Remplir Use in Prostate Surgery Signals Global Opportunity

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Stock Orthocell Ltd (OCC.ASX)
Release Time 16 Sep 2025, 9:05 a.m.
Price Sensitive Yes
 Remplir Use in Prostate Surgery Signals Global Opportunity
Key Points
  • Remplir used in nerve-sparing robotic-assisted radical prostatectomies to protect nerves and reduce complications
  • Potential to significantly reduce rates of erectile dysfunction and urinary incontinence after prostate cancer surgery
  • Represents a significant expansion of Remplir's total addressable market
Full Summary

Orthocell Limited has announced that its flagship nerve repair device, Remplir, has been introduced to urologists in Australia for use in nerve-sparing robotic-assisted radical prostatectomies (RARP). Remplir has been used in approximately 40 surgical cases to assist in improving recovery of erectile function and urinary continence post-surgery. Prostate cancer is the most diagnosed cancer among men in Australia, with over 26,000 new cases in 2024. Radical prostatectomy, the complete removal of the prostate gland, is a common first-line treatment, but is associated with high rates of urinary incontinence (up to 35%) and erectile dysfunction (up to 80%) due to damage to the neurovascular bundle (NVB) of nerves and blood vessels surrounding the prostate. While robotic-assisted RP (RARP) offers increased precision and preservation of prostate anatomy, damage to the NVB is still difficult to avoid. Remplir, a nerve wrap used in peripheral nerve repair procedures, is being adopted by Australian urologists in nerve-sparing RARP to protect the NVB and potentially reduce the rates of ED and UI. Orthocell is currently collating clinical data on initial patients who underwent radical prostatectomies with Remplir in Australia and will release the data once available. The company will also invest in further clinical studies to build evidence and assist medical education initiatives to drive further adoption of Remplir in this market. Orthocell believes the use of Remplir in nerve-sparing RARP represents a significant opportunity to expand Remplir's Total Addressable Market.

Outlook

Orthocell is well-positioned to drive rapid product adoption and deliver a step change in revenue in FY26. Remplir rollout in the US$1.6 Billion US market continues to build momentum, with in-country representatives making significant progress working with distributors to gain hospital approvals, on-board surgeons and establish active accounts. The Company is also accelerating the launch of Remplir in Canada and remains on schedule to submit its EU/UK application in Q4 CY25.