CurveBeam AI Advances China JV and Clinical Programs Despite Regulatory Delays

Steady Device Orders Amid Challenging Market Conditions

CurveBeam AI (ASX:CVB) secured purchase orders for five devices in Q3 FY26, maintaining the pace from the previous quarter with four of those orders for its flagship HiRise™ CT scanners. Orders spanned the US, Europe, and China, including two devices sold to WEGO Orthopaedics in China to support training and technology transfer ahead of local manufacturing. Despite this, receipts from customers fell to A$1.4 million, down 7% year-on-year and a steep 40% quarter-on-quarter, reflecting broader economic headwinds impacting capital equipment purchases in the US and a slow H1 in Europe.

The company carried forward A$4.8 million in purchase orders and receivables into Q3 and expects A$5.4 million entering Q4, with revenue recognition lagging purchase orders due to installation and training timelines. This dynamic underscores the importance of monitoring order flow alongside cash receipts for a full picture of sales momentum.

Regulatory Milestones Shift to Second Half 2026

Regulatory progress remains a mixed bag. CurveBeam AI’s FDA 510(k) submission for its bone mineral density (BMD) module for multi-detector CT (MDCT) scans received feedback requiring additional clinical data and supplemental analysis. This has pushed the targeted clearance from mid-2026 to the second half of the calendar year. The company plans a two-step FDA clearance process, with a subsequent Special 510(k) filing to extend the BMD module to the HiRise™ device.

Meanwhile, in China, the National Medical Products Administration (NMPA) has requested supplemental data for the HiRise™ device application. CurveBeam AI is actively compiling this information and remains on track for clearance in H2 CY26. This clearance is pivotal, as it would enable device sales in China and trigger milestone payments, with further royalties expected once WEGO commences local manufacturing and sales. The partnership with WEGO, a subsidiary of Shandong Weigao Orthopaedic Materials, has already delivered a A$4 million strategic investment, the first tranche of a planned A$10 million total injection contingent on commercial and regulatory milestones. This deal includes a 10-year exclusive licensing agreement for China and surrounding territories, positioning CurveBeam AI for accelerated growth in a major orthopaedic market.

Clinical Collaborations Expand Robotic Surgery Footprint

CurveBeam AI continues to deepen its integration with leading robotic surgery systems. The company held multiple meetings with senior R&D executives from a top robotic surgery vendor to align on final clinical data requirements for HiRise™ compatibility. It is finalising expanded clinical data collection using upgraded hardware and software, with vendor regulatory review anticipated to validate the system. Progress also continues on developing a total hip arthroplasty (THA) protocol for a different leading robotic platform, broadening CurveBeam AI’s ecosystem partnerships and clinical applications. These initiatives signal a strategic push to embed the company’s imaging and AI technologies within advanced surgical workflows.

Cash Position and Funding Outlook

Operational cash outflows rose to A$4.2 million in Q3 FY26, compared to A$2.1 million in the prior quarter, which included a R&D tax incentive receipt. The quarter closed with a cash balance of A$4.3 million, translating to approximately one quarter of funding runway based on current operating burn. CurveBeam AI is actively managing costs and prioritising customer installations and receipt collections to improve cash flow. The company is also exploring a range of funding alternatives, including non-dilutive options such as debt and strategic investments, to support ongoing operations and growth initiatives.

Adding to its leadership strength, CurveBeam AI appointed Patrick Fisher as an independent non-executive director in March 2026. Fisher brings over two decades of global orthopaedic industry experience, currently serving as President of Global Biologics and Limb Reconstruction at Orthofix, with prior senior roles at Stryker and Wright Medical Group.

CurveBeam AI’s strategic partnership with WEGO Orthopaedics is a significant validation of its technology platform, combining patented AI imaging solutions with weight-bearing CT devices. This collaboration not only provides capital but also a pathway to scale in the Chinese market, contingent on regulatory approvals that remain on a cautious timeline. The company’s progress on clinical validation with robotic surgery systems further positions it in a niche but growing segment of orthopaedic care.

Investors should watch for the upcoming regulatory milestones in both the US and China, the pace of purchase order fulfilment, and any updates on funding initiatives as CurveBeam AI navigates a complex phase balancing commercial expansion with capital constraints.

The company’s recent A$4 million strategic investment from WEGO Orthopaedics underpins its China ambitions, while its ongoing FDA and China regulatory pathways highlight the challenges and opportunities ahead in product approvals.