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 its study "Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic/Chorionic Membrane Allograft for Plantar Fasciitis—A Feasibility Study"
has been electronically published in the journal, Foot & Ankle International. The study publication was authored by Charles M. Zelen
, DPM, Attila Poka, MD, and James Andrews
, MD. The hard copy is scheduled to be published in the October 2013
edition of Foot & Ankle International. The electronic publication of the study is available at http://fai.sagepub.com/content/early/recent.
The randomized clinical trial examined the efficacy of dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for the inflammation associated with chronic refractory plantar fasciitis. The study determined that this injection for plantar fasciitis can reduce inflammation and promote healing and may be an alternative to surgical intervention. "In summary, this RCT concluded that patients with chronic/refractory plantar fasciitis randomized to receive a single-dose injection of AmnioFix® experienced significant improvement in symptoms and increased function within one week of injection, with continued improvement over the eight-week study period," said Parker H. Petit
, Chairman and CEO.
"This is our first randomized control trial (RCT) conducted on our amnion allograft use in plantar fasciitis. This degenerative condition is one of the most common orthopedic complaints relating to the foot. In fact, it affects more than one million U.S. patients each year. Plantar fasciitis is extremely challenging and frustrating for both patients and clinicians," added Petit.
, President and COO, stated, "We believe the use of, AmnioFix®, our dHACM allograft injection, is an effective treatment for patients with inflammation associated with chronic plantar fasciitis and may reduce costs by decreasing the need for repeat office visits or costly surgical interventions. The standard of care management of plantar fasciitis leads to resolution of symptoms in many patients, although several months to even years of treatment are often required. A treatment that reduces inflammation and promotes the healing of soft tissue, allowing for rapid return to activities of daily living has been highly sought after. We believe the use of our dHACM allograft fulfills this need in the market for a rapidly effective treatment for patients with inflammation associated with chronic plantar fasciitis."
About the Company
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 the device technologies HydroFix® and CollaFix™, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies are processed from human amniotic membrane that is derived from the 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 170,000 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 effect of AmnioFix® on decreasing the need for repeat office visits or costly surgical interventions for patients with chronic plantar fasciitis. 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 the use of AmnioFix® on patients with chronic plantar fasciitis may not result in the anticipated decreases in office visits and costs of surgical interventions, 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
. 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.