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Perth-based regenerative medicine company Orthocell Limited (ASX: OCC) has secured approval for its Remplir nerve repair device across the United States Department of Defense (DoD) and Veterans Affairs (VA) hospital networks, opening access to more than 220 military hospitals and medical centres.
The approval represents a significant expansion of the company's US commercial footprint and follows a humanitarian delivery of Remplir to Ukraine earlier this month.
At the end of March, Orthocell had already secured 32 Value Analysis Committee (VAC) approvals providing access to more than 115 hospitals across 17 US states, with a further 57 VAC applications pending.
Remplir is a collagen nerve repair wrap designed for peripheral nerve surgery, particularly after severe injuries or surgeries. The treatment delivers a biological, resorbable membrane that acts as a protective, tension-free wrap around damaged nerves.
The device is manufactured using Orthocell's proprietary CelGro collagen medical device technology platform.
“Securing access to the US 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," says Orthocell CEO Paul Anderson.
"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."
The humanitarian delivery of Remplir to Ukraine this month was used in 23 surgical procedures on injured soldiers.
The procedures covered both primary and secondary nerve repair applications, with remote surgeon training provided by Australian orthopaedic surgeon and key opinion leader Dr Alex O'Beirne.
Orthocell says it intends to collect clinical data from the Ukraine procedures going forward.
Anderson says the Ukraine experience reinforces Remplir's "unique handling, transportability, and clinical utility" in challenging surgical environments.
The company has acknowledged the support of Vasyl Myroshnychenko, Ambassador of Ukraine to Australia, in facilitating the humanitarian delivery.
Orthocell's US distributor network currently spans 17 states, and the addition of the DoD and VA networks significantly broadens the addressable market for Remplir beyond the civilian hospital system.
"Orthocell is well positioned to capitalise on this expanded access with its existing network of distributors and in-house sales and medical education teams, and will continue to pursue opportunities to increase utilisation of Remplir across key U.S. healthcare segments, including military and veteran care," says the company.
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