Intelligent Ultrasound Regulatory News (IUG)

13 Jan 2022

Intelligent Ultrasound Group plc

("Intelligent Ultrasound" or the "Group")

2021 Full Year Trading update

Intelligent Ultrasound Group plc (AIM: IUG), the ultrasound artificial intelligence (AI) software and simulation group, continued to make significant progress across the business and is pleased to announce that Group revenue for the year to 31 December 2021 is expected to have increased by 47% to £7.6m (2020: £5.2m).

The Group's Simulation Division, performed particularly strongly, with revenue expected to have grown by 44% to £7.4m (2019: £5.2m), helped by strong direct sales in the UK and US markets that grew by 58% to £5.2m (2020: £3.3m) and a recovery in the Group's reseller markets in Europe and Asia, that grew by 16% to £2.2m (2020: £1.9m).

In addition to the Group's core ScanTrainer, BodyWorks and HeartWorks simulator platforms, the division launched its new BabyWorks simulator platform in the second half of the year, aimed at the global neonate and paediatric markets. It will also launch its new HeartWorks 3D Echo simulator module at the International Meeting on Simulation in Healthcare (IMSH) in Los Angeles this month.

Revenue relating to the Group's Clinical AI Division is expected to be £0.2m (2020: £0.0m). These first AI related products provide real-time support to clinicians whilst they are scanning and include the ScanNav Assist obstetric AI software that is utilised by GE Healthcare as SonoLyst on their Voluson SWIFT ultrasound machine; the CE approved ScanNav Anatomy Peripheral Nerve Block (PNB) regional anaesthesia highlighting device and NeedleTrainer that incorporates the PNB software to teach ultrasound-guided needling skills.

The Group remains confident that the expected increase in face-to-face medical exhibitions and congresses, that are fundamental to the launch process of the Group's new products, and the continued roll-out of ScanNav Assist and PNB will accelerate AI revenue growth in 2022. The need for an additional US-based Human Factors study has pushed the regulatory approval and anticipated launch of the PNB clinical system in the US to the summer, but the Group still envisages the PNB system will contribute to US revenues in 2022.

Bringing all these AI related products to market during the year puts the Group in a strong position to continue the growth of its 'Classroom to Clinic' ultrasound business and be a global leader in AI related ultrasound software and simulation.

 Group operating loss for the year is expected to be between £4.2m and £4.4m (2020: loss of £4.5m). This includes approximately £2.4m (2020: £2.0m) of expensed R&D costs primarily attributable to investment in the Group's Clinical AI Division. Group management, plc costs and share-based payment charges included in the loss are expected to be £1.3m (2020: £1.0m).

Cash during the year has been well managed, with cash at bank at 31 December 2021 expected to be approximately £5m (31 December 2020: £8.8m) which represents a significant improvement in the second half of the year. With a number of potential growth opportunities relating to additional AI related product

development programmes, as well as increases in the machine learning, direct sales and marketing teams; the Group will continue to monitor investment, overheads and cash against the anticipated sales growth curve in 2022 and beyond.

In summary, the Group expects the strong performance of 2021 to continue in 2022, with growing revenue from the Group's simulation and AI related products and the product development teams continuing to launch new products that will support longer term revenue growth in the 'Classroom to Clinic' market.

Stuart Gall, CEO of Intelligent Ultrasound Group plc, commented: "This has been a very positive year for the Group. We have increased Group revenue by almost 50%, launched a range of AI products into the exciting real-time ultrasound image analysis market, are building an excellent partnership with the world's leading ultrasound company - GE Healthcare, and have also expanded our simulation portfolio with a range of product extensions. All this has been achieved despite the ongoing pandemic that has restricted our activities, especially the US based studies required for regulatory clearance for new products, as well as the critical phase of new product introduction at shows and medical exhibitions. With a growing range of both AI and simulation related products, an established operational base, and strong second half sales continuing the trend from the first half of the year, we are well placed to continue this growth during 2022 and beyond and remain excited about the long-term potential of the 'Classroom to Clinic' business."

This announcement contains inside information for the purposes of the UK version of Article 7 of Regulation (EU) 596/2014 ("MAR").

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About Intelligent Ultrasound Group

Intelligent Ultrasound (AIM: IUG) develops artificial intelligence-based clinical image analysis software tools for the diagnostic medical ultrasound market and hi-fidelity virtual reality simulators for the ultrasound training market. Based in Cardiff in the UK and Atlanta in the US, the Group operates two divisions:

Clinical AI Division

Focusses on developing deep learning-based algorithms to make ultrasound machines smarter and more accessible. Products in the market include:

ScanNav Assist

ScanNav Assist uses machine-learning based algorithms to automatically identify and grade ultrasound images. GE Healthcare's SonoLyst software on their Voluson SWIFT ultrasound machine incorporates the ScanNav Assist AI technology and has received CE and FDA regulatory approval. SonoLyst is the world's first fully integrated AI tool that recognises the 20 views recommended by the International Society of Ultrasound in Obstetrics and Gynaecology mid-trimester practice guidelines for fetal imaging.

ScanNav Anatomy

ScanNav Anatomy PNB uses machine-learning based algorithms to simplify ultrasound-guided needling by providing the user with real-time AI-based anatomy highlighting software for a range of medical procedures. ScanNav Anatomy has received CE approval and has also been submitted for FDA regulatory approval.

ScanNav Anatomy PNB is therefore not available for sale in the US or any other territory requiring government approval for this type of product.

Simulation Division 

Focusses on hi-fidelity ultrasound education and training through simulation. Its main products are the ScanTrainer OBGYN training simulator, the HeartWorks echocardiography training simulator, the BodyWorks Eve Point of Care and Emergency Medicine training simulator with Covid module and the new AI-based Anatomy PNB training simulator and the new BabyWorks Neonate and Paediatric training simulator. To date almost 1,300 simulators have been sold to over 650 medical institutions around the world.

www.intelligentultrasound.com