Virtuoso Surgical Robot Helps Enable Innovative ARPA-H Project on Artificial Intelligence

Virtuoso Surgical, Inc., a Nashville based medical device company, is pleased to announce their role in a landmark, multi-institution award from the federal Advanced Research Projects Agency for Health (ARPA-H) program to advance Autonomy at a Less Invasive Scale in Surgery (ALISS) (https://arpa-h.gov/research-and-funding/mission-office-iso/awardees) and enable fully autonomous surgical procedures. The award provides up to $12 million in funding and is being led by Vanderbilt Engineering Professor and Virtuoso Surgical Co-founder and President, Robert J. Webster, III, Ph.D.

The award brings together robotics and artificial intelligence experts from Vanderbilt, Johns Hopkins University, University of Tennessee (Knoxville) and University of Utah. World-renowned expert robotic surgeons from Vanderbilt University Medical Center (VUMC) and Johns Hopkins lead clinical development efforts in the project. The award supports placement of the Virtuoso Surgical System at three of the participating research sites, and all artificial intelligence (AI) and machine learning (ML)  development will take place using this platform. The project also creates a team of embedded AI/ML experts within Virtuoso Surgical to support the university research teams.

“Fully autonomous surgical robots will transform medicine,” Virtuoso Surgical President Robert Webster said. “Not only will they make routine procedures safer and more affordable, but they will also address the worldwide shortage of surgeons and expand global access to lifesaving surgeries.”

Virtuoso Surgical is a surgical robotics company co-founded by Webster and Duke Herrell, M.D., Professor of Urology and founder of VUMC’s Minimally Invasive Urologic Surgery and Robotics Programs, who now serves as Virtuoso’s CEO. The Virtuoso Surgical System serves as an ideal platform for development of autonomous surgery facilitated by artificial intelligence, machine-learning and computer vision.

The key to the team’s novel approach is demonstration-based learning. “By enabling robots to learn from, and be coached by, human surgeons, we will create brand new machine learning algorithms beyond anything that exists today,”  Webster said. “Surgeons will literally train robots just like they train residents and fellows today. The result will be systems that initially help surgeons be more accurate and efficient, and eventually fully automate surgical procedures.”

By initially having human surgeons teleoperate the Virtuoso Surgical System as the human performs surgery, the robot can “shadow” the human’s decision-making, learning more generalized skills. “Our algorithms are watching the commands the surgeon sends to the robot and what they were looking at through the robot’s camera at the time,” said Alan Kuntz, Ph.D., Assistant Professor at University of Utah, and one of the key leaders of the artificial intelligence algorithm development.

“By looking at the history of those commands, the algorithms can infer how what the surgeons did changed based on what they saw. The robot can then apply these learned strategies to new surgical decisions that it hasn’t encountered before. We will further enable the robot to understand its own uncertainty, knowing what it doesn’t know,” Kuntz elaborates, “so that it can ask a human surgeon for input, clarification or to take over when it is unsure of how to proceed. That’s a key building block for robust autonomy.”

Within the next three years, the research team plans to demonstrate a robotic surgical device capable of removing tumors from the trachea and prostate without the direct intervention of a surgeon. These will initially be demonstrated in simulated conditions and not on live patients. The team also foresees this research having future application to uterine fibroids, bladder tumors, spine procedures and brain cysts, among other clinical applications in the future.

“Creating a system that can learn from human surgeons — and continue to improve performance — will be a game changer,” Duke Herrell said. “Our vision is not to replace surgeons, but to vastly expand the work they do to improve patients’ lives and long-term health outcomes.”

The team includes advanced robotics, imaging and artificial intelligence researchers from many of the top surgical robotics and computer science labs in the U.S. with 14 PhDs, 22 post graduate researchers and 5 leading surgeon scientists forming the research team.

About Virtuoso Surgical

Virtuoso Surgical has developed a groundbreaking robotic surgery system that radically improves minimally invasive endoscopic surgery. The Virtuoso Surgical system features a pair of instrument delivery arms made of concentric nitinol tubes that mimic a surgeon’s hand motions to offer unprecedented control and dexterity to a full range of endoscopic applications. The system uses patented technology developed by Virtuoso’s founders at Johns Hopkins University and Vanderbilt University with funding from the National Science Foundation and the National Institutes of Health. For additional information about Virtuoso Surgical, visit www.virtuososurgical.net. This device has not been approved by the FDA and is not for sale in the United States.

EndoTheia Announces Successful Clinical Study Results for a Novel Medical Device for Endoscopic Surgery

EndoTheia, Inc. has announced the completion of a successful first-in-human clinical study performed at Vanderbilt University for their groundbreaking technology that radically improves minimally invasive endoscopic surgery. EndoTheia is pleased to report that all primary and secondary endpoints were successfully met with no adverse events. This news follows the company’s recent announcement that the FDA recently named EndoTheia’s ENT endoscopic surgery technology a Breakthrough Device.

EndoTheia’s new device is designed to answer the FDA’s “call to action” highlighting alarming infection rates in difficult-to-sterilize reusable duodenoscopes, and calling on medical device companies to create  new, cost effective, disposable devices to treat biliary disease. “EndoTheia is proud to have been able to respond to this call-to-action from the FDA in a unique and outside-the-box way,” said Robert J. Webster, III, PhD, Co-Founder and President of EndoTheia. “We took a look at what others were doing within the space and saw mostly incremental advancements and/or costly fully disposable endoscope solutions.”

EndoTheia’s system completely eliminates the need for the duodenoscopes that concern the FDA, replacing them with inexpensive, disposable components that allow standard endoscopes to perform their same functions. “EndoTheia is pleased to report the success of this first-in-human clinical study. It is a major milestone for EndoTheia and for the 700,000 patients suffering from biliary disease per year domestically,” stated Joshua Gafford, PhD, Co-Founder and Chief Technology Officer of EndoTheia.

“We are deeply appreciative of the patients and clinical investigators who participated in this study, and look forward to the broad clinical impact of this technology following FDA clearance,” said Gafford. He went on to thank Launch Tennessee for their support and for helping to fund the successful trial through a generous SBIR/STTR matching grant awarded to EndoTheia in August 2022.

Dr. Keith Obstein, Professor of Medicine, Division of Gastroenterology at Vanderbilt University Medical Center, noted, “This device enabled us to clearly visualize the duodenal papilla en face with a standard forward-viewing endoscope, which normally would not be possible, and has the potential to eliminate the risk of infection from reusable duodenoscopes. This would be a huge win for patients, hospitals, and healthcare systems.”

The results of this clinical study will support EndoTheia’s FDA 510(k) application for its biliary product, scheduled for submission later this year. EndoTheia plans to follow this initial product with several other product lines using its proprietary technology in urology, neurosurgery, interventional pulmonology, gastroenterology, orthopedics, and otolaryngology.

About EndoTheia, Inc.

EndoTheia has developed a novel technology that radically improves dexterity in minimally invasive endoscopic surgery. This technology harnesses the power of micro-machined advanced materials to create highly dexterous manipulators at millimeter and sub-millimeter scales to improve therapeutic outcomes in complex flexible endoscopic procedures. This patented technology was invented and developed by EndoTheia’s founders at Vanderbilt University and the University of Tennessee, Knoxville, with funding from the National Institutes of Health. For additional information about EndoTheia and the FDA Breakthrough Device designation, visit www.endotheia.com.