next steps in the ongoing research and development of its product, RCH-01, for the treatment of male and female androgenetic alopecia. "As we march toward commercialization of this product based on this first-in-human data, our aim is to revolutionize the way we prevent, treat, and even reverse hair loss," stated RepliCel President and CEO, R. Lee Buckler.

The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgentic apolecia."The purpose of collecting efficacy data in these early-stage trials," stated RepliCel's Clinical Consultant, Darrell Panich, "is for our clinical team and management to obtain data that can be used to inform basic decisions about further development, provide provocative insights into the product's potential, and - perhaps most importantly - provide useful feedback which we can use to drive decisions about process and product development, ongoing research, and future clinical trial parameters."

"We are very pleased with the unquestionable safety profile of RCH-01," stated RepliCel's Co-founder and Chief Medical Officer, Dr. Rolf Hoffmann. "Five-year safety follow-up is rare for cell therapy products and demonstrates our commitment to the highest quality of clinical research. Furthermore, the efficacy signals we see validate the research and development strategy we have had in place since we saw the six-month post-injection data in 2012."

Stryker Corporation (NYSE: SYK) is a medical technology company. The Company offers a diverse array of innovative products and services that deal in Orthopedics, Medical, Surgical, Neurotechnology and Spinal products that help improve patient and hospital efficiency. The Neurotechnology and Spine segment includes neurovascular products, spinal implant systems and other related products. The Company's products include implants, which are used in joint replacement and trauma surgeries, as well as other products that are used in a range of medical specialties.

Zimmer Biomet Holdings Inc. (NYSE: ZBH) is a global leader in musculoskeletal healthcare, announced early in February the international release of the Subchondroplasty® (SCP®) Procedure. The SCP Procedure is a minimal invasive outpatient intervention procedures that addresses the defects associated with subchondral bone marrow lesions (BMLs). Patients are diagnosed using an MRI and physical exam, BMLs are associated with stress fractures or micro-fractures of the bone adjacent to the joint. Left untreated, these defects may lead to cartilage degeneration, limited function, pain and a greater risk for joint deterioration. "The Subchondroplasty procedure addresses a previously unmet need in my practice for patients with chronic and painful bone marrow lesions," said Dr. Christopher Baker, Orthopedic Surgeon at Florida Orthopedic Institute in Tampa, Florida. "These patients no longer benefit from conservative treatment, yet are not ready for total joint replacement surgery," he added.

Baxter International Inc. (NYSE: BAX) and ScinoPharm Taiwan Ltd. announced a strategic partnership to develop, manufacture and commercialize five injectable drugs used in a range of cancer treatments such as lung cancer, multiple myeloma, and breast cancer. The arrangement also provides Baxter the option to partner with ScinoPharm-one of the world's leading active pharmaceutical ingredient manufacturers-on as many as 15 additional injectable molecules. "Combining Baxter's differentiated manufacturing expertise and global commercialization capabilities with ScinoPharm's recognized API experience enables Baxter to increase patient access to difficult-to-manufacture, high-quality oncolytic medicines," said Robert Felicelli, president, Pharmaceuticals, Baxter. "The ScinoPharm collaboration will further expand Baxter's presence in generic injectables, which will continue to be enhanced through our recently executed agreement to acquire Claris Injectables Limited."

NuVasive Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. The platform combines three product categories: its MaXcess retractors, specialized implants and fixation products, nerve monitoring systems and service offerings that collectively enable surgeons to detect and navigate around nerves, while directing customized access to the spine for implant delivery. NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. 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.

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