MiMedx Group, Inc., the leading regenerative medicine company, announced 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."
