Completion of First Optilume® Procedure in Europe

Laborie Medical Technologies, in Partnership with Urotronic Inc., Announces Completion of First Optilume® Procedure in Europe

The Optilume® Drug Coated Balloon is a new novel technology for the treatment of urethral stricture.

BURLINGTON, Mass., February 1st, 2021 – Laborie Medical Technologies Inc. (LABORIE), a leading diagnostic and therapeutic medical technology company, today announced the first Optilume® procedures were performed in Mannheim, Germany on January 22, 2021 by Dr. Georgi Tosev (Mannheim Urology).

In October 2020, LABORIE and Urotronic Inc. (Urotronic), entered into a multi-faceted, strategic partnership1. Urotronic, a Minnesota-based medical device company, is currently conducting clinical trials in the United States to support regulatory approval of Optilume®, a drug-coated balloon (DCB) technology for use in urethral strictures and benign prostatic hyperplasia (BPH) and was recently granted CE Mark approval for use in urethral strictures in Europe2.

Following the successful procedure, Dr. Georgi Tosev commented, “In the last few decades, there has been stagnation in the treatment of urethral strictures. We’re very excited to add this new treatment to our range of minimally invasive specialty procedures.”

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 data3 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. This 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 strictures4. 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.

Dr. Tosev continued, “Patients have frequent relapses after direct visualization internal urethrotomy. Many of them fear a more invasive therapy in the sense of an open urethroplasty. The balloon seems to be a good compromise; in fact, this treatment offers better success rates than conventional balloon dilatation and is less invasive than urethroplasty.”

Dr. Tosev summarized, “I think that Optilume will become a game changer in the treatment of the urethral strictures.”

For Further Information:
James Wright
Laborie Medical Technologies
Phone: + 00 44 (0) 7902 104 354
Email: jwright@laborie.com

About Laborie Medical Technologies
Globally headquartered in Boston, Massachusetts, LABORIE is a global developer and manufacturer of innovative medical technologies, offering complete care pathways and market-leading solutions through its broad portfolio of diagnostic and therapeutic products and services in Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology. LABORIE is a portfolio company of Patricia Industries. For more information visit www.laborie.com.

About Urotronic Inc.
Urotronic, Inc., headquartered in Plymouth, Minnesota, is a clinical-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) and urethral stricture. The prevalence of BPH and lower urinary tract issues rises markedly with increased age. BPH affects 70% of men 60-69 years of age and 80% 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. For more information on Urotronic and our products, please visit us at urotronic.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.

REFERENCES

  1. Cision PR Newswire 8th October 2020 https://www.prnewswire.com/news-releases/laborie-medical-technologies-enters-into-strategic-partnership-with-urotronic-301148859.html
  2. Cision PR Newswire 23rd September 2020 https://www.prnewswire.com/news-releases/new-treatment-for-urethral-strictures-optilume-receives-ce-approval-301136116.html
  3. 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 Journal15(2). https://doi.org/10.5489/cuaj.6661
  4. 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/