The latest U.S. IDE (investigational device exemption) Pivotal clinical study, titled ROBUST III, will enroll up to 200 men from 20 clinical sites across the United States and will start immediately. The first FDA-approved U.S. trial of the Optilume (DCB) for an Early Feasibility Study (EFS) began in November 2017 and is currently underway in five medical centers around the country.
“Physicians are looking for a technology that is minimally invasive and also curative,” said Dr. Sean Elliott, principal investigator of the ROBUST studies and vice chair of Urology from the University of Minnesota. “The Optilume drug coated balloon has the potential to decrease the rate of recurrence and provide physicians and their patients better outcomes based on early clinical results.”
There are roughly 1.5 million doctors’ office visits in the United States to treat urethral strictures, which block the pathway for urine to exit the body from the bladder and can result in a painful, frustrating slowing of the urinary stream.
One in five men will develop a urinary stricture and the number of urological procedures is expected to grow rapidly as Baby Boomers age and are more susceptible to urinary tract problems. The most common treatments lead to high rates of recurrence and are frustrating for urologists to treat given the poor outcomes.
The Optilume DCB pairs mechanical dilation with powerful drug therapy to provide a simple, out-patient procedure, according to doctors involved in the clinical trials. In the latest U.S. IDE Pivotal clinical study, patients will be randomized—either receiving Urotronic’s Optilume DCB or the current standard of care based on physician preference.
In addition to the two U.S. trials, a third clinical trial of the Optilume DCB is underway in Latin America titled Robust I.
Early results from Robust I reveal the Optilume DCB treatment met all the primary and secondary clinical study endpoints, namely significant improvement of symptom scores and urinary flow rates, according to Ramon Virasoro, M.D., Co-Principal Investigator of ROBUST III and Robust study physician from Eastern Virginia Medical Center.
“Moreover, patient quality of life symptom scores significantly improved by 70 percent or higher at three, six, and 12 months, peak urinary flow rates improved 17 ml/sec at three months with continuous improvement through 12 months," Virasoro said.
Urethral strictures are often caused by infections, trauma or other medical procedures that subsequently injure the lining of the urethra. As the injury heals it develops scar tissue and narrows the tube that carries urine out of the body.
“We are honored to provide urologists and their patients a solution to prevent recurrence of urinary tract strictures with our Optilume Drug Coated Balloon technology,” said David Perry, president and CEO of Urotronic Inc. “We hope to repeat the compelling clinical results from our ROBUST I Latin America study with the pending U.S. Pivotal study, and demonstrate a minimally invasive treatment option that can be performed in a variety of clinical settings, including as an in-office procedure.”
Urotronic Inc., headquartered in Plymouth, Minn., is an early-stage medical device company currently conducting clinical trials to support global commercialization of its products. The Optilume drug-coated balloon technology provides a low cost, minimally-invasive treatment option for men suffering from urinary track conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). The prevalence of BPH and lower urinary tract issues rises markedly with increased age. BPH affects 70 percent of men 60-69 years of age and 80 percent of those 70 years of age or older, whereas one in five men will develop a urethral stricture at age 65 or greater. The drug-coated balloon technology under development creates a paradigm change from the methods currently used by urologists to treat these conditions.