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.