Sydney Southwest Private Hospital a first mover with novel technology for the treatment of urethral stricture, Optilume^®

22 December 2021

Dr. Kayvan Haghighi and team post-surgery

Optilume^® (Urotronic, Inc. MN, USA) is currently under review by the Therapeutic Goods Administration (TGA) for general approval in Australia and was used, in the procedure described below, under approval received through the departments Special Access Scheme approval pathway. Optilume received Conformité Européene (CE) Mark approval⁷ in 2020 in the Europe Union and is currently under clinical investigation in the United States and is limited by federal law to investigational use with FDA approval anticipated for Dec 2021.

Sydney, NSW – December 2021 – This month, Healthscope’s Sydney Southwest Private Hospital (SSWPH) treated a patient with recurrent anterior urethral stricture disease with a novel medical device, the Optilume^® Urethral Drug Coated Balloon.

The procedure performed by Urologist, Dr. Kayvan Haghighi is expected to have a significant impact for the treatment of anterior urethral stricture disease, offering an alternative, minimally invasive treatment option that traditionally would need frequent selfmanagement, endoscopic retreatment or require open surgery.

General Manager of SSWPH, Jenny Connor, said of the successful surgery:

“At Sydney Southwest Private Hospital we pride ourselves on providing our patients with the best possible outcomes through world class facilities and specialists who are at the frontline of clinical innovation. The successful implementation of Optilume by Dr. Haghighi gives us great confidence that this device will eventually become available to more patients who suffer from anterior urethral stricture disease. We are delighted that our patient is recovering well from surgery and we wish him all the best.”

Dr. Haghighi recommended Optilume to his patient, after they had previously undergone several urethral dilation procedures only months apart. Although effective, those procedures only provided short-term relief due to the reformation of scar tissue and subsequent recurrence of the patient’s urethral stricture.

Urethral stricture is relatively common and, in many instances, is a debilitating disease estimated to affect millions of men globally⁴. First line treatment for anterior urethral stricture, following appropriate clinical assessment, is typically performed endoscopically via urethral dilation or, more commonly, direct vision internal urethrotomy (DVIU). Clinical evidence, and recommended guidelines⁵, state there is no statistically significant difference between the success of urethral dilation and DVIU⁶. However, 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-treatment³.

The Optilume device used by SSWPH combines balloon dilation of the urethra with simultaneous delivery of an anti-proliferative drug to prevent recurrence of the blockage. Three-year1 clinical data and one-year² randomised control trial clinical data have 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 of the urethra, associated with stricture recurrence³.

David Baker, Director of Device Matters Pty Ltd., the Australian distributor of Optilume stated: "We are excited to be able to provide Optilume to Australian urologists and their patients during this period using the TGA’s Special Access Scheme pathway. We anticipate the TGA’s final assessment of our application for full approval early in 2022. Subject to full approval for use of the Optilume device in Australia, this technology has the potential to reduce burdens across the Australian healthcare landscape as a treatment that can be performed as a day procedure and provide a simple, safe and durable alternative treatment to existing methods."

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About Urotronic, Inc.
Urotronic, Inc. headquartered in Plymouth, Minnesota, is a 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 urethral stricture. The Optilume^® drug coated balloon technology creates a paradigm change from the methods currently used by urologists to treat urethral stricture disease. For more information on Urotronic, please visit urotronic.com. Urotronic, Inc. signed a definitive agreement entering into a multi-faceted, strategic partnership with Laborie Medical Technologies in 20208 .

Device Matters Pty Ltd.
Device Matters is an independent consultancy and distributor of medical device technologies across Australia and New Zealand. With a combined 35 years of personal experience in the medical device and healthcare sector, leaders of the business David and Caroline offer client’s genuine value by providing a complete suite of services to commercialise medical device technologies.

About Dr. Kayvan Haghighi
Dr. Kayvan Haghighi is a Urologist who has been servicing the Southwest of Sydney and the Southern Highlands since 2007. He was educated in Adelaide, undertook his Urology training in New South Wales and then completed a prestigious Fellowship at Beaumont Hospital in Dublin, Ireland. Dr. Haghighi operates at Liverpool Hospital and Sydney Southwest Private Hospital. Dr. Haghighi consults in his offices at Campbelltown, SOMA at Gregory Hills, Bowral, and Liverpool.

References:

1. Elliott SP, Virasoro R, Estrella R, et al. MP56-06 The Optilume Drug Coated Balloon for Recurrent Anterior Urethral Strictures: ROBUST I Clinical Study 3-year follow up, N = 43. J Urol 2021;206(3S):e971.
2. Elliott SP, Coutinho K, Robertson KJ, D’Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson C and Virasoro R, One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume Drug-Coated Balloon for Anterior Urethral Strictures, The Journal of Urology^® (2021), doi: 10.1097/JU.0000000000002346
3. Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5. PMID: 9679876.
4. 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
5. N. Lumen (Chair), F. Campos-Juanatey, K. Dimitropoulos, T. Greenwell, F.E. Martins, N. Osman, S. Riechardt, M. Waterloos Guidelines Associates: R. Barratt, G. Chan, F. Esperto, R. La Rocca, A. Ploumidis, W. Verla; EAU Guidelines Office, Arnhem, the Netherlands. https://uroweb.org/guideline/urethral-strictures/
6. 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.
7. Cision PR Newswire 23rd September 2020 https://www.prnewswire.co.uk/newsreleases/new-treatment-for-urethral-strictures-optilume-r-receives-ce-approval822764109.html
8. Cision PR Newswire 8th October 2020 https://www.prnewswire.com/newsreleases/laborie-medical-technologies-enters-into-strategic-partnership-withurotronic-301148859.html