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 tis
|SOURCE MiMedx Group, Inc.|
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