Neocis Inc. Announces FDA Clearance for First Robotic System for Dental Implant Procedures
Miami, Fla. –Neocis Inc. today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market Yomi®, a robotic guidance system for dental implant procedures. Yomi is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.
Dental implant surgery is the standard of care for replacing missing teeth. Nearly 4 million implants are placed annually in the United States by 15,000 dental specialists and nearly 150,000 general practice dentists. More than 15 million implants are placed annually worldwide. The surgical robotics market is growing significantly across several medical markets and is estimated to reach $20 billion by 2021. Yomi is the only surgical robotic system focused on the dental industry.
Yomi delivers physical guidance through the use of haptic robotic technology, which constrains the drill in position, orientation, and depth. This assistive technology leaves the surgeon in control at all times. Unlike plastic surgical guides, Yomi allows for clear visualization of the surgical site and does not require custom manufacturing. Yomi also provides flexibility during the surgery by allowing the surgeon to dynamically change the plan.
“Yomi is a precision instrument that makes sure your implant goes exactly where you planned to put it,” said Dr. Jeffrey Ganeles, D.M.D., periodontist at South Florida Center for Periodontics and Implant Dentistry and founding faculty at Nova Southeastern College of Dental Medicine. “I’ve done thousands of implants free-hand. Yomi will be a game changer for dental implant surgery.”
“We are excited to achieve this important milestone for Yomi,” said Alon Mozes, Ph.D., CEO and Co-founder of Neocis. “We look forward to further demonstrating the benefits of Yomi to the surgeon’s practice and their patients and to bringing the system to select key opinion leaders in the United States.”
Dr. Federico Grande, D.D.S., M.D., an oral surgeon with the Center for Specialized Dentistry, discussed the benefits to his practice and his patients. “Showing my patients the benefits of robotic guidance with Yomi gives them comfort. They know they are getting state-of-the-art treatment and reliable results.”