Following US Food and Drug Administration (FDA) 510(k) clearance in April 2025, the first US surgical procedure using Orthocell Ltd (ASX:OCC, OTC:ORHHF)’s Remplir™ nerve repair device has now been completed.
The surgery is the first in-market use of Remplir in the United States’ US$1.6 billion nerve repair market and is significant milestone in the product’s commercial rollout.
The procedure was facilitated through Orthocell’s growing distributor network in the US, now comprising 14 specialist partners across 25 states.
With the procedure done and around A$30 million in the bank and no debt, OCC is on track to deliver sales growth for the first half of financial year 2026 (1H FY26).=
First surgical case performed in Ohio
The inaugural surgery was conducted overnight at a hospital in Ohio, where Remplir™ was used to repair a foot nerve injury. Orthocell’s Medical Education team observed the procedure, which was performed using product manufactured at the company’s Perth, Western Australia facility. The successful case is expected to drive surgeon engagement and familiarity, building broader clinical confidence in Remplir™.
“This first US surgery is a significant milestone for Orthocell and for the roll out of Remplir™ in the US. It signals the start of our commercial journey in the world’s largest healthcare and nerve repair markets, and reflects our commitment to delivering innovative, clinically proven solutions to surgeons and their patients,” Orthocell CEO and MD Paul Anderson said.
Anderson noted that early clinical cases are vital to surgeon education and long-term sales momentum.
“We are confident our efforts in the US are on track to drive material growth in sales of Remplir during the second half of calendar 2025,” he said.
Distribution strategy expanding footprint
The Ohio case emerged directly from Orthocell’s US distributor network, which includes 14 specialist partners with strong surgeon and hospital relationships across 25 states.
These distributors are central to the company’s strategy to promote Remplir™ adoption and support its integration into clinical practice across key regions.
Orthocell is targeting a global peripheral nerve repair market estimated at more than US$3.5 billion. With around 2 million procedures performed annually across key markets, the company sees strong growth potential.
Product backed by clinical validation
Remplir™ is a collagen-based wrap designed to enhance the regeneration of damaged peripheral nerves.
It has demonstrated superiority over traditional suture techniques, delivering improved patient outcomes, faster return to function and enhanced nerve tissue restoration.