Globally Significant Opportunity Emerges as Remplir™ is used in Nerve-Sparing Prostate Cancer Surgery

Globally Significant Opportunity Emerges as Remplir™ is used in Nerve-Sparing Prostate Cancer Surgery

Potential to reduce the risk of erectile dys function and urinary incontinence

PERTH, Australia, Sept. 16, 2025 /PRNewswire/ -- Regenerative medicine company Orthocell Limited (ASX:OCC, "Orthocell" or the "Company") is pleased to announce 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.

Orthocell is collating clinical data on initial patients who underwent radical prostatectomies with Remplir in Australia and will release the clinical 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 CEO and MD, Paul Anderson, said: "The use of Remplir™ in nerve-sparing robotic-assisted radical prostatectomy highlights the product's versatility and superior performance in the protection and reconstruction of damaged peripheral nerves.

"Surgeons across multiple specialties—including orthopaedics, plastic and reconstructive surgery, and now urology—are increasingly adopting Remplir to simplify procedures, minimise scarring, and improve functional recovery.

"This represents a significant step forward in Remplir's organic expansion into broader peripheral nerve repair applications and has the potential to substantially increase the device's global total addressable market."

Summary Points

• Australian urologists are using Remplir during prostate cancer surgery in a promising new application aimed at reducing post-surgical complications due to peripheral nerve injury — a development with potential for globally significant impact.
• Currently up to 80% of men experience erectile dysfunction, and up to 35% suffer from urinary incontinence, after radical prostatectomy due to damage of the peripheral nerves in the neurovascular bundle (NVB) surrounding the prostate.
• Despite procedures aimed at preserving nerve function (i.e. nerve-sparing), and with the enhanced surgical precision offered by robotic assisted radical prostatectomies (RARP), there remains a significant risk of post-surgical erectile dysfunction and/or urinary incontinence.
• Similar to peripheral nerve repair procedures that restore function to the arms and legs, Remplir can be used to protect the NVB from damage and promote restoration of normal nerve function. Remplir has been used in approximately 40 nerve-sparing RARP by urologists across Australia.
• Orthocell is currently collaborating with urologists to collect and analyse retrospective outcome data from these nerve-sparing procedures using Remplir, with data to be released once available. The Company also intends to invest in further research to build evidence and assist medical education initiatives related to this innovative use of Remplir for peripheral nerve repair.
• The Company believes the use of Remplir in nerve-sparing RARP represents a significant opportunity to expand Remplir's Total Addressable Market.
• Remplir rollout in the US$1.6 Billion US market^[1] 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. Initial US surgical cases continue to build.

^[1] Nerve repair market sizes estimated using referenced papers from both US and OUS databases and studies.

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SOURCE Orthocell Ltd