Orthocell (ASX:OCC) has taken a significant step into one of the world’s most complex healthcare environments, securing approval for its Remplir nerve repair device for use across the United States Department of Defence and Veterans Affairs hospital networks.
The decision opens the door to approximately 51 military hospitals and 170 VA medical centres, dramatically expanding the company’s reach in the United States and positioning it within systems that routinely handle some of the most challenging trauma cases.
The milestone builds on a period of growing momentum for the regenerative medicine company, which has been steadily increasing its commercial footprint in the US. Orthocell has already obtained Value Analysis Committee approvals, giving it access to more than 115 hospitals, while additional applications remain under review. This layered approach to market entry reflects a deliberate strategy to scale adoption through institutional channels while leveraging its existing distributor network, which now spans 17 states.
With the new approval in place, Orthocell said it plans to focus on military and VA surgeons working within these hospital systems. Many of the facilities fall within the company’s current distribution footprint, allowing it to move quickly and efficiently as it seeks to embed Remplir into clinical practice.
The opportunity is underpinned by real-world clinical experience. Remplir has already been used in 23 surgical procedures on injured soldiers in Ukraine, covering both primary and secondary nerve repair. That experience has provided insight into how the device performs in high-pressure environments where portability, ease of use and reliability are critical.
The Ukraine experience demonstrates Remplir's real-world performance in a conflict environment and highlights key attributes of the device, including its portability, ease of use, and suitability for treating major traumatic injuries commonly encountered in military settings. Orthocell believes this validation strengthens the case for its adoption within defence healthcare systems, where surgeons frequently manage complex nerve damage under demanding conditions.
Orthocell Managing Director Paul Anderson framed the development as a pivotal moment for the company’s broader US ambitions. “Securing access to the U.S. Department of Defence and Veterans Affairs hospital networks is a significant milestone for Orthocell and a major step forward in our U.S. commercial strategy. This approval enables us to engage directly with military and VA surgeons treating complex nerve injuries and to leverage our existing distributor network to drive adoption of Remplir across these key institutions. Importantly, Remplir has already demonstrated its value in conflict-related injuries in Ukraine, highlighting its suitability for the types of trauma commonly encountered within military healthcare systems.”