Highlights

  • Around 100 prostate cancer surgeries in Australia have now used Remplir in nerve-sparing procedures.
  • The application may help reduce complications linked to peripheral nerve injury during prostatectomy.
  • The Company estimates the U.S. total addressable market could expand from USD 1.6B to USD 2B.

Orthocell Limited (ASX:OCC) reports increasing use of Remplir™ during prostate cancer surgery, with approximately 100 procedures completed nationwide. The product is being adopted in nerve-sparing robotic-assisted radical prostatectomy (RARP) as surgeons investigate its potential role in supporting postoperative erectile function and urinary continence.

Prostate cancer remains the most frequently diagnosed cancer among Australian men, with more than 26,000 new cases reported in 2024. Radical prostatectomy (RP), the standard treatment for localised disease, can lead to complications such as erectile dysfunction and urinary incontinence. Depending on patient factors and the surgical approach, erectile dysfunction may affect up to 80% of men 12 months after surgery, while urinary incontinence may impact up to 35% of patients within three months post-procedure.

Despite the adoption of nerve-sparing techniques and the use of robotic systems such as the da Vinci Surgical System, damage to the neurovascular bundle (NVB) remains a common challenge. Surgeons in Australia are applying Remplir to the NVB during prostatectomy with the aim of protecting peripheral nerves and supporting recovery of function.

Expanding Commercial Opportunity

The Company states that incorporating Remplir into nerve-sparing RARP could expand its U.S. total addressable market from USD 1.6B to approximately USD 2B. This market estimate reflects the roughly 115,000 prostatectomies performed annually in the U.S., most of which involve robotic-assisted procedures.

Orthocell is establishing a commercialisation advisory board and increasing its research activities to strengthen scientific evidence ahead of a planned medium-term U.S. product launch. No additional FDA approvals are required for this application. Compilation of initial Australian clinical performance data is underway, with the results intended to support medical education and formal product launches in approved international markets.

Clinical Evidence and International Rollout

The Company is gathering clinical data from early procedures involving Remplir in Australia, aiming to release the findings once analysis is complete. This information will form part of a broader evidence base supporting global market activities.

Remplir’s U.S. rollout continues, with more than 4,000 units shipped and early surgical cases increasing. In-country representatives are engaged with distributors to progress hospital approvals, initiate surgeon onboarding and establish active clinical accounts. Orthocell is also advancing launch activities in Canada and preparing to submit EU/UK applications in Q4 CY25.

Share Price Snapshot

OCC was trading 6.96% higher at AUD 1.075 per share as of 20 November 2025.