Orthocell’s Remplir™ Accelerates in Prostate Surgery, Eyes $2B U.S. Market

Growing Adoption in Australia

Orthocell Limited (ASX – OCC) has announced encouraging momentum for its Remplir™ product in nerve-sparing robotic-assisted radical prostatectomy (RARP) surgeries, with around 100 procedures now completed by multiple surgeons nationwide. This marks a promising step in applying Remplir’s peripheral nerve repair technology to reduce the high rates of post-surgical complications such as erectile dysfunction and urinary incontinence, which affect a significant proportion of prostate cancer patients.

Despite advances in surgical techniques, damage to the neurovascular bundle (NVB) remains a persistent challenge, often leading to debilitating side effects. Remplir™ is being used as a nerve wrap to protect and support healing of these critical nerves during surgery, aiming to improve patient outcomes.

Expanding the U.S. Market Opportunity

Orthocell sees a substantial commercial opportunity in the U.S., where approximately 115,000 prostatectomies are performed annually, most using robotic assistance. By integrating Remplir™ into nerve-sparing procedures, the company estimates its total addressable market could grow from $1.6 billion to nearly $2 billion. This expansion reflects the product’s potential to address a significant unmet clinical need in a large and lucrative market.

Importantly, Orthocell does not anticipate requiring additional FDA approvals for this new application, smoothing the path for a medium-term U.S. launch. The company is proactively establishing a commercialisation advisory board and investing in further clinical research to strengthen the evidence base that will underpin market entry and physician education.

Progress in the U.S. and Beyond

The rollout of Remplir™ in the U.S. is progressing steadily, with over 4,000 units shipped and initial surgical cases building momentum. Orthocell’s in-country representatives are actively working with distributors to secure hospital approvals and onboard surgeons, laying the groundwork for broader adoption.

Meanwhile, clinical data from the Australian cases is being compiled and will be released to support medical education initiatives and formal product launches in approved international markets, including Canada and the EU/UK. This data will be critical in demonstrating Remplir’s clinical benefits and driving confidence among surgeons and healthcare providers.

Strategic Positioning and Outlook

With a strong cash position of approximately $50 million and no debt, Orthocell is well-positioned to accelerate Remplir’s adoption and capitalize on this expanding opportunity. CEO Paul Anderson highlighted the significance of this development, noting that the product’s growing use in nerve-sparing prostate surgery reflects its broader potential in peripheral nerve protection and repair.

As prostate cancer remains the most commonly diagnosed cancer among Australian men, innovations that improve post-surgical quality of life are highly sought after. Orthocell’s strategic focus on building clinical evidence and commercial infrastructure suggests a deliberate and measured approach to capturing this market.