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MIMEDX Engages Nordic Bioscience Clinical Development A/S to Propel Registrational Trials of Placental Biologic Injectable for Knee Osteoarthritis
Image Analysis Group to Provide Imaging Strategy and Advanced Imaging Analytics in Support of MIMEDX’s Knee Osteoarthritis Clinical Trial Program MARIETTA,
About this update from Mimedx Group, Inc
[{"type":"text","content":"Image Analysis Group to Provide Imaging Strategy and Advanced Imaging Analytics in Support of MIMEDX’s Knee Osteoarthritis Clinical Trial Program MARIETTA, Ga., June 15, 2022 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a transformational placental biologics company, today announced a collaboration agreement with Nordic Bioscience Clinical Development A/S (NBCD), a world-class Contract Research Organization (CRO) specializing in Osteoarthritis (OA) clinical trials. Image Analysis Group, an expert imaging company, will also provide advanced tools to detect the potential for the Company’s placental biologic injectable, micronized dehydrated Human Amnion Chorion Membrane (mdHACM), to act as a Disease Modifying Osteoarthritis Drug (DMOAD) and potentially moderate the progression of OA. The Company plans to initiate its registrational Knee Osteoarthritis (KOA) clinical trial program later this year, using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and WOMAC Function as co-primary endpoints. Robert B. Stein, M.D., Ph.D., MIMEDX President, Regenerative Medicine & Biologics Innovation, said, “We have significant evidence that mdHACM injected into the knees of people with OA provides lasting pain relief and improves function, and we believe it has potential as a DMOAD. MIMEDX has discovered how to preserve the remarkable healing properties of placental membranes when we produce mdHACM, and we have demonstrated that it contains many proteins that influence the biology of cartilage-forming cells and reduce inflammation. We believe these active proteins contribute to the striking, long-lasting benefits we have seen in patients receiving a single injection of mdHACM into their osteoarthritic knee. Following an extensive review and selection process, we are very excited to have world-class partners who are at the forefront of advancing meaningful medicines; working in collaboration accelerates our ability to gather quality data for our future Biologics License Application (BLA), and our potential to bring tremendous benefit for people living with OA.” David Mason, M.D., MIMEDX Chief Medical Officer, added, \"NBCD has well-established expertise in the field of OA and a proven track record of conducting clinical studies of the highest quality to help advance drug development...