RegulatorySpineSports Medicine

MiMedx pleased with FDA Draft Guidance on Minimal Manipulation of HCT/Ps

MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spinal, Sports Medicine, Ophthalmic and Dental sectors of healthcare, commented on the Draft Guidance for Industry on Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (“HCT/Ps”) that the Food and Drug Administration (“FDA”) published for comment on December 23, 2014.

Parker H. “Pete” Petit, Chairman and CEO, stated, “MiMedx is pleased that the FDA has decided to engage industry participants and others in shaping the future of regulation of HCT/Ps. We believe we have much to contribute to this topic and welcome the opportunity to provide our comments.”

Bill Taylor, President and COO, added, “It is evident to us that FDA’s view on minimal manipulation has evolved since its prior public statements on the subject. It is also obvious that the agency began selective enforcement of this evolved view some sixteen months ago when it issued MiMedx an Untitled Letter without first having vetted its new position through any public process. This is fundamentally unfair. Other members of industry who have products that may be impacted by this guidance when it is finalized have been given notice and an opportunity to comment on the draft guidance prior to its application to them, whereas MiMedx had no such benefit prior to FDA taking the action that it did with respect to our micronized products in August 2013. There are at least nine other companies with competitive products that appear to be impacted by this draft guidance. To our knowledge, none of these companies have been asked to take their products off the market, and all of these companies will have time to comment, make transition plans, and take other actions they deem necessary under the circumstances.”

Petit continued, “Positions taken by FDA in the Untitled Letter issued to MiMedx in August 2013 with respect to our micronized products represent significant departures from long-standing precedents on which industry has justifiably relied. This action was taken with no systematic input from the scientific and medical experts in the field or industry participants. Although we appreciate the prospect of an open forum, we do not believe the issuance of draft guidance on which comments may be submitted is an adequate substitute for the public process that should support such a sweeping change in the longstanding interpretation of agency regulations. We intend to urge the FDA to consider a more robust process and formal transition period for industry to come into compliance with any new requirements, similar to the approach FDA took with respect to Laboratory Developed Tests.”

Petit added, “It is a fundamental principle of administrative law that federal agencies must treat similarly situated parties similarly. As disclosed in our quarterly report on Form 10-Q, the Company has asked the FDA to consider alternative formulations of a particulate product to replace its current micronized product. We were prepared to submit a plan to discontinue sales of the current form of our micronized products. In light of the December 23, 2014, Draft Guidance and the agency’s apparent willingness to let similar products remain on the market pending completion of the guidance review process, we have proposed to FDA that we continue to sell our current micronized products until we have been afforded an opportunity to participate in the full guidance document review, the Draft Guidance is finalized and similarly situated competitors are required to comply.”

Petit concluded, “We want to be treated the same as other industry participants. Also, as previously stated, our announced 2015 forecast for revenue to range from $175 million to $190 million is not dependent on our ability to continue to market a micronized product. Nor do we expect the Draft Guidance to impact our ability to achieve the forecasted revenues. In addition, I am pleased to advise shareholders that we will exceed the upper end of our revenue guidance for both the 4th quarter and full year 2014. We will provide further details in a press release on January 12, 2014, prior to the J.P. Morgan Healthcare Conference.”

Source:

MiMedx Group, Inc.

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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