CurveBeam Faces Regulatory and Market Hurdles Despite Capital Raise and China Deal Talks

Innovating Orthopaedic Imaging

CurveBeam AI Limited (ASX – CVB) is advancing its position in the medical imaging sector with its HiRise™ cone beam CT scanner, a device that uniquely captures weight-bearing images of patients' lower extremities. This capability allows surgeons to assess joints and bones under natural load, offering a more precise and actionable view compared to traditional non-weight-bearing CT scans. The HiRise™ scanner is FDA cleared, TGA listed, and CE marked, with clinical validation supporting its diagnostic advantages.

The technology has gained traction among leading orthopaedic institutions and thought leaders, bolstered by a partnership with Stryker Corporation, a global orthopaedic leader with a market capitalization around US$144 billion. Stryker markets the HiRise™ device within its Foot & Ankle division, integrating it into surgical planning workflows.

Capital Raising to Accelerate Growth

In a recent capital raising, CurveBeam secured A$6.5 million through a placement priced at A$0.09 per share, representing a discount to recent trading prices. The proceeds will be allocated to sales and marketing efforts, research and development, supply chain enhancements, and general working capital. This injection aims to support the company’s expansion plans, including increased device rollouts and further product innovation.

CurveBeam is also introducing vendor financing options to broaden market access, particularly targeting orthopaedic practices that may find outright purchase challenging. This financing model is expected to expand sales reach across North America and Europe, while building a recurring revenue base.

Global Expansion and Strategic Partnerships

Geographically, the United States remains the primary market, with approximately 17,000 potential installation sites identified. The company has already placed over 150 devices worldwide, supported by a network of distributors and sales representatives across Europe, Asia, the Middle East, and Australia.

CurveBeam is actively negotiating a confidential, non-binding term sheet with a Chinese medical device distributor and manufacturer. This proposed agreement would grant exclusive distribution and manufacturing rights in China, Hong Kong, Macau, and Taiwan, alongside an equity investment of up to A$10 million. While promising, this deal remains subject to final approvals and conditions.

Advancing Technology Integration

Beyond current offerings, CurveBeam is validating an enhanced version of HiRise™ for compatibility with robotic arm-assisted surgery devices used in knee and hip procedures. Successful integration could significantly increase the device’s value proposition and sales potential. The company is also developing a SaaS-based bone mineral density diagnostic model, targeting FDA clearance in the first half of 2026, which could generate high-margin recurring revenues.

Looking further ahead, CurveBeam is developing the SkyRise™ platform, designed for full-body scans focusing on spinal and shoulder assessments, incorporating AI-driven anatomical landmark recognition and dual imaging capabilities.

Risks and Market Challenges

Despite the promising outlook, CurveBeam faces several risks including regulatory hurdles, reimbursement uncertainties, manufacturing scale-up challenges, and the need for market acceptance of its SaaS diagnostic solutions. The company also contends with intellectual property protection, reliance on distributors, and cybersecurity concerns. Investors should note that the Chinese partnership and robotic device validations are ongoing processes with uncertain timelines.