Clayton received his second patent in 2011 for the Temporomandibular Disorder â€œEar Systemâ€ â€” TMDes. It is a custom-fitted prosthesis placed in a patientâ€™s ear canal to relieve the pain from temporomandibular joint disorder pain, better known as TMJD. The temporomandibular joint is the hinge linking your jaw to your skull and is responsible for all of your mouth movements, from talking to chewing. In the U.S., more than 10 million people suffer from chronic TMJD pain, according to the National Institute of Dental and Craniofacial Research.
FDA approval was granted last September after studies revealed the TMDes showed 16 percent greater pain reduction than a bite splint, according to a clinical measurement called the craniomandibular index; a 70 percent greater pain reduction, according to a symptom severity index; and 56 greater pain reduction, according to a visual analog scale.
A bite splint, or night mouth guard, has been the only TMJD pain alternative for years.
The key now, Clayton said, is to find $3 million to $5 million in investment capital.
â€œWe really need to raise patient awareness. Virtually no one knows that this is available,â€ Clayton said. â€œWe need to hire several people in the sales force to be trained and penetrate the various dental society meetings. TMJD affects a lot of people. The market is huge.â€