Scientific Study Confirms How MiMedx dHACM Allografts Effectively Promote Wound Repair

MARIETTA, Georgia, Sept. 12, 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 that the most recent peer-reviewed scientific study of the MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been electronically published  in the journal Advances in Wound Care. The electronic publication of the paper, "Identification of ECM Components and Biological Factors in Micronized Dehydrated Human Amnion/Chorion Membrane," can be found at
http://online.liebertpub.com/doi/abs/10.1089/wound.2016.0699.

The paper was authored by Jennifer Lei, PhD; Lauren B. Priddy, PhD; Jeremy J. Lim, PhD; Michelle Massee; and Thomas J. Koob, PhD.

The use of bioactive extracellular matrix ("ECM") grafts such as amniotic membrane is an attractive treatment option for enhancing wound repair. In this scientific study, the concentrations, activity, and distribution of matrix components, growth factors, proteases, and protease inhibitors were evaluated in MiMedx PURION® Processed dHACM.  This scientific study is the first published study to characterize components that function in wound healing, including protease inhibitors and protease content and activity, in micronized dHACM and any amniotic membrane product.

Study Highlights include:

• MiMedx dHACM tissue contained ECM components, including collagens I and IV, hyaluronic acid, heparin sulfate proteoglycans, fibronectin, and laminin, as well as numerous growth factors, cytokines, chemokines, proteases, and protease inhibitors that are known to participate in the wound healing process.
• Though matrix metalloproteinases (MMPs) were present in MiMedx dHACM tissues, inhibitors of MMPs overwhelmingly outnumbered the MMP enzymes by a ratio of more than 28:1.
• MMPs in the MiMedx tissue exist either in their latent form or are likely complexed with active inhibitors.
• Overall, this work provides a better understanding of how MiMedx micronized dHACM tissue can be used to effectively promote wound repair.

Matrix metalloproteinases (MMPs) are a class of proteinases with diverse roles in tissue remodeling. MMP expression is increased during physiological tissue remodeling including bone turnover and fracture healing, pregnancy, angiogenesis, and wound healing. However, unregulated MMP expression can result in excessive tissue breakdown and pathological conditions; therefore, inhibitors of MMPs are necessary to modulate MMP activity.

Thomas J. Koob, Chief Scientific Officer, said, "Due to the dynamic nature of the tissue and its biologic factor-rich ECM, fresh amniotic membranes have demonstrated efficacy in wound healing applications, and the PURION Process has been shown to retain these natural biological activities. These study results identified ECM components and characterized a variety of growth factors, cytokines, proteases, and inhibitors present in MiMedx dHACM tissues. We believe that at an injury site, the administration of MiMedx micronized dHACM tissue will deliver matrix molecules, a cocktail of growth factors and cytokines, and protease inhibitors that collectively promote healing. Ultimately, the use of MiMedx micronized dHACM in the treatment of chronic wounds may advance the current standards of wound care."

Parker H. Petit, Chairman and CEO, added, "This publication explains the presence of MMP inhibitors, their role in balancing MMP activity, and the overall modulation effects of the MiMedx dHACM tissue.  One particular competitor has attempted to discredit our tissue's effectiveness because of the presence of MMPs.  Unfortunately, their pseudo-scientific approach fails to take into consideration whether the MMPs are enzymatically active, and also fails to take into account the abundance of MMP inhibitors and the modulation effect of our PURION Processed tissue.  This publication should clearly set the record straight and set a high standard for scientific exploration of the mechanism of action for amniotic tissue."

Physiological wound healing is a well-coordinated sequence of events in which signaling and remodeling of the ECM are integral components. After injury, the wound progresses through hemostasis, inflammation, proliferation, and repair/remodeling, ultimately resulting in the regeneration of functional tissue. In contrast, a chronic wound may result from delayed resolution of the inflammatory phase. The combination of excessive proinflammatory cytokines and reactive oxygen species induce upregulation of proteases and MMPs that not only degrade ECM but also alter the activity of growth factors and proteins necessary for progression to tissue repair/regeneration.  Therefore, the use of MiMedx micronized dHACM may restore balance to the prolonged inflammatory state and promote healing of chronic wounds through delivery of inhibitors of MMPs.

Koob stated, "The healing effects of MiMedx amniotic membrane on chronic wounds are thought to be due at least in part to the inherent capacity of the membrane to coordinate ECM remodeling, an essential function not only during pregnancy but also for wound healing. This study evaluated the concentrations and distribution of vital ECM components and growth factors, along with MMPs and their inhibitors, in MiMedx micronized dHACM, and serves as the first exploration into the structure and composition of the micronized form of the tissue. Ultimately, understanding how amniotic membrane therapies such as MiMedx dHACM are efficacious in the treatment of chronic wounds is crucial to advancing the standards of wound care."

Bill Taylor, President and COO, commented, "Successful closure of chronic wounds often requires advanced therapies to resolve the persistent inflammatory state and repair the lost and/or damaged tissue.  Throughout pregnancy, the amniotic membrane ECM undergoes physiological remodeling to maintain structural integrity while allowing for expansion during growth of the fetus. The balance of MMPs and their inhibitors is crucial for maintenance of the ECM during pregnancy. Likewise, this research shows that the balance of MMPs and their inhibitors are crucial in response to damaged tissue and the closure and healing of a wound."

About MiMedx

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 the administration of MiMedx micronized dHACM at an injury site will deliver matrix molecules, a cocktail of growth factors and cytokines, and protease inhibitors that collectively promote healing; that ultimately, the use of MiMedx micronized dHACM for chronic wounds may advance the current standards of wound care; and that the publication discussed herein should set the record straight in regards to the presence of MMP inhibitors in MiMedx PURION Processed tissue and their role in modulation of MMPs. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that micronized dHACM may not work as expected on all patients; micronized dHACM may function differently in the clinical setting than in the scientific setting; that the publication is not accepted by the scientific community as an informative work in the area of MMPs and MMP inhibitors, 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.

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