• Remplir has been used in ~100 surgical cases to assist in improving recovery of erectile function and urinary continence post-surgery
• Remplir's use in nerve-sparing robotic-assisted radical prostatectomy (RARP) presents a significant opportunity to expand Orthocell's total addressable market in the U.S. from U.S.$1.6 billion to approximately U.S.$2 billion
• Orthocell is establishing a commercialization advisory board and investing in additional research to strengthen the scientific evidence base for this innovative peripheral nerve repair application, ahead of a targeted U.S. product launch in the medium term

Orthocell Limited (ASX: OCC) has announced that adoption of its Remplir product by Australian urologists is accelerating, with the product now being used in ~100 surgical cases to assist in improving recovery of erectile function and urinary continence following prostate cancer surgery. The company believes that using Remplir in nerve-sparing robotic-assisted radical prostatectomy (RARP) presents a significant opportunity to expand its total addressable market in the U.S. from U.S.$1.6 billion to approximately U.S.$2 billion, based on the ~115,000 prostatectomies performed annually in the U.S., the majority of which are conducted robotically. To capitalize on this opportunity, Orthocell is establishing a commercialization advisory board and investing in additional research to strengthen the scientific evidence base for this innovative peripheral nerve repair application, ahead of a targeted U.S. product launch in the medium term. The company is also collating clinical data on initial patients who underwent radical prostatectomies with Remplir in Australia, which will be released to support the scientific foundation for formal product launch in existing approved markets. Prostate cancer is the most commonly diagnosed cancer among men in Australia, with over 26,000 new cases in 2024 alone, and radical prostatectomy carries high rates of post-operative complications, including erectile dysfunction and urinary incontinence, which significantly impact quality of life. Remplir, a nerve wrap used in peripheral nerve repair, is being adopted by Australian urologists in nerve-sparing RARP to protect and heal the neurovascular bundle, potentially lowering rates of these post-surgical complications. With over 12,000 RARP procedures performed annually in Australia and strategic distribution support, Remplir's introduction is well-positioned to expand into new surgical specialties.

Orthocell believes that the use of Remplir in nerve-sparing RARP presents a significant opportunity to expand its Total Addressable Market in the U.S. from U.S.$1.6 billion to approximately U.S.$2 billion.

To support a targeted U.S. product launch in the medium term, the Company is setting up a commercialization advisory board and investing in further research to strengthen the scientific evidence base for this new application of Remplir. The Company's Remplir rollout in the U.S. market 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.