Orthocell’s Remplir finds early traction in complex prostate surgery

Five-patient pilot produces early functional recovery signals

Orthocell Limited (ASX:OCC) has produced an encouraging, though very early, set of results for Remplir in nerve-sparing robotic prostatectomy, reporting that three of five patients were pad-free by six months after surgery. The small pilot involved clinically complex prostate cancer cases in which extensive tumour removal limited nerve preservation, making recovery of urinary continence and erectile function more difficult than in less advanced cases.

Two patients achieved pad-free continence within three to four months, while a third reached that point by six months. The two patients who had not regained full continence had pre-existing urinary symptoms before surgery. Of the four patients who had erectile function before their operations, one reported erections with oral medication at 12 months and two reported partial function with second-line treatment; one had not regained erectile function when assessed.

The results are descriptive rather than proof of efficacy. The series contains only five patients, has no control group and was conducted in a particularly challenging cohort, including patients with cancers extending beyond the prostate and several with conditions such as diabetes, high blood pressure or obesity. All five had undetectable PSA levels when reported, although one had a small amount of tumour tissue that could not be surgically removed.

Remplir placement supports larger clinical programme

On the usability question, the pilot was cleaner: Remplir was successfully positioned over the prostate nerve regions in all five robotic procedures, without technical difficulties or significant additional operating time. Orthocell said there were no Remplir-related complications during surgery or over approximately 12 months of follow-up.

The company now plans a larger prospective clinical trial to investigate whether Remplir can support a more consistent and earlier return of urinary continence and erectile function after nerve-sparing robotic prostatectomy. That evidence is intended to support medical education, broader adoption and an initial US commercialisation effort. The update follows the company’s US Remplir sales growth, which had already included growing hospital and surgeon adoption during Orthocell’s first full year of US sales.

Orthocell says Remplir is already approved in seven jurisdictions, including Australia, New Zealand, the United States, Canada, Singapore, Hong Kong and Thailand, and that no additional regulatory approvals are required for prostatectomy use in those markets. The potential market is substantial on the company’s estimates: more than 12,000 robotic-assisted radical prostatectomies are performed annually in Australia and about 115,000 prostatectomies in the US, where the company estimates the application could lift Remplir’s total addressable market from US$1.6 billion to approximately US$2.0 billion. More than 300 Australian prostatectomy procedures have now used the product, with multiple surgeons reportedly using it routinely.

Orthocell had A$44.1 million in available funds at 30 June 2026, comprising A$5.0 million in cash and A$39.1 million in term deposits, and reported no debt. That gives the company funding capacity for the next phase, but the commercial case still depends on whether results from a much larger study can reproduce the early recovery signals and translate into sustained surgeon adoption.