CurveBeam AI Secures $4M Milestone, Advances FDA and China Regulatory Pathways

Q2 FY26 Sales and Cash Flow Highlights

CurveBeam AI’s Q2 FY26 update reveals a steady commercial momentum with five purchase orders secured, including four units of its flagship HiRise™ device and one LineUp system. Customer receipts for the quarter reached A$2.40 million, a slight dip compared to the same quarter last year but a notable 75% increase from the previous quarter. The company carried forward A$5.1 million in purchase orders and receivables, underpinning a solid revenue pipeline despite the typical two-to-six month lag between orders and revenue recognition.

Milestone Payment and Strategic Partnership with WEGO Orthopaedics

A significant highlight was the $4 million milestone payment triggered by the commercialisation agreement with Shandong WeiYing, a subsidiary of WEGO Orthopaedics. Although the payment is still undergoing inbound controls review in Australia, the company has received the SWIFT transmission receipt, signalling imminent receipt. This milestone not only provides a cash injection but also validates the ongoing partnership, which is advancing regulatory engagement and promotional activities for the US-manufactured HiRise™ system in China under the National Medical Products Administration (NMPA) registration.

Regulatory Progress in the US and China

CurveBeam AI is actively pursuing regulatory approvals critical to its growth strategy. The company submitted its FDA 510(k) application for the bone mineral density (BMD) module designed for multidetector CT (MDCT) scans in December 2025, aiming for clearance by mid-2026. This product targets acute care hospitals treating hip, femur, and pelvis fractures, a modest but important market segment in the US. Concurrently, the collaboration with WEGO Orthopaedics has accelerated promotional efforts in China, with HiRise™ gaining traction at the Annual Congress of the Chinese Orthopaedic Association and under the applicable NMPA registration.

Advancing Robotic Surgery System Integration

Another critical development is the progress on validating HiRise™ compatibility with a leading robotic surgery system. After engaging senior vendor executives, CurveBeam AI is finalising a validation plan to meet data and regulatory requirements. While the project has faced internal prioritisation challenges within the vendor’s organisation, the recent alignment suggests a collaborative pathway forward. The company remains confident in completing this validation and updating product labelling accordingly, which could open new avenues in robotic-assisted surgical applications.

Financial Position and Operational Costs

Cash flow from operations improved compared to the previous quarter, with a negative A$2.15 million outflow versus A$4 million previously. The receipt of a A$2.56 million R&D tax concession rebate bolstered the quarter’s cash position, closing at A$4.03 million. Including the pending milestone payment, the pro-forma cash balance stands at approximately A$8.03 million. However, operational costs increased due to higher manufacturing outflows, transaction-related expenses, and additional payroll periods in the US business.