This decision by the FDA is hardly a surprise to anyone who has followed this company for awhile. The company announced last month the additional staffing and structure was in place to conduct the BLA.
The PR reiterates that this just affects the micronized products. But wth Epifix relying on the Sec 361 exemption also is there any risk there? The company keeps saying no, but if you read Sec 361, amniotic tissue wouldn't qualify when used on an adult. Just depends how strict FDA wants to be. Has mgmt ever said the FDA told them they are totally fine with Epifix and its Sec 361 exemption? Or is that the next shoe to drop? Would seem odd for FDA to bring that up now, but the FDA is not a logical organization.
FDA is well aware that Amniotic membrane has been used for over 100 years in wounds. The original author is misleading. FDA didn't say no. It said IND and BLA and nothing about pulling any injectables from market at this time.
MARIETTA, Ga., Dec. 4, 2013 /PRNewswire/ -- MiMedx Group, Inc. (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.