Neocis’ Yomi Robotic System Receives FDA 510(k) Clearance for Bone Reduction

New bone reduction feature expands the scope of robot-assisted dental surgery by enabling clinicians to use the Yomi platform for more phases of full-arch rehabilitation

Miami, Florida, UNITED STATES


MIAMI, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Neocis®, manufacturer of Yomi® and the global leader in robot-assisted dental implant surgery, announced today that the Yomi system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for guided bone reduction – Neocis’ second FDA clearance this year and 14th to date. 

Yomi, the first and only FDA-cleared robotic system for dental surgery, assists clinicians in planning and operative phases of dental implant placement via interactive digital planning (using YomiPlan™ software) and physical guidance of surgical instrumentation, respectively. The Yomi robot, which received a Cellerant Best of Class Technology Award this summer, has been used in the placement of more than 21,000 implants and 850+ full-arch cases since its commercial launch. 

This new indication allows dental professionals to perform robot-guided alveoloplasty of the mandible and/or maxilla (commonly referred to as bone reduction), helping them take on complicated full-arch cases with confidence and efficiency. First, a patient's CT scan is used to digitally plan the bone reduction and placement of implants. During a procedure, Yomi’s guide arm provides haptic feedback to keep the burr from deviating beyond pre-planned resection boundaries. Unlike static guides, robot-assisted bone reduction allows clinicians to freely visualize, irrigate, and palpate the surgical site as well as modify their treatment plan intraoperatively without sacrificing accuracy.

This combination of in-depth virtual planning and robotic guidance helps the user achieve a smooth, level ridge, which is critical to predictable and lasting restorative outcomes. Currently in the midst of a multi-site limited market release, Yomi’s bone reduction functionality is expected to be commercially available early next year. 

“Not only does this allow implant clinicians to tackle full-arch restoration with a whole new level of accuracy and confidence, it pushes robot-assisted dental surgery into exciting new territory,” said Alon Mozes, Neocis Co-founder and CEO. “This clearance is one of our most significant yet, as dental professionals can now use Yomi to perform truly volumetric 3D surgery.”

Ridge reduction, an important preliminary step in many full-arch cases, involves flattening the surface of a patient’s alveolar bone to create a stable foundation for multiple implants, which are used to anchor a full-arch prosthesis. 

“Neocis continues to push the limits of implant dentistry, and Yomi’s new bone reduction functionality is a clear testament to that,” said Dr. Donald Nikchevich, an oral and maxillofacial surgeon based in Southern California and Yomi Diamond Doctor of Excellence. “As someone who performs full-arch rehabilitation regularly, I’m excited to be able to execute ridge reduction with the accuracy, efficiency, and confidence that surgical robotics affords.”

This new indication was cleared by the FDA just a few weeks after Neocis announced the close of an oversubscribed $40 million funding round, led by one of the dental industry’s largest specialist investors. They were joined by Intuitive Ventures, the independent VC arm of Intuitive Surgical, and several of Neocis’ existing partners. 

About Yomi
The Yomi robotic system is a computerized robotic navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Since 2016, Yomi has been helping clinicians around the country plan and place dental implants with a high level of precision and efficiency, so they can operate with confidence, expand their practices, and deliver an excellent patient experience. The platform has assisted in the placement of more than 21,000 implants. Visit neocis.com to learn more about Yomi or schedule a hands-on demo.

About Neocis
Neocis is transforming dental surgery with robotics. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Neocis is venture-backed with funding from Intuitive Ventures, DFJ Growth, Mithril Capital Management, Norwest Venture Partners, Vivo Capital, Section 32, and surgical robotics pioneer Fred Moll. For more information, visit neocis.com.

Contact
For more information, please contact the Neocis media relations team at info@neocis.com