Orthocell (ASX:OCC) completed its US Food and Drug Administration 510(k) regulatory study for Remplir, a collagen wrap product used in peripheral nerve repair, according to a Monday filing with the Australian bourse.

The regulatory study is a crucial part of Orthocell's application with the US FDA for marketing clearance for Remplir, the filing said.

The study met all endpoints, showing Remplir enables consistent and predictable recovery of upper arm and hand function following nerve repair. Clinical results showed 85% of nerve repairs with Remplir achieved functional muscle recovery 24 months post-treatment.

The regenerative medicine company plans to submit its 510(k) application this month, with US FDA clearance expected in the first quarter of 2025.

Remplir is already approved in Singapore, Australia, and New Zealand. The company plans to launch the product in Canada, the UK, Europe, and other ASEAN markets.

Orthocell's shares rose nearly 10% in recent Monday trade and earlier hit an all-time high.

Price (AUD): $0.89, Change: $+0.08, Percent Change: +9.88%