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 […]
Osiris levels $7m trade theft, breach-of-contract suit against MiMedx over Stability Biologics deal
Osiris Therapeutics leveled trade theft and breach-of-contract charges worth nearly $7 million against a regenerative medicine rival, stemming from the Stability Biologics acquisition by MiMedx (NSDQ:MDXG). Columbia, Md.-based Osiris said it inked a distribution deal back in 2013 to have Stability sell a pair of its products through the end of 2015. But after MiMedx paid $10 million for […]
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. Get the full story at our sister site, […]
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 settles former employee breach of contract suit
MiMedx (NSDQ:MDXG) said today it agreed to a confidential lawsuit settlement with former employee William Mills, who the company previously alleged broke contract by selling another company’s medical products while employed at MiMedx. The Marietta, Ga.-based company said that Mills voluntarily resigned from his position in January this year, and that the lawsuit was a “dispute solely […]
FDA OKs trial for MiMedx AmnioFix knee treatment, prelims
MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product. The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both […]
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. Get the full story at our sister site, Drug Delivery Business […]
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 loses appeal in placental allograft tissue patent spat
A Federal Circuit Court this week affirmed a Patent Trial and Appeal Board ruling which found a MiMedx (NSDQ:MDXG) tissue graft patent invalid in a spat between the company and the Musculoskeletal Transplant Foundation. The ruling came from a 3-judge panel, delivered in a 1-line order without an opinion, affirming the PTAB’s decision from last month […]
MiMedx divests Stable Biologics subsidiary in transition to focus on biopharma
MiMedx (NSDQ:MDXG) said today it inked a definitive agreement with the former shareholders of Stability Inc. to divest itself of Stability Biologics, which it acquired last January. The Marietta, Ga.-based company said the divestiture is part of its plan to transition back into a biopharmaceutical-focused company. “The transaction is expected to be completed in the 3rd […]
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. Get the full story at our sister site, Drug […]
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