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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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July 15, 2014
10:00 EDTMDXGOn The Fly: Analyst Initiation Summary
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06:57 EDTMDXGMiMedx initiated with a Buy at Needham
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July 14, 2014
10:56 EDTMDXGMiMedx says EpiFix addded as covered product in Jurisdiction H
MiMedx Group announced that the Medicare Administrative Contractor responsible for Jurisdiction H, which has approximately five million beneficiaries in Texas, Oklahoma, Louisiana, New Mexico, Colorado, Mississippi and Arkansas, has revised its Local Coverage Determination, LCD, for bioengineered skin substitutes in the hospital outpatient and physician office settings to include EpiFix. The revision to the LCD, entitled Bioengineered Skin Substitutes, names MiMedx's wound care allograft, EpiFix, as eligible for Medicare coverage when medically necessary and reasonable, subject to the coverage indications and limitations set forth in the LCD. The revision was published on July 10, effective for dates of service on or after June 16. Parker H. "Pete" Petit, Chairman and CEO, said, "As we discussed in our shareholder call on April 25, the contractor for Jurisdiction H previously had issued a draft consolidated LCD under which all skin substitutes with a Q-code were eligible for coverage if the case met the medically necessary and reasonable threshold. This LCD was to go into effect on March 27. On the effective date, the draft LCD was rescinded, and the contractor reverted to the previous LCD. The previous Jurisdiction H LCD covered only a few named skin substitutes and did not include coverage for EpiFix. In the update issued on July 10, the contractor has added EpiFix as a covered product. EpiFix was the only product added in that update. We are very pleased that EpiFix has been included in the revised LCD for this Medicare jurisdiction."

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