Orthocell Ltd (ASX:OCC, OTC:ORHHF) has delivered a seventh consecutive quarter of record revenue, reporting $3.2 million in sales for the December 2025 quarter as early momentum builds from its US nerve repair product Remplir.
The result represents a 45% increase on the prior corresponding period and a 7% lift on the previous quarterly record, extending a run of consistent growth that the company says reflects rising adoption across both established and emerging markets.
Revenue growth driven by Remplir expansion
Orthocell said revenue growth was driven primarily by increasing penetration of Remplir in existing markets, alongside initial contributions from the US, where the product was cleared in mid-2025.
US sales reached $90,000 in December alone, marking what the company described as the start of a longer-term uplift from a market estimated at US$1.6 billion. Orthocell also reported achieving its first 100 US sales during the quarter.
Across the past seven quarters, the company has delivered a compound quarterly growth rate of 10.4%, underpinned by growing surgeon adoption of Remplir and continued sales of its dental membrane product Striate+.
US commercialisation tracking ahead of plan
Orthocell said its US commercial rollout is progressing ahead of internal expectations, with its distributor network now covering more than 25 states and around 40% of the US population.
During the quarter, the company submitted 61 applications to hospital Value Analysis Committees, with 23 approvals already secured. It also completed 11 major medical education meetings across key US states, introducing surgeons to Remplir’s clinical data and surgical workflow benefits.
New markets open up in Canada and Hong Kong
Beyond the US, Orthocell made progress expanding Remplir into new geographies.
A second Canadian distributor was appointed during the quarter, providing national coverage of the estimated US$75 million Canadian nerve repair market. First Canadian sales are expected in the March 2026 quarter.
In Hong Kong, the company appointed an exclusive in-country distributor, with the first surgical case expected shortly. Orthocell highlighted Hong Kong’s strategic importance as a potential gateway to the wider Guangdong–Hong Kong–Macao Greater Bay Area.
Europe and UK regulatory pathway underway
Orthocell also submitted a regulatory application during the quarter to enable commercial distribution of Remplir into the European Union and UK nerve repair market, which it estimates at US$750 million annually.
Regulatory approval is expected in the September 2026 quarter. The company noted there are an estimated 500,000 peripheral nerve repair procedures performed each year across the EU and UK, positioning the region as a potential second-largest market for Remplir after the US.
Balance sheet strengthened by $30m raising
Financially, Orthocell closed the quarter with cash reserves of $49.4 million following completion of a $30 million institutional placement. The raising attracted strong international and domestic demand, including participation from new US-based institutions.
Cash receipts from customers totalled $1.2 million for the quarter, while net operating cash outflows were $6.3 million as the company continued to invest in commercial expansion and R&D.
Broadening the product pipeline
During the quarter, Orthocell increased its investment in Marine Biomedical, securing global distribution rights to the PearlBone bone regeneration technology. A US FDA 510(k) submission for PearlBone is expected by March 2026.
The company also reported growing interest in the use of Remplir for nerve-sparing prostate cancer surgery, with around 100 procedures now performed. Orthocell believes this application could expand Remplir’s US total addressable market to around US$2 billion over time.
CEO and managing director Paul Anderson said the company enters 2026 well funded to continue scaling commercialisation as it builds on early US adoption.
“Our primary focus during the quarter continued to be the commercialisation of Remplir in the US, and it’s pleasing to see early traction with more than 100 units now sold,” he said. “We certainly expect to see that momentum build significantly during 2026.”