MiMedx announced last week that they would divest their subsidiary Stability Biologics LLC to the stockholders from whom MiMedx acquired the company in January 2016. This move will enable the company to focus on their biopharma strategy, which is based on further developing their human placental tissue platform technology.
Stability developed and processed bioactive bone graft products and tissue allografts, including structural/particulate bone, structural allografts, demineralized bone matrix (DBM), skin products for burns and traumatic wound care and the bone grafting material Physio. As MiMedx developed its plan to transition fully to a biopharma company, which it intends to complete by 2020, they concluded that Stability was no longer a strategic fit.
MiMedx is now focusing on completing BLA submissions for AmnioFix Injectible, their lead product candidate, for the treatment of muscloskeletal pain. The company recently announced that it has submitted INDs for phase III plantar fasciitis and achilles tendonitis clinical trials, with the BLAs expected to be submitted in 2019 and launches projected for mid-2020. The company is also performing clinical investigations into the use of the treatment for osteoarthritic knee pain, with a BLA in that indication expected to be filed in 4Q:20. And while the company is primarily focused on the wound healing and orthopedic therapeutic areas, they have publicly announced potential applications in other sectors as well, including pain management, respiratory and cardiac.