Regenerative medicine company Orthocell (ASX:OCC) has reached a key milestone in its US expansion, achieving 100 unit sales of its flagship nerve repair product, Remplir.
This marks a significant early adoption step in the US$1.6 billion nerve repair market and reflects growing clinical uptake in complex peripheral nerve procedures.
The milestone has been driven by Orthocell's medical education programs and a specialist distributor network spanning 25 states, reaching approximately 40% of the US population.
To date, more than 250 surgeons have engaged in training programs, supported by 14 contracted medical advisory board members, contributing to early case volumes that are expected to grow throughout 2026.
Orthocell’s progress follows 61 submissions to US hospital Value Analysis Committees, with 17 approvals secured ahead of schedule—a critical step in enabling hospital access and sales.
The company has also established a US-based warehousing and fulfilment platform, with the first 4,000 units of Remplir shipped from Australia to ensure product availability.
Looking ahead, Orthocell plans to leverage its US experience to support international expansion, including the first Remplir surgeries in Canada in early 2026.
The company remains focused on accelerating market adoption, backed by a strong balance sheet of circa $50 million in cash and no debt, and continued investment in clinical evidence and medical education initiatives.
At the time of reporting, Orthocell's share price was $1.01.