Scientific Study Demonstrates That MiMedx Allografts Stimulate Cellular Proliferation And Migration In A Variety Of Adult Stem Cells

MARIETTA, Ga., July 15, 2015 /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 its latest peer-reviewed scientific study, "Dehydrated Human Amnion/Chorion Membrane Regulates Stem Cell Activity In Vitro," was electronically published in the Journal of Biomedical Materials Research: Part B – Applied Biomaterials. 

The electronic publication of the peer-reviewed article is now available in the Wiley Online Library and can be found at http://onlinelibrary.wiley.com/doi/10.1002/jbm.b.33478/abstract. The paper was authored by Michelle Massee; Kathryn Chinn; Jennifer Lei; Jeremy J. Lim, PhD; Conan S. Young, PhD; and Thomas J. Koob, PhD. The hard copy publication is expected to follow in a future issue of the Journal of Biomedical Materials Research: Part B – Applied Biomaterials.

Chronic wound management, including the management of diabetic foot ulcers and venous ulcers, remains a significant clinical challenge, affecting approximately 6.5 million patients in the United States with cost of care exceeding $25 billion annually. Between 20% and 40% of foot ulcers fail to heal with initial treatment and progress to the chronic state, where tissue damage in these wounds may eventually require amputation of the affected limb. The lack of progression toward healing in chronic wounds is hampered by an impaired response in one or more critical phases of healing. The most important of these is chronic inflammation, which must be remedied before the wound can progress to the tissue regenerative phase.

Prior studies have demonstrated that adult stem cells are important for the normal maintenance and repair of wounded tissues through their ability to differentiate, remodel extracellular matrix (ECM), modulate the immune response, and secrete growth factors and cytokines that stimulate cell migration and neovascularization. Stem cells, including mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSCs), are recruited to a healing wound, where they support normal physiological healing in a variety of essential ways.

MiMedx dehydrated human amnion/chorion membrane (dHACM), which contains over 50 growth factors, cytokines, chemokines, and tissue inhibitors of metalloproteinases (TIMPs), have been shown in previously published peer-reviewed scientific studies to stimulate paracrine responses in cells involved in healing and tissue repair, such as human dermal fibroblasts, microvascular endothelial cells, and stem cells, and the recruitment of both hematopoietic and mesenchymal stem cells to the treated site of injury. This recently published study was established to evaluate the impact of MiMedx PURION® Processed dHACM on various reparative stem cells, including MSCs, adipose derived stem cells (ADSCs), and HSCs using in vitro cell closure and proliferation models, and the measurement of changes in the growth factor/cytokine secretion profile for each cell type to further elucidate the mechanisms by which dHACM may enhance healing.

Study Highlights include:

• dHACM extracts stimulate cellular proliferation and migration responses in a variety of adult stem cells, including bone marrow-MSCs (BM-MSCs), ADSCs, and HSCs.
• BM-MSCs, ADSCs and HSCs responded to dHACM treatment with significant increases in cell proliferation after 24 hours.
• Treatment of ADSCs and BM-MSCs with dHACM extracts accelerated closure of pre-defined cell-free zones using an in vitro cell closure model.
• Because dHACM was demonstrated to promote the proliferation of stem cells, the closure of the cell-free zone observed is likely a result of a combination of both stem cell migration and proliferation.
• Growth factors and growth factor regulatory molecules were secreted in response to dHACM. These growth cytokines are known to stimulate cell proliferation, migration, differentiation, cell survival, and protein synthesis, and have been shown to enhance healing of wounds.
• Immunomodulatory cytokines were also upregulated in MSCs, ADSCs, and HSCs. These cytokines are known to regulate various pro- and anti-inflammatory cues that are required for healing.
• Study results contribute to an understanding of how different types of stem cells respond to dHACM in vitro and how dHACM-treated stem cells may contribute to the mode of action for resolving chronic inflammation and ultimately promoting healing.

Parker H. Petit, Chairman and CEO, said, "The study results not only further validated the therapeutic potential of harnessing the healing power of the patient's own stem cells when they travel to the injury site, but more importantly, this study confirmed the capability of  PURION Processed dHACM  to cause the cells to migrate toward the wound as well as proliferate."

Bill Taylor, President and COO, stated, "This scientific study established that MiMedx PURION Processed dHACM stimulates cellular proliferation and migration in a wide variety of adult stem cells. Moreover, growth factors that are known to stimulate cell migration and differentiation, and previously shown to enhance wound healing, were secreted in response to dHACM.  As opposed to other amniotic membrane technologies that only affect the anti-inflammatory responses of the cells in chronic wounds, this study established that dHACM causes the optimal therapeutic means of healing chronic wounds by modulating both pro- and anti-inflammatory mechanisms to fully regulate the inflammatory mechanisms necessary for complete healing."

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane.  "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  Our biomaterial platform technologies are AmnioFix®, EpiFix® and CollaFix™.  AmnioFix® and EpiFix® are our tissue technologies processed from human amniotic membrane derived from donated placentas. Through our donor program, a mother delivering via full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 400,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. CollaFix™, our next technology platform 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.  CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness.

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, that the study establishes that dHACM is the optimal therapeutic means of healing chronic wounds and that there is further therapeutic potential in harnessing the healing power of stem cells.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the medical community may be slow to apply the results of the study in clinical applications, and even if the medical community does adopt dHACM in chronic wound care, it nevertheless may not adopt MiMedx's PURION Processed dHACM, 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, 2014 and its most recent Form 10Q. 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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