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 -- 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.