In the race to capitalize on patient-driven interest in stem cells, biologic solutions and “regeneration” of a more vital, healthy and functional body, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence.
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.
Phase III study results demonstrated that Anika Therapeutics' CINGAL® provided superior immediate and short term OA pain relief after injection vs. hyaluronic acid alone, and superior relief at 26 weeks vs. saline.
Zimmer Biomet announced FDA approval of an expanded 26-week efficacy claim for single-injection Gel-One® Cross-linked Hyaluronate viscosupplement for the treatment of knee pain associated with osteoarthritis.
Bioventus entered into a multi-year agreement with Institut Biochimique, gaining exclusive U.S. distribution rights for GELSYN-3™ 3-injection hyaluronic acid product for pain relief associated with knee OA.
In late 2015, FDA assigned Anika Therapeutics' CINGAL to the Center for Drug Evaluation and Research (CDER) and not the Center for Device and Radiological Health (CDRH) for its premarket review-a decision with which Anika's leadership says it disagrees.