The VA advised its facilities not to use injectable amniotic tissue products for the most common uses after a Journal report on MiMedx’s regulatory lapse
MiMedx drove sales of its tissue grafts through improper means to the Department of Veterans Affairs and other clients, according to former employees. Gretchen Morgenson of The Wall Street Journal investigates the alleged fraud and the help the company got from its friends in government. By Gretchen Morgenson June 14, 2019 12:16 p.m.
Related Coverage The VA’s advisory reiterated a memo the agency sent to its pharmacy-benefits managers in late January, urging facilities not to provide injectable human amniotic membrane or amniotic fluid tissue products “for managing plantar fasciitis, tendinitis or osteoarthritis since evidence is currently limited or is lacking.”
MiMedx makes wound treatments from amniotic membranes—the tissue that protects a fetus—that can be applied topically or by injection. Photo: Kristoffer Tripplaar/Sipa USA/Associated Press A Food and Drug Administration inspection of a MiMedx facility in February 2016 identified 13 deficiencies, including for purity and sterility, in the company’s micronized product manufacturing.
The company has said it is under investigation by the Justice Department, the Securities and Exchange Commission and the Department of Veterans Affairs. The agencies have declined to comment on the status of the probes. MiMedx’s former chief executive, Parker ‘Pete’ Petit, who stepped down in July, is running a proxy contest to try to regain a position on the company’s board. Photo: CNBC A lawyer for Mr. Petit said MiMedx’s audit committee “has disgraced itself by issuing false, defamatory, and self-serving ‘findings’ of misconduct” by Mr. Petit, who has denied wrongdoing while at the company.
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