Orthocell Limited has reported a record half-year revenue of $6.2 million, driven by accelerating sales of its regenerative medicine products and expanding global footprint. The company’s US commercial launch of Remplir™ is gaining momentum alongside new market entries in Canada, Hong Kong, and Europe.
- Record H1 FY26 revenue up 48% to $6.2 million
- Remplir™ approved in 45 US states with growing hospital accounts
- Exclusive Canadian distribution secured, first sales expected H1 CY26
- EU and UK regulatory submission underway, approval targeted Q3 CY26
- Strong balance sheet with $49.4 million cash and term deposits
Record Revenue and Profit Growth
Orthocell Limited (ASX: OCC), a regenerative medicine company specialising in collagen medical devices and cell therapies, has delivered a standout half-year financial performance for the six months ending 31 December 2025. The company posted record revenue of $6.2 million, a 48% increase compared to the prior corresponding period, supported by two consecutive record quarters. Gross profit rose 63% to $3.0 million, with gross margins improving to 55%, reflecting operational efficiencies and a higher contribution from the premium Remplir™ product line.
US Commercial Launch Gains Traction
The US market is proving pivotal for Orthocell’s growth strategy. Remplir™, its flagship peripheral nerve repair product, is now approved for sale in 45 states, with the remaining five expected shortly. The company has lodged 78 hospital Value Analysis Committee submissions, securing 27 approvals and establishing 19 active accounts. Orthocell’s dedicated US sales team and distributor network are driving surgeon engagement and product adoption, with revenue momentum expected to accelerate as more hospital approvals come online.
Expanding International Footprint
Beyond the US, Orthocell has secured exclusive national distribution across all Canadian provinces, targeting a US$75 million addressable market with first sales anticipated in the first half of calendar 2026. The company also appointed a distributor in Hong Kong, completing its first surgical case and gaining access to the Greater Bay Area’s 100 million population. Meanwhile, a regulatory application for the EU and UK nerve repair markets was submitted in December 2025, with approval expected by Q3 2026, opening a potential US$750 million market.
Portfolio and Clinical Advances
Orthocell is broadening its regenerative medicine portfolio through a strategic investment in Marine Biomedical Pty Ltd, increasing its stake to 12% and securing global distribution rights for PearlBone™, a marine-derived bone graft substitute. The company is also advancing clinical studies in nerve-sparing prostate surgery, aiming to reduce post-operative complications such as erectile dysfunction and urinary incontinence, with initial US clinical data expected in the second half of FY26.
Strong Capital Position and Leadership
The company strengthened its balance sheet with a $30 million institutional placement during the period, ending December 2025 with $49.4 million in cash and term deposits. Leadership was bolstered by key executive appointments including a new CFO and CCO, alongside a new Non-Executive Director, positioning Orthocell for its next phase of global commercialisation and scale-up.
Bottom Line?
Orthocell’s robust revenue growth and strategic global expansion set the stage for a pivotal year ahead, with market adoption and regulatory milestones poised to shape its trajectory.
Questions in the middle?
- How quickly will Remplir™ sales scale across the remaining US states and hospitals?
- What impact will the upcoming EU and UK approvals have on Orthocell’s international revenue?
- How will clinical data from nerve-sparing prostate surgery influence US market adoption?