Australian regenerative medicine company Orthocell Limited (ASX: OCC) announced on Thursday that it has secured approval for its Remplir nerve repair device to be used across the United States Department of Defence and Veterans Affairs hospital networks.
The approval grants access to about 51 Department of Defence military hospitals and 170 Veterans Affairs medical centres. It follows 32 Value Analysis Committee approvals already providing access to more than 115 hospitals, with a further 57 applications pending.
Orthocell will use its existing US distributor network, which covers 17 states, to target military and Veterans Affairs surgeons. The company expects a significant portion of these facilities to be serviced through its current distribution footprint.
The expansion into defence healthcare builds on recent clinical use of Remplir in 23 surgical procedures on injured soldiers in Ukraine for primary and secondary nerve repair. Orthocell views the Ukraine experience as validation of Remplir's suitability for major traumatic injuries commonly encountered in military settings and supportive of its applicability within defence healthcare systems.
Implantica submits final FDA response for RefluxStop PMA application
Artivion completes acquisition of Endospan following FDA approval of NEXUS Aortic Arch System
AngioDynamics reports 24-month PRESERVE data showing durable NanoKnife outcomes in prostate cancer
Cepheid receives CE mark for IVDR‑compliant gastrointestinal PCR panel
Abingdon Health supports UK launch of LVOne stroke triage test
Fesarius Therapeutics reports publication of DermiSphere hDRT data
Shield Therapeutics announces Phase II trial initiation of ACCRUFeR in Japan for PAH
Johnson & Johnson secures EU approval for ETHICON 4000 surgical stapler