Laborie’s Optilume® Urethral Drug Coated Balloon Technology Wins Approval from Australia TGA

Laborie’s Optilume® Urethral Drug Coated Balloon Technology Wins Approval from Australia TGA

  • Optilume® combines balloon dilation of the urethral stricture with the delivery of an anti-proliferative drug to prevent recurrence of the blockage.  
  • The minimally invasive technology is expected to have a significant impact in the urological community, offering a new treatment option for urethral strictures that traditionally would require major surgery or need frequent retreatment1 

PORTSMOUTH, N.H., February 28, 2022 – Leading diagnostic and therapeutic medical technology company, Laborie Medical Technologies Corp. (Laborie), announced that the Therapeutic Goods Administration (TGA) regulation authority in Australia has approved the use of Optilume® Urethral Drug Coated Balloon technology for the treatment of anterior urethral stricture. 

Urethral stricture is a relatively common condition that blocks the pathway for urine to exit the body from the bladder and can result in a painful, frustrating slowing of the urinary system – it is estimated to affect up to 100,000 males in Australia. Multiple endoscopic treatments of the same stricture have proven to lead to progressively worsening outcomes, recurrence, and retreatment1.  

“In recent months, there has been limited access to Optilume for patients and urologists in Australia via the TGA’s Special Access Scheme approval pathway. Now, with approval and wider availability of the technology, we are confident that Optilume will be the treatment that breaks the cycle of recurrent anterior urethral strictures,” said Michael Frazzette, President & CEO of Laborie.  

Published one-year randomized control trial evidence2, and additional one-year and three-year clinical follow up data3,4 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.  

Dr. Justin Chee, a consultant urologist of Melbourne, explains, “My early experience in 30 patients using Optilume confirms an improvement over traditional treatments with ongoing clinical follow-up to determine its long-term effect currently in progress. This novel technology has the potential to positively impact how urethral strictures are managed in the future, and offers my practice an alternative treatment for men with recurrent anterior urethral stricture that want to avoid further traditional endoscopic treatments or open surgery. 

In September 2020, Optilume received Conformité Européene (CE) Mark approval in the European Union and in December 2021, Laborie acquired an exclusive license to Optilume, following approval from the U.S. Food and Drug Administration (FDA) in early December 2021. 

About Laborie Medical Technologies 

Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class Clinical Education & Information program. Laborie is a portfolio company of Patricia Industries. For more information visit www.laborie.com. 

About Patricia Industries 

Patricia Industries, a part of Investor AB, invests in best-in-class companies with strong market positions, brands and corporate cultures within industries positioned for secular growth. We invest with an indefinite holding period and partner with great management teams to create value for people and society by building strong and sustainable businesses.  

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 our board participation, industrial experience, global network and financial strength, we work continuously to support our companies to remain or become best-in-class.  

About Dr. Justin Chee 

Dr. Justin Chee is a urological surgeon dedicated to excellence in reconstructive surgery of the genitourinary system. Dr. Chee’s special interests include the surgical management of urethral stricture disease and prosthetic urology including male urinary incontinence and erectile dysfunction. Dr. Chee is founding faculty of International Society of Reconstructive Urology (ISORU) and is the current Leader of the Special Advisory Group for Reconstruction & Pediatric Urology, Urological Society of Australia and New Zealand (USANZ). 

References 

1.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. 

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, Virasoro R. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures. J Urol. 2021 Dec 2:101097JU0000000000002346. doi: 10.1097/JU.0000000000002346. Epub ahead of print. PMID: 34854748. 

3.DeLong, J. M., Ehlert, M. J., Erickson, B. A., Robertson, K. J., Virasoro, R., & Elliott, S. P. (2022). One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture. Société Internationale d’Urologie Journal, 3(1), 21-27. https://doi.org/10.48083/MLXK5817 

4.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. 

 

Media Contact: 

Julia Glater
Director, Internal Communications
Laborie Medical Technologies
jglater@laborie.com 
603.403.7365