CurveBeam AI (ASX:CVB) Wins China Clearance for HiRise CT and Raises A$7.35M in the Quarter

Sonal Goyal

21 October 2026 01:26 PM AEDT

CurveBeam AI (ASX:CVB) Wins China Clearance for HiRise CT and Raises A$7.35M in the Quarter

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Key Highlights

CurveBeam AI received purchase orders for five HiRise devices in Q1 FY27, two in the US and three in Europe, while customer receipts were A$1.80 million.
HiRise received regulatory clearance in China on 12 October 2026, triggering a A$1.0 million payment from Weiying, with A$3.0 million in further payments tied to China sales.
The company raised a total of A$7.35 million through a placement, a share purchase plan and a shortfall offer with a further placement, and ended the quarter with A$5.83 million in cash.
Net operating cash outflow fell 44% to A$1.36 million from A$2.42 million in Q4 FY26, equal to 4.3 quarters of funding on the Appendix 4C measure.

CurveBeam AI Limited (ASX:CVB), a developer of point-of-care specialised CT imaging equipment and AI-enabled software-as-a-service clinical assessment tools, reported purchase orders for five HiRise scanners and customer receipts of A$1.80 million for the quarter ended 30 September 2026, its first quarter of FY27. The company also disclosed US FDA clearance for its CT-based bone mineral density technology and a A$7.35 million capital raising during the quarter. After the quarter closed, HiRise received regulatory clearance in China on 12 October 2026, which triggers a A$1.0 million payment from its partner Weiying.

Five HiRise Purchase Orders and A$1.80 Million in Receipts

Purchase orders secured in Q1 FY27 totalled five HiRise devices, two in the US and three in Europe, which the company described as its best first-quarter sales result to date. CurveBeam AI treats a signed purchase order (PO) for a CT scanner as its key sales metric, while revenue is recognised only once a device is delivered, installed and training is complete. The cycle from PO to installation and full payment typically runs two to six months.

Receipts from customers were A$1.80 million, down 30% from A$2.58 million in Q4 FY26 but up 31% from A$1.37 million in the comparative quarter of FY26. The company carried A$4.2 million of purchase orders and receivables into Q1 FY27 and carries A$4.9 million into Q2 FY27. During the quarter it also cut operating expenses through staff reductions and other savings, lowering annualised cash-related operating expenditure to approximately $15 million.

China Clearance Triggers a A$1.0 Million Weiying Payment

HiRise received regulatory clearance in China on 12 October 2026, following successful responses to the second round of feedback from the NMPA. The clearance triggers a A$1.0 million payment from Weiying and is expected to pave the way for an initial order from Weiying/WEGO of U.S.-manufactured HiRise systems for distribution in China. A further A$3.0 million in payments is tied to China sales: A$1.0 million upon the sale of the first 10 systems and A$2.0 million upon the sale of the first 50, in addition to revenue from product sales.

Launch preparations advanced during the quarter, including Key Opinion Leader outreach, identification of prospective reference sites and training of personnel on HiRise manufacturing, assembly and service. The company said it is encouraged by the commitment to a market launch in FY27. WEGO purchase orders are payable 50% on order, 20% on shipment and 30% when installed.

FDA Bone Density Clearance and Robotic Surgery Validation

In September the company received US FDA 510(k) clearance for its first CT-based bone mineral density (BMD) product, for multidetector CT (MDCT) scans. It will now complete validation of automated region-of-interest selection and the reporting of T and Z scores, and plans to use the clearance as the foundation for a Special 510(k) submission extending BMD to the HiRise platform, supported by data collection that is being scoped and budgeted. The company put the initial US target market at about 300,000 hip fracture patients a year across 2,000 to 2,400 acute care hospitals, an estimated 135 patients per site per year.

On robotic surgery, CurveBeam AI has added enhanced patient stabilisation methods and software-based anatomical alignment refinements. Latest trial scans with a robotic-assisted surgery system showed HiRise data could be processed through applicable software workflows with motion failure rates below acceptable thresholds, advancing formal validation for total knee replacement. Validation has been extended to total hip replacement, under appropriate regulatory and clinical governance requirements, and collaboration with other robotic surgery platforms is continuing.

How the Quarter Left Cash and Funding

CurveBeam AI raised A$7.35 million in the quarter: a A$5.0 million placement at A$0.02 per share, a share purchase plan raising A$0.6 million at A$0.018, and a shortfall offer plus further placement raising A$1.75 million at A$0.018. Net cash used in operating activities was A$1.36 million, 44% below the A$2.42 million in Q4 FY26, and that figure includes A$1.772 million of government grants and tax incentives. Borrowings of A$1.246 million were repaid, and the quarter closed with a cash balance of A$5.83 million, up from A$1.636 million at the start, equal to 4.3 quarters of funding on that operating outflow. The company said Q2 cash flow will benefit from the A$4.9 million of carried-forward orders and any receipts on new HiRise and WEGO orders. Payments to related parties totalled A$351,000, covering directors' fees, interest, salary and superannuation.

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