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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.
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October 15, 2014
07:46 EDTMDXGMiMedx transforming into profitable medicine company, says Canaccord
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October 14, 2014
05:47 EDTMDXGMiMedx to host analyst day
Analyst day to be held on October 14 at 10 am. Webcast Link
October 13, 2014
07:32 EDTMDXGMiMedx sees FY15 revenue $175M-$185M, consensus $161.32M
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07:32 EDTMDXGMiMedx sees FY14 revenue $116M-$117M, consensus $112.51M
07:32 EDTMDXGMiMedx sees Q4 revenue $37.3M-$38.3M, consensus $36.4M
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07:32 EDTMDXGMiMedx reports Q3 revenue $33.5M, consensus $30.99M
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