Urotronic Conducting Clinical Trial for Device to Treat Urethral Blockages
Plymouth-based urology device company Urotronic is conducting a feasibility study for a drug-coated balloon that could dramatically change treatment for blockages in the urethra for millions of men.
Currently, urologists typically treat urethral blockages, called strictures, by removing them with rods, cutting them out or by inserting and then inflating a balloon, similar to a catheterization for treating blockages in arteries for heart patients. All those treatments, however, come with an important downside, in that they damage the lining of the urethra, and the healing process can cause a narrowing of the passageway and the formation of scar tissue, making further blockages more likely.
To address that problem, Urotronic, founded in 2015, is developing a balloon that’s coated in a drug called Paclitaxel, which reduces the formation of scar tissue and therefore, the recurrence of the blockages, explains CEO Dave Perry.
“Our device, just like the others, creates micro tears of fissures in the tissue, but those are unique in that they provide uptake for the drug to reside in the tissue, and then prevent the smooth muscle cells from dividing and proliferating and laying down scar tissue,” Perry said.
Perry hopes that the device, called The Optilume, will prevent patients from having to undergo a more invasive surgical procedure to removes strictures called an urethroplasty, which is similar to a “bypass surgery for the urethra” and has a high rate of success, but involves a painful recovery process. “You live on a cushioned donut for a month-and-a-half to two months. Not very pleasant,” Perry said,
According to Urotronic, there are 1.5 million office visits a year in the US for the treatment of urethra blockages, and The Optilume is expected to cost around $1,500. “It’s a pretty big market,” Perry said.
Urotronic has already conducted a 53-patient clinical trial in Latin America, which Perry said showed promising results they hope they can duplicate in the U.S.
The U.S. based trial, which will be conducted at the University of Minnesota and four other medical centers around the country, will begin soon and continue over the course of five years.