Osteopore Limited (ASX:OSX) is a Singapore-founded medical device company that has spent 2026 announcing market access in Asia and the Middle East while funding itself largely through convertible notes. Those steps sit alongside an auditor's Going Concern emphasis.

What the company does

Osteopore makes 3D-printed, bioresorbable scaffolds for bone regeneration across several therapeutic areas, according to its half-year report. The company listed on the ASX on 23 September 2019. Its products span orthopaedic, craniofacial, dental and neurosurgical uses.

Regulatory approvals, trials and distribution

Market access, approval, trial activity and sales are different things. On 26 May 2026 the company announced orthopaedic device approval in Hainan, which it described as a Hainan FDA approval, and on 24 June it reported neuro product approval in a major Thailand centre. On 9 September it announced market access to Thailand's orthopaedic market. Approval or access allows sales to be attempted; it does not itself create revenue.

On the clinical side, the company reported that recruitment for a cleft lip clinical study with QCH was completed on 26 June, that the first two patients were treated by 29 June, and that the first patient was treated in an OSX-PAH jaw reconstruction trial on 30 June. These are trial progress milestones, not regulatory approvals for those uses, and we found no results.

On 6 August 2026 Osteopore announced a three-year distribution agreement with Dubai-based Al-Umnia Medical LLC for orthopaedic bone reconstruction products in Saudi Arabia, the UAE, Oman, Qatar and Bahrain, with a one-year extension option. The agreement can be terminated if sales targets are not met, and the products must still be registered locally. No minimum purchase values were disclosed, so any Revenue contribution is unquantified.

Financial position and funding

For the half-year to 30 June 2026, revenue was A$1,428,421, down 8 per cent, which the company attributed mainly to a stronger Australian dollar. The net loss after tax was A$2,012,559. Quarterly revenue for the June quarter was A$676,000 compared with A$754,000 in the March quarter, reflecting slow uptake of custom-made cranioplasty products and distribution changes in Europe.

Cash was A$1,254,607 at 30 June, up from A$626,972 at 31 December 2025, and net operating cash outflow was A$895,096, an improvement on A$1,275,507. Net liabilities were A$1,802,292. The auditor drew attention to a material uncertainty about going concern while not modifying its conclusion, and Pitcher Partners replaced Grant Thornton as auditor on 31 July 2026, subject to ratification.

The company relies on a redeemable convertible note Facility of up to A$20 million in four A$5 million tranches with Advance Opportunities Fund entities. The notes carry 4 per cent interest and convert into shares at 80 per cent of a five-day volume-weighted average price. About A$2.45 million of Face Value was outstanding at 30 June, A$1.75 million was raised through notes in the period, and Issued Shares had risen to about 678 million, largely through conversions. Conversion at a discount is dilutive, and the accounts' forecast assumes continued drawdowns.

Risks and milestones

Risks include dependence on convertible funding, slow commercial uptake, reliance on third-party distributors and the time that regulatory registrations take. No confirmed future milestone dates were found in the sources read.