Orthocell's Remplir™ Technology: A Game Changer in Prostate Cancer Surgery

The Rise of Remplir™ in Prostate Cancer Treatments

Orthocell Limited (ASX: OCC) is witnessing a growing acceptance of its product, Remplir™, among Australian urologists. This innovative technology is proving pivotal in the field of prostate cancer surgery, especially in nerve-sparing procedures intended to minimize postoperative complications. Remplir has been successfully utilized in approximately 100 surgical cases, assisting in the recovery of erectile function and urinary continence following surgery.

The potential market for Remplir in the United States is considerable, estimated to increase from approximately $1.6 billion to around $2 billion. This projection is based on the annual performance of about 115,000 prostatectomies in the U.S., the majority of which are conducted using robotic systems. As a strategic response to this opportunity, Orthocell is forming a commercialization advisory board and allocating resources toward further research to solidify the scientific backing for this new application of peripheral nerve repair. The company is gearing up for a targeted product launch in the U.S. market in the medium term without requiring additional FDA approvals.

Orthocell is also in the process of compiling clinical data on initial patients who have undergone radical prostatectomies with Remplir in Australia. This data, once completed, will serve as vital evidence to support the scientific legitimacy of the product in established markets.

Paul Anderson, CEO and Managing Director of Orthocell, expressed excitement regarding the swift adoption of Remplir by urologists in Australia. He sees this as a reflection of the product's broader potential in the realm of peripheral nerve protection and repair. Anderson emphasizes that this adoption could herald significant improvements in patient outcomes following complex surgeries.

Understanding Prostate Cancer and Its Treatment Options

Prostate cancer remains one of the most common cancers diagnosed in men in Australia, with over 26,000 new cases recorded in 2024 alone. For localized tumors, the primary treatment option is the radical prostatectomy (RP), which involves removing the prostate gland and surrounding tissue to destroy cancer cells. Although effective, RP is associated with high rates of postoperative complications, including erectile dysfunction (ED) and urinary incontinence (UI), both of which greatly diminish the quality of life for patients. The risk of ED can reach up to 80% in men one year post-surgery, while UI affects about 35% of patients just three months following the procedure.

Robotic-assisted radical prostatectomy (RARP) enhances surgical precision, allowing for better preservation of prostate anatomy, thus lowering—but not fully eliminating—the associated risks of these complications.

The Role of Remplir in Robotic-Assisted Surgeries

Aftercare complications such as erectile dysfunction and urinary incontinence post-radical prostatectomy are often the result of damage to the neurovascular bundles (NVB) surrounding the prostate. Maintenance of these nerves is crucial for preserving sexual function and urinary control. Approximately 75% of patients may be eligible for nerve-sparing procedures, but avoiding NVB damage remains challenging.

Remplir serves as a protective nerve wrap used in peripheral nerve repair. Australian urologists are beginning to implement Remplir in nerve-sparing RARP to safeguard and heal the NVB, which might lead to reduced rates of postoperative complications. With roughly 12,000 RARP procedures conducted annually in Australia utilizing the da Vinci Surgical System, and supported by strategic distribution through Device Technologies, the conditions are ripe for Remplir's expansion into new surgical specializations.

Orthocell is in a strong financial position, boasting around $50 million in cash and no debt, ensuring it can advance product adoption rapidly and significantly increase revenue in fiscal year 2026. The roll-out of Remplir within the projected $2 billion U.S. market is steadily gaining momentum, with in-country representatives making important strides in liaising with distributors to secure hospital approvals, onboard surgeons, and set up active accounts. Initial surgical cases in the U.S. are beginning to accumulate, and the company is proactively expediting the launch of Remplir in Canada, while staying on track for submitting its EU/UK application in the fourth quarter of 2025.

This evolving landscape positions Remplir not just as a promising product for proprietary use but also as a transformative solution aimed at revolutionizing patient care in the field of prostate cancer surgery.