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.

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.