Urotronic Inc., Announces Completion of the First Optilume(R) Procedure in Asia

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

MINNEAPOLIS,Sept. 22,2021 --Urotronic,Inc.,aMinnesota based medical device company,today announced the first Optilume® Drug Coated Balloon procedure for the treatment of urethral stricture,was successfully performed in Hong Kong by Clinical Assistant Professor,Dr. Wayne Lam of The University of Hong Kong.

Following the successful procedure,Dr. Lam commented,"The procedure went straightforward and is easily reproducible. It gives us great pleasure to be able to offer patients in Hong Kong,and across Asia,this novel technology as part of our treatment service for urethral stricture. With the potential of fewer recurrences that is often seen with existing endoscopic treatment options,the Optilume® Drug Coated Balloon provides an opportunity to innovate patient care for urethral stricture disease whilst providing benefits to the health system realized through prevention of interventions required to manage the condition."

Urethral stricture is relatively common,and in many instances debilitating diseaseestimated to effect over a 6 million men throughoutAsiaalone suffering with debilitating urethral strictures1. The condition blocksthe 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,recurrence,and retreatment. After a third endoscopic treatment,the failure rate approaches 100% two-years post-treatment2.

Optilume® 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 data3highlighted that Optilume® 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.

Dr. Lam continued to add,"We look forward to welcoming suitable patients from across Asia. Early data in clinical trials of the Optilume® Drug Coated Balloon are very encouraging,with a reported 81% of patients free from repeat intervention,including self-catheterization,at 24 months3. Longer term comparison study data is expected to be published in the future which will determine the long-term efficacy of the technology versus existing treatment options."

About Urotronic Inc.

Urotronic,headquartered in Plymouth,Minnesota,is a clinical-stage medical device company currently conducting clinical trials to support global commercialization of their products. The Optilume® 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 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 aturotronic.com. Urotronic,Inc. signed a definitive agreement,entering into a multi-faceted,strategic partnership with LABORIE Medical Technologies in 20204.

REFERENCES

Alwaal A,Blaschko SD,McAninch JW,Breyer BN. Epidemiology of urethral strictures.Transl Androl Urol. 2014;3(2):209-213. doi:10.3978/j.issn.2223-4683.2014.04.07

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.

Mann,R. A.,Virasoro,R.,DeLong,J. M.,Estrella,R. E.,Pichardo,M.,Rodríguez Lay,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

Cision PR Newswire 8th October 2020 https://www.prnewswire.com/news-releases/laborie-medical-technologies-enters-into-strategic-partnership-with-urotronic-301148859.html

Contact: info@urotronic.com