MiMedx Announces Next Steps After Discussions With The FDA COMPANY REITERATES GUIDANCE
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 us 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," concluded Taylor.
MiMedx® is an integrated developer, manufacturer 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 200,000 allografts to date to distributors and OEMs 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 Company's ability to reach agreement with the FDA on a transition plan, the Company's ability to successfully complete the IND/BLA process for one or more applications, the Company's ability to continue marketing its micronized products, the Company's ability to achieve the 2013 and 2014 revenue projections and that such projections are not dependent on the micronized products, the clinical and cost effectiveness of the Company's products, and the effect of the CMS final rule regarding packaging skin substitutes on the Company's revenues and its position in the market. 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 Company is unable to come to final agreement with the FDA on a transition plan, that the Company does not successfully complete the IND/BLA process for one or more applications, that the Company is unable to continue marketing its micronized products, the potential that the Company's products will not perform as expected or will not gain acceptance in the medical community, that the new CMS reimbursement will not put the Company in a favorable position in the market or have a favorable impact on revenues, that the Company fails to achieve its 2013 or 2014 revenue goals, 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, 2012, and the Company's Forms 10-Q filed in 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.