Intelligent Ultrasound Group PLC CE approval of ScanNav Anatomy: PNB (1969V)

TIDMIUG

RNS Number : 1969V

Intelligent Ultrasound Group PLC

13 April 2021

Intelligent Ultrasound Group plc

("IUG" or the "Company")

CE approval of ScanNav Anatomy: Peripheral Nerve Block

UK launch expected in Q2

Intelligent Ultrasound Group plc (AIM: IUG), the ultrasound artificial intelligence (AI) software and simulation company, announces CE approval of ScanNav Anatomy: Peripheral Nerve Block ("ScanNav PNB").

ScanNav Anatomy uses the latest AI technology to automatically highlight the live ultrasound image to enhance the accuracy and standardisation of ultrasound image interpretation, by making it easier to identify key anatomical structures. This supports the performance of healthcare professionals who are suitably qualified but who perform ultrasound-guided procedures on a less frequent basis.

ScanNav PNB supports nine common peripheral nerve blocks (a form of local anaethesia) and will be sold as a stand-alone device, with in-built AI software, that can be plugged into existing anaesthesiology ultrasound machines. The device will provide clinicians with continuous feedback from real-time highlighting of their live ultrasound. Users can also re-familiarise themselves with blocks that are carried out less frequently using the system's integrated 3D animations.

ScanNav PNB is also available as a training simulator for medical learning on volunteers, prior to patient contact.

Increasingly, ultrasound-guided peripheral nerve blocks are being used as a prudent alternative to general anaesthesia, but not all anaesthetists have the specialist knowledge of ultrasound anatomy to perform them. Through the adoption of ScanNav PNB, it is hoped that hospitals will be able to increase the number of ultrasound-guided nerve blocks that they can perform.

The Company intends to sell the stand-alone system to the UK market using its existing in-house sales resources, with an expected launch in Q2 2021. In addition, the Company continues to progress the product's FDA regulatory filing to enable a version of the product to be sold in the US, as well as seeking to licence an integrated version of the product to the major ultrasound manufacturers.

Lead clinician and consultant anaesthetist, Dr David Burckett-St.Laurent, said: "ScanNav PNB will help tip the balance of safety and confidence in favour of performing regional anaesthesia. I feel privileged to have been working with a company that is leading the world in developing AI-based ultrasound software. Our aim has been to make a real clinical difference to patients by increasing the availability of regional anaesthesia through cutting edge technology. It is very exciting that the product has now moved out of the lab and into clinical practice."

Stuart Gall, CEO of Intelligent Ultrasound Group plc, commented: "We're delighted to have received CE mark approval for our second AI product. Building on the success of ScanNav Assist, our first obstetric AI software that is integrated into GE Healthcare's recently launched SWIFT ultrasound machine, ScanNav Anatomy PNB will launch into the anaesthesiology ultrasound market and continues the Group's expansion into AI-based real-time clinical ultrasound image analysis. We are particularly pleased that many of the independent clinicians who used ScanNav PNB during product testing think that it would benefit them in their everyday clinical practice."

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

For further information, please contact:

 
Intelligent Ultrasound Group                                                     www. intelligentultrasound.com 
 plc 
Stuart Gall, CEO                                                                       Tel: +44 (0)29 2075 6534 
 Helen Jones, CFO 
 
Cenkos Securities - Nominated Advisor                                                  Tel: +44 (0)20 7397 8900 
 and Broker 
Giles Balleny / Max Gould (Corporate 
 Finance) 
Dale Bellis / Julian Morse (Sales) 
 
Walbrook PR                                    Tel: +44 (0)20 7933 8780 or intelligentultrasound@walbrookpr.com 
Anna Dunphy / Paul McManus                                                  Mob: +44 (0)7876 741 001 / Mob: +44 
                                                                                                (0)7980 541 893

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 510(k) clearance from the FDA for sale in the USA. 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. To date over 1,000 simulators have been sold to over 600 medical institutions around the world.

www.intelligentultrasound.com

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April 13, 2021 02:00 ET (06:00 GMT)

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