PORTSMOUTH, N.H., Jan. 5, 2022 /PRNewswire/ -- Laborie Medical Technologies Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, announced that it has acquired a perpetual, exclusive license to the Optilume® Urethral Drug Coated Balloon (DCB), following approval from the U.S. Food and Drug Administration (FDA) in early December. Optilume DCB was granted CE mark approval for use in male anterior urethral strictures in 2020.
Optilume's paclitaxel-coated balloon technology was developed in response to patient and physician dissatisfaction with current endoscopic solutions for urethral strictures. This innovative, proprietary technology represents a paradigm change from the methods currently used by urologists to treat these conditions and provides a durable, cost effective, minimally invasive treatment option for millions of patients suffering from these conditions globally.
"As the ROBUST 1 and ROBUST 3 clinical trials demonstrated, Optilume significantly reduces the incidence of stricture recurrence," said Dr. Sean Elliott, principal investigator for the Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) trials. "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."2
Urethral stricture affects men with an increasing incidence from about 1 in every 10,000 at 25 years old to about 1 in every 1,000 men at 65 or older.3
"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," said Michael Frazzette, President & CEO of Laborie. "Optilume is the treatment that breaks the cycle of recurrent urethral strictures."
Laborie's strategic partnership with Urotronic Inc. (Urotronic), the medical device company that conducted Optilume's clinical trials (ROBUST 1, ROBUST 2 and ROBUST 3), demonstrates Laborie's continued commitment to expand the use of less invasive treatments and improve outcomes for patients suffering from urological disorders.
- Elliott SP, et al. MP56-07: Interim Results for the ROBUST III Trial Evaluating the Optilume Drug Coated Balloon for Anterior Urethral Strictures. J Urol 2021;206(3S):e971.
- Data on file
- Mundy, A R. "Management of urethral strictures." Postgraduate medical journal vol. 82,970 (2006): 489-93. doi:10.1136/pgmj.2005.042945
About Laborie Medical Technologies
Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class Clinical Education & Information program. Laborie is a portfolio company of Patricia Industries. For more information visit www.laborie.com.
About Patricia Industries
Patricia Industries is a long-term owner that invests in companies and works to develop each company to its full potential. Patricia Industries is a part of the industrial holding company Investor AB, whose main owners are the Wallenberg foundations.
About Investor AB
Investor, founded by the Wallenberg family in 1916, is an engaged owner of high-quality, global companies. We have a long-term investment perspective. Through board participation, as well as industrial experience, our network and financial strength, we work continuously to support our companies to remain or become best-in-class.
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SOURCE Laborie Medical Technologies Inc.
