Orthopedic sales for the company declined 9.5% in 1Q20 before dropping by nearly half through April. However, the company sees initial recovery signs as countries gradually restart elective procedures.
Regenerative medicine is an emerging market with solutions to not only heal but also grow tissue and bone. Renovos is addressing the issue of biological molecule diffusion through a synthetic nanoclay gel technology platform called Renovite.
Ortho Regenerative Technologies confirmed the safety profile of ORTHO-R biopolymer as well as statistical significance over standard-of-care following completion of a pivotal preclinical study in rotator cuff tear repair.
Histogenics plans to evaluate the range of potential strategic alternatives for its NeoCart® cell therapy following FDA's indication that an additional clinical trial would be required before acceptance of a Biologics License Application submission.
Histogenics' Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year.
At AAOS, we sat down with the CEOs of Bioventus and Histogenics to ask about opportunities that their companies are embracing, as well as the health of the orthobiologics market. Both mentioned advancements in therapies demonstrated through clinical trials and outcomes, and both discussed the importance of keeping younger, active patients healthy and mobile. Here we recap a portion of those conversations.
Study results demonstrated that improvements in pain and function from use of Vericel's MACI vs. microfracture in the treatment of knee cartilage defects were sustained for five years following surgery.
Five-year results from a clinical trial of the Cartiva Synthetic Cartilage Implant in the treatment of great toe arthritis demonstrated pain relief and functional outcomes equivalent to first MTP arthrodesis at two years post-op.
Histogenics closed its previously-announced US $30.0MM private placement. Funds will support development of NeoCart® novel cartilage repair therapy, including completion of the ongoing Phase III clinical trial.
Rotation Medical completed a US $12MM Series B extension financing. Proceeds will support U.S. commercialization of its rotator cuff repair system, comprising a proprietary bioinductive implant and disposable instruments.
Histogenics acquired development and commercialization rights to NeoCart® for the Japanese market from its partner, Purpose Co. NeoCart autologous cell therapy is designed to treat knee cartilage defects.
Regentis Biomaterials closed a US $15MM Series D investment round. Funds will primarily support a pivotal U.S. clinical trial of GelrinC®, a cell-free implant for the treatment of articular knee cartilage injuries.
FDA tentatively scheduled a 2Q16 meeting of the Orthopaedic and Rehabilitation Devices Panel to review Cartiva's Premarket Approval Application for the Synthetic Cartilage Implant in the treatment of great toe osteoarthritis.
CartiHeal completed a US $15MM financing round. Funds will support ongoing manufacturing scale-up, EU product commercialization in 2017 and clinical studies in new therapeutic areas for Agili-C™ cartilage regeneration technology.
Vericel submitted a Biologics License Application to FDA for MACI™ matrix applied characterized autologous cultured chondrocytes, an investigational product intended to treat adult symptomatic cartilage defects of the knee.