Regulatory Delays Cloud CurveBeam AI’s Strong Sales Momentum

Record Purchase Orders Signal Growing Market Traction

CurveBeam AI (ASX: CVB) has delivered a standout performance in the second quarter of fiscal year 2025, securing ten purchase orders (POs) for its specialised HiRise™ CT scanners. This represents a 150% increase compared to the same period last year and marks the highest quarterly order intake for the company to date. Notably, five of these orders came through its key partner Stryker, underscoring the strength of their commercial relationship.

The first half of FY25 saw a near doubling of total purchase orders to thirteen, up from seven in the prior corresponding period. These orders translate into approximately A$5 million in future sales, providing a solid revenue pipeline as devices are shipped and installed.

Strategic Expansion with Stryker in Australasia

Following a non-binding term sheet signed in December 2024, CurveBeam AI formalised a definitive agreement with Stryker Australia and New Zealand. This deal expands the company’s footprint in its home market and New Zealand, leveraging Stryker’s established distribution channels. The partnership is expected to accelerate adoption of HiRise™ scanners, particularly among orthopaedic practices integrating robotic surgical systems.

With approximately 5,800 group orthopaedic practices and 5,200 hospital-based systems in the US alone targeted for HiRise™ placements, the expanded collaboration with Stryker is a critical step in capturing this sizeable market opportunity.

Operational Efficiency and Cash Flow Improvements

CurveBeam AI reported a significant reduction in cash outflows from operations, down to A$2.7 million in Q2 FY25 from A$5.3 million in the prior year quarter. This improvement was driven by lower product manufacturing costs and disciplined spending, despite a rise in staff costs due to payroll timing and restructuring expenses.

Customer receipts hit a record A$2.6 million for the quarter, reflecting strong order conversion and cash collection. The company ended the quarter with A$8.8 million in cash and anticipates an additional A$6 million in receipts from existing purchase orders in the second half of FY25, providing a runway of over three quarters.

Regulatory Pathway for BMD Module Faces Extended Timeline

On the regulatory front, CurveBeam AI advanced its Bone Mineral Density (BMD) software module development, targeting FDA clearance via a 510(k) Class II pathway. A key milestone was the December 2024 Q-Sub meeting with the FDA, which confirmed the pathway but introduced a new requirement: additional comparative data with Dual Energy X-ray Absorptiometry (DXA) for 20-25% of trial patients.

This expanded trial scope is expected to add approximately six months to the timeline, pushing the FDA submission target to mid-2025 and clearance to the first half of calendar year 2026. While this delay introduces some uncertainty, the company remains committed to meeting these regulatory milestones.

Progress on Enhanced HiRise™ Validation for Robotic Surgery

Validation efforts for the enhanced HiRise™ scanner, designed to integrate with hip and knee robotic surgical systems, continued steadily through the holiday period. The company is processing matched datasets and expects to complete validation by the end of Q3 FY25. Successful validation is anticipated to unlock further sales opportunities as robotic systems become a standard pre-surgical imaging requirement.

Outlook and Strategic Focus

CurveBeam AI’s board remains confident in the company’s trajectory, noting that sales and marketing investments are being carefully managed to align with market demand and penetration goals. The expanded Stryker partnership and robust order book provide a strong foundation for growth, while ongoing product development and regulatory progress position the company well for future SaaS revenue streams.