MiMedx to launch next generation new lyophilized version of OrthoFlo
MiMedx Group, Inc., the leading regenerative medicine company, announced 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 US 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.