Highlights

  • Orthocell reported record FY26 revenue of A$13.2 million, up 44% year-on-year.
  • June-quarter revenue increased 20% to A$3.8 million.
  • Remplir reached 70 U.S. hospitals and 76 surgeons by 30 June 2026.
  • FY27 targets include 100–150 hospitals and 150–200 surgeons in the U.S.
  • Available funds stood at A$44.1 million at the end of FY26.

Orthocell Limited (ASX:OCC) has outlined its next commercial growth phase after reporting record annual and quarterly revenue, wider adoption of its Remplir nerve repair product and continued expansion across the United States. The company’s Q4 FY26 investor presentation showed that U.S. commercialisation remained ahead of internal expectations, while management set higher hospital, surgeon and distributor coverage targets for FY27.

Orthocell shares were trading at A$0.81 during the afternoon session on 14 July 2026, down 4.71% for the day. The stock remained 34.68% lower over the past year.

Orthocell is an Australian medical technology company focused on regenerative medicine products for nerve and tendon repair. Its principal commercial product, Remplir, is approved and selling in Australia, New Zealand, the United States, Canada, Singapore, Hong Kong and Thailand. The company is also progressing market access in the United Kingdom and European Union and has begun a U.S. regulatory program for its SmrtWrap tendon repair application.

The company estimates the global nerve repair market at approximately US$3.5 billion and describes the U.S. opportunity as a market of about US$2 billion. Orthocell is targeting commercial penetration in a market involving an estimated 700,000 peripheral nerve repair procedures each year.

Record Revenue Caps Three Years of Commercial Growth

Orthocell reported FY26 revenue of A$13.2 million, representing a 44% increase from the previous financial year.

The June quarter delivered record quarterly revenue of A$3.8 million, up 20% from A$3.2 million in the March quarter. The company said the quarterly result reflected performance across its commercial operations, particularly continued growth in Remplir sales.

FY25 revenue was A$9.1 million, meaning the business added approximately A$4.1 million of revenue in FY26. According to the presentation, Remplir accounted for the majority of the annual increase, supported by contributions from collagen devices, cell therapies, interest and sundry income.

Orthocell described the result as an extension of a three-year period of consistent commercial growth.

U.S. Remplir sales reached A$0.33 million in the June quarter, increasing 10% from the prior quarter. Since the first U.S. sale on 26 June 2025, cumulative revenue from the product has reached A$0.92 million.

Management expects U.S. revenue to increase materially in upcoming quarters as account access, surgeon participation and distributor coverage continue to build.

Remplir Reaches 70 U.S. Hospitals

By 30 June 2026, 70 hospitals in the United States had purchased at least one unit of Remplir.

This represented quarterly growth of 27% in the cumulative number of hospitals buying the product. Orthocell also reported that more than 100 Value Assessment Committee applications had either been submitted, were in progress or had received approval.

Hospital access is a central part of the U.S. commercialisation process because many healthcare facilities require internal product assessment and approval before surgeons can use a new medical device.

Orthocell said the number of purchasing hospitals had reached 70 within slightly more than one year of the first U.S. sale. On the company’s calculations, this represented compound quarterly growth of 189% since launch.

For FY27, Orthocell is targeting between 100 and 150 cumulative hospitals with one or more Remplir device sales.

The company plans to continue opening accounts through further Value Assessment Committee applications and by working with distributors to support approvals at individual hospitals.

Surgeon Adoption Rises to 76

The cumulative number of U.S. surgeons purchasing Remplir increased to 76 by the end of June 2026.

This was 55% higher than the previous quarter and above the company’s initial expectations for early adoption.

Orthocell said surgeon onboarding is being supported by education, product demonstrations, clinical information and feedback from existing users. The company indicated that surgeon response to the product remained favourable during the quarter.

Since the first commercial sale, cumulative surgeon participation has recorded compound quarterly growth of 195%, according to the presentation.

Orthocell has set a FY27 target of between 150 and 200 surgeons who have purchased at least one unit of Remplir.

Achieving that range would require the company to approximately double the number of participating surgeons from the level reported at 30 June 2026.

Distributor Network Covers Around Half of U.S. Population

Orthocell had 18 distributors operating across more than 20 U.S. states by the end of FY26.

The network covered approximately 50% of the U.S. population, spanning areas on the East and West coasts. The company stated that distributor coverage exceeded its previous target by 25%.

For FY27, Orthocell is targeting distribution coverage equal to 80% of the U.S. population and operations across more than 30 states.

The company intends to work with existing and new distribution partners to expand state coverage while increasing the number of trained representatives with product and procedure expertise.

Orthocell believes broader distributor reach should support more hospital submissions, surgeon education and device availability across the U.S. market.

The company’s presentation also noted that quarterly U.S. Remplir unit sales reached 119 devices. This represented compound quarterly growth of 230% since the first sale in June 2025.

U.S. Strategy Targets Initial Share of Large Procedure Market

Orthocell estimates that approximately 700,000 peripheral nerve repair procedures are performed in the United States each year.

The company’s stated long-term objective is to target 10% of that market, with an initial commercial focus on approximately 5%.

Its initial target equates to around 35,000 procedures and approximately 60,000 Remplir devices, based on an estimated average use of 1.7 devices per procedure.

Orthocell estimates that cash flow breakeven could be reached at approximately 6,000 procedures, requiring around 10,000 devices under current pricing and cost assumptions.

The company clarified that the breakeven estimate refers to the point at which net operating cash flow reaches zero and depends on the continuation of its current commercial assumptions.

The FY27 hospital, surgeon and distributor targets are intended to build the market access required to move towards these longer-term procedure and device volumes.

Australian Sales Continue to Expand

While the United States remains the principal growth market, Orthocell also reported continued adoption of Remplir in Australia.

The company described Australian sales growth during the June quarter as favourable and indicated that the market continued to contribute to overall commercial performance.

Orthocell’s strategic approach is divided across several priorities, including winning in the Americas, building a wider global footprint, continuing growth in Australia, New Zealand and Asia, and advancing its product pipeline.

The presentation did not provide a separate Australian revenue figure for the quarter. However, management stated that sustained domestic growth accompanied the expansion of U.S. sales.

Asian Commercial Footprint Broadens

During the quarter, Orthocell appointed a distributor for Remplir in Thailand.

The appointment added another market to its Asia-Pacific network and followed earlier commercial progress in Singapore and Hong Kong.

Remplir is now approved and selling in Australia, New Zealand, the United States, Canada, Singapore, Hong Kong and Thailand.

The company had previously appointed an exclusive distributor in Hong Kong and completed the first surgical use of the product in that market. It also achieved its first Canadian sale and appointed initial distributors in Canada.

Orthocell’s international rollout is being pursued through market-specific distributor arrangements, allowing the company to build access without establishing a wholly owned sales operation in each jurisdiction.

The company also expanded the humanitarian reach of Remplir during the quarter through an initiative supplying the product to victims of war in Ukraine.

UK and European Clearance Expected in Second Half of 2026

Orthocell said its market access program for the United Kingdom and European Union remained on schedule.

Regulatory submissions for both markets have already been lodged, and the company expects clearance during the second half of calendar year 2026.

Orthocell has also appointed an exclusive distributor for the United Kingdom ahead of the anticipated approval.

The company did not provide a specific launch date or sales target for these markets. Commercial timing will depend on the regulatory process and completion of the remaining market preparation activities.

UK and European approval would extend Remplir’s commercial footprint into additional developed healthcare markets and support the company’s wider global expansion strategy.

Orthocell cautioned that regulatory timelines may change due to circumstances outside its control.

Prostate Surgery Opportunity Gains Attention

The company is also evaluating the use of Remplir in nerve-sparing prostate cancer surgery.

Orthocell said this commercial opportunity continued to gain momentum during the quarter, with initial patient data expected in the second half of calendar year 2026.

The presentation did not provide revenue forecasts or procedural volume targets for this application.

The opportunity represents a possible extension of Remplir beyond its current use in peripheral nerve repair and could broaden the product’s addressable clinical market if future evidence and commercial development support adoption.

Further information is expected after the initial patient data become available.

SmrtWrap Enters U.S. Regulatory Program

Orthocell has commenced a U.S. Food and Drug Administration regulatory program for SmrtWrap, its tendon repair application.

The company expects to complete a U.S. pre-submission process for SmrtWrap during the second half of calendar year 2026.

SmrtWrap forms part of Orthocell’s broader product pipeline and supports the company’s objective of expanding beyond nerve repair into tendon-related applications.

No expected approval date or U.S. commercial launch timeline was included in the presentation.

The regulatory work remains at an earlier stage than the commercial rollout of Remplir, which is already approved and generating sales in multiple markets.

Available Funds Stand at A$44.1 Million

Orthocell ended FY26 with A$44.1 million in available funds.

This total comprised A$9.4 million in cash and cash equivalents and A$34.7 million held in security and term deposits with maturities ranging from three to 12 months.

Available funds declined by A$3.9 million from A$48.0 million at the end of the March quarter.

Orthocell reported no long-term secured debt facilities and no royalty liabilities. The company maintains a short-term premium funding facility used for insurance premiums, which is repaid within the relevant policy period.

Based on annualised normalised operating cash burn for the June quarter, management calculated a cash runway of approximately 4.6 years.

Orthocell said the available funding is sufficient to support commercial execution, capital projects and research and development activities through to its anticipated cash flow breakeven point, with no additional funding required under its current plans.

Customer Receipts Increase During the Quarter

Receipts from customers reached A$2.5 million in the June quarter, up from A$1.6 million in the preceding quarter.

For the full financial year, receipts from customers totalled A$7.6 million.

Payments to suppliers and employees were A$6.6 million in Q4 FY26, compared with A$4.9 million in the March quarter. Full-year payments totalled A$25.3 million.

Orthocell attributed the quarterly increase in expenditure to higher production requirements and the timing of payments as commercial activity expanded.

Government grants and net interest received totalled A$0.5 million in the June quarter and A$4.9 million for FY26.

The reported operating cash burn was A$3.6 million for the quarter, compared with a small positive operating cash result of A$0.1 million in Q3. The previous-quarter result included the annual A$3.0 million research and development tax incentive refund.

After excluding the annual tax refund and non-recurring expenditure, normalised operating cash burn was A$2.4 million in Q4, broadly unchanged from A$2.5 million in Q3.

Capital Investment Supports Manufacturing Capacity

Capital expenditure and other investments totalled A$1.0 million in the June quarter and A$2.3 million across FY26.

The company said this spending was consistent with the use of proceeds outlined during its equity raising.

Investment areas included increasing Orthocell’s equity position in Marine Biomedical and progressing capital projects intended to expand manufacturing capacity.

Orthocell reported that these capital projects remained on schedule and within budget at the end of June 2026. Work will continue during FY27.

The company also continued investing in its enterprise resource planning system, processing automation and other operational improvements.

Non-recurring expenditure related to enterprise systems, automation, prepayments and other one-off activities totalled A$1.2 million in the June quarter and A$3.3 million for the full year.

What Could Investors Watch Next?

Orthocell’s next phase will centre on converting broader U.S. access into higher Remplir sales and revenue.

The company enters FY27 with 70 purchasing hospitals, 76 surgeons and distributor coverage of around half the U.S. population. Its new targets call for 100–150 hospitals, 150–200 surgeons and 80% population coverage across more than 30 states.

Upcoming regulatory and clinical milestones may also shape the company’s wider expansion. These include expected UK and European clearance, initial prostate surgery patient data and the SmrtWrap U.S. pre-submission program, all targeted for the second half of calendar year 2026.

With A$44.1 million in available funds and no long-term secured debt, management believes the company is funded to continue commercial investment and product development through to anticipated cash flow breakeven.