- 01Record five HiRise orders in September quarter.
- 02China clearance unlocks $1m milestone payment and distribution preparations.
- 03Quarter-end cash was $5.83m; operating cash outflow fell 44%.
CurveBeam AI (ASX: CVB) secured five orders for its HiRise medical imaging systems in the September quarter, its strongest opening-quarter device sales result to date.
The point-of-care computed tomography (CT) specialist booked two orders in the US and three in Europe, while customer receipts reached $1.80 million.
Receipts declined 30% from the preceding quarter but increased 31% against the corresponding period last year, reflecting the timing of installations and payments.
Following the quarter, HiRise secured Chinese regulatory clearance on 12 October, unlocking an initial milestone payment and supporting preparations for commercial distribution.
Orders Support Expansion
CurveBeam carried $4.9m in outstanding purchase orders and receivables into the December quarter, compared with $4.2m entering September.
Device orders generally take two to six months to progress through installation and full payment, creating a timing difference between orders, customer receipts and recognised revenue.
China’s National Medical Products Administration clearance triggered a $1m payment from partner Weiying, which is preparing for an initial order of US-manufactured HiRise systems.
The distribution arrangement provides for another $3m in potential milestone payments, comprising $1m after sales of the first 10 systems and $2m after the first 50, separate from product revenue.
Preparations include engagement with clinical opinion leaders, selection of potential reference sites, and training for manufacturing, assembly and servicing.
Broader Clinical Applications
During September, the US Food and Drug Administration granted 510(k) clearance for CurveBeam’s first CT-based bone mineral density technology for multidetector CT scanners.
The company is completing validation work covering automated selection of measurement regions and reporting of T and Z scores before pursuing a second submission to extend the capability to HiRise.
CurveBeam identifies acute-care and joint-replacement settings as initial applications, including an estimated 300,000 annual hip-fracture patients across 2,000 to 2,400 hospitals in the US.
Separately, refinements to patient stabilisation and anatomical alignment have enabled HiRise imaging data to pass initial processing tests with a major robotic-assisted surgery platform.
Formal validation for knee replacement remains in progress, with comparable hip replacement trials planned under the relevant clinical and regulatory requirements.
Strong Cash Position
CurveBeam finished September with $5.83m in cash after raising $7.35m through a placement, share purchase plan, and subsequent shortfall and placement offers.
The funding included an initial $5m placement at two cents per share, a $0.6m share purchase plan and a further $1.75m at 1.8 cents per share.
Net operating cash outflow decreased 44% to $1.36m from $2.42m in the June quarter, assisted by $1.77m in government grants and tax incentives during September.
Cost reductions spanning staffing and other operating expenses brought annualised cash-related operating expenditure to approximately $15m.
Based on the September operating outflow, CurveBeam reported estimated available funding of 4.3 quarters, while the timing of future receipts remains dependent on order fulfilment and customer payments.
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