CurveBeam AI Limited reported a remarkable 150% increase in device purchase orders in Q2 FY25, driven by strong demand for its HiRise™M platform and a new commercial agreement with Stryker. The company is advancing validation of its Enhanced HiRise™ for robotic surgical systems, despite a regulatory delay for its BMD SaaS module.
- 150% increase in device purchase orders in Q2 FY25 compared to prior year
- Record quarter for HiRise™M orders, with five units ordered via Stryker
- Formal agreement signed with Stryker Australia and New Zealand expanding market reach
- Validation progressing for Enhanced HiRise™ robotic surgical system integration
- FDA filing for BMD SaaS MDCT module delayed by six months due to additional data requests
Strong Sales Momentum in Q2 FY25
CurveBeam AI Limited has delivered a standout performance in the second quarter of fiscal 2025, securing purchase orders for ten devices, an impressive 150% increase compared to the four devices ordered in the same quarter last year. This surge is largely attributed to heightened demand for the HiRise™M platform, which accounted for eight of these orders, including five through a strategic partnership with Stryker.
The company’s total purchase orders for the first half of FY25 reached thirteen, nearly doubling the seven orders recorded in the prior corresponding period. This momentum signals growing market acceptance of CurveBeam’s advanced imaging solutions, particularly in the competitive medical device sector focused on orthopedic and robotic surgical applications.
Expanding Commercial Footprint with Stryker
Building on this sales momentum, CurveBeam formalized a commercial agreement with Stryker Australia and New Zealand, extending its collaboration beyond previous arrangements. This deal not only strengthens CurveBeam’s presence in its home market but also leverages Stryker’s established distribution channels to accelerate adoption of the HiRise™ platform.
Such partnerships are critical in the medical devices industry, where integration with leading surgical systems and trusted distributors can significantly influence market penetration and revenue growth.
Advancing Enhanced HiRise™ Validation
CurveBeam is progressing steadily with the validation of its Enhanced HiRise™ platform, designed to support robotic surgical systems for hip and knee procedures. The platform, now FDA 510(k) cleared, features a higher energy X-ray source enabling improved imaging of larger patients and identification of key anatomical landmarks.
Validation efforts at two upgraded U.S. sites have yielded promising results, with image quality comparable to multidetector CT (MDCT) scans. The company is processing matched datasets critical for robotic system integration, targeting completion by the end of Q3 FY25. Successful validation is expected to catalyze a significant increase in HiRise™ orders, marking a potential inflection point for CurveBeam’s growth trajectory.
Regulatory Setback for BMD SaaS Module
On the regulatory front, CurveBeam encountered a delay in its FDA filing for the Bone Mineral Density (BMD) SaaS module designed for MDCT scanners. Following a Q-Sub meeting with the FDA in December 2024, additional data comparing BMD results with dual-energy X-ray absorptiometry (DXA) for 20-25% of trial patients was requested. This requirement extends the filing timeline by approximately six months, pushing expected FDA clearance into the first half of calendar 2026.
While this postponement may temper near-term revenue recognition from the BMD SaaS module, the company remains focused on its broader pipeline and commercial opportunities that are not contingent on this filing.
Financial Position and Outlook
CurveBeam’s cash position at the end of Q2 FY25 stood at A$8.8 million, providing an estimated 3.2 quarters of funding runway. Operational cash outflows decreased to A$7.1 million from A$8.3 million in the prior year quarter, reflecting improved cost management despite some restructuring expenses.
Receipts from customers hit a record A$2.6 million for the quarter, up from A$1.3 million a year earlier, bolstered by the increased purchase orders. The company anticipates an additional A$6 million in cash inflows over the second half of FY25 as devices are shipped and installed, potentially surpassing first-half receipts.
Management remains confident in the sales pipeline and is actively pursuing opportunities beyond those reliant on robotic dataset validation, aiming to sustain growth momentum through the remainder of the financial year.
Bottom Line?
CurveBeam’s robust order growth and strategic partnerships set the stage for expansion, but the FDA delay underscores the regulatory hurdles ahead.
Questions in the middle?
- How will the six-month FDA filing delay impact CurveBeam’s revenue and market positioning?
- What are the prospects for further commercial agreements beyond Stryker in key regions?
- Can the Enhanced HiRise™ validation accelerate adoption in robotic surgical systems as anticipated?