Utilising artificial intelligence in medtech to address orthopaedic diagnostics and procedures, Curvebeam AI (ASX: CVB) has received FDA clearance for its Enhanced HiRise scanner. This approval allows the HiRise imaging scanner to be used in everyday medical practices and paves the way for CurveBeam AI to expand and commercially launch in the US. 

Infused with AI capabilities and equipped with advanced algorithms, Enhanced HiRise scanner has an ability to provide high-resolution and unprecedented clear scans. 

The scanner offers weight-bearing and non-weight-bearing CT scans, providing critical information for diagnosing orthopaedic and musculoskeletal conditions. It also facilitates real-time analysis, prompting diagnostic accuracy, targeted treatment plans which ultimately will enhance patient care. CurveBeam AI expects to have multiple sites using the Enhanced HiRise for custom robotic surgeries by the end of the current quarter.

Greg Brown, CEO & Managing Director of CurveBeam AI, commented, “We are both excited and pleased to receive the FDA 510(k) clearance for our Enhanced HiRise platform. This is an important milestone that allows us to plan both the commercial launch of the Enhanced HiRise and validation of custom protocols for personalised knee and hip procedures, including robotic systems.

“This critical step permits knee and hip patients to be imaged on the HiRise in a routine setting. We are targeting this quarter to have multiple sites utilising the Enhanced HiRise for custom robotic surgeries.”

Across different demographics, about 2.2 million (8.3%) Australians have chronic musculoskeletal conditions. According to statistics published by WHO in 2023, with a prevalence of 365 million people, the knee is the most frequently affected joint followed by hip and hand. Medical scans and imagery plays a vital role in the efficacy of treatments. 

Last week, CurveBeam AI reported it had received 10 purchase orders during the June 2024 quarter which is 4 more than the 6 it received in the March quarter. 

For the March 2024 quarter, CurveBeam AI reported $2.2 million in cash receipts, which represented an increase on the previous quarter in sales. However this resulted in $4.5 million negative operating cash flow, which took their 9 months YTD operating cash outflow to $17 million

As of 31 March 2024, the Company had $11.7 million of cash on hand.

CVB shares responded well to the FDA approval to reach a high of $0.29 in early morning trade, a rise of 23% on their last close price of $0.235, but still below their IPO Offer Price of $0.48 when the company listed on the ASX in August 2023.