Virtuoso Surgical Robotic System Used To Perform Successful First-in-Human Bladder Cancer Removal Cases: Enables Cutting Edge Surgical Approach

Virtuoso Surgical Inc., a Nashville-based surgical robotics company, today announced the first-in-human use of its Virtuoso system, ushering in a new era of precision and minimally invasive options for bladder cancer patients. The Virtuoso system features two robotically controlled, needle-sized (< 1 mm) manipulators that operate from the tip of a rigid endoscope. The robotic system facilitated a series of endoscopic bladder lesion excisions using the advanced en bloc technique that removes the bladder lesion intact rather than piecemeal. The groundbreaking case series was performed by Dr. Jeremy Teoh, a world-renowned bladder cancer surgeon and researcher, at The Chinese University of Hong Kong (CUHK).

“We are excited to see the Virtuoso system used successfully in its first human cases, particularly to allow surgeons to provide patients a best-in-class procedure such as the en bloc bladder tumor resection,” said Dr. S. Duke Herrell, CEO of Virtuoso Surgical, who is also a urologic surgeon. “This milestone is a testament to our team’s dedication to advancing surgical robotics and our commitment to partnering with leading clinicians, like Dr. Jeremy Teoh and CUHK, to transform patient care. The Virtuoso system is engineered to empower surgeons with superior control and precision, which is critical for delicate operations.”

Dr. Teoh is a leading advocate for the use of the en bloc technique, which is believed to offer significant advantages, including a reduced risk of tumor cell spillage, potentially helping to reduce the high recurrence rates of bladder cancer. This approach has also been demonstrated to significantly enhance staging accuracy and improve pathological specimen quality in numerous studies.

A recent award-winning RCT by Dr. Teoh et al. in European Urology demonstrated a decreased risk of cancer recurrence at 1 year with the manual en bloc technique. Despite noted benefits, en bloc procedures are not commonly performed in the U.S., likely due to the dexterity limitations of current equipment, which makes the procedure challenging to learn and perform effectively. The Virtuoso system is specifically designed to overcome these challenges and was used to remove a total of eleven lesions in six patients successfully.

Dr. Jeremy Teoh commented, “The ability to perform an en bloc resection for bladder cancer with this level of robotic assistance is a game-changer even for an expert in the technique. The Virtuoso system offered exceptional maneuverability, dexterity and visual clarity, enabling meticulous dissection. This approach has the potential to enable the widespread adoption of en bloc techniques, thereby minimizing local recurrence and providing a more definitive pathological specimen, which is crucial for guiding subsequent treatment decisions. We are extremely optimistic about what this technology means for the future of bladder cancer surgery and patient outcomes.”

The Virtuoso system’s advanced instrumentation and multiple-arm dexterity are designed to improve rigid endoscopy by providing retraction and precise control through the company’s patented concentric tube robotic arm technology. The concentric tube robot was an invention originally conceived by Vanderbilt University professor Robert J, Webster, III, Ph.D., founder and President of Virtuoso, while part of a team of advanced medical robotics researchers at Johns Hopkins University. Dr. Webster commented, “Our vision at Virtuoso Surgical is to give surgeons unprecedented dexterity. This will enable them to perform the less invasive, more accurate surgeries that improve patients’ lives and long-term health outcomes.”

Dr. Herrell added, “We are unlike any surgical robot out there today. The Virtuoso system is designed for a different set of procedures and approaches that have not yet benefited from robotics. This is a new type of robot, significantly smaller in scale, which enables us to bring our surgical skills deep into the body with less invasiveness for the patient.”

This first-in-human use marks the beginning of a new phase for the Virtuoso system, with plans for expanded clinical trials and the introduction of new clinical applications across multiple additional surgical specialties. Virtuoso Chief Operating Officer and Chief Technology Officer Richard J. Hendrick, Ph.D., noted, “We believe the Virtuoso system will be useful in multiple areas of the body where rigid endoscopes are used to deliver interventional tools. Dexterous instruments at the tip of the endoscope that can work in small spaces have the potential to enhance existing procedures and enable entirely new, less invasive approaches.” The company has already done early feasibility studies in uterine fibroids, pulmonary procedures and neurosurgery, and is exploring endoscopic spine procedures, among others.

Virtuoso Surgical plans to continue advancing this revolutionary technology in collaboration with Dr. Teoh and the exceptional team at The Chinese University of Hong Kong (CUHK). The company plans to submit an IDE application to the FDA for the study of the device’s use in the U.S.

Note: This study was done under CUHK Ethics Board approval. The Virtuoso system is not FDA-approved and is not for sale in the United States.

About Virtuoso Surgical

Virtuoso Surgical has developed a groundbreaking robotic surgery system that radically improves minimally invasive endoscopic surgery. The Virtuoso 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 utilizes patented technology initially developed by Virtuoso’s founders at Johns Hopkins University, Vanderbilt University, and Vanderbilt University Medical Center, 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 U.S. Food and Drug Administration (FDA) and is not for sale in the United States.

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.

Robotic Surgery Pioneer Virtuoso Surgical Awarded $1.8 Million in SBIR Funding

Medical device company Virtuoso Surgical, Inc. has been awarded a $1.8 million Small Business Innovation Research (SBIR) NIH grant to be received over the next two years. Virtuoso’s robotic surgery system enables a new scale of robotic tools and maneuvers in endoscopic surgery that are not possible using today’s instruments.

“We are honored to receive this SBIR Phase II grant as we move toward commercialization of our groundbreaking robotic surgical system,” said S. Duke Herrell, III, MD, FACS, CEO, Co-Founder and Chief Medical Officer of Virtuoso Surgical. “The Virtuoso system gives surgeons their hands back, enabling them to use two ’hands’ to perform procedures deep within the body, at the tip of an endoscope, with unprecedented control and dexterity.”

“For this SBIR Phase II grant, Virtuoso will continue its research regarding the use of its patented robotic technology to improve bladder lesion removal,” Dr. Herrell said. “Bladder lesion removal often does not obtain key information such as depth of invasion or margins if the lesion is a cancer, and we know that outcomes can be improved for these surgeries and patients.”

“We look forward to continuing to collaborate in this research with world renowned simulation and education expert Ahmed Ghazi, MD, and his colleagues at the Johns Hopkins University Simulation Innovation Lab at the Brady Urological Institute,” Dr. Herrell said.

While Virtuoso Surgical’s initial clinical applications will likely be bladder lesions and benign prostatic hyperplasia (BPH) tissue removal, the technology is a platform that will improve many if not all surgical procedures where tools are delivered through rigid endoscopes.

The Virtuoso Surgical system includes two robotically controlled, needle-sized manipulators working from the tip of a rigid endoscope that is less than half the diameter of a U.S. dime. The scope itself is far smaller than current robotic endoscope hardware, and the manipulators are 1mm in diameter. Equipped with a camera, the endoscope comes with an array of manipulators depending on the procedure, including a tissue grasper, retractor, tissue snare, laser aiming manipulator and electrosurgical tools.

In addition to Dr. Duke Herrell, the Virtuoso Surgical team includes Co-founder and President Robert J. Webster, III, PhD, who also founded the Vanderbilt Institute for Surgery and Engineering (VISE) with Dr. Herrell. They developed the Virtuoso Surgical system with a design team helmed by COO, Co-founder and Lead Engineer Richard Hendrick, PhD. Pending regulatory approval, company executives anticipate first-in-human use in early 2024 followed by regulatory submission pursuant of FDA approval for sale in the United States.

The Virtuoso Surgical system has demonstrated feasibility in animal, cadaver and tissue model studies examining use in surgeries for bladder cancer, uterine fibroids (among other intrauterine procedures), enlarged prostate (benign prostatic hyperplasia – BPH), central airway obstruction removal and endoscopic neurosurgery. The technology can provide dexterity in rigid endoscopic procedures, including in urology, neurosurgery, pulmonology, gynecology, orthopedics, thoracic surgery, otolaryngology (ENT) and other sub-specialties.

Virtuoso Surgical Resources

Videos of Robotic Surgery System in Action

Articles

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 and the initial public offering of common stock, visit www.virtuososurgical.net and www.virtuososurgical.net/investors. This device has not yet been approved by the FDA and is not for sale in the United States.

 

 

Virtuoso Surgical Unveils Design of Groundbreaking Robotic Surgery System: System Resets Scale and Reimagines Future of Robotic Endoscopic Surgery

Nashville-based medical device company Virtuoso Surgical, Inc. has unveiled its revolutionary robotic surgery system. Virtuoso’s patented technology reimagines endoscopic surgery in scale, function and cost.

“Virtuoso gives surgeons their hands back, equipping them to lift tissue, apply tension and maintain traction – in tight spaces within the body,” said S. Duke Herrell, III, MD, FACS, CEO, Co-Founder and Chief Medical Officer of Virtuoso Surgical. “These are groundbreaking maneuvers in endoscopic/endoluminal surgery that are not possible with today’s instruments.”

The unveiling of the product marks the end of the design stage for Virtuoso Surgical and progress in the regulatory phase. In September 2022, the company’s  first public offering of common stock became effective after review by the United States Securities and Exchange Commission and the Financial Industry Regulatory Authority.

Virtuoso Surgical Co-Founder and President Robert J. Webster, III, PhD also co-founded the Vanderbilt Institute for Surgery and Engineering (VISE) with Dr. Duke Herrell. They developed the Virtuoso Surgical system with a design team helmed by COO and Lead Engineer Richard Hendrick, PhD. The system enables surgeons to use two hands to perform dexterous maneuvers deep within the body, at the tip of an endoscope. Company executives anticipate regulatory submission in 2024, pursuant of FDA approval for sale in the United States.

“Virtuoso Surgical was born to reimagine the possibilities of endoscopic surgery, and we are pleased to move closer to making this system widely available to U.S. physicians,” Robert J. Webster, III, PhD, said. “Easier to use, more nimble and more effective than existing instruments, it stands to drastically broaden the possibilities of rigid endoscopic surgery.”

The Virtuoso Surgical system includes two robotically controlled, needle-sized manipulators working from the tip of a rigid endoscope that is less than half the diameter of a U.S. dime. The scope itself is far smaller than current robotic endoscope hardware, and the manipulators are 1mm in diameter. Equipped with a camera, the endoscope comes with an array of manipulators depending on the procedure, including a grasper, spatula, snare, laser aiming manipulator and electrosurgical tools.

“Our team set out to bring the stability and dexterity of robotic surgery to the rigid endoscopy space, and we have achieved that with the Virtuoso Surgical system,” Richard Hendrick, PhD, said. “This innovation equips surgeons to operate as though their hands were inside the body, with the minimally invasive advantages of rigid endoscopy.”

The Virtuoso Surgical system has demonstrated feasibility in animal, cadaver and tissue model studies in surgeries for bladder cancer, uterine fibroids (among other intrauterine procedures), enlarged prostate (benign prostatic hyperplasia – BPH), central airway obstruction removal and endoscopic neurosurgery.

The technology can provide dexterity in any procedure where tools are delivered through rigid endoscopes, including in urology, gynecology, neurosurgery, interventional pulmonology, orthopedics, thoracic surgery, ear, nose and throat (ENT) and other sub-specialties.

 

Virtuoso Surgical Resources

Videos of System in Action

Articles

 

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 and the initial public offering of common stock, visit www.virtuososurgical.net and www.virtuososurgical.net/investors. This device has not yet been approved by the FDAand is not for sale in the United States.

EndoTheia Inc. Announces FDA Breakthrough Device Designation for Technology to Improve Endoscopic Surgery

EndoTheia Inc., a Nashville-based medical device company, announced today that it has gained priority status from the FDA by receiving a Breakthrough Device designation from the agency for its technology that radically improves minimally invasive flexible endoscopic surgery. It is only the seventh device in the category of Ear Nose and Throat (ENT) devices to ever receive this designation. The designation will streamline the regulatory process, enabling EndoTheia to rapidly bring its innovative solution to doctors and patients.

EndoTheia’s Breakthrough Device leverages foundational technology that was originally invented at Vanderbilt and the University of Tennessee. This technology, based on extremely thin-walled, laser-machined metallic tubes, enables the creation of highly flexible, steerable devices that can pass through standard endoscopes, while also carrying within themselves interventional tools. The steerability that these devices provide to endoscope-delivered tools opens the door for new diagnostic and therapeutic applications of flexible endoscopy. EndoTheia’s disruptive platform technology can be used across a vast array of clinical specialties, including urology, gastroenterology, neurology, and otology.

“EndoTheia was founded in 2018 to develop the next generation of medical devices for flexible endoscopy with the goal of increasing effectiveness through added flexibility and dexterity,” stated Robert J. Webster, III, PhD, Co-Founder and President of EndoTheia. “EndoTheia’s technology is currently the only viable option to add dexterity to flexible endoscopy, without re-engineering the endoscope itself. This empowers surgeons to provide much more accurate and precise therapeutic interventions in a wide range of clinical specialties.” The National Institutes of Health has corroborated this sentiment by providing millions of dollars of grant funding to EndoTheia to commercialize products in urology, gastroenterology, and otolaryngology.

Duke Herrell, III, MD, FACS, Co-Founder and Chief Medical Officer of EndoTheia, added, “We are excited that the FDA has recognized the huge potential of EndoTheia’s technology through Breakthrough Device designation. The FDA has affirmed our view that there is nothing else out there capable of doing what we do for flexible endoscopy, and that our technology represents a breakthrough treatment option for patients who currently face irreversibly debilitating disease.”

EndoTheia’s team of internationally recognized clinical and engineering experts includes Dr. Webster and Dr. Herrell, along with Joshua Gafford, PhD, Chief Technical Officer, and Caleb Rucker, PhD, Chief Scientific Officer and primary inventor of the Company’s underlying technology. Drs. Webster and Herrell, along with others, co-founded the Vanderbilt Institute for Surgery and Engineering (VISE), and Dr. Rucker leads the REACH Robotics Lab at the University of Tennessee, Knoxville. Dr. Gafford has been the leading the internal development and commercialization efforts at EndoTheia since the Company’s incorporation in 2018.

EndoTheia has demonstrated feasibility in animal, cadaver, and tissue model studies in surgeries for biliary disease, ureteroscopy kidney stone removal, endoscopic submucosal dissection (ESD), endoscopic neurosurgery, sinus surgery, and middle ear surgery. EndoTheia’s technology can provide dexterity in any procedures where tools are delivered through flexible endoscopes, including urology, neurology, interventional pulmonology, gastroenterology, colorectal, orthopedics, otolaryngology (ENT), and other sub-specialties.

About EndoTheia, Inc.

EndoTheia has developed a groundbreaking technology that radically improves minimally invasive endoscopic surgery. This technology harnesses the power of intelligently micro-machined smart 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 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.