Laborie Medical Technologies has acquired a continuous, exclusive license to the Optilume Urethral Drug Coated Balloon (DCB) from US-based medical device maker Urotronic.
Optilume is a low cost, minimally invasive treatment option for urinary tract conditions such as urethral strictures and benign prostatic hyperplasia (BPH).
Urethral stricture is a scar formed in or around the urethra, restricting the flow of urine from the bladder and can result in slowing of the urinary stream, with pain and irritation.
Optilume DCB works by dilating the urethral lumen and delivering paclitaxel directly to the stricture, to reduce the incidence of stricture recurrence.
Its paclitaxel-coated balloon technology will address patient and physician dissatisfaction with current endoscopic solutions for urethral strictures, said the company.
Laborie president and CEO Michael Frazzette said: “Until now, there has been no treatment for urethral stricture that provides ambulatory recovery, minimal complications and durable outcomes, all in a simple outpatient procedure. Optilume is the treatment that breaks the cycle of recurrent urethral strictures.”
The company has partnered with Urotronic to expand the use of less invasive treatments and improve outcomes for patients suffering from urological disorders.
Urotronic has evaluated Optilume in three clinical trials, dubbed (Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease) ROBUST-1, ROBUST-2, ROBUST-3.
Optilume was granted US Food and Drug Administration (FDA) approval in early December 2021, and CE mark approval in 2020, to treat male anterior urethral strictures.
ROBUST trials principal investigator Sean Elliott said: “As the ROBUST 1 and ROBUST 3 clinical trials demonstrated, Optilume significantly reduces the incidence of stricture recurrence.
“At three years, durability continued with a 77% freedom from reintervention rate, a 176% increase in Qmax, and a 65% decrease in IPSS. Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty.”
In October last year, Laborie acquired Pelvalon, a US-based medical device company focused on treatments for female pelvic and bowel health, for an undisclosed sum.
