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MiMedx Announces Next Steps After Discussions With The FDA
Date:12/4/2013

MARIETTA, Ga., Dec. 4, 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, provided an update today on its continuing discussions with the Food & Drug Administration (FDA) regarding the regulatory classification of its micronized products.  The Company received a communication from the FDA explaining the basis for the Agency's position regarding the micronized products.  The Company has responded to the FDA that while it does not agree with the Agency's position, it understands the Agency's interest in further regulating this emerging technology.  Accordingly, the Company has proposed to the FDA that it will pursue the Investigational New Drug (IND) and Biologics License Application (BLA) process for certain micronized products, and, in parallel, also proposed to enter into negotiations with the FDA on a plan to transition the micronized products to licensed biological products and continue to market the micronized products under specific conditions.  The Company has informed the FDA that it is ready to immediately commence discussions regarding this transition plan.  While there is no guarantee that the FDA would agree to any particular transition plan, the Company is hopeful that it can reach a mutually satisfactory agreement with the FDA in this regard. 

Parker H. "Pete" Petit, Chairman and CEO said, "We are pleased that the FDA has recently clarified its issue with our micronized products and has continued a dialogue with us to bring this matter to resolution.  We are in agreement with the Agency that this relatively new technology must enter the market in an orderly and safe manner with proper regulatory oversight.  A top priority for u
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SOURCE MiMedx Group, Inc.
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