Neocis, Inc., the leader and pioneer in robot-assisted dental implant surgery, announced today that they have received 510(k) clearance from the US Food and Drug Administration (FDA) for a new Yomi® edentulous indication. The clearance allows for a new splint attachment which broadens Yomi’s application to include full arch implant cases as well as partially edentulous cases. The American College of Prosthodontists estimates that over 36 million Americans are missing all their teeth. The new Yomi edentulous splint will enable doctors to use Yomi’s technology to reach more of this population.
“I am delighted today to report that we have received 510(k) clearance for Yomi to assist with full arch implant surgeries. With this clearance, Yomi doctors will be able to leverage robotic technology to treat more patients and restore more smiles,” said Alon Mozes, PhD, Chief Executive Officer of Neocis.
Uday Reebye, MD, DMD, a leader in Oral and Maxillofacial Surgery with a practice in Durham, NC, was an investigator in the clinical study that supported the FDA clearance. He said, “The advent of Yomi’s full arch protocol is a dramatic shift in dental implant surgery. A reduction in time to surgery, improved surgical efficiency, and accuracy, combined with a minimally invasive approach, have made Yomi’s full arch protocol the gold standard. Using Yomi, I was able to complete full arch surgery on average in 21 minutes.”
Scotty Bolding, DDS, MS, a renowned oral surgeon who practices in both Fayetteville, AR, and St. Petersburg/ Tampa Bay, FL, was also an investigator in the clinical study. He said, “I was so impressed by the accuracy of the first cases using Yomi robotic guidance in fully edentulous patients. The splints were extremely stable, easy to use, and remarkably accurate. Additionally, there was excellent visibility in the surgical field that you cannot get with any available guide today. There is no doubt in my mind that Yomi will set the standard for the multi-implant cases in the future. I have been placing dental implants for over 30 years, and I have never experienced the precision or accuracy that was demonstrated with the new full arch splint.”
Yomi® is the first and only FDA-cleared robot-assisted dental surgery system. 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. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. The system offers precise and accurate physical guidance through haptic robotic technology, which constrains the drill in position, orientation, and depth. The assistive technology provides the surgeon with complete control and, unlike plastic surgical guides, allows for clear visualization of the surgical site. Yomi can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. A minimally invasive flapless surgical approach has been proven to lead to faster surgery, faster recovery, and less pain for the patient. The Yomi Robotics system has been used to place over 2000 dental implants across the United States.
About Neocis, Inc.
Neocis Inc. is a private company located in Miami, Florida that is transforming dental surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. Neocis manufactures and markets Yomi®, the first and only robot-assisted surgical platform for the dental industry. Neocis is venture-backed, including funding from Mithril Capital Management, Norwest Venture Partners and robotic surgery industry pioneer Fred Moll. For more information visit www.Neocis.com.