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 Group Inc.
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 […]
MiMedx touts data from study of AmnioFix, EpiFix allograft
MiMedx (NSDQ:MDXG) today announced the publication of a study of its AmnioFix and EpiFix allografts in treating myocardial infarction patients, touting enhanced vascularization and recruitment of autologous stem cells within infarcted cardiac tissue. Data from the study was published in the Journal of Cardiology & Cardiovascular Therapy, the Marietta, Ga.-based company said. “There is a critical […]
MiMedx touts Aetna reimbursement win for EpiFix implant
MiMedx (NSDQ:MDXG) said today that it won coverage from Aetna Inc. for its EpiFix allograft effective December 23rd. The insurance company classified EpiFix as “medically necessary” for the treatment of partial and full-thickness neuropathic diabetic foot ulcers when used in combination with standard diabetic ulcer care. The non-viable cellular amniotic membrane allograft helps to regenerate soft […]
MiMedx enters legal spat with 2 former sales reps
MiMedx (NSDQ:MDXG) this month released information on lawsuits filed against and by the company involving 2 former sales reps. The Marietta, Ga.-based company said it terminated the employees after finding that they had sold other company’s products “in violation of their contractual and common law duties to MiMedx.” MiMedx said it filed suits against the former employees […]
MiMedx picks up regenerative focused Stability Biologics
MiMedx (NSDQ:MDXG) said it completed its acquisition of human tissue product provider Stability Biologics, paying $10 million at closing and saying it expected the buy to be accretive to its full year 2016 adjusted EPS. Nashville, Tenn.-based Stability Biologics produces tissue products at its national processing center in San Antonio, Texas, for use in surgical, spinal […]
MiMedx revives Organogenesis beef
MiMedx (NSDQ:MDXG) CEO Pete Petit last week renewed a beef with regenerative medicine rival Organogenesis, accusing that company of being behind a short-seller’s letter advising investors to bet against MiMedx. Early this year, Marietta, Ga.-based MiMedx bailed out of a lawsuit against Canton, Mass.-based Organogenesis alleging “malicious actions” and interference from Organogenesis in the U.S. Veterans Affairs Dept. decision to stop using its […]
Organogenesis lauds Apligraf CE data
Organogenesis said today that a comparative effectiveness analysis of its Apligraf skin substitute has shown improved outcomes over competitor MiMedx‘s (NSDQ:MDXG) Epifix. The study, published this week in Wound Repair & Regeneration, examined healing rates of patients with diabetic foot ulcers treated either with Apligraf or Epifix. Data from the 218-patient, 99-center retrospective study showed a 97% […]