MARIETTA, Ga., Oct. 3, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that a poster detailing an EpiFix® case study received the award for the highest scoring abstract in the case study category at the recent Symposium on Advanced Wound Care ("SAWC"). In all, six posters chronicling the clinical effectiveness of EpiFix® were accepted for presentation at the recent SAWC.
The abstract titledA Long-term Follow-up Study of Chronic Diabetic Foot Ulcers Healed with Dehydrated Human Amniotic/Chorionic Membrane Allografts was recognized at the SAWC as the highest scoring poster abstract in the Case Study category. The authors honored at the SAWC for the winning abstract were Charles M. Zelen, DPM, FACFAS, FACFAOM, FAPWCA; Thomas E. Serena MD, FACS; and Donald E. Fetterolf, MD, MBA, FACP.
The five other posters presenting EpiFix® cases and studies were:
- Clinical and Cost Effectiveness of Dehydrated Human Amniotic/Chorionic Membrane Allografts for the Treatment of Non-Healing Wounds.
- Dehydrated Human Amniotic Membrane for the Treatment of Pressure Ulcers in Spinal Cord Injured Veterans: A Case Series.
- Dehydrated Human Amnion/Chorion Membrane Tissue Graft for the Treatment of Intractable Ulceration: A Series of Extraordinary Outliers.
- Use of Dehydrated Human Amniotic Membrane Allografts to Promote Healing in Patients with Refractory Non-Healing Wounds.
- Viable Indications for the Use of Human Amniotic Membrane Allograft: A Case Series.
The six poster abstracts presented results of treatment with EpiFix® for a wide range of applications, including the treatment of non-healing wounds, pressure ulcers in spinal cord injured veterans, diabetic foot ulcers and intractable ulceration. The poster abstracts presented case and study results that showed closure of multiple different types of non-healing wounds using EpiFix®. In one poster abstract comparing EpiFix® with a competitor's human fibroblast derived dermal substitute, the study cases demonstrated an 82% reduction in cost of wound closure in non-healing wounds treated with EpiFix®. In another poster abstract, the case study examined the use of EpiFix® for the treatment of difficult intractable wounds and concluded that difficult wounds which did not heal after treatment with a payer approved amount of bioengineered skin substitute, even those wounds secondary to radiation, responded and healed with EpiFix® treatment.
Parker H. "Pete" Petit, Chairman and CEO, said "In general, the abstracts accepted for presentation at the SAWC cited the use of EpiFix® for treatment of wounds that previously were treated with commercially available living cell skin substitutes without wound closure and healing, but had successful healing and closure with EpiFix®."
Each year, the SAWC recognizes the highest scoring poster abstracts in four categories: Case Study, Clinical Research, Informational/Educational Report, and Laboratory Research. The winning poster presented a case series following up on the rates of recurrence of chronic DFUs after previous healing with use of EpiFix®. Evaluation of clinical records was made with IRB approval and patient consent. Eighteen of 22 eligible patients returned for follow-up examination, which was conducted 9 12 months after original healing with EpiFix®. Only one patient had recurrent DFU during the follow-up period, while 17, or 94.4%, remained fully healed. These findings support the long-term effectiveness of dehydrated human amnion/chorion membrane ("dHACM") for treatment of DFU. The study concluded that dHACM is a clinically viable and economically feasible treatment option that should be considered by clinicians who treat diabetic pedal ulcers.
Petit added, "We are pleased that an abstract identifying the impressive healing properties of our EpiFix® allograft received this top recognition. The identification and implementation of an ideal treatment regimen for diabetic foot ulcers (DFUs) is an increasingly common issue faced by clinicians. Therapies that promote rapid and complete healing, thus reducing the risk for infection and amputation, can substantially improve quality of life while decreasing financial burdens. We believe our EpiFix® allograft is a clinically effective and economic solution to these needs."
Bill Taylor, President and COO, stated, "Human amniotic membrane has been used as an allograft to treat wounds for over a century. However, our proprietary PURION® process has led to the development of our EpiFix® dHACM allograft. Studies have shown strong clinical and cost effectiveness of EpiFix® for healing of DFUs, pressure ulcers, and wounds that have failed to heal with other treatment modalities with minimal, if any, waste. Use of competitive skin substitutes routinely result in waste of over 75% of their graft because they come in only one very large size, which is generally at least 15 times greater than the average DFU. EpiFix® has size appropriate grafts and does not waste such material."
MiMedx® is an integrated developer, manufacturer 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, mothers delivering full-term Caesarean section births 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, effective and minimally manipulated implant for homologous use. MiMedx® is the leading supplier of amniotic tissue, having supplied over 190,000 allografts to date to distributors and OEMs for application in the Wound Care, Surgical, 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 long-term clinical and cost effectiveness of EpiFix®. 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 the potential that EpiFix® will not perform as expected or will not gain acceptance in the medical community, 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, 2012, and the Company's most recent Form 10-Q. 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.