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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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November 18, 2014
08:06 EDTMDXGMiMedx reports abstracts to be presented at Desert Foot Conference
MiMedx Group announced that fourteen poster abstracts chronicling the company's dehydrated human amnion/chorion membrane allografts to be clinically effective and cost effective in the healing of chronic wounds, difficult lower extremity wounds that have failed prior wound treatment modalities, challenging surgical wounds, chronic neuropathic wounds, wounds threatening the loss of limbs, and other hard-to-heal wounds will be presented at the 11th Annual Desert Foot High Risk Diabetic Foot Conference in Phoenix, Arizona, beginning November 19, and concluding on November 21.
November 17, 2014
16:06 EDTMDXGMiMedx reports results of EpiFix vs. Apligraf comparative study
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