by

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, Nov. 15, 2022 — 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.

by

Neocis Secures $40M in Additional Funding to Continue Transforming Dental Surgery With Robotics

Neocis closed its latest round of funding, led by a prominent dental investor, with participation from Intuitive Ventures and existing partners DFJ Growth, Vivo Capital, Mithril Capital Management, Norwest Venture Partners, and Fred Moll. This additional funding comes as robotic adoption within implant dentistry continues to increase dramatically; to date, the Yomi system has been used to place more than 20,000 implants. 

MIAMI, Oct. 27, 2022  — Neocis®, manufacturer of Yomi® and the global leader in robot-assisted dental implant surgery, announced today that the company has completed its latest round of financing. 


The oversubscribed $40M round was led by one of the dental industry’s largest specialist investors. They were joined by Intuitive Ventures, the independent VC arm of Intuitive Surgical that is accelerating the future of minimally invasive care. These new investors were joined by Neocis’ existing partners, bringing total investment in the Miami-based business to more than $160 million since its founding in 2009. 


Started by Alon Mozes and Juan Salcedo, Neocis manufactures and markets Yomi, dentistry’s first and only FDA-cleared robotic surgical system. The innovative platform assists clinicians during all phases of implant placement via streamlined digital planning and haptic guidance of surgical instrumentation–so they can place implants with accuracy, efficiency, and confidence. The Yomi system is often used to perform flapless procedures, a less invasive surgical approach with proven patient benefits.


“Neocis shares Intuitive Ventures’ commitment to advancing positive patient outcomes in minimally invasive care through innovative technology and solutions,” said Oliver Keown, MD, Managing Director at Intuitive Ventures. “We believe Neocis’ deep commitment to addressing customer and patient need through a broadening robotic ecosystem and their impressive technology platform that expands access to high-quality dental care, makes them a transformative force in this rapidly evolving market.”


This latest infusion of capital will allow Neocis, which the South Florida Business Journal recently named one of the fastest growing companies in South Florida, to advance its mission of transforming dental surgery through advanced robotics. The company will use these funds to continue accelerating research and development efforts, bolstering marketing and educational initiatives, and expanding the footprint of its sales, clinical support, and business optimization teams.


“We are thrilled to be joined by discerning investors aligned with Neocis’ mission to advance precision dentistry,” said Ajay Royan, Managing General Partner and Founder of Mithril Capital Management, an early investor in Neocis. “The future of dental robotics is limitless, and this latest round of capital will help the Neocis team continue innovating at the highest level.”


“For a company in the dental robotics space, I couldn’t dream up a better syndicate of investors than this,” said Alon Mozes, Neocis Co-Founder and CEO. “This new backing underscores Neocis’ strong position in a growing market and will help us further our product development and commercial efforts.”


The finalization of this new round of funding comes just a few months after Yomi was named one of the best dental technologies of the year by Dental Products Report and Cellerant Consulting Group–the first time a Neocis product has received a Cellerant Best of Class Technology Award. 


To learn more about Neocis and the Yomi system, visit neocis.com. 


About Intuitive Ventures
Intuitive Ventures is accelerating the future of minimally invasive care. Leveraging Intuitive’s entrepreneurial spirit, industry-leading knowledge, innovative technologies, and commercial reach, Intuitive Ventures invests in transformative opportunities advancing positive outcomes in healthcare. The team develops meaningful, long-term relationships with groundbreaking early-stage start-ups with tremendous financial opportunity that are leading the way in advancing minimally invasive care. Through its inaugural $100 million fund and with leadership combining decades of investing and operational experience, the Intuitive Ventures team is transforming minimally invasive care. Learn more at ventures.intuitive.com


About Yomi
Yomi 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. 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 20,000 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.

 

by

YomiPlan Go, the latest software mode in the expanding YomiPlan suite, received 510(k) clearance from the U.S. Food and Drug Administration in June following a successful clinical study – Neocis’ 13th FDA clearance to date.

by

YomiPlan Go is a software-based workflow that allows doctors to directly visualize a patient’s anatomy, set the desired location and angulation of an implant using their drill tip, and then perform an osteotomy under robotic guidance.

by

Miami, FL, [July 28, 2020]— Neocis, Inc., the leader and pioneer in robot-assisted dental implant surgery, announced today that they have received 510(k) clearance from the U.S. 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 of 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.

Dr. 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.”

Dr. Scotty Bolding, DDS, MS,  a renowned oral surgeon practicing in Fayetteville, AR,  who was also an investigator in the clinical study, 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.”

 

About Yomi
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.

Contact
Cassie Hallberg
Vice President of Marketing
(732) 688-8839
info@neocis.com

by

MIAMI, May 12, 2020 (GLOBE NEWSWIRE) — Neocis, Inc., the leader and innovator in dental implant surgery using advanced robotics, today announced a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new component for use with Yomi. This component reduces the CT scanner field-of-view (FOV) requirements, which broadens the target market for adopting robot-assisted dental surgery.

Yomi, the first and only FDA cleared robot-assisted dental surgery system, provides robot-assisted guidance relative to a pre-operative plan based on a CT scan. Many dental offices have in-office cone beam CT scanners, which provide a true 3D visualization of the patient as compared to a 2D x-ray or projected panoramic scan. The Yomi system is compatible with all DICOM format CT scans, which includes most scanners on the market. CT scanners vary in the field-of-view that they offer. With the latest clearance, Yomi will be compatible with a wider variety of scanners across a larger range of fields-of-view.

“Increasing the compatibility of Yomi enables us to reach a wider market of implant surgeons,” said Alon Mozes, PhD, Chief Executive Officer of Neocis. “As we continue to improve the technology and the workflow, we’re excited to get this into the hands of more dental implant surgeons so they can benefit from the use of robot-assisted technology.”

Dr. Arthur Lyford, a Yomi user and practicing dentist in New Hampshire, says, “Yomi continues to get easier to incorporate into my practice. I use it for every dental implant. This latest development will make the workflow even easier and provide an opportunity for any dentist with a CT scanner to adopt this state-of-the-art technology.”

About Yomi

Yomi® is the first and only FDA cleared robot-assisted dental surgery system. It is indicated for use to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. Yomi provides computerized navigation to assist in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system offers 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® enables a minimally invasive flapless approach, which 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 1000 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.

Contact
Cassie Hallberg
Vice President of Marketing
(732) 688-8839
info@neocis.com