MiMedx Files Its Initial Investigational New Drug Application
MARIETTA, Ga., July 23, 2014 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, processor and marketer of patent-protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it has filed its initial Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”).
The IND submission, which was filed yesterday, July 22, 2014, is the Company’s initial submission for certain indications of its micronized allografts towards targeted Biologics License Applications (“BLAs”). As communicated in the Company’s December 4, 2013, press release, this IND filing is the first major milestone in the process, which is expected to culminate in at least two separate BLAs for certain indications of the Company’s micronized allografts.
Parker H. “Pete” Petit, Chairman and CEO, stated, “I am very pleased that we were able to complete this initial IND submission to the FDA on an accelerated schedule. This first step in the BLA regulatory pathway for certain of our micronized allografts is strategically important as a guidepost for our future pursuit of other amniotic tissue products that may need approval via the FDA’s BLA process. We are committed to efficiently satisfying all facets of this process and successfully transitioning our micronized products from Section 361 HCT/Ps to licensed biologics.”
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, 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 250,000 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 effect of the filing of the IND application and the Company’s ability to transition its micronized products to licensed biologics or pursue BLAs for future products. 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 IND application will not be granted, that the associated clinical trials will not be successful, that the Company will not apply for or be granted one or more BLAs, 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, 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.
SOURCE MiMedx Group, Inc.