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.

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