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Devices Urology Regulatory

 News Release - September 23, 2020

New Treatment for Urethral Strictures, Optilume(R), Receives CE Approval

Urotronic's Drug Coated Balloon Provides Minimally-Invasive, Durable Alternative for Stricture Patients in Europe

MINNEAPOLIS, Sept. 23, 2020 -- (Healthcare Sales & Marketing Network) -- Urotronic, Inc., a Minnesota-based medical device company announced today it has received Conformité Européene (CE) Mark approval for its innovative Optilume catheter in Europe. European patients will now have access to this breakthrough technology.

Optilume combines balloon dilation of the urethral stricture with the delivery of an anti-proliferative drug to prevent recurrence of the blockage. Published two-year clinical follow up data1 highlighted that Optilume performed as intended in both opening blockages and preventing the formation of scar tissue which can develop quickly after any medical intervention. The minimally invasive technology is expected to have a significant impact in the urology community, offering a new treatment option for urethral strictures that traditionally would require major surgery or need frequent retreatment.

It is estimated that over a million men throughout Europe suffer with debilitating urethral strictures2. 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 and can significantly impact patients' quality of life.

Peter Duffy, who has received the treatment in New Zealand where Optilume is currently available, explains, "I was exhausted from getting up all night to urinate, constantly on antibiotics, and it was uncomfortable to urinate; unfortunately, after a urethrotomy, I suffered from a recurring stricture. I'm grateful that I finally found Optilume and can now live a comfortable life that I'm able to enjoy."

Mr. Oliver Kayes, Consultant Urologist, Leeds Teaching Hospitals NHS Trust, United Kingdom, says "There has been a significant need for new and alternative treatments for urethral stricture disease. We continually need to challenge how to deliver the most cost-effective treatments for men with de novo or recurrent strictures. Novel therapies should match patient expectations regarding success alongside accelerated care pathways and recovery where possible. Exciting early data suggest that Optilume can significantly improve success rates including improved durability and potentially fewer side effects over conventional endoscopic dilatation or urethrotomy techniques in men."

David Perry, President and CEO of Urotronic, Inc. stated, "We are excited to introduce Optilume to European physicians and their patients who suffer from this debilitating disease. The technology has the potential to reduce burdens across the European healthcare landscape as a treatment that is easy to learn and can be performed in a short outpatient procedure."

About Urotronic, Inc.

Urotronic, Inc., headquartered in Plymouth, Minnesota, US, 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 minimally invasive treatment option for men suffering from urinary tract conditions like urethral strictures and benign prostatic hyperplasia (BPH). For more information on Urotronic Inc., and our products, please visit us at urotronic.com

Media Contact: Justin Hartlen | +1-902-412-5090 | hartlenj@urotronic.com

References:
  1. Mann, R. A., Virasoro, R., DeLong, J. M., Estrella, R. E., Pichardo, M., Rodríguez Lay, R., Espino, G., Roth, J. D., & Elliott, S. P. (2020). A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study. Canadian Urological Association Journal, 15(2). https://doi.org/10.5489/cuaj.6661
  2. Alwaal A, Blaschko SD, McAninch JW, Breyer BN. Epidemiology of urethral strictures. Transl Androl Urol. 2014;3(2):209-213. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4708169/


Source: Urotronic

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Please address inquiries directly to the issuing company.



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