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.

Virtuoso Leadership Meets with FDA in Washington, DC

Multiple members of the Virtuoso Surgical leadership team traveled to Washington, DC, to meet face-to-face with FDA staff regarding Virtuoso’s recent pre-submission. Mark Pickrell, General Counsel, led this meeting for Virituoso Surgical, which was an opportunity to discuss the detailed bench, animal and clinical testing that will be completed to support upcoming FDA submissions. The Virtuoso team was very pleased with the meeting and has good visibility on our regulatory path moving forward.

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, M.D., 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.

Robots to Improve Surgery for All – IEEE Pulse Article

Smaller tools with better maneuverability and more precise control, new imaging approaches, and advanced software applications will improve patient outcomes

Surgeons around the world are now using robot-assisted tech to help them perform minimally invasive operations ranging from hernia repair and gall bladder removal to knee replacement and cancer-related colectomy, often manipulating the surgical tools from a computer console some distance from the patient.

Why is the medical industry so interested in robots for these laparoscopic or keyhole operations? One of the biggest advantages is that they help the average surgeon perform at a higher level, according to Robert Webster, Ph.D., Virtuoso Surgical Co-founder, President and CTO, and Vanderbilt University’s Richard A. Schroeder professor of mechanical engineering and head of Vanderbilt’s Medical Engineering and Discovery Laboratory. “You’d be amazed at what the best-of-the-best doctors can do with just a straight endoscope that has a laser fiber sticking out of it. They free-hand that crazy, long, metal rod, lever it around, and do really delicate surgeries out of the tip,” he described. “But a typical surgeon doesn’t have that skill set. So what surgical robotics is really good at is democratizing health care, and conveying the skills of the truly elite doctors to all surgeons, and therefore to all patients.”

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Virtuoso Surgical Creating the 4th Lane Surgical Robotics Highway – MD+DI Article

Writes Editor-in-Chief Omar Ford in MD+DI, Virtuoso Surgical is going for a “different” segment in surgical robotics than other established players in the space.

While it might be a bit daunting to carve out a strong place in the space, Virtuoso Surgical, a surgical robotics maker, said it stands out from other competitors and is creating a “4th lane on the surgical robotics highway.”

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Virtuoso Surgical Announces First Public Offering of Common Stock to Advance its Revolutionary Robotic System for Endoscopic Surgery

Virtuoso Surgical, Inc., a Nashville-based medical device company, announced today that its $20 million stock offering has become effective after review by the United States Securities and Exchange Commission and the Financial Industry Regulatory Authority.

Virtuoso Surgical has developed a robotic surgery system that radically improves minimally invasive endoscopic surgery. Virtuoso uses patented technology developed by the Company’s founders at Johns Hopkins University and Vanderbilt University with funding from the National Science Foundation and the National Institutes of Health.

Virtuoso Surgical’s offering is made under SEC Regulation A, Tier 2, which means that any U.S. person can invest in the Company. The offering is for the sale of common stock, and this is the first offering of the Company’s common stock to the public.

“Virtuoso Surgical was founded to make minimally invasive surgery more effective by providing surgeons with dexterous, accurate and cost-effective tools for endoscopic surgery,” stated Robert J. Webster, III, PhD, Co-Founder and President. “We are not aware of any technology that accomplishes the dexterity, precision and force of the Virtuoso Surgical device, at such a small diameter. It enables surgeons to use two hands to perform more accurate interventions deep in the body through endoscopes.”

Duke Herrell, III, MD, FACS, Co-Founder, Interim CEO and Chief Medical Officer of Virtuoso Surgical, added, “We are excited about the opportunity to sell our common stock to the public. We expect to complete the design of our system by the end of this year, and to conduct final testing of the system in 2023. The capital that we will raise through this offering of common stock will, we believe, propel our system through final design, testing and FDA approval for sale in the United States.”

Virtuoso Surgical’s team of internationally recognized clinical and engineering experts includes Dr. Webster and Dr. Herrell, along with Richard Hendrick, PhD, Chief Operating Officer. Drs. Webster and Herrell, along with others, co-founded the Vanderbilt Institute for Surgery and Engineering (VISE), and Dr. Hendrick has been the lead engineer for Virtuoso since it began operations in 2017.

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 procedures where tools are delivered through rigid endoscopes, including urology, gynecology, neurology, interventional pulmonology, orthopedics, thoracic surgery, ear, nose and throat (ENT) and other sub-specialties.

 

Virtuoso Surgical Resources

Videos of Several First Surgeries

Academic Publications

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 tools that mimic a surgeon’s hands 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.

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Journal Editor In Chief Highlights Virtuoso System in: ‘Robotic Hysteroscopy: Sounds Crazy, No?’

Virtuoso is the subject of an editorial in the Journal of Minimally Invasive Gynecology, which concludes “…my excitement is considering the new procedures that we may be able to perform transcervically. This includes treating deep intramural myomas, hysteroscopic suturing, more complete resection of adenomyosis, and alternative therapies for congenital uterine anomalies. I offer my congratulations and encouragement for the authors and developers of this novel robotic technology.”

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Virtuoso Surgical’s Innovative Surgical Technology Featured in “MedTech Outlook”

“Virtuoso Surgical: Endoscopic Surgery Reimagined”
MedTech Outlook, July 2020

Virtuoso Surgical’s system replaces single, straight tools in many rigid endoscopic procedures, enabling surgeons to grasp, manipulate, and cut tissues with unparalleled bimanual dexterity. This capability gives surgeons the ability to perform advanced rigid endoscopic surgery – a task often limited by the tool and the surgeon’s experience with it.

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Virtuoso Surgical Announces Initial Public Offering to Advance its Groundbreaking Robotic System for Endoscopic Surgery

Virtuoso Surgical, Inc., a Nashville-based medical device company, announced today that its $20 million stock offering has become effective after review by the United States Securities and Exchange Commission and the Financial Industry Regulatory Authority.

Virtuoso Surgical has developed a robotic surgery system that radically improves minimally invasive endoscopic surgery. Virtuoso uses patented technology developed by the Company’s founders at Johns Hopkins University and Vanderbilt University with funding from the National Institutes of Health.

The Virtuoso system features a pair of instrument delivery arms made of concentric nitinol tools that mimic a surgeon’s hands to offer unprecedented control and dexterity to a full range of rigid endoscopic surgeries. Virtuoso’s robotic manipulators are the size of a needle, or nearly 10 times smaller than other state-of-the-art robotic instruments.

Virtuoso’s offering is made under SEC Regulation A, Tier 2, which means that any U.S. person can invest in the Company. The offering is for the sale of Class A preferred stock, which is intended to protect investors from follow-on dilution while generating potential returns comparable to historic venture capital portfolio investments.

Virtuoso Surgical operates at the intersection of robotics and minimally invasive surgery. Rigid endoscopy is the oldest, largest, and most mature segment of minimally invasive surgery, with an annual global market size of approximately $20 billion.

“Virtuoso Surgical was founded to make minimally invasive surgery more effective by providing surgeons with dexterous, accurate, and cost-effective tools for rigid endoscopes,” stated Robert J. Webster, III, PhD, Co-Founder and President. “We are not aware of any technology that accomplishes the precision and force of the Virtuoso device for operation through standard rigid endoscopes.”

Webster continued, “We believe that nearly all surgical procedures currently attempted with a rigid endoscope stand to benefit from our platform technology. We anticipate that this advanced technology will enable new procedures and surgical techniques while improving many existing procedures and techniques.”

The Virtuoso technology is built on over 10 years of innovation in academic labs. Rigid endoscopes are currently used in almost every area of surgery, including neurologic, thoracic, orthopedic, urologic, and gynecologic procedures. The Company is actively developing and testing the system for numerous endoscopic applications.

Virtuoso’s team of internationally recognized clinical and engineering experts include Dr. Webster, who developed the technology in collaboration with Duke Herrell, MD, a urological surgeon and Virtuoso’s Chief Medical Officer, and Richard Hendrick, PhD, Chief Operating Officer. Drs. Webster and Herrell, along with others, co-founded the Vanderbilt Institute for Surgery and Engineering (VISE). Mark Pickrell serves as Chief Administrative Officer and General Counsel of Virtuoso.

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 tools that mimic a surgeon’s hands 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 Institutes of Health. For additional information about Virtuoso, visit www.virtuososurgical.net.

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