Orthocell’s US Remplir Sales Reach $300K as Cash Reserves Hit $48M

Steady Revenue Growth Anchored by US Market Entry

Orthocell Limited (ASX:OCC) delivered a solid $3.2 million revenue in the March 2026 quarter, maintaining momentum from the previous quarter despite currency headwinds. Notably, US sales of the Remplir nerve repair device hit $300,000, with March alone contributing $170,000, signaling early signs of a potential revenue inflection in the sizeable US$1.6 billion nerve repair market. Year-to-date revenue of $9.4 million already surpasses the full FY25 total, marking a 45% lift over the prior corresponding period.

The company’s consistent revenue performance underscores growing adoption of Remplir alongside its established Striate+ product, with expanding surgeon and hospital uptake across Australia, Singapore, and now the US. Orthocell’s CEO Paul Anderson highlighted the "acceleration in US revenue" as a key milestone reflecting the scaling of commercial efforts.

Expanding US Footprint and Defence Sector Breakthrough

Orthocell’s US commercialisation is gaining traction, with Remplir now approved in 115 hospitals and actively purchased by 55. Surgeon adoption is rising, with 49 clinicians using the product and unit sales climbing to 115 in the quarter, a 328% compound quarterly growth rate since launch in June 2025. The distributor network covers 16 states, reaching approximately 40% of the US population, with plans to onboard additional distributors and regional sales directors to complete national coverage.

Significantly, Orthocell recently secured approval for Remplir across the US Department of Defence hospital network, encompassing 221 military and veterans hospitals. This follows 23 surgical uses on soldiers with nerve injuries sustained in Ukraine, underscoring Remplir’s suitability for trauma and defence applications. The company has already completed the first surgical case within this system, a rapid conversion from approval to clinical use that demonstrates effective surgeon engagement and distributor activity. This development builds on the company’s broader US rollout and growing surgeon adoption, as noted in the recent first Remplir surgery in US military hospital network coverage.

Strong Cash Position Supports Global Expansion

Orthocell’s financial health remains robust, with cash and term deposits totaling AU$48 million as of 31 March 2026. This liquidity provides a runway of approximately 4.6 years at current operating expenditure levels, positioning the company well to fund ongoing commercialisation and R&D activities without immediate need for further capital. The quarter saw a $3 million R&D tax incentive refund bolster cash flow, while net operating cash flow improved by $5.9 million from the prior quarter, reaching near breakeven.

Looking beyond the US, Orthocell is progressing market access in Canada, with initial sales expected soon following distributor training and hospital engagement. In the UK and EU, Orthocell has appointed LEDA Orthopaedics as the exclusive Remplir distributor, with regulatory approval anticipated in the second half of calendar 2026. This sets the stage for surgeon engagement and hospital procurement ahead of launch, tapping into a peripheral nerve repair market valued at around US$750 million.

New Clinical Applications Expand Market Potential

Orthocell is also advancing Remplir’s use in nerve-sparing prostate cancer surgery, with approximately 200 procedures performed across Australia. This new indication could expand the US total addressable market from US$1.6 billion to roughly US$2 billion. Initial clinical data from these procedures is being compiled and is expected to be released following the publication of a surgeon-led academic paper in the June quarter.

Meanwhile, the company continues to develop its SmrtGraft tendon repair product, supplied in Australia under special access, with plans to pursue a more commercially viable US regulatory pathway given the broader market opportunity.