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The Markets
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Pharma & Biotech

Orthocell flags strong March quarter as US Remplir rollout gathers pace

Orthocell Ltd (ASX:OCC, OTC:ORHHF) has reported a solid March 2026 quarter, highlighted by $3.2 million in revenue, growing US traction for nerve repair product Remplir and a cash position of $48 million as the company advances commercial expansion across multiple markets.

Revenue for the quarter was in line with the previous period, but the standout was early momentum in the United States, where Remplir sales reached $300,000. Of that, $170,000 was generated in March alone, suggesting an acceleration in demand as the company builds out its commercial footprint in what it sees as a US$1.6 billion addressable market.

Year-to-date revenue for the first 9 months of FY26 reached $9.4 million, up 45% on the prior corresponding period, supported by continued sales growth in established markets and early commercial contribution from the US.

Total revenue by quarter (A$M).

Orthocell’s balance sheet also strengthened during the quarter, with the company receiving a $3 million research and development tax incentive refund. At 31 March 2026, it held $7.8 million in cash and cash equivalents plus $40.2 million in term deposits, underpinning what management described as a strong position for ongoing commercial execution.

In the US, Orthocell continued to expand market access for Remplir. Its distributor network now covers more than 16 states and about 40% of the population. The company completed 6 major medical education events and a series of journal club meetings aimed at increasing surgeon awareness and adoption.

Commercial progress was also reflected in hospital access and clinical uptake. Orthocell secured 32 Value Analysis Committee approvals during the quarter, opening access to more than 115 hospitals, while a further 57 applications remain pending. Of the hospitals approved, 55 have now purchased Remplir, while 49 surgeons have used the product. Unit sales for the March quarter totalled 115.

“This quarter reflects continued strong progress in the commercialisation of Remplir, particularly in the United States, where we are seeing growing surgeon adoption and increasing revenue contribution. The consistency of our revenue performance and the growth in key commercial metrics, including hospital uptake, surgeon utilisation and distributor expansion, is particularly encouraging. Notably, the acceleration in U.S. revenue in March provides early evidence of a potential inflection point as these commercial efforts begin to scale," Orthocell CEO and MD, Paul Anderson, said.

"Subsequent to the end of the quarter, we secured approval for Remplir to be used across the US Department of Defence hospital networks, comprising 221 medical centres, and have already completed the first surgical case in this system. This rapid transition from approval to clinical use highlights both the strength of our commercial strategy and the effectiveness of our surgeon engagement activities. With a very strong cash position and expanding global footprint, Orthocell is well-positioned to continue executing on its commercial strategy and drive further adoption of Remplir across key markets.”

Defence, Canada and UK/EU add to growth pipeline

Orthocell also pointed to increasing real-world use of Remplir in defence-related settings, with the product used in 23 surgical procedures in Ukraine on soldiers with combat-related nerve injuries. After the end of the quarter, the company secured approval for Remplir to be used across US Department of Defense hospital networks and completed its first surgical case within that system.

Outside the US, Orthocell said work continued with distributors and key opinion leaders in Canada, with initial sales expected in the near term.

In the UK and Europe, the company appointed LEDA Orthopaedics as exclusive distributor for Remplir in the UK, ahead of anticipated regulatory approval in the second half of calendar 2026.

Orthocell also highlighted an emerging opportunity in nerve-sparing prostate cancer surgery, where about 200 procedures have now been completed in Australia using Remplir in a new application. The company believes this could expand its US addressable market from US$1.6 billion to about US$2 billion, with initial clinical performance data expected to be announced in the June quarter

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