Orthocell Ltd (ASX:OCC, OTC:ORHHF) is accelerating efforts to unlock a promising new commercial pathway for its Remplir™ nerve repair device, as Australian urologists increasingly adopt the technology during radical prostate cancer surgery.
Around 100 prostatectomies nationwide have now incorporated Remplir™, marking a rapid emergence of a new clinical application aimed at reducing post-surgical erectile dysfunction and urinary incontinence — two of the most common and debilitating complications following nerve-sparing robotic-assisted radical prostatectomy (RARP).
The company says the early momentum strengthens the case for a medium-term US launch. No further FDA approvals are required for this indication, and Orthocell believes use of Remplir™ in nerve-sparing RARP could expand its US total addressable market from US$1.6 billion to roughly US$2 billion, supported by an estimated 115,000 prostatectomies performed each year in the US, most of them robotic.
A new clinical frontier for Remplir™
While Remplir™ is already cleared in major markets for peripheral nerve protection and repair, urologists in Australia are now applying the bioabsorbable nerve wrap during prostate surgery to protect the neurovascular bundle (NVB) — the cluster of nerves and blood vessels essential for sexual function and continence.
Even with modern robotic systems, NVB damage remains common. Erectile dysfunction affects up to 80% of patients 12 months after surgery, and urinary incontinence up to 35% shortly after the procedure. Nerve-sparing techniques reduce these risks but cannot eliminate them.
Orthocell says surgeons are using Remplir™ to shield the NVB during RARP with the aim of improving postoperative nerve recovery. Clinical performance data from the first Australian prostatectomy patients is now being compiled and will underpin medical education programs and future product launches in already-approved markets, with a focus on the US.
Building the evidence base ahead of US expansion
To support the opportunity, Orthocell has established a commercialisation advisory board and is investing in further clinical and scientific research for this emerging application. A targeted US launch remains planned for the medium term.
Remplir™’s broader US rollout continues to build, with more than 4,000 units shipped and in-country representatives working with distributors to secure hospital approvals, train surgeons and activate new accounts. The company recently expanded its North American footprint with a second Canadian distributor, complementing progress in the US market.
Read more: Orthocell adds second Canadian distributor, unlocking Canada’s US$75M market
Eyeing broader clinical potential
Orthocell CEO and managing director Paul Anderson said growing surgeon adoption highlights Remplir™’s expanding utility.
“We’re thrilled to see Remplir being adopted by urologists in Australia for nerve-sparing prostate surgery, reflecting its broader potential in peripheral nerve protection and repair,” he said. “This demonstrates the utility of the product and represents the potential for a meaningful step forward in improving patient outcomes following these complex surgeries.”
Positioned for FY26 growth
The latest update follows several milestones in recent months, including a $30 million placement to accelerate US commercialisation, the first surgical case in Hong Kong, and the new distribution partnerships in Canada.
Read more: Orthocell completes first surgical case with Remplir™ in Hong Kong
Orthocell also posted its sixth consecutive quarterly revenue record in Q3 FY25, supported by rising Remplir™ uptake in the US.
Read more: Orthocell posts sixth straight quarterly revenue record as Remplir US rollout accelerates
With about $50 million in cash and no debt, the company says it is well-capitalised to drive its next phase of growth, including expanded marketing, surgeon onboarding and clinical evidence generation across prostate surgery and other nerve repair indications.
Remplir™’s international expansion continues across Australia, New Zealand, Singapore, Thailand, Canada and Hong Kong, with EU/UK submissions on track for Q4 CY25.