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

PORTSMOUTH, NH, February 28, 2022 /PRNewswire/ — Laborie Medical Technologies Corp. (Laborie), a leading diagnostic and therapeutic medical technology company, announced that the regulatory authority of the Therapeutic Goods Administration (TGA) in Australia 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 lead to a painful and frustrating slowdown in the urinary system – it is estimated to affect up to 100,000 men worldwide. Australia. Multiple endoscopic treatments of the same stenosis have been shown to lead to progressively worse outcomes, recurrences, and retreatments1.

“In recent months, access to Optilume has been limited for patients and urologists in Australia through the TGA’s Special Access Regime approval pathway. Now, with the approval and wider availability of technology, we are confident that Optilume will be the treatment that breaks the cycle of recurrent anterior urethral strictures,” said Michael FrazzetteChairman and Chief Executive Officer of Laborie.

Published evidence from one-year randomized controlled trials2and additional one-year and three-year clinical follow-up data3.4 pointed out that Optilume worked as expected to both open blockages and prevent the formation of scar tissue which can develop quickly after any medical procedure.

dr. Justin Cheea consultant urologist from melbourneexplains, “My experience with this new technology has confirmed that not only is it an improvement over traditional treatments, but that Optilume has the potential to positively impact the future management of urethral strictures. moreover, it offers my practice an alternative treatment for men with recurrent anterior urethral stricture who wish to avoid other traditional endoscopic treatments or open surgery.”

In September 2020Optilume has received European Conformity (CE) approval in the European Union and December 2021, Laborie acquired an exclusive license for Optilumefollowing approval by the United States Food and Drug Administration (FDA) at the start December 2021.

About Laborie Medical Technologies
Based at Portsmouth, New Hampshire, Laborie is a global medical technology company specializing in urology, urogynecology, gastroenterology, obstetrics, gynecology and neonatal health. We manufacture and supply high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals consider us the leading market experts in our business segments, and we back our products with a world-class clinical education and education program. Laborie is a holding company of Patricia Industries. For more information, visit www.laborie.com.

About Patricia Industries
Patricia Industries, part of Investor AB, invests in leading 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, sustainable businesses.

About Investor AB
Investor, founded by the Wallenberg family in 1916, is a committed owner of high quality global businesses. We have a long-term investment perspective. Through our board membership, industry experience, global network and financial strength, we work continuously to help our companies remain or become best-in-class.

About the 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 and prosthetic urology, including male urinary incontinence and erectile dysfunction. Dr. Chee is the founding faculty of the International Society for Reconstructive Urology (ISORU) and is the current head of the Special Advisory Group for Reconstruction and Pediatric Urology, Urological Society of Australia and New Zealand (USANZ).

The 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 of the ROBUST III randomized controlled trial evaluating Optilume® Medication coated balloon for anterior urethral strictures. J Urol. December 2, 2021: 101097JU0000000000002346. doi: 10.1097/JU.0000000000002346. Epub ahead of print. PMID: 34854748.
3. DeLong, JM, Ehlert, MJ, Erickson, BA, Robertson, KJ, Virasoro, R., & Elliott, SP (2022). One-year results of the ROBUST II study evaluating the use of a drug-coated balloon for the treatment of urethral stricture. Journal of the International Society of Urology, 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.

SOURCE LABORIE MEDICAL TECHNOLOGIES, CORP.