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 neocis
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.
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
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
MIAMI, April 22, 2020 (GLOBE NEWSWIRE) — Neocis, Inc., the manufacturer of the Yomi Dental Robotics System, is proud to announce that several of their employees are volunteering their personal time and sharing their professional expertise to help The Ventilator Project. The Ventilator Project is a non-profit effort to design a new ventilator that is low-cost and highly scalable. Neocis employees have a deep background in medical device manufacturing and robotics development, which are critical components of a new ventilator design.
Tyler Mantel, Co-founder of The Ventilator Project, stated, “Our mission is to solve the impending worldwide ventilator shortage, and technology is a key component. In just a few weeks, we’ve on-boarded experienced staff and established key relationships in manufacturing. Neocis has supported our efforts with guidance in engineering, project management, and regulatory affairs.”
The Ventilator Project is currently fundraising to accelerate its growth and timeline to produce urgently needed ventilators. To inquire about supporting or participating in the project, please visit https://theventilatorproject.org/donate/ or email info@TheVentilatorProject.org.
“Neocis is committed to using technology to improve healthcare, so when our employees wanted to apply their knowledge to help ease the worldwide shortage of ventilators, we wanted to support them,” said Alon Mozes, PhD, CEO of Neocis. “We believe robotics will play an important role in a new era of infection control, and we look forward to applying it to the dental industry and beyond. The Ventilator Project is a worthy cause that can leverage much of our experience in robotics and medical devices.”
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.
About The Ventilator Project
The Ventilator Project (TheVentilatorProject.org) is a non-profit effort to develop low-cost highly scalable ventilators to address the shortfall of millions of ventilators that will occur worldwide as a result of COVID-19. By avoiding standard supply chains, The Ventilator Project will avoid bottlenecks that will interfere with addressing the need by large manufacturers of ventilators.
Contact
Cassie Hallberg
Vice President of Marketing
(732) 688-8839
info@neocis.com
March 30, 2020 by Neocis
Miami, FL, [March 30, 2020]— Neocis, Inc., the leader and pioneer in robot-assisted dental implant surgery, announced today that they had filed for 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new Yomi® edentulous splint. This new splint will enable the Yomi Dental Robotic system to go beyond placing implants on partially edentulous patients to assisting doctors with full arch implant 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 help restore the dentition and smiles of people who are missing their teeth.
“Our doctors have been asking for a splint that would enable Yomi to assist with restoring full arches. After the conclusion of a successful clinical study of our new edentulous splint, I am delighted today to report that we have filed for 510(k) clearance,” said Alon Mozes, PhD, Chief Executive Officer and President of Neocis.
Dr. Uday Reebye, MD, DMD, a leader in Oral and Maxillofacial Surgery, who was the lead investigator in the Yomi Edentulous splint’s clinical study said, “Since there is no plastic surgical guide needed, there was no wait for surgical guide fabrication, and no physical guide impeding access or visualization. Robotic haptic guidance securely constrained the handpiece to the virtual restorative plan. Given the accuracy, precision, and intraoperative flexibility of robotic surgical platforms, this preliminary data supports the promise of Yomi robotic guidance to augment dental implant therapy for fully edentulous arches.”
Dr. Scotty Bolding, DDS, MS, a nationally recognized leader in Oral and Maxillofacial Surgery, who was an investigator in the Yomi Edentulous splint’s 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. 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 1800 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