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

s is that the patients who can benefit from our micronized products will have access to these therapies."

The Company's proposal to the FDA was in response to the FDA's explanation to the Company that "[c]ryo-milling cut, dehydrated amniotic/chorionic membrane results in a micron-sized powder and the loss of the tensile strength and elasticity that are essential characteristics of the original amniotic/chorionic tissue relating to its utility to function as a 'physical membrane' (i.e. covering, barrier)."  For this reason, the Agency believes that the micronized products are more than minimally manipulated and the products therefore are not eligible for marketing solely under Section 361 of the Public Health Service Act.  As noted above, the Company disagrees with this analysis.

"As we have previously highlighted, the review by the FDA and its regulatory pathway decision is relevant only to the Company's micronized tissue products and has no applicability to our sheet tissue products, which we will continue to market on the same basis as previously.  We therefore reiterate our revenue guidance for the remainder of 2013 as well as our guidance for 2014," commented Bill Taylor, President & COO.  "In addition, we believe the recent Centers for Medicare and Medicaid Services (CMS) final rule on packaging skin substitutes will provide even greater opportunity for MiMedx than previously anticipated, due to the tiered pricing contained in the final rule and the pass-through status of EpiFix® in 2014.  MiMedx continues to be the industry leader providing advanced wound care solutions that have low 'cost to closure' using our size appropriate grafts that minimize wastage.  The cost and clinical effectiveness of EpiFix was supported by our initial diabetic foot ulcer (DFU) trial, which was the first and only such trial using amniotic tissue published in an indexed peer-reviewed journal," conclu
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SOURCE MiMedx Group, Inc.
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