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U.S.-Based Remote Robotic-Assisted Surgery Demonstration Successfully Completed Through Collaborations with Virtual Incision, Sovato, City of Hope, and University of Illinois Chicago

Press Release, Recent News

— Wet lab demonstration showcases the safe enablement, reproducibility, and scale of remote robotic-assisted surgeries across twenty procedures and four specialties —

— Initial preclinical data presented at the 15th Clinical Robotic Surgery Association’s Worldwide Congress —

LINCOLN, Nebraska – November 25, 2024 – Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (RAS) device and Sovato Health, the world’s only comprehensive solution designed to enable remote surgery and procedure programs, today announced the successful completion of a preclinical demonstration of nearly 40,000-miles combined distance. Four surgeons performed a total of 20 procedures on porcine models as part of the remote capabilities test, representing approximately 2,000 miles for each procedure.

Francesco Maria Bianco, M.D. from the University of Illinois Chicago, and Yanghee Woo, M.D., Yasmin Zerhouni, M.D., and Clayton Lau, M.D., from City of Hope National Medical Center, which is ranked among the nation’s top 5 cancer centers by U.S. News & World Report, leveraged the combined technology of Virtual Incision and Sovato to complete the remote cholecystectomy, colectomy, gastric mobilization / gastrostomy / primary closure, and nephrectomy procedures on porcine models. Yuman Fong, M.D., chair and professor of City of Hope’s Department of Surgery and president-elect of Clinical Robotic Surgery Association (CRSA), oversaw the design and completion of the wet lab demonstrations.

The Sovato Platform provided the surgical-grade network connectivity between the physicians’ location in Santa Barbara, CA, and the porcine models in Chicago, IL, as well as clinical workflows and immersive audio-visuals for intraoperative communication. The results demonstrate the safe enablement of surgery at a distance for a variety of complex and routine surgical procedures and the unique benefits miniaturization offers in expanding access to robotic-assisted surgery.

Remote surgery will help address the needs of more than half the world’s population that does not currently have access to high-quality surgical care, including 83 million Americans who must travel for routine procedures.1 Robotic-assisted technologies have the potential to enable minimally invasive surgery for these patients by allowing a surgeon to operate from a distant location. MIRA, the first miniaturized robotic-assisted surgery (miniRAS) device in development, is roughly 1,000 times lighter than existing RAS technologies. As the only small form factor RAS device, it has the potential to make remote surgery more feasible by enabling transportation, storage, and setup time at locations where robotics is not currently available.

“Virtual Incision’s vision is that miniaturization could make robotic-assisted surgery available to any patient, anytime, anywhere, and we believe this could potentially extend even further with the possibility of remote surgery,” said Piet Hinoul, M.D., Ph.D., chief medical officer at Virtual Incision. “This experiment demonstrates the usability and reproducibility across multiple specialties, even when operating from a distance. We look forward to continuing to assess MIRA for use across a broad range of procedures and are eager to extend upon the benefits miniaturization brings.”

As the remote-enabling technology, Sovato provided stable network connectivity, with low latency of less than 60 milliseconds and 0% packet loss, enabling clear person-to-person communication and effective completion of the procedures, in addition to a user-reported intraoperative experience comparable to performing remote procedures in person.

“These wet lab results provide evidence that by connecting the people, devices, and information systems required for remote surgery, the Sovato Platform restores situational awareness and provides clear person-to-person communication for all the caregivers participating in remote procedures,” said Dennis Fowler, MD, MPH, chief medical officer at Sovato. “We are thrilled by the ongoing success of these demonstrations and the continued confidence and enthusiasm the surgeons have toward remote capabilities.”

“The successful completion of these remote robotic-assisted procedures with miniaturized robotics proves we are close to enabling unprecedented access to best-in-class surgical care,” Dr. Fong said. “Remote surgery will allow a surgeon sitting in one location to help patients in many locations – in different cities, states, or even countries. Remote capabilities will extend surgical expertise, enhance training opportunities, and provide access to high-quality surgical care like never before. City of Hope is proud to lead this encouraging step forward in clinical robotics that could become the future of our surgical industry, and most importantly, we are proud of the access this technology will provide, where patients anywhere can be operated on by specialized cancer surgeons like those at City of Hope.”

About the MIRA Surgical System

MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek form factor is designed to offer the benefits of RAS during colectomy procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds (less than one kg) and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room – a dedicated mainframe room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe. With MIRA, every operating room is RAS-ready.

About Virtual Incision

Virtual Incision is on a mission to simplify robotic-assisted surgery (RAS), so more patients and their surgeons can access its benefits every day. Headquartered in Lincoln, Nebraska, and holding over two hundred patents and patent applications, the company developed MIRA, the first-of-its-kind miniature RAS system. Virtual Incision’s goal is to make every operating room RAS-ready. For more information, visit our website or follow us on LinkedIn and X.

Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. For important safety information, indications for use, risks, and warnings, please refer to www.virtualincision.com/safety-information. All remote surgical procedures using a modified version of the MIRA Surgical System are for demonstration purposes only and have not been evaluated by the U.S. Food and Drug Administration.

About Sovato

Sovato is creating unprecedented access to high-quality surgical care by enabling and orchestrating safe, scalable, and profitable remote robotic-assisted surgery and procedure programs that span the entire surgical journey. Sovato is the world’s first and only robotagnostic platform enabling remote surgery and procedure programs for healthcare organizations at a global scale. Based in Santa Barbara, CA, the company is co-founded by Cynthia Perazzo, MBA, and industry pioneer Yulun Wang, PhD, the founder of Computer Motion (merged with Intuitive Surgical) and InTouch Health (acquired by Teladoc Health). For more information, visit www.Sovato.com or follow company updates on LinkedIn.

The Sovato Platform has not been evaluated by the U.S. Food and Drug Administration and is not currently available for sale in the U.S.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include but are not limited to, statements regarding our plans, beliefs, expectations, assumptions, and other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions.

References:

  1. https://jamanetwork.com/journals/jamasurgery/article-abstract/2796554

Media Contact:

Erin Crowley

Health+Commerce

erin@healthandcommerce.com

https://virtualincision.com/wp-content/uploads/2024/11/©2024_SOVATO_ChristianLee-18-scaled.jpg 2560 1707 ashlynn meyer /wp-content/uploads/2022/08/logo-mrk-wht.svg ashlynn meyer2024-11-25 05:30:592024-11-25 05:30:59U.S.-Based Remote Robotic-Assisted Surgery Demonstration Successfully Completed Through Collaborations with Virtual Incision, Sovato, City of Hope, and University of Illinois Chicago
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Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informed decision.

Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications.

For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information. For the product’s indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospital experience.

MIRA Surgical System Precaution Statement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Contact

Virtual Incision
1501 Old Cheney Rd
Lincoln, NE 68512

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