MiMedx CEO Parker H. “Pete” Petit and COO and President William C. “Bill” Taylor have resigned as a board-directed independent investigation continues into accounting practices, Marietta, Ga.–based MiMedx (Nasdaq: MDXG) announced today. Petit and Taylor’s exit comes after recent departures of MiMedx’s CFO and corporate controller and treasurer. In addition to the resignations of top brass, the […]
MiMedx wins FDA regenerative med status for AmnioFix
MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week. The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee. “The FDA’s RMAT designation for AmnioFix Injectable is […]
MiMedx shares tumble on internal accounting investigation, delayed 2017 earnings
MiMedx (NSDQ:MDXG) shares have lost nearly a third of their value today after the company announced it is delaying the release of its 2017 financial results due to an internal investigation into alleged issues with sales and distribution practices at the company. The Marietta, Ga.-based company said that its board’s audit committee has tapped a group of […]
MiMedx closes Stability Biologics sale
MiMedx (NSDQ:MDXG) said this week that it completed the divestiture of its subsidiary, Stability Biologics, back to the former stockholders of Stability, Inc. The deal, which closed on Sept. 30, included a promissory note issued by Stability Biologics for $3.5 million in favor of MiMedx. “When we signed the definitive agreement for the divestiture, we communicated […]
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
MiMedx wins FDA nod for AmnioFix pivotal trial
MiMedx (NSDQ:MDXG) said today that the FDA has approved its Phase III Achilles tendonitis trial. The 158-patient study is designed to compare the company’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. The trial, which is the company’s second late-stage study of AmnioFix, will start […]
MiMedx files IND for Achilles tendonitis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND application with the FDA for the company’s late-stage Achilles tendonitis trial. The 158-patient study is designed to compare MiMedx’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. If approved, the trial will be the second […]
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