MARIETTA, Ga., April 29, 2015 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG) announced today that one oral abstract and four poster abstracts showing the Company's EpiFix® allografts to be clinically superior and cost effective in the healing of chronic diabetic lower extremity ulcerated wounds, venous leg ulcers, diabetic foot ulcers, and burn injuries will be presented at the 2015 Symposium on Advanced Wound Care and Wound Healing Society (SAWC Spring/WHS) meeting, the leading national wound healing conference now in its 28th year. The symposium begins today, April 29, 2015, and concludes on May 2, 2015, and MiMedx will be exhibiting from April 30th through May 2nd.
The poster abstract chronicling the first ever multi-center randomized comparative effectiveness study showing superiority in examining side by side the performance, outcomes, wastage and cost of EpiFix as compared to Apligraf® or standard of care as a treatment for chronic lower extremity diabetic ulcers will be the recipient of an SAWC award. "We are pleased that this ground breaking study was selected as 3rd place Overall in the category of Clinical Research," said Parker H. "Pete" Petit, CEO of MiMedx.
The study article, authored by Charles M. Zelen, DPM FACFAS; Lisa Gould, MD PhD; Thomas E. Serena, MD FACS; Marissa J. Carter, PhD MA; Jennifer Keller, DPM; and William W. Li, MD, showed that MiMedx's EpiFix is superior to Apligraf® (the comparative bioengineered skin substitute) in both the rate of wound healing and the speed at which wounds are completely healed. Not only did EpiFix achieve superior clinical results, but the study also clearly demonstrated the dramatic cost savings of EpiFix over Apligraf. This study confirmed the wastage and excessive expense that are caused when size appropriate grafts are not made available to the practicing physicians.
MiMedx, 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, will also sponsor a Breakfast Symposium entitled "The Dynamic Impact of EpiFix, A Bioactive Tissue Matrix for the Treatment of Chronic Wounds." With physicians and study authors Charles Zelen, DPM; Thomas Serena, MD; Steve Bergquist, MD; and Matthew Garoufalis, MD, serving as moderators, the program will detail the healing properties and superb clinical outcomes of EpiFix.
Bill Taylor, President and COO of MiMedx, said, "We are honored to have our dHACM allografts and our proprietary PURION® Process highlighted in oral and poster presentations as well as EpiFix break-out symposia during the prestigious SAWC Spring/WHS meeting. It is always gratifying when independent clinical research and peer reviewed publications demonstrate the clinical and cost effectiveness of our allografts."
The abstracts chronicling independent case studies and respective conclusions relative to MiMedx allografts are:
- Abstract: "A Prospective, Randomized, Controlled, Multi-Center Comparative Effectiveness Study of Dehydrated Human Amnion/Chorion Membrane Allograft, Bioengineered Skin Substitute, or Standard Care for Treatment of Chronic Diabetic Lower Extremity Ulcers," authored by Charles M. Zelen DPM FACFAS, et al., concludes that:
- Wounds treated with dHACM (EpiFix) healed twice as many chronic diabetic lower extremity ulcers four times faster at one-fifth the cost of wounds treated with bioengineered skin substitutes "BSS" (Apligraf), indicating that dHACM allografts are more clinically and cost effective than the comparative BSS for the treatment of lower extremity ulcers in patients with diabetes.
- This is the first multi-center randomized comparative effectiveness study examining side by side the performance, outcomes, and utilization of two advanced wound care products as a treatment for chronic lower extremity diabetic ulcers.
- Abstract: "Evaluation of a Surrogate Outcome Used in a Study of Dehydrated Human Amnion/Chorion Membrane for the Treatment of Venous Leg Ulcers," authored by Thomas E. Serena, MD, et al., concluded that:
- Intermediate endpoints that can predict the ultimate outcome of treatment are beneficial for researchers of new wound healing products or techniques allowing for more rapid evaluation of potentially promising innovations.
- The current follow-up analysis validates the intermediate outcome used in the initial RCT which showed that VLU treated with dHACM had greater reduction in wound size within the first 4 weeks of treatment than VLU treated with compression alone.
- Abstract: "The Use of Particulate Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Diabetic Foot Ulcers," authored by Brandon Hawkins, DPM, concludes that:
- Particulate dHACM was found to be easily applied, clinically effective and well tolerated as a treatment for plantar ulcers in diabetic patients.
- These results are similar to those reported in a randomized trial which reported an average time of 2.4 weeks until complete healing and 90% of DFUs with complete healing by 4 weeks with weekly dHACM allograft sheets.
- Abstract: "Clinical Outcomes Following the Use of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Severe Skin and Tissue Loss Resulting from Burn Injuries: A Case Series," authored by Nicole Gaid, MB BCh BAO, et al, concludes that:
- In addition to its effectiveness in enhancing the healing of chronic wounds, this case series provides evidence that dHACM presents a valuable adjunct in the management of burn injuries.
- Rapid, reliable and effective healing occurred with dHACM treatment to not only improve the quality of healing, but also optimize overall health outcomes and patient quality of life.
MiMedx is exhibiting at the conference in booth #323.
EpiFix is a human amniotic allograft tissue offering uniquely processed through the Company's proprietary PURION® Process. EpiFix dehydrated human amnion/chorion membrane (dHACM) can reduce inflammation and reduce scar tissue formation for enhanced healing. With a variety of sizes available, EpiFix minimizes graft waste. The Company's PURION Process combines cleaning, dehydration and sterilization, making EpiFix a reliable, 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 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 include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is 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.
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. 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 nay have 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, 2014. 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.