Laborie Medical Technologies, in Partnership with Urotronic Inc., Announces Completion of First Optilume® Procedures in the National Health Service (NHS), United Kingdom (UK)

PORTSMOUTH, N.H., June 22, 2021 /PRNewswire/ -- Laborie Medical Technologies Inc. (LABORIE), a leading diagnostic and therapeutic medical technology company, today announced the first Optilume® procedures were performed in the UK at NHS Trust on June 11, 2021 by Dr. Pareeta Patel and Professor. Nick Watkin.

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 North America to support regulatory approval of Optilume®, a drug-coated balloon (DCB) technology for use in urethral strictures and benign prostatic hyperplasia (BPH) and in September 2020 was granted CE Mark approval for use in urethral strictures in Europe².

Following the successful procedures, Dr. Patel commented, "We're delighted to be pioneering the Optilume® Drug Coated Balloon technology to advance patient care for the treatment of urethral stricture. All of the procedures were performed safely and went very well. Optilume offers a minimally invasive alternative with the potential of fewer recurrences that is often seen in existing endoscopic treatment options. We look forward to closely monitoring our patient results and further developing this service as part of our treatment options for men suffering from urethral stricture at Epsom Urology".

In the UK, 16,000 men require admission to hospital each year because of urethral stricture disease and 12,000 of them need an operation at an annual cost of £10 million^3,4 . 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. Multiple endoscopic treatments of the same stricture are proven to lead to progressively worsening outcomes. After a third endoscopic treatment, the failure rate approaches 75% by 6 months and reaches 100% by two-years post-treatment⁵.

Optilume® DCB combines balloon dilation to open the urethral stricture with the delivery of an anti-proliferative drug to prevent recurrence of the blockage. Published two-year clinical follow up data⁶ highlighted that Optilume® DCB performed as intended in both opening blockages and preventing the formation of scar tissue, which can develop quickly following traditional endoscopic 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 may require major surgery or need frequent endoscopic retreatment.

Professor. Watkin continued to add, "We're encouraged by the early data seen in clinical trials of the Optilume® Drug Coated Balloon, and as a specialist urethral reconstruction centre in the UK we believe offering a range of clinically effective treatment options and providing choice enables our service to evolve to the needs of patients and the health service. This novel technology has the potential to positively impact how urethral strictures are managed in the future benefiting patient's quality of life and potentially providing cost effectiveness to our national health service".

About Laborie Medical Technologies

Globally headquartered in Portsmouth, New Hampshire, 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 AB, 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.    The interactive population pyramid. Office for National Statistics. Available from: URL: http://www.statistics.gov.uk/populationestimates/flash_pyramid/default.htm. 
4.     Main procedures and interventions: 4-character OPCS codes 2009-10. The NHS Information Centre. http://www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937&categoryID=215 
5.     Steenkamp JW, Heyns CF, de Kock ML. Internal urethrotomy versus dilation as treatment for male urethral strictures: a prospective, randomized comparison. J Urol. 1997 Jan;157(1):98-101. PMID: 8976225.
6.     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}

SOURCE Laborie Medical Technologies Inc.