MARIETTA, Ga., July 25, 2016 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today its expansion of its regenerative medicine portfolio with plans for the nationwide launch of the Company's next generation new lyophilized version of OrthoFlo.
The lyophilized version of OrthoFlo is an extension of the Company's amniotic fluid product family, and it provides superior product safety characteristics and enhanced logistical capabilities. Lyophilization, often referred to as freeze drying, is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. Thus, MiMedx lyophilized amniotic fluid does not have to be cryopreserved to maintain its effectiveness, which eliminates the need for freezers. Lyophilization also allows the allograft to rehydrate easily and quickly for use in various applications.
The lyophilized OrthoFlo is terminally sterilized, which enhances safety. In addition, the lyophilized OrthoFlo provides advanced ease of use for the physician, can be stored at ambient temperature and has a five (5) year shelf life. OrthoFlo, which is utilized in the hospital and sports medicine outpatient market settings, addresses the physician's demand for regenerative medicine therapies to enhance patient care solutions in orthopedic and sports medicine applications.
OrthoFlo is derived from amniotic fluid donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section. Amniotic fluid contains a) nutrients that facilitate fetal growth; b) carbohydrates, growth factors, proteins, lipids and electrolytes; and c) hyaluronic acid, a principal component that enhances viscosity and lubrication in synovial fluid. OrthoFlo contains an array of well-known regulatory proteins, growth factors, cytokines and chemokines that are naturally occurring in amniotic fluid as well as the fluid surrounding many joints.
Parker H. "Pete" Petit, Chairman and CEO, said, "We believe the heightened demand for a product with the characteristics of OrthoFlo is being driven by a number of factors. The active demographic of the U.S. population experiencing sports-related injuries to soft tissues and joints are demanding better and longer lasting solutions. In addition, the rising rates of obesity in the non-active demographic of the U.S. population and the growing occurrence of osteoarthritis are resulting in conditions that require treatments similar to those performed in the repair of sports-related injuries."
Christopher M. Cashman, Executive Vice President and Chief Commercialization Officer, commented, "OrthoFlo will add to our portfolio of regenerative medicine solutions that serve the Orthopedics and Sports Medicine sectors of healthcare. There is immense potential in each of these healthcare sectors. We believe OrthoFlo will enhance our product offerings for these regenerative medicine markets and facilitate expanded growth opportunities as we offer biologic solutions that competing products cannot deliver. This addition should further our leadership role with amniotic technology."
Bill Taylor, President and COO, stated, "Processed with our proprietary methodology, OrthoFlo retains the critical properties of amniotic fluid which protect, cushion, provide lubrication, and reduce inflammation of the affected soft tissue or joint. Current treatments on the market may provide short term relief and improvement but offer minimal long term relief and negligible lasting impact. We believe our OrthoFlo product is a clinical and cost effective solution that addresses this treatment need. Additionally, our new lyophilized product is a major advancement in logistics and safety."
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ brand; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix, EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft; EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.
We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the Company's belief that there is heightened demand for a product like lyophilized OrthoFlo, the Company's belief that the product will facilitate expanded growth opportunities, the Company's belief that the product will further its leadership role with amniotic technology, that OrthoFlo is a clinical and cost effective solution to meet certain treatment needs, and that the lyophilized OrthoFlo is a major advancement in logistics and safety. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that demand for, and acceptance of, any new product by the medical community may not be as expected; factors such as insurance reimbursement may impact physician use of the product; lyophilized OrthoFlo may not perform clinically or logistically as anticipated; as with any human tissue product, absolute safety of lyophilized OrthoFlo cannot be guaranteed, even if safety is enhanced by terminal sterilization, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015 and its most recent 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.