Urotronic’s Drug-Coated Balloon Catheter Granted License for Urethral Stricture Treatments in Canada

Urotronic has received license to begin treating urethral strictures with its Optilume drug-coated balloon (DCB) in Canada. The development is expected to have a significant impact across Canada, where just a handful of physicians currently perform a majority of all stricture treatments. 
 
“We are quite excited to see this come to market,” said Dr. Conrad Maciejewski, a reconstructive urologist who treats patients at The Ottawa Hospital and is one of just nine Canadian doctors who practice reconstructive urology.
 
Millions of men around the world suffer with debilitating urethral strictures.  The condition blocks the pathway for urine to exit the body from the bladder and can result in a painful, frustrating slowing of the urinary system. Strictures can be caused by infections, trauma, and other medical procedures that injure the lining of the urethra. The number of urological procedures is growing rapidly as Baby Boomers age and are more susceptible to urinary tract problems, according to doctors involved clinical trials.
 
Urortonic’s Optilume device combines balloon dilation with the delivery of an anti-proliferative drug to prevent recurrence of the blockage.  In clinical trials performed in Latin America, the drug-coated balloon has performed as intended in both opening blockages and preventing the formation of scar tissue, which can develop quickly after any medical intervention.
 
Maciejewski sais there is a significant need for new and alternative urethral stricture treatments. He said many of his patients would prefer to avoid major reconstructive surgery (called urethroplasty) and are also not satisfied with the 40 percent success rate of a common endoscopic intervention known as an urethrotomy. “This is the first time we’ve had a product that can significantly exceed those success rates with better durability and potentially less side effects compared to a major surgery,” he noted.
 
“We are excited to introduce our innovative drug coated balloon to the Canadian market and look forward to working with physicians and their patients who suffer from this debilitating disease,” said David Perry, president and CEO of Urotronic. Urologists across Canada are also encouraged by the potential of Optilume. The device has the potential to lift the burdens of the current Canadian market by adopting a treatment that is easy to learn and can be performed in a short outpatient procedure.
 
“If we were able to offer, in the hands of general urologists or even specialists, something less invasive, more accessible and with better results than what our current less invasive options provide, that would be a great option and, I think, a lot of people would seriously consider it,” Maciejewski said.
 
A Canadian post-market trial is currently scheduled.  The U.S. Food and Drug Administration also continues to monitor clinical trials involving the Optilume DCB in the United States.
 
Urotronic Inc., headquartered in Plymouth, Minn., is an early stage medical device company currently conducting clinical trials to support global commercialization of their 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. The drug-coated balloon technology under development creates a paradigm change from the methods currently used by urologists to treat these conditions.