Highlights

  • Orthocell (ASX:OCC) reported FY2026 Revenue of $13.2 million, up 44% on FY2025.
  • June quarter revenue reached a record $3.8 million, increasing 20% quarter-on-quarter.
  • U.S. Remplir sales reached approximately $0.33 million during the June quarter, with 119 units sold.
  • The number of U.S. hospitals purchasing Remplir increased 27% quarter-on-quarter to 70, while surgeons using the product rose 55% to 76.
  • Orthocell ended FY2026 with $44.1 million in cash and deposits and no debt.

Orthocell Limited (ASX:OCC) has reported record FY2026 revenue of $13.2 million, supported by continued expansion of its Remplir nerve repair device across the U.S. healthcare market.

The regenerative medicine company’s June quarter revenue reached $3.8 million, representing a 20% increase from the March quarter and contributing to annual revenue growth of 44% compared with FY2025.

The latest results highlight ongoing commercial activity for Remplir, alongside further development of Orthocell’s broader regenerative medicine platform.

Remplir Drives U.S. Commercial Expansion

Remplir was the key contributor to Orthocell’s commercial progress during FY2026. The collagen-based nerve repair device is used in reconstructive and orthopaedic surgery to support nerve repair and regeneration following injury or surgical procedures.

During the June quarter, U.S. Remplir sales reached approximately $0.33 million, with 119 units sold. The company reported that the number of U.S. hospitals purchasing Remplir increased 27% quarter-on-quarter to 70.

The number of surgeons using the product also increased during the period, rising 55% quarter-on-quarter to 76.

Orthocell has continued expanding access to U.S. healthcare networks, with approvals secured for sales into U.S. Department of Veterans Affairs and Department of Defense hospital networks. The company reported 44 Veterans Affairs Facility approvals, representing a 38% increase from the prior quarter.

International Markets Add Further Distribution Opportunities

Alongside U.S. expansion, Orthocell continued developing its international distribution network.

International revenue outside the U.S. contributed more than 9% of total quarterly revenue. During the period, the company signed new distribution agreements in Canada and Thailand.

Orthocell is also targeting the commencement of sales in the United Kingdom and Europe during the first half of FY2027.

The company’s international strategy forms part of its broader commercialisation activities as it expands Remplir access across additional healthcare markets.

Financial Position Supports Commercial Activities

Orthocell ended FY2026 with $44.1 million in cash and deposits, comprising $9.4 million in cash and $34.7 million held in term deposits.

The company reported that it remains debt-free and does not have Royalty obligations on its products.

Orthocell stated that its Balance Sheet supports continued Investment in U.S. commercialisation activities, international distributor onboarding and clinical evidence generation.

The company’s revenue growth continues to be generated from a developing commercial base, with further expansion dependent on hospital adoption, surgeon usage and international market execution.

Building a Broader Regenerative Medicine Platform

Orthocell is an Australian regenerative medicine company developing collagen-based medical devices through its proprietary tissue engineering platform.

In addition to Remplir, the company markets Striate+, a dental barrier membrane product. Striate+ has received regulatory approval in Colombia and Ecuador, extending Orthocell’s presence in Latin America.

The company is also building clinical experience in a prostate cancer-related surgical application, with more than 250 procedures completed across 39 surgeons in Australia.

Orthocell’s technology platform uses collagen-based materials processed through its Manufacturing methods to support tissue regeneration applications.

Future Focus on U.S. Growth and New Markets

Orthocell’s near-term focus remains on expanding Remplir adoption within the U.S. market by adding hospitals and surgeons, while increasing utilisation across existing accounts.

The company will also focus on converting Veterans Affairs and Department of Defense network approvals into ongoing order activity.

Internationally, the company is targeting the commencement of UK and European sales in the first half of FY2027, while monitoring distributor performance in Canada and Thailand.

Further updates may also include progress across Striate+ regulatory approvals, international expansion and additional developments related to the prostate cancer surgical application.

Investor Takeaway

Orthocell’s FY2026 results show continued commercial development of its Remplir product, with record annual revenue, higher U.S. hospital participation and increased surgeon adoption.

The company enters FY2027 with $44.1 million in cash and deposits, providing funding capacity for further commercialisation and market expansion activities.

Investors may continue watching whether Remplir adoption continues to expand across U.S. healthcare networks, the contribution from new international markets, and the company’s ability to build revenue from its regenerative medicine products.