EndoTheia Announces Successful Clinical Study Results for a Novel Medical Device for Endoscopic Surgery

EndoTheia, Inc. has announced the completion of a successful first-in-human clinical study performed at Vanderbilt University for their groundbreaking technology that radically improves minimally invasive endoscopic surgery. EndoTheia is pleased to report that all primary and secondary endpoints were successfully met with no adverse events. This news follows the company’s recent announcement that the FDA recently named EndoTheia’s ENT endoscopic surgery technology a Breakthrough Device.

EndoTheia’s new device is designed to answer the FDA’s “call to action” highlighting alarming infection rates in difficult-to-sterilize reusable duodenoscopes, and calling on medical device companies to create  new, cost effective, disposable devices to treat biliary disease. “EndoTheia is proud to have been able to respond to this call-to-action from the FDA in a unique and outside-the-box way,” said Robert J. Webster, III, PhD, Co-Founder and President of EndoTheia. “We took a look at what others were doing within the space and saw mostly incremental advancements and/or costly fully disposable endoscope solutions.”

EndoTheia’s system completely eliminates the need for the duodenoscopes that concern the FDA, replacing them with inexpensive, disposable components that allow standard endoscopes to perform their same functions. “EndoTheia is pleased to report the success of this first-in-human clinical study. It is a major milestone for EndoTheia and for the 700,000 patients suffering from biliary disease per year domestically,” stated Joshua Gafford, PhD, Co-Founder and Chief Technology Officer of EndoTheia.

“We are deeply appreciative of the patients and clinical investigators who participated in this study, and look forward to the broad clinical impact of this technology following FDA clearance,” said Gafford. He went on to thank Launch Tennessee for their support and for helping to fund the successful trial through a generous SBIR/STTR matching grant awarded to EndoTheia in August 2022.

Dr. Keith Obstein, Professor of Medicine, Division of Gastroenterology at Vanderbilt University Medical Center, noted, “This device enabled us to clearly visualize the duodenal papilla en face with a standard forward-viewing endoscope, which normally would not be possible, and has the potential to eliminate the risk of infection from reusable duodenoscopes. This would be a huge win for patients, hospitals, and healthcare systems.”

The results of this clinical study will support EndoTheia’s FDA 510(k) application for its biliary product, scheduled for submission later this year. EndoTheia plans to follow this initial product with several other product lines using its proprietary technology in urology, neurosurgery, interventional pulmonology, gastroenterology, orthopedics, and otolaryngology.

About EndoTheia, Inc.

EndoTheia has developed a novel technology that radically improves dexterity in minimally invasive endoscopic surgery. This technology harnesses the power of micro-machined advanced 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 invented and 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.

Florida Urology Center Joins Forces with U.S. Urology Partners

U.S. Urology Partners announced today its strategic partnership with Florida Urology Center, a full-service specialty group which has set the standard of care in the region for three decades. Florida Urology Center provides comprehensive services in five locations throughout Florida, including Ormond Beach, Port Orange, Orange City, New Smyrna Beach and Palm Coast.

U.S. Urology Partners is one of the nation’s largest independent providers of urological and related specialty services, including general urology, surgical procedures, advanced cancer treatment and other ancillary services. The rapidly growing U.S. Urology Partners clinical network now consists of more than 40 locations throughout the East Coast and Midwest. U.S. Urology Partners partnered with NMS Capital in 2018 to support urology practices in communities across the country.

Corina Tracy, Chief Executive Officer of U.S. Urology Partners, stated, “We are honored to welcome Florida Urology Center, which is well-known for its quality care and advanced technology, including a state-of-the-art surgery center. The addition of Florida Urology Center expands our multi-regional clinical network, which now spans the East Coast and the Midwest. Through collaboration among our partner practices, we are able to make an even greater impact on delivering the highest level of urological care in the communities we serve.”

Greg A. Parr, M.D., of Florida Urology Center stated, “We are pleased to join U.S. Urology Partners and share a common dedication to providing the highest quality of comprehensive urological care. Our partnership with U.S. Urology Partners will enable us to continue improving the lives of patients by offering the most current diagnostic and therapeutic alternatives available in the region and investing in the latest technologies. Through the support provided by U.S. Urology Partners to our growing practice, the Florida Urology Center care team can remain focused on our most important priority—our patients.”

U.S. Urology Partners assists urology practices through an experienced team of healthcare executives and resources. The practices benefit from U.S. Urology Partners’ substantial investment in people, technology and services to better address patient and employee needs in the communities they serve, while being well positioned for continued growth.

About U.S. Urology Partners

U.S. Urology Partners is one of the nation’s largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment and other ancillary services. The U.S. Urology Partners clinical network consists of more than 40 locations throughout the East Coast and Midwest. U.S. Urology Partners was formed to support urology practices with an experienced team of healthcare executives and resources, and is backed by NMS Capital. The U.S. Urology Partners corporate office is in Nolensville, Tennessee, just outside of Nashville. For additional information about U.S. Urology Partners, please visit www.us-uro.com.

 About Florida Urology Center

Established in 1992, Florida Urology Center has five convenient locations throughout Florida, including Ormond Beach, Port Orange, Orange City, New Smyrna Beach and Palm Coast. Florida Urology Center is committed to providing quality healthcare to its patients through education, training, clinical research, and support. The practice is dedicated to improving the lives of its patients by offering the most current diagnostic and therapeutic alternatives available. Facilities are equipped with the latest state-of-the art technology to provide the safest and most comprehensive care. Most of the surgeries are performed in Florida Urology Center’s outpatient surgery center licensed by the state of Florida and certified by Medicare. For more information about Florida Urology Center, please visit www.floridaurology.com.

Nationally Recognized Urological Expert Dr. T.J. Tausch Joins Central Ohio Urology Group

Central Ohio Urology Group is pleased to announce that Timothy “T.J.” Tausch, M.D., M.S., M.B.A. has joined its care team. Dr. Tausch joins Central Ohio Urology Group from Walter Reed National Military Medical Center, where he was Director of Trauma, Reconstructive and Prosthetic Urology, Residency Program Director and Urology Consultant to the White House.

With a clinical network of 15 offices in the region, Central Ohio Urology Group is one of the nation’s leading providers of comprehensive urological services, including general urology, men’s health, women’s health, cancer care, advanced cancer treatment and radiation oncology. Central Ohio Urology Surgery Center is one of the first ambulatory surgery centers in the country to offer robotic surgery.

Corina Tracy, Chief Executive Officer of U.S. Urology Partners, the parent company of Central Ohio Urology Group, stated, “We are honored to welcome Dr. T.J. Tausch to our urological care team. Dr. Tausch’s fellowship training and extensive experience in trauma, reconstructive and prosthetic urology provides us with leading edge insight into the most advanced, effective treatments available. His expertise will help us continue to expand our level of care, improving the quality of life of people in the communities we serve.”

Born and raised in Wayne County, Dr. Tausch returns to Ohio following 15 years on active duty in the United States Army. After graduating from the University of Notre Dame, Dr. Tausch attended medical school at Case Western Reserve University, where he received a dual M.D./M.S. degree in applied anatomy. Dr. Tausch completed his General Surgery Residency (Pre-Urology) and Urology Residency at Madigan Army Medical Center in Tacoma, Washington. He further specialized in Trauma, Reconstructive and Prosthetic Urology with a fellowship at University of Texas Southwestern Medical Center in Dallas. Dr. Tausch also earned an M.B.A. from the George Washington University School of Business.

Dr. Tausch said, “I am excited to be back in Ohio, where I was born and raised. My practice focuses on helping people with urologic problems – repairing issues caused by side effects of cancer treatment, urologic trauma, surgical complications and general effects of aging. With my arrival, Central Ohio Urology Group will now be able to offer state-of-the-art reconstructive options for all urology patients.”

“I often tell my patients, ‘I might not be the surgeon who saves your life, but I promise to do everything I can to make it better.’ I look forward to bringing my training and expertise to patients in Ohio, and doing my best to help those with urologic problems maximize their quality of life,” added Dr. Tausch.

To learn more about Dr. T.J. Tausch or to schedule an appointment with the Central Ohio Urology Group care team, please visit www.centralohiourology.com or call (614) 396-2684.

About Central Ohio Urology Group

Central Ohio Urology Group is one of the nation’s leading providers of urological services with a network of 15 offices in the region. Headquartered just outside of Columbus in Gahanna, Ohio, Central Ohio Urology Group provides comprehensive services, including general urology, men’s health, women’s health, cancer care, advanced cancer treatment and radiation oncology. Facilities in the Columbus area include an Advanced Prostate Cancer Clinic, as well as the state-of-the-art Central Ohio Urology Surgery Center that is one of the first ambulatory surgery centers in the country to offer robotic surgery. Central Ohio Urology Group’s experienced care team provides more than 50 urological specialties and subspecialties. Central Ohio Urology Group is an affiliate of U.S. Urology Partners, one of the largest independent providers of urological and related specialty services in the nation, which is backed by NMS Capital. For more information, visit www.centralohiourology.com and www.us-uro.com.