Neocis announced today that it received FDA 510(k) clearance for its Yomi surgical robot system for use in guided bone reduction.
This represents the second FDA clearance for Neocis this year, and its 14th in total.
Miami-based Neocis designed its Yomi surgical robot for dental surgery. It assists clinicians in the planning and operative phases of dental implant placement. For example, Yomi offers interactive digital planning software and physical guidance for surgical instrumentation.
The new indication for Yomi allows dental professionals to perform robot-guided alveoloplasty of the mandible and/or maxilla. This is commonly referred to as bone reduction, according to a news release.
A CT scan of the patient digitally plans the bone reduction and placement of implants. During the procedure, Yomi’s guide arm provides haptic feedback. This keeps the burr from deviating beyond pre-planned resection boundaries. Neocis said robot-assisted bone reduction allows clinicians to freely visualize, irrigate and palpate the surgical site. Also, they can modify their treatment plan intraoperatively without sacrificing accuracy.
“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.”
About Neocis
The company said its platform offers in-depth virtual planning and robotic guidance to achieve a smooth, level ridge. This is critical to predictable and lasting restorative outcomes. Yomi, currently amid a multi-site limited market release, may be available for bone reduction early next year.
More good news for Neocis follows last month’s completion of an oversubscribed financing round worth $40 million.
Intuitive Surgical’s independent VC arm, Intuitive Ventures, participated in the round. In total, Neocis brought in more than $160 million since its founding in 2009.
Neocis plans to use the funds to accelerate R&D efforts. The company also intends to bolster its marketing and educational initiatives with the funds. Additional uses include expanding its footprint in sales, clinical support and business optimization.
“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.”