Orthocell Accelerates US Nerve Repair Sales with 45% Revenue Surge to A$13.2M

Orthocell posts record FY26 revenue growth driven by expanding US and international sales of its collagen medical devices, while investing ahead in manufacturing capacity and product pipeline.

  • 45% revenue growth to A$13.2 million
  • First full year of US Remplir sales with growing hospital and surgeon adoption
  • Manufacturing expansion approved with A$5–5.5 million investment
  • A$44 million cash reserves post A$30 million capital raise
  • Loss after tax widens to A$13.9 million on commercialisation investment
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Record Revenue Growth Driven by US Market Expansion

Orthocell Limited (ASX:OCC) has reported a 45% increase in revenue for the full year ended 30 June 2026, reaching a record A$13.2 million. This growth was primarily fuelled by accelerating sales of its collagen medical devices Remplir™ and Striate+™, with the US market playing a pivotal role as Orthocell completed its first full year of commercial sales in the region.

Remplir™, a collagen nerve wrap designed for peripheral nerve repair, generated A$0.33 million in revenue in the June quarter alone, marking steady progress in a market where hospital adoption and surgeon engagement are still in early stages. Orthocell’s US commercial footprint now covers 50% of the population across 20+ states, with 70 hospitals purchasing Remplir and 76 surgeons actively using the product. The company is focused on converting this market access into routine clinical use, recognising the lengthy approval and adoption cycle in US hospitals.

International Expansion and Diversified Revenue Streams

Beyond the US, Orthocell broadened Remplir’s reach with initial commercial sales in Canada and Hong Kong, and appointed a specialist distributor in Thailand, targeting a region with significant nerve injury prevalence. Regulatory submissions for the UK and European Union were lodged in December 2025, with approvals anticipated by the end of 2026, setting the stage for further geographic diversification.

Striate+, the resorbable collagen membrane for dental guided bone regeneration, continued to perform strongly under global partner BioHorizons Implant Systems Inc. The product expanded into new markets including Brazil, Colombia, and Ecuador, with approximately 60,000 units manufactured in Perth during the year. This segment provides a steady manufacturing base and complements the company’s broader regenerative medicine portfolio.

Investing Ahead in Manufacturing and Product Development

Orthocell is proactively scaling its manufacturing capacity with Board approval of a Stage 1 expansion at its ISO 13485-certified Perth facility, involving an anticipated A$5 to A$5.5 million investment. This program aims to quadruple collagen-device production capacity, introduce automation, reduce cycle times, and improve efficiency to support expected growth in existing and emerging markets.

The company is also advancing its product pipeline, initiating a US regulatory program for SmrtWrap™, a collagen-based tendon repair device extending Orthocell’s proprietary SMRT™ collagen platform. Additionally, Orthocell increased its strategic investment in Marine Biomedical Pty Ltd, securing a first right of refusal over PearlBone™, a marine-derived bone repair product under development.

Financial Position Strengthened by Capital Raise

Orthocell completed a A$30 million placement in October 2025, boosting its cash and term deposits to A$44 million at year-end, with no long-term debt or royalties payable on product sales. Despite a widening loss after tax to A$13.9 million, reflecting increased investment in commercialisation and operations, the company maintains a strong balance sheet to fund its growth strategy.

The Board emphasises disciplined execution, particularly in deepening US market adoption, while continuing to grow established markets and prepare for further international launches. Orthocell’s integrated business model, combining proprietary Australian manufacturing with tailored commercial routes, underpins its ambition to become a global regenerative medicine leader.

Bottom Line?

Orthocell’s FY26 results underscore a company investing heavily to convert early US market access into sustainable revenue, with manufacturing expansion and pipeline development setting the stage for the next growth phase.

Questions in the middle?

  • How quickly will Remplir transition from hospital approvals to routine clinical use in the US?
  • What timelines and hurdles remain for regulatory approvals in the UK and European Union?
  • How will Orthocell balance investment in manufacturing capacity with actual market demand growth?