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Neocis Announces New FDA 510(k) Clearance Enabling the Yomi® Dental Robotic System to Assist with Full Arch Implant Treatment

July 28, 2020 by neocis

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

Neocis Announces New FDA 510(k) Clearance for Yomi® to Enhance CT Scanner Compatibility

May 13, 2020 by neocis

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

Dental Robotics Company, Neocis, Supports The Ventilator Project, a Not For Profit Addressing the Worldwide Shortage of Ventilators

April 23, 2020 by neocis

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

Neocis Files 510(k) To Enable the Yomi® Dental Robotic System to Assist with Full Arch Implant Treatment

March 30, 2020 by neocis

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

The First Surgical Robot Designed for Dental Implant Surgery, Yomi®, Surpasses 1000 Implants.

January 7, 2020 by neocis

This Milestone Signals the Arrival of Surgical Robotics Technology in the Dental Space.

 

Miami, FL, [January 7, 2020] — Since 2000 more than 4 million robotic-assisted surgeries have taken place across multiple medical specialties including Cardiovascular, Neurology, and Orthopedics. Until the launch of Yomi, the first and only FDA cleared robot-assisted dental surgery system, dentistry has not been able to benefit from this revolutionary technology. Successfully placing dental implants requires careful pre-operative planning and a high degree of accuracy and precision.  Surgical robotic technology helps doctors to achieve these objectives. Neocis, the leader and pioneer in dental robotics, announced today that over 1000 implants were placed in 2019 using the Yomi robotics system, signaling the arrival of surgical robotics technology in the dental space.

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.

“This is an exciting milestone for Neocis,” said Alon Mozes, Ph.D., Chief Executive Officer of Neocis. “This has been the direct result of streamlining our workflow and increasing the system functionality. We’re excited to see our increased sales and utilization further underscore the appetite for robotics in the dental industry.”

Dr. Joe Griffin, a dentist with Cornerstone Dental Arts and new Yomi user, says, “We’ve been able to use Yomi for many cases thanks to a quick learning curve. The system has been easy to incorporate into our practice. We see this clearly establishing a new standard of care for implant patients.” 

About Yomi
Yomi® is indicated for use 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® provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient. Learn more at www.neocis.com.

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
(732) 688-8839
info@neocis.com

 

Henry M. Goldman School of Dental Medicine becomes first U.S. dental school to acquire, implement robotic-assisted surgery

October 9, 2019 by neocis

BOSTON, MASSACHUSETTS – Boston University’s Henry M. Goldman School of Dental Medicine (GSDM) announced today that they have become the first U.S. dental school to acquire, install, and use two surgical robotic devices for dental implant surgeries. 

These devices will provide an opportunity for the School’s predoctoral students and postdoctoral residents to learn how state-of-the-art robotic technology, with its accuracy and precision during dental surgery, can augment and enhance clinical practice and patient care.

The robot-assisted surgical device, known as Yomi, was developed by Miami-based healthcare start-up Neocis. It is the first (and to date, only) such device cleared by the U.S. Food and Drug Administration for dental implant surgery. 

“This technology is truly revolutionary and will change – and improve – the way we approach dental implant surgeries at the Henry M. Goldman School of Dental Medicine,” said Dr. Alexander Bendayan, GSDM’s assistant dean of digital development & clinical training. “Introducing this advanced technology to our patient treatment centers will ensure that our predoctoral students and postdoctoral residents are prepared to be leaders in the field and will help to establish new standards of care for the profession.”  

Using the Yomi system, the provider performing the surgical procedure first creates a virtual plan for the placement of a dental implant using detailed 3D scans of the patient’s mouth. The system then uses physical cues to guide the provider along the precise implementation of that plan – but is also able to adjust dynamically to accommodate mid-procedure changes. Yomi augments a provider’s  ‘feel,’ giving real-time feedback via haptic technology to guide a provider along the treatment plan. But the provider controls the handpiece at all times: By design, the Yomi system complements, rather than overrides, a provider’s clinical expertise.

“We believe that Yomi may become a new standard of care for dental implants, and are thrilled to be working alongside the faculty, students, and residents at GSDM to implement this technology,” said Dr. Alon Mozes. “By embedding the technology at the dental-school level, we are building comfort and skill with this technology from the ground up.”

The School, with the assistance of trained technicians from Neocis, completed installing and calibrating the robotic devices in late September. GSDM faculty members participated in a rigorous two-day training on the Yomi system on September 25-26, 2019; additional two-day trainings will be held throughout October and November. Once trained, faculty members will use the Yomi system on their own patients and will also instruct GSDM predoctoral students and postdoctoral residents on the technology. Neocis will provide ongoing service and support.

With the acquisition of Yomi, GSDM continues its commitment to pioneering new dental technologies in its predoctoral and postdoctoral educational programs. In 2015, GSDM became the first dental school in the U.S. to implement CAD/CAM guided dental implant surgery, first using CEREC and SICAT guides and then, in 2018, introducing Nobel Biocare guides. All predoctoral students at GSDM currently have the opportunity to place a dental implant using guided surgery – a rarity for U.S. predoctoral dental programs – and soon will be able to also gain experience using the first robot-assisted dental surgical system in the U.S.

“At the Henry M. Goldman School of Dental Medicine, innovation is more than a buzz word: It’s a mindset,” said Dr. Jeffrey W. Hutter, dean and Spencer N. Frankl professor in dental medicine. “Our School has always been a leader in embracing cutting-edge dental technologies, and I am proud to continue that tradition of innovation with Yomi.”

 

###

 

About Boston University Henry M. Goldman School of Dental Medicine: Founded in 1963, the Boston University Henry M. Goldman School of Dental Medicine is the premier academic dental institution promoting excellence in dental education, research, oral health care, and community service to improve the overall health of the global population. With a faculty of more than 240 educators, clinicians, and researchers and more than 250 staff members, the School offers a full spectrum of predoctoral and postdoctoral education programs and a complete range of graduate programs and degrees to more than 700 students. 

About Neocis, Inc.: Neocis® is a private company located in Miami, Florida, that is transforming dental implant surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. The company’s FDA cleared Neocis Guidance System, or Yomi®, is indicated for use 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® provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient.

Neocis Announces FDA 510(k) Clearance of Additional Drill for Use with Yomi®

September 30, 2019 by neocis

MIAMI, Sept. 30, 2019 (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 dental drill for use with Yomi. This new clearance leads to an easier workflow and provides enhancements to the surgeons’ drilling experience.

Yomi, the first and only FDA cleared robot-assisted dental surgery system, 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.

“Streamlining the workflow for our robot-assisted surgery system is the most critical part of enabling this technology to be broadly adopted,” said Alon Mozes, PhD, Chief Executive Officer of Neocis. “We are laser-focused on creating a great experience for the surgeon and the patient.”

Dr. Scotty Bolding, a nationally recognized leader in Oral and Maxillofacial Surgery, says, “I am tremendously impressed with the team at Neocis. They are truly listening to the professionals and continue to advance the robotic technology to make the system more accurate and user-friendly. This latest FDA clearance is just another example of how they are making the system easier to use and making YOMI not only routine in our practice, but establishing the standard of care for our patients.”

About Neocis, Inc.
Neocis® is a private company located in Miami, Florida that is transforming dental implant surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. The company’s FDA cleared Neocis Guidance System, or Yomi®, is indicated for use 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® provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient. Learn more at www.neocis.com.

Contact
Info@neocis.com

Neocis Inc. Closes $30M Equity Funding Round

July 15, 2019 by Lesa-Gaye Spencer

MIAMI, July 15, 2019 (GLOBE NEWSWIRE) — Neocis Inc. today announced that it closed a $30 million equity financing round to support expanded commercialization and R&D efforts.

The Miami, FL based company said that the round was raised from existing investors, including Mithril Capital Management, and joined by new investor Norwest Venture Partners.

Dr. Robert Mittendorff, Partner at Norwest Venture Partners, will join the Board of Directors. “Norwest is excited to join the Neocis team. We believe there is a huge opportunity for robotics to transform healthcare. Neocis has demonstrated their ability to revolutionize dental surgery,” said Dr. Mittendorff.

“Having a group of investors and a Board of Directors so experienced in successfully commercializing robotic surgery will be critical as Neocis charges into the next phase of growth,” said Dr. Alon Mozes, CEO and Co-founder of Neocis. “This funding will secure our opportunity to expand sales and adoption of Yomi® and continue to innovate in the robotic surgery space.”

Neocis received FDA clearance for Yomi, its robot-assisted dental surgery system. Yomi is indicated for use 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 provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient.

 

About Neocis Inc.

Neocis®, a privately held company focused on improving health care through robotic assistance, manufactures and markets Yomi®, the first and only robot-assisted surgical platform for the dental industry. Headquartered in Miami, Fla., 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
info@neocis.com

[button link=”https://www.neocis.com/contact/” color=”orange” newwindow=”yes”] Contact Neocis[/button]

What’s it like to incorporate Yomi robotics into your dental implant practice?

July 12, 2019 by Lesa-Gaye Spencer

Sean Pierce, DDS shares his journey from Yomi test drive to first case as a robotically-trained dental implant surgeon.

Read more and watch the video

Video courtesy of Pierce Aesthetics.

Neocis announces article in June 2019 Oral Health article Journal

June 12, 2019 by Lesa-Gaye Spencer

Implant surgery with robotic guidance – Digital workflows for patient care

Oral Health Magazine, June 2019
Bao-Thy N. Grant, DDS, Board-Certified Oral and Maxillofacial Robotic Surgeon at theCenter for Oral Reconstruction & Education

This article introduces Yomi-Enabled Surgery (“YES”) for dental implant therapy, including two case reports from early clinical experience of a board-certified oral and maxillofacial surgeon at the Center for Oral Reconstruction & Education, a full-scope oral and maxillofacial surgery private practice in Orange, California, USA.

“We believe that as oral surgeons embrace robotic surgery, through case planning accuracy, surgical precision, surgeon comfort, patient safety, and transformed surgical techniques, we can enhance patient care in our field.” – Bao-Thy N. Grant, DDS

Read more

Neocis Announces FDA 510(k) Clearance of Additional Dental Materials for Use with Yomi®

January 7, 2019 by Matt Wittenbrink

New materials provide important enhancements to robot-assisted dental implant surgery workflow

Miami, FL, [January 7, 2019] — 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 additional dental materials to use with Yomi. This clearance will expand workflow options to dental surgeons to achieve robot-assisted guidance.

Yomi, the first and only FDA cleared robot-assisted dental surgery system, 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.

Alon Mozes, PhD, Chief Executive Officer of Neocis stated, “Workflow options enabled by this new clearance offers more flexibility in the implementation of robot-assisted dental surgery and helps us to expand our reach to the more than four million dental implants performed in the U.S. each year. Workflow enhancements enabled by this new clearance are a direct result of our corporate commitment to the voice of the customer.”

“It has been great to work with Neocis as a Pioneer. This latest FDA clearance helps to provide me with even more workflow options for incorporating Yomi into my practice,” says Dr. Uday Reebye, oral surgeon in North Carolina and Yomi pioneer user.

Neocis previously received FDA clearance in February 2018 for a Chairside Splint to be used with Yomi, which enabled a same-day workflow that facilitated completion of dental implant surgery with robot-assisted guidance in a single visit.

About Neocis, Inc.
Neocis® is a private company located in Miami, Florida that is transforming dental implant surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. The company’s FDA cleared Neocis Guidance System, or Yomi®, is indicated for use 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® provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient. Learn more at www.neocis.com.

Contact
Leigh Salvo or Carrie Mendivil
(415) 937-5404
investors@neocis.com

Neocis Announces Additions to Leadership Team

December 19, 2018 by Matt Wittenbrink

Christopher Sells Named Vice President, Sales and Marketing
Erik Beuckelaers Named Vice President, Finance & HR
Dennis Moses Named Vice President, Engineering

Miami, FL, [December 19, 2018] — Neocis, Inc., the leader and innovator in dental implant surgery utilizing advanced robotics, announced today the addition of three experienced leaders in the medical device industry to the Company’s management team.

  • Christopher Sells has been named Vice President, Sales and Marketing. Sells most recently served as Vice President, New Business for Mazor Robotics where he was responsible for a number of key operational areas including new product launches and U.S. commercial optimization. He also served as Mazor’s Vice President of Sales as the company’s first U.S. employee. Previously, he held senior sales and operations roles with Hansen Medical, Intuitive Surgical, Neotonus, and Indigo Medical.
  • Erik Beuckelaers has been named Vice President, Finance & HR. He most recently served as Head of Finance, IT and Facilities at Verb Surgical, Inc., the surgical robotics and digital surgery joint venture between Johnson & Johnson and Google. Previously, Beuckelaers held numerousroles at Johnson & Johnson over nearly 10 years, including roles as Acclarent Head of Finance and Janssen R&D Manager Immunology Portfolio Strategy.
  • Dennis Moses has been named as Vice President, Engineering. Moses most recently served as Director of System Engineering for Verb Surgical, Inc. Prior, he served in numerous roles of increasing responsibility over nearly 15 years with Stryker Corporation. During his tenure, he participated in multiple major hardware and software releases and was successful in introducing and advancing a novel robotic solution for orthopedic surgery. Moses has led cross functional design and development efforts in various technologies and the medical device industry.

Mr. Sells, Mr. Beuckelaers, and Mr. Moses are part of the senior leadership team reporting directly to Alon Mozes, Chief Executive Officer.

“I am pleased to bring these strong executives to our senior management team during this pivotal stage in our company’s growth. Chris, Erik, and Dennis are all experienced industry leaders, each with a record of excellence and accomplishment in driving innovation, growth and operational improvements for a range of successful medical device and robotics companies. Following the addition of Dr. Fred Moll to the Neocis Board of Directors in July, we welcome the addition of these leaders who I am confident will add value as we change implant dentistry with the world’s first robot-assisted dental surgical system,” said Alon Mozes, Chief Executive Officer.

About Neocis, Inc.
Neocis® is a private company located in Miami, Florida that is transforming dental implant surgery with advanced robotics, with a vision of advancing healthcare through the latest technology. The company’s FDA cleared Neocis Guidance System, or Yomi®, is indicated for use 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® provides surgical guidance through the use of haptic robotic technology, software, and multisensory feedback to help achieve the right position, angulation, and depth to place the implant exactly according to plan. Yomi® enables a minimally invasive flapless approach, which has been proven to lead to faster surgery, faster recovery, and less pain for the patient. Learn more at www.neocis.com

Contact
Leigh Salvo or Carrie Mendivil
(415) 937-5404
investors@neocis.com

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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. More Info

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