MiMedx Group, Inc., 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 plans for the nationwide launch of AmnioFill, the first product in the MiMedx placental collagen matrix product family to be commercially launched.
Physicians are in need of a product to treat larger acute and chronic wounds encountered in the surgical setting. Slated for nationwide release later this month, AmnioFill is being offered in multiple sizes and configurations to address this and other surgical needs.
AmnioFill is a collagenous matrix derived from the placenta and comprised of placental extracellular matrix (ECM) tissue. AmnioFill is a tissue allograft containing ECM proteins, growth factors, cytokines and other specialty proteins present in placental tissue. Over 226 growth factors, cytokines and chemokines, including important modulators of inflammation and factors critically important in wound healing, are contained in the AmnioFill placental tissue. MiMedx employs terminal sterilization in addition to aseptic processing techniques in its proprietary processing methodology to enhance the safety of AmnioFill and its other amniotic and placental products.
Parker H. “Pete” Petit, chairman and CEO, said, “AmnioFill will be a great addition to our product lines, addressing the needs of both wound care and surgical markets. For example, we expect that AmnioFill will be an ideal solution for physicians in the treatment of dehisced surgical wounds and other deep complex and hard-to-heal surgical wounds that require a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue.”
Christopher M. Cashman, executive vice president and chief commercialization officer, commented, “The historical costs to treat these types of wounds are significant, and the quality of life issues of non-resolved wounds of this nature can be devastating. There were 53 million outpatient procedures performed in the United States in 2010. Despite advances in preoperative care, the rate of surgical wound dehiscence has not decreased in recent years with 1% to 3% of patients experiencing wound dehiscence. For example, breast reconstruction incisional dehiscence rates range from 10% to 15% in a setting with radiation therapy and abdominal wall surgical dehiscences have a mortality rate as high as 45%.”
Bill Taylor, president and COO, stated, “Our published scientific studies have demonstrated that our dehydrated Human Amnion/Chorion Membrane (dHACM) allografts cause stem cells to migrate and proliferate. Moreover, these scientific studies also demonstrated our dHACM allografts promote angiogenesis. Multiple clinical studies have confirmed that stem cell migration, proliferation and recruitment as well as angiogenesis are essential in wound healing.”
Cashman added, “AmnioFill is designed to provide a scaffold for recruited cells to attach, populate and proliferate. The placental tissues in the scaffold should modulate the activity of the recruited cells to generate new tissue for these larger acute and chronic surgical wounds. When used earlier in the treatment of these complex wounds, we believe AmnioFill becomes an even more cost effective approach as a step therapy for wound closure.”
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 and AmnioFill brands; 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 proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 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 AmnioFill will be a great addition to its product lines, addressing the needs of both wound care and surgical markets; that AmnioFill will be an ideal solution for physicians in the treatment of dehisced surgical wounds and other deep complex and hard-to-heal surgical wounds that require a connective tissue matrix to replace or supplement damages or inadequate integumental tissue; and that, when used earlier in the treatment of complex wounds, AmnioFill becomes an even more cost effective approach as a step therapy for wound closure. 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 third party reimbursement may impact physician use of product; AmnioFill may not be used as anticipated or perform as anticipated in the clinical setting; AmnioFill may not be as cost effective as anticipated, 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.