The Impact of MiMedx EpiFix® to be Presented at SAWC Conference
Poster Abstracts Demonstrate Clinical and Cost Effective Results of EpiFix Allografts in healing diabetic foot ulcers, chronic diabetic lower extremity ulcerated wounds, venous leg ulcers, refractory non-healing wounds, and hard to treat wounds
MARIETTA, Ga., April 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 nine poster abstracts showing the clinical and cost effective healing results of the Company's Dehydrated Human Amnion/Chorion Membrane (dHACM) allografts will be presented at the 2016 Symposium on Advanced Wound Care and Wound Healing Society (2016 SAWC Spring/WHS) meeting. The symposium is the leading national wound healing conference and is now in its 29th year. The 2016 SAWC Spring/WHS begins April 13, 2016, and concludes on April 17, 2016, and MiMedx will be exhibiting from April 14th through April 16th in booth #615.
Eight of the nine poster abstracts will report on the clinical and cost effectiveness of EpiFix dHACM allografts in the healing of diabetic foot ulcers, chronic diabetic lower extremity ulcerated wounds, venous leg ulcers, refractory non-healing wounds, and hard to treat wounds. One poster abstract will chronicle the outstanding results of the MiMedx dHACM allografts in limb salvage and skin grafting cases.
Parker H. "Pete" Petit, CEO, said, "We are honored that our allografts and their remarkable healing results are so prominently featured throughout this prestigious symposium. The best accolades our products can receive are independent and leading physicians emphasizing the positive clinical impacts and cost savings these allografts have on their patients. We are also proud to unveil our latest wound care product addition, EpiCord™, at the SAWC. It is a minimally manipulated, dehydrated, non-viable cellular umbilical cord allograft for homologous use. EpiCord provides a protective environment for the healing process and provides a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue."
MiMedx will also sponsor a Breakfast Symposium entitled "The Dynamic Impact of EpiFix: Defining the New Standard for Bioactive Healing" on Friday from 7:30am to 9:00am in Room 206 of the Georgia World Congress Center. Physicians and study authors Thomas Davenport, MD; Jeffrey Frenchman, DPM; Charles Zelen, DPM; and Barry White, MD, will serve as moderators for the program and will describe the excellent clinical outcomes of their treatment cases using EpiFix as well as study conclusions evidencing the superb healing properties of EpiFix.
In-booth education will be provided on April 14th and 15th by two prominent physicians. Stephen Bergquist, MD, will present "EpiFix Utilization in Advanced Wound Care" on April 14th at 6:30pm and April 15th at 12:30pm. Brandon Hawkins, DPM, will present "The Benefits of EpiFix for Advanced Wound Care and Surgical Applications" on April 14th at 7:15pm and April 15th at 1:30pm.
Bill Taylor, President and COO of MiMedx, said, "We are pleased to have the excellent results of our dHACM allografts featured in oral and poster presentations at the 2016 SAWC Spring/WHS meeting. We have stressed that independent clinical research with resulting peer reviewed publications of the outcomes and results are the significant influencers of why our allografts have been so widely desired by practicing physicians and so quickly endorsed for coverage from health plans. The SAWC is a terrific forum for the clinical and cost effectiveness of our allografts to be showcased."
The abstracts chronicling independent case studies and respective conclusions relative to MiMedx allografts include:
- Abstract: "A Prospective, Randomized, Controlled, Multi-Center Comparative Study Examining Clinical Efficacy and Cost of Advanced Wound Care in 100 Patients with Chronic Diabetic Lower Extremity Ulcers"
Authors: Charles M Zelen, DPM FACFAS; Thomas E Serena, MD FACS; Lisa Gould, MD PhD; Lam Le, MD; Marissa J Carter, PhD MA; Jennifer Keller, DPM; William W Li, MD
- Abstract: "A Single Center Prospective Evaluation of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft Mesh in the Treatment of Diabetic Foot Ulcers"
Authors: Charles M Zelen DPM, FACFAS; Thomas E Serena, MD; Matthew Garoufalis, DPM; William Li, MD
- Abstract: "Dehydrated Human Amnion/Chorion Membrane Application in a Patient with a Post-Surgery Large Scalp Wound with Exposed Bone"
Authors: Rachael Tombleson, RN, CWCN; Thomas E. Steffens, DO, Grand Junction VA, Grand Junction, CO
- Abstract: "The Use of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts to Expedite Healing in Patients with Six Major Types of Refractory Non-Healing Wounds: 117 Cases"
Authors: Darshan Nagesh, DPM, Patrick Sanchez, DPM, Robin Lenz, DPM, Hannah Park, DPM, Sarah Park, DPM, Jake Ruff, DPM, Anna Tien, DPM, Justin Goldsmith, DPM, Andrea Seat, DPM, Matthew Garoufalis, DPM, Jesse Brown VA, Chicago, IL
- Abstract: "A Novel Application Technique with dHACM for Large VLUs"
Authors: Patrick J. Sanchez, DPM, Robin C. Lenz, DPM, Darshan Nagesh, DPM, Hannah K. Park, DPM, Jake Ruff, DPM, Sarah Park, DPM, Justin Goldsmith, DPM, Anna Tien, DPM, Andrea Seat, DPM, Matthew Garoufalis, DPM, Jesse Brown VA, Chicago, IL
- Abstract: "Healing of Chronic Lower Extremity Wounds Utilizing a 4-Week Assessment of Healing to Initiate Treatment with Appropriate Sized dHACM and Subsequently Achieve Healing"
Authors: Anna Tien, DPM, Justin Goldsmith, DPM, Patrick Sanchez, DPM, Jake Ruff, DPM, Robin Lenz, DPM, Andrea Seat, DPM, Hannah Park, DPM, Darshan Nagesh, DPM, Sarah Park, DPM, Matthew Garoufalis, DPM, Jesse Brown VA, Chicago, IL
- Abstract: "Limb Salvage with Dehydrated Human Amniotic/Chorionic Membrane and Split Thickness Skin Grafting"
Authors: Radbeh Torabi, MD, Frank Lau, MD, Amy Strong, PhD MPH, M'liss Hogan, MD, Charles Dupin, MD, Oren Tessler, MD
- Abstract: "Injectable Dehydrated Human Amnion/Chorion Membrane Allograft as an Advanced Wound Treatment for Pyoderma Gangrenosum: a Case Report"
Author: Windy Cole, DPM, Akron General Medical Center, Akron, OH
- Abstract: "Use of Dehydrated Human Amnion/Chorion Membrane Injectable Allograft in the Management of Hard to Treat Wounds"
Author: Brandon Hawkins, DPM, CWS, FACCWS, Bakersfield Heart Hospital Center for Wound Healing, Bakersfield, CA
MiMedx is exhibiting at the conference in booth #615.
EpiFix is a human amniotic allograft tissue offering uniquely processed through the Company's proprietary PURION® Process. EpiFix dHACM modulates inflammation and reduces scar tissue formation for enhanced healing. With a variety of sizes available, EpiFix minimizes graft waste. EpiFix is a minimally manipulated, dehydrated non-variable cellular amniotic membrane allograft that preserves and delivers multiple extracellular matrix proteins, growth factors, cytokines and other specialty proteins present in amniotic tissue. The Company's PURION Process combines cleaning, dehydration and sterilization, making EpiFix a safe, sterilized tissue that may be stored at ambient conditions for up to 5 years.
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. Our biomaterial platform technologies are AmnioFix®, EpiFix®, OrthoFlo, Physio®, AlloBurn™, and CollaFix™. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Elected in advance of delivery through our donor program, a mother delivering a healthy baby via scheduled full-term Caesarean section birth may 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 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. We recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section. Through the recent acquisition of Stability Biologics, our newest proprietary platforms include Physio, a unique bone grafting material comprised of 100% bone tissue with no added carrier, thus maximizing bone forming potential, a demineralized bone matrix (DBM) to complement our product portfolio offerings within the Orthopedic market and AlloBurn, a skin product for burns. 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. The Company's wholly-owned subsidiary, Stability Biologics, LLC, is accredited by the American Association of Tissue Banks (AATB) and registered with the FDA. The Company distinguishes its revenue in two primary regenerative medicine specialties of "Wound Care" and "SSO." The Company defines SSO as surgical, sports medicine and orthopedics with spinal procedures included in orthopedics and abdominal, and lower pelvic procedures included in surgical.
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 significance of case study results, that independent clinical research with resulting peer reviewed publications of the outcomes and results are the significant influencers of why the Company's allografts have been so widely desired by practicing physicians and so quickly endorsed for coverage from health plans, that use of the EpiFix will result in cost savings, and the significance of new product EpiCord. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that other case studies may have different or less favorable results, independent clinical research may not have the influence on physicians and insurers as believed, usage by physicians and endorsement by health insurers may not continue, EpiFix may not result in cost savings in all cases, EpiCord may not gain acceptance in the medical community as quickly or widely as expected or at all, 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. 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.
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SOURCE MiMedx Group, Inc.