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 a MiMedx-sponsored study from Georgia Institute of Technology has been published in Arthritis Research & Therapy. The article, titled “Intra-articular injection of micronized dehydrated human amnion/chorion membrane attenuates osteoarthritis development” was authored by Nick Willett, Tanushree Thote, Angela Lin, Shamus Moran, Yazdan Raji, Sanjay Sridaran, Hazel Stevens and Robert Guldberg. The electronic publication of the study is available at http://arthritis-research.com/content/16/1/R47
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The editor of “Nature Reviews Rheumatology” wrote a highlight article on the study stating that “A paper published in Arthritis Research & Therapy suggests that intra-articular injection of an amniotic membrane allograft can block cartilage damage in a rat medial meniscal transection (MMT) model of OA [Osteoarthritis].” The highlight article was published on the Journal’s website today, and can be found at http://www.nature.com/nrrheum/journal/vaop/ncurrent/full/nrrheum.2014.26.html
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“This is the first in a series of pre-clinical work completed on our micronized PURION® Processed amniotic tissue. The results from this in-vivo animal study are extremely promising, and the Company is very pleased to be associated with Georgia Tech and Dr. Guldberg on these studies,” said Parker H. “Pete” Petit, Chairman and CEO. “To be recognized in a highlight article in Nature, which is the number one scientific journal worldwide, speaks volumes to the significance of this study,” added Petit.
“This is a sponsored study of a product concept we have had in development that began about 2 years ago. This concept utilizes our micronized PURION® Processed dehydrated human amnion chorion membrane (“dHACM”) in an intra-articular injection. This project represents the first MiMedx tissue product that we anticipated would require a different FDA regulatory path from our Section 361 tissue products, and it will likely take the Biologics License Application (BLA) regulatory pathway. We expect follow-on pre-clinical studies for this and other applications of our PURION® Processed tissues over the coming year,” commented Bill Taylor, President and COO.
“According to the CDC, osteoarthritis affects an estimated 26.9 million Americans, and there are over 1 million knee and hip replacements each year. The positive impact on the return to normal function and mobility for arthritis sufferers and the potential reduction of arthritis formation could have a large impact on health economics. The conclusions of this study essentially indicate that PURION® Processed (“dHACM”) may slow the progression of osteoarthritis. Besides the overall market size, the real opportunity with this product concept is that it could improve the quality of life of many seniors and potentially delay or prevent the need for a knee, hip or shoulder replacement,” added Petit.
About MiMedx
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 and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 200,000 allografts to date 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 significance of the study results, the prospect for follow-on studies, the expectation that the results of those studies will confirm the results of the initial study, and the prospect that the studies will lead to a commercial product that is approved for marketing by the U.S. Food and Drug Administration. 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 that the Company does not undertake follow-on studies or that the results of any follow-on studies do not have favorable results, that the studies do not result in a commercial product or that the product does not receive requisite regulatory approvals, 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 Forms 10-Q filed in 2013. 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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