FDA approval to manufacture partial TMJ prostheses

This article is not meant for patients - the focus of TMD's medical coverage is designing and manufacturing of medical devices and equipment and is aimed toward those in the industry, not the end-users.

Nexus CMF officials announce that the company has entered into an exclusive licensing agreement with Mayo Clinic to develop new technology for a partial temporomandibular joint (TMJ) prosthesis.

The patented hemiarthroplasty approach is for a non-anatomical patient-specific implant that sits flat on the bone to create more freedom of movement for the patient’s jaw joint. This design entails surgical reshaping of the bone and is for patients with osteoarthritis where the interpositional disc is displaced or perforated resulting in bone-on-bone contact. The technology was developed by Eugene Keller, M.D., oral and maxillofacial surgery at Mayo Clinic and professor of surgery, Mayo Medical School; Kai-Nan An, Ph.D., biomechanics and engineering at Mayo Clinic; and Evre Baltali, DD.S., Ph.D., oral and maxillofacial surgery, now in private practice with Acibadem Hospital Eskisehir in Turkey.

Nexus CMF will seek to develop this hemiarthroplasty surgical approach – which has undergone a 60-patient study at Mayo prior to its licensing – using its Patient-Specific TMJ Fossa-Eminence Prosthesis System.

Currently the only medical device company with FDA approval to produce partial TMJ prostheses, Nexus CMF is also the only company in the United States to manufacture both stock and patient-specific TMJ prostheses.

“It has been a great experience collaborating with Dr. Keller and Dr. Baltali on this new technology as they and their colleagues at Mayo Clinic are truly leaders in their medical specialties,” says Andrew Olson, director of sales and marketing at Nexus CMF. “We are thrilled to be able to offer a wide variety of viable prosthesis options that cater to different patient needs and surgical philosophies.”

Mayo Clinic and Drs. E. Keller, Kai-Nan An and E. Baltali have a financial interest in technology referenced in this news release. Revenue Mayo receives is used to support its mission of patient care, education, and research.

Source: Nexus CMF