Scientific And Clinical Review Confirms Potential Of MiMedx dHACM Allografts For Regenerative Applications In Orthopedics

MARIETTA, Ga., June 15, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed scientific and clinical review article of the MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been electronically published in the journal  Techniques In Orthopaedics.

The paper entitled "Dehydrated Human Amnion/Chorion Membrane Allografts as a Therapy for Orthopedic Tissue Repair" was authored by Jennifer Lei, PhD; Lauren B. Priddy, PhD; Jeremy J. Lim, PhD; and Thomas J. Koob, PhD. The electronic publication in Techniques In Orthopaedics can be found at http://journals.lww.com/techortho/Abstract/publishahead/Dehydrated_Human_Amnion_Chorion_Membrane__dHACM_.99929.aspx. The article will also be published in a special Symposium issue of Techniques in Orthopaedics on "Emerging and Evolving Materials for Orthopaedics." Guest Editors for this Symposium issue are David L. Safranski, PhD (MedShape, Inc., Atlanta, GA) and Ken Gall, PhD (Duke University, Durham, NC).

Over 226 growth factors and bioactive proteins have been identified to date in dHACM allografts, and these collective proteins have been shown to regulate activity of a variety of cell types, including stem cells that are critical for orthopedic repair. An independent comparison by a contract research organization demonstrated that micronized MiMedx PURION® Processed dHACM has significantly higher content of growth factors and bioactive proteins than two other commercially available placental-derived flowable products: FloGraft® FREEDOM (Applied Biologics) cryopreserved amnion and amniotic fluid product and PX50® (Skye Biologics) placental tissue matrix. Therefore, dHACM retains high levels of growth factors, cytokines, and chemokines.

In addition to an established history in promoting healing of chronic wounds, amniotic membrane allografts have recently been used in various orthopedic applications to reduce pain, prevent scar tissue formation, and promote healing. MiMedx PURION Processed dHACM (EpiFix® and AmnioFix®) allografts have been used in various orthopedic applications, including tendon and ligament repair, treatment of cartilage and joint space disorders, and spine procedures. The general outcomes achieved by physicians for these applications include:

• Tendon and Ligament Repair:
• dHACM reduced pain and improved function following treatment of plantar fasciitis, anterior cruciate ligament (ACL) reconstruction, supraspinatus and infraspinatus tendon (rotator cuff) injury, common extensor tendon tear, lateral epicondylitis (tennis elbow), patellar tendon tear, and Achilles tendinopathy.
• Cartilage and Joint Space Disorders:
• dHACM increased production of hyaluronic acid by human fibroblast-like synoviocytes in vitro, including in cells derived from osteoarthritis and rheumatoid arthritis donors.
• In a rat model of osteoarthritis, injection of micronized dHACM into the knee joint space attenuated cartilage degeneration with a significant reduction in lesions, erosions, and proteoglycan loss.
• Spine Procedures:
• dHACM has been successfully used during transforaminal lumbar interbody fusion (TLIF) to minimize postlaminectomy epidural adhesions and scarring, resulting in significantly lower patient pain scores.

Parker H. Petit, Chairman and CEO, stated, "The outcomes that physicians have reported they are achieving when utilizing our dHACM allografts in orthopedic procedures are very impressive. We wanted to support those clinical outcomes with a comprehensive scientific and clinical review of orthopedic applications using dHACM." 

Study Background and Conclusions:

Amniotic membrane allografts are composed of extracellular matrix components such as collagen, fibronectin, and laminin, and contain a vast array of diverse growth factors and cytokines. dHACM allografts have been shown in randomized clinical trials to be effective therapies to enhance healing, and have demonstrated the ability to recruit the migration of stem cells to the site of injury in vitro and in vivo. The regenerative properties of dHACM include the ability to reduce scar tissue formation, modulate inflammation, and enhance healing, and these properties suggest that dHACM may be an effective therapy to promote healing within a variety of orthopedic tissues.

In this scientific review, the basic structure, function, and components of dHACM are discussed, and its current in vitro, in vivo, and clinical usages in orthopedic tissue repair applications are summarized as follows:

• The delivery of growth factors, cytokines, and protease inhibitors by dHACM allografts modulates the three main phases of healing including inflammation, proliferation, and remodeling.
• Current research and clinical cases for repairing orthopedic tissues have shown that dHACM allografts have promising results in repairing injured and diseased tissues due to their ability to reduce scar tissue formation, modulate inflammation, and enhance healing.
• dHACM allografts have been evaluated for repair of tendon and ligament, attenuation of cartilage and joint space diseases, and prevention of scarring and adhesion formation in spinal fusion procedures.
• Therefore, the use of dHACM allografts has great potential for regenerative applications in orthopedics.

Bill Taylor, President and COO, said, "Clinical usage in orthopedic repair is rapidly growing. We have numerous clinical trials ongoing in the area of orthopedics to evaluate the clinical efficacy of dHACM allografts in plantar fasciitis treatments, Achilles tendon repair, lumbar decompression and microdiscectomy, and total knee arthroplasty. We look forward to sharing the results of these studies when completed."

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

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 results of clinical use of MiMedx products in various procedures and the significance of growth factor and protein content in various products.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that individual physician and patient clinical experiences may vary, other studies may show different or less favorable results,   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, 2016 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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