Orthocell Ltd (ASX:OCC, OTC:ORHHF) has cracked the United States market, recording its first sales revenue from its flagship nerve repair product Remplir™, after initial surgeries in Ohio and Florida.
The milestone comes just over three months after the company secured regulatory clearance in the US, in what was a swift transition from approval to commercial traction in an estimated US$1.6 billion (A$2.4 billion) market.
The early procedures were performed at Ambulatory Surgery Centres, offering a valuable opportunity to train US surgeons while confirming that the company’s fulfilment and billing systems are ready to scale.
Backed by logistics partner Uniphar, Orthocell is now laying the groundwork for a broader rollout, with momentum expected to build across the second half of 2025.
“Translating Remplir’s regulatory clearance in the US to first sales revenue in a little over three months is a testament to the hard work we’ve done with our US rollout plan. This covers everything from our key internal hires in sales, marketing and medical affairs, appointing specialist distributors, Australian manufacturing ramp up and working with our on-the-ground US logistics partner,” Orthocell CEO and MD, Paul Anderson, said.
Commercialisation strategy builds US market traction
The first US surgical use of Remplir™ occurred on June 26 in Ohio, with follow-up procedures in Florida.
These early-stage surgeries, conducted in outpatient settings, have provided a strategic entry point into the market, allowing Orthocell to familiarise key US surgical stakeholders with Remplir™ and its application.
The surgeries were facilitated through the company’s network of specialist distributors, reflecting a model previously used to scale operations in Australia.
“I must stress these early-stage day surgery cases are an ideal starting point and represent the perfect strategic platform to build from. This approach is similar to the market access model we have successfully undertaken in Australia where early surgery cases build familiarity and knowledge, leading to widespread adoption and therefore revenue growth,” Anderson said.
“We expect to follow a similar path in the US, albeit on a far larger scale. We are confident our efforts in the US are on track to drive growth in sales of Remplir during the second half of calendar 2025.”
Operational execution supports rapid revenue conversion
The conversion from FDA 510(k) clearance to revenue generation within a three-month window demonstrates the success of Orthocell’s US rollout strategy. This includes recent internal hires in sales, marketing, and medical affairs, as well as scaled-up Australian manufacturing and localised logistics through Uniphar. The validation of Orthocell’s fulfilment and invoicing processes confirms readiness for broader distribution and scalability.
Remplir™ supported by strong clinical data, large addressable market and strong cash position
Remplir™, a collagen wrap for peripheral nerve repair, is supported by clinical evidence showing improved nerve regeneration, earlier functional recovery, and superior tissue restoration compared to standard suture techniques.
Orthocell is addressing a global nerve repair market valued at more than US$3.5 billion (A$5.3 billion), with around two million peripheral nerve repair surgeries annually across key global markets.
As at June 30, 2025, Orthocell held approximately A$28.6 million in cash and no debt, positioning the company to expand its commercial footprint in the US and other territories. With approvals in Australia, New Zealand, Singapore, and now the US, Orthocell is strategically advancing Remplir™ and its wider regenerative product portfolio globally.