Orthocell’s Remplir Used by Australian Urologists in Prostate Cancer Surgery

Regenerative medicine company Orthocell (ASX: OCC) has introduced its flagship nerve repair device Remplir to Australian urologists for use in nerve-sparing robotic-assisted radical prostatectomies (RARP).

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.

Remplir can protect the NVB from damage and promote restoration of normal nerve function, and works in a similar way to peripheral nerve repair procedures that restore function to the arms and legs.

US Market Rollout

Orthocell is collaborating with urologists to collect and analyse retrospective outcome data from nerve-sparing surgical procedures using Remplir.

A rollout to the $2.4 billion US market continues to build momentum, with in-country representatives making significant progress on hospital approvals and surgeon onboarding.

The company is also accelerating the launch of Remplir in Canada, and remains on schedule to submit its EU/UK application before year end.

Versatility and Superior Performance

Orthocell managing director Paul Anderson said Remplir could offer 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,” he said.

“This represents a significant step forward in the device’s organic expansion into broader peripheral nerve repair applications and has the potential to substantially increase our global addressable market.”

Positive Study Results

Interim results from a recent Remplir study demonstrated an 81.1% treatment success rate following nerve repair procedures.

Real world evidence (RWE) patient data collected from the study demonstrated that 81.2% of muscles innervated by repaired nerves achieved functional motor recovery, while 89.5% of nerve decompression procedures resulted in significant improvement or complete relief of symptoms with no post-treatment complications or adverse reactions were reported.

“This data confirms the superior and predictable outcomes that Remplir delivers and is testament to why over 200 surgeons across more than 165 hospitals so far are now using the product,” Mr Anderson said, adding that the data was valuable from a commercial and regulatory perspective as it demonstrated the performance of Remplir across a heterogenous patient population in the real world.

“RWE is an increasingly valuable contributor to regulatory decision-making as it provides evidence of product safety and performance from everyday clinical settings, in contrast to the carefully-controlled patient populations and conditions of clinical trials.”

Most-Diagnosed Cancer

Prostate cancer remains the most-diagnosed cancer among men in Australia, with more than 26,000 new cases in 2024 alone.

In cases where the tumour has not spread beyond the prostate, first-line treatment is radical prostatectomy involving complete removal of the prostate gland and some of the surrounding tissue to ensure removal of all cancer cells.

This procedure causes high rates of post-surgical urinary incontinence and erectile dysfunction, which can have a significant impact on patient quality of life.

While there are still significant risks associated with the procedure, the introduction of RARP offers increased precision and preservation of prostate anatomy not possible by other means.