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May 20, 2014
13:50 EDTMDXGMiMedx declines to participate in NAD review proceeding
MiMedx Group announced it has declined to participate in the adjudication of an advertising challenge filed with the National Advertising Division of the Council of Better Business Bureaus. The NAD administers a self-regulation program designed to ensure the integrity and credibility of national consumer advertising. As part of this program the NAD will review challenges filed by competitors and consumers. Participation in the process is voluntary. The challenge was initiated by Organogenesis, manufacturer of Apligraf and Dermagraft, two skin substitute products that compete with MiMedx's EpiFix allograft. Specifically, Organogenesis alleged that by comparing MiMedx's allografts to its products, MiMedx implies that its allografts have been approved by the FDA through the same Pre-Market Approval process as the Organogenesis products. Organogenesis further alleged that only PMA approved products may be marketed to promote wound healing. MiMedx contends that neither of these allegations has merit. As to the substance of Organogenesis' claims, MiMedx noted that it believes them to be incorrect. The FDA guidance document cited as authority by Organogenesis in its challenge has no relevance to products regulated as "human cells, tissues, and cellular and tissue-based products" or "HCT/Ps," such as EpiFix. Products that qualify for regulation as HCT/Ps follow a different, but equally legitimate, regulatory path from the PMA regulatory process. Additionally, the 2006 NAD decision cited in Organogenesis's challenge is distinguishable because the product at issue in that decision was completely decellularized, while EpiFix is not. Accordingly, EpiFix contains critical cytokines and growth factors that are not present in decellularized products. MiMedx has the utmost respect for the NAD and its procedures. The advertising industry self-regulatory process administered by the NAD is extremely valuable to advertisers, competitors, and consumers. But as MiMedx explained in its response to the NAD, MiMedx does not believe the NAD is the appropriate forum for vetting matters that are within the regulatory purview of the FDA. Moreover, many of the "advertising statements" that Organogenesis cites as objectionable are not even related to advertising nor directed to consumers, such as statements by MiMedx to its shareholders or comments made in a white paper submitted to the Centers for Medicare and Medicaid Services in response to CMS' request for industry input on the topic of its proposed methodology for the reimbursement of skin substitutes in the hospital outpatient setting. For those reasons, MiMedx respectfully declined to participate in the NAD's self-regulatory process.
News For MDXG From The Last 14 Days
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September 2, 2015
09:49 EDTMDXGMiMedx says MTF issued 'second inaccurate' press release
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September 1, 2015
14:35 EDTMDXGMTF 'stands by all statements' made in August 26 press release about PTAB ruling
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August 27, 2015
10:26 EDTMDXGMiMedx says 'inaccuracies' contained in MTF press release on PTAB rulings
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August 26, 2015
09:43 EDTMDXGMiMedx announces publication of study on allografts to regulate diabetic cells
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August 24, 2015
08:56 EDTMDXGMiMedx patent win strengthens IP position, says Brean Capital
Brean Capital noted MiMedx won two Patent Trial and Appeal Board rulings which are involved in the configuration process of two of MiMedx's core products. The firm said the rulings are important wins for the company and strengthens its intellectual properties position. Brean Capital reiterated its Buy rating and $16 price target on MiMedx shares.
August 21, 2015
08:32 EDTMDXGMiMedx patent infringement lawsuits receive rulings from trial and review board
MiMedx announced the Patent Trial and Appeal Board has ruled in favor of the Company's primary EpiFix and AmnioFix patents. In April 2014, MiMedx filed patent infringement lawsuits in the United States District Court for the Northern District of Georgia against Liventa Bioscience, Inc., Medline Industries, Inc. and Musculoskeletal Transplant Foundation, Inc. for permanent injunctive relief and unspecified damages. In May 2014, the Company also filed a separate action against Transplant Technology, Inc. d/b/a Bone Bank Allograft and Texas Human Biologics Ltd. for patent infringement. In both suits, MiMedx asserted that these organizations infringed and continue to infringe at least six MiMedx patents. As part of their defense strategy, two of the four defendants submitted certain of the MiMedx patents to the inter partes review process, which means they are asking the PTAB to review the subject matter covered by the MiMedx patents and decide whether it was proper for the patents to have been granted in the first place. In general, the inter partes review process works as follows: If the PTAB rejects the request for inter partes review, it essentially means that the PTAB found no basis to challenge the patent on obvious or anticipation grounds. If the PTAB grants inter partes review, it means that the PTAB has found that it is worth reviewing the patent, but by no means is it an indication in and of itself that there is something wrong with the subject patent. MiMedx received two recent rulings from the PTAB. One PTAB ruling was made in regard the inter partes review request related to the MiMedx primary EpiFix patent and the other recent PTAB decision was for the inter partes review request related to the MiMedx AmnioFix patent. In both rulings, the PTAB found no basis to challenge these patents and fully rejected the request for review on these patents.

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