FDA Approves Clinical Trial of a New Treatment Approach for Enlarged Prostate

Urotronic Inc., a medical device company pioneering a new solution that could dramatically change the way millions of men around the world with enlarged prostates are treated, has received U.S. Food and Drug Administration (FDA) approval to begin its U.S. pivotal study for the Optilume BPH Catheter System.  
 
The FDA-approved clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. More than 12 million American men are reported to suffer from enlarged prostates or Benign Prostatic Hyperplasia (BPH) and over 750,000 new cases are diagnosed each year. 
 
“The Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn’t surgically cut, burn, lase, steam or leave anything behind in the prostate like the other BPH technologies,” said Dr. Steven Kaplan, professor, Icahn School of Medicine at Mount Sinai and director of the Men’s Wellness Program, Mount Sinai Health System in New York, N.Y., and the principal investigator of PINNACLE. “This technology holds tremendous promise.”
 
Kaplan said the Optilume BPH balloon is also the first minimally invasive in-office therapy to provide symptom scores and flow rates similar to the more invasive gold standard known as TURP (transurethral resection of the prostate).
 
Millions of men struggle to deal with the symptoms of BPH, including frequency, nocturia, intermittency, urgency, weak stream and straining to urinate as a result of being refractory or non-responsive, or unwilling to deal with the side effects of medical therapy, or reluctant to undergo an invasive surgical procedure requiring general anesthesia.   
 
“We are excited about the accomplishments our team has made,” said Urotronic CEO David Perry.  “FDA approval is really a validation of our work to this point highlighting Urotronic’s potential to truly transform the urology market through an innovative approach and treatment for men suffering from BPH.”
 
The Optilume BPH procedure is a minimally invasive treatment that gives urologists the opportunity to offer an office-based or outpatient treatment option that may provide relief to men who are looking for an alternative to currently available BPH treatment offerings. 
 
Dr. Kaplan and other investigators will monitor the progress of the PINNACLE clinical trial, which will get underway shortly and will follow the patients for a period of five years. The FDA will monitor the progress as well.
 
“This technology is very disruptive, and the end beneficiary is going to be the patients,” said investor and company board member Doug Kohrs. “Urotronic has embarked on an anatomy sparing approach to treating BPH that no one else has ever taken.”

The Optilume BPH Catheter System is an investigational device, not available for sale.
 
The prospective PINNACLE U.S. trial markets will include but will not be limited to; Advanced Urology Institute, Daytona Beach, Fla; Arkansas Urology, Little Rock, Ark.; Chesapeake Urology Associates, Baltimore; Cornell University, New York, N.Y.; Regional Urology LLC, Shreveport, La.; Sheldon Freedman Urology LTD, Las Vegas; Western New York Urology Associates, Cheektowaga, N.Y.; Associated Urologists of N.C., Raleigh; AUUA (Academic Urology & Urogynecology of Arizona), Phoenix; Carolina Urology Clinical Research (CUCR), Myrtle Beach, S.C.; Carolina Urology Partners, Charlotte, N.C.; Mount Sinai, New York, N.Y.; Urology of Virginia, Norfolk, Va.; Chesapeake 2, Baltimore; and Integrated Medical Professionals, Long Island, N.Y.
 
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 tract 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. The drug-coated balloon technology under clinical investigation creates a paradigm change from the methods currently used by urologists to treat these conditions.