SALT LAKE CITY & DENVER--(BUSINESS WIRE)--TMJ Medical acknowledged Tuesday receiving a postmarket surveillance study order from the U.S. Food and Drug Administration. TMJ Medical is one of three medical device manufacturers approved to market temporomandibular joint (TMJ) implants in the United States. Each manufacturer received the same FDA order.
In a press release Monday, the FDA indicated it was requiring implant manufacturers to conduct the studies due to reports that some TMJ devices were being replaced earlier than the expected minimum five-year life span.
Our company has not yet manufactured any implants, noted Jared Crocker, president of TMJ Medical. However, we recognize that we received this order from the FDA because we acquired the premarket approvals for these devices from a company named TMJ Implants, Inc., which is no longer in business.
TMJ Implants, Inc. declared bankruptcy in June 2010. In a competitive bidding process, TMJ Medical acquired the assets of the defunct company during bankruptcy proceedings in September 2010.
During our due diligence process on TMJ Implants, Inc., we found that some devices had been implanted nearly 40 years earlier and were still providing relief to patients from their TMJ disorders, Crocker said. This performance was part of the appeal in acquiring these assets.
Crocker signaled that his company plans to adhere to FDA requirements. Yes, we intend to fully comply with all regulatory requirements within the U.S. and elsewhere, Crocker said. In fact, we are actively working to secure regulatory approval for our new manufacturing facility.
When asked about his outlook for the surveillance studies, Crocker was enthusiastic. We have been preparing to conduct rigorous medical research on many topics related to TMJ disorders generally and these devices specifically. While the FDA order advances our timeline, the surveillance studies dovetail nicely with our planned business activities.
About TMJ Medical
TMJ Medical is a manufacturer of medical devices for the treatment of temporomandibular joint disorders. It is the only company offering implants in both standardized stock components, and patient-specific devices. Also, TMJ Medical is the only company to offer a partial replacement prosthesis for TMJ disorders, which allows for a simpler and less-invasive procedure when surgeons determine a total joint replacement is not needed and a more conservative approach is called for.