Ayla – your CST Assistant has been registered in the UK as a certified Medical Device Software for dementia therapy
Copenhagen, Denmark, 1 October 2024 – Brain+ A/S (Nasdaq First North: BRAINP)
Brain+ A/S (“Brain+” or “the Company”) informs that Ayla – your CST Assistant has been registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA). The registration follows the successful certification of the product as a Medical Device Software in accordance with the UK Conformity Assessment (UKCA) regulations. With this important regulatory mark in place, Brain+ can now commercially launch Ayla – your CST Assistant as the only medical device software in the UK certified to deliver Cognitive Stimulation Therapy (CST) to people with dementia. Commercial release of Ayla – your CST Assistant on different digital distribution platforms will take place over the next couple of days, marking the formal starting point for outreach to NHS sites and leading to the expected signing of the first UK sales contracts in Q4 2024.
Brain+, a leading innovator in dementia healthtech solutions, informs that Ayla - your CST Assistant has been registered with the Medicines and Healthcare products Agency (the MRHA) in the United Kingdom (UK). The MRHA is the UK government agency that regulates pharmaceuticals, advanced therapy medical products, and medical devices. The registration with the MHRA follows the successful certification of Ayla – your CST Assistant in the form of a UK Compliance Assessment (UKCA) marking as a Class I Medical Device Software. The UKCA marking is valid for medical devices placed on the market in England, Wales and Scotland.
Over the next couple of days, Brain+ will make Ayla – your CST Assistant commercially available on different UK software distribution platforms.
Ayla – your CST Assistant is a novel software solution, designed to revolutionize the way CST therapists deliver group-based Cognitive Stimulation Therapy (CST) to people with dementia. CST is the one non-pharmacological dementia therapy, which is recommended in NICE, the UK’s national health guidelines. Ayla – your CST Assistant offers a platform for providing dynamic adaptation of CST delivery to better fit the varying needs and capabilities of group participants. In addition, it significantly reduces therapy preparation time, by delivering readily available curated CST content, co-developed in a clinical validation process with leading experts in the field. This will allow the target customers, initially mainly the UK National Health Services (NHS) to offer scaled high-quality CST delivery. Several leading UK CST experts have endorsed Ayla – your CST Assistant.
The UKCA marking of Ayla – your CST Assistant is a regulatory validation of the product’s clinical efficacy and safety and key to opening the doors to the NHS and to one of the world’s most attractive markets for digital dementia care solutions. It allows Brain+ to position Ayla – your CST Assistant as the only medical device software in the UK to deliver digital Cognitive Stimulation Therapy (CST).
In the coming weeks the product will be further certified according to the data privacy, cyber security, and usability standards set by the NHS (NHS DSPT, NHS DTAC and CyberEssentials). In addition, a CREST-accredited penetration testing will be conducted leading up to Ayla - your CST Assistant from end October being included on the G-Cloud 14 procurement platform used by the NHS to enable easier sale to NHS sites and trusts.
Contact Information
CEO and Co-founder: Kim Baden-Kristensen, + 45 31 39 33 17 (SMS), kim@brain-plus.com
Brain+ mission: Become the preferred provider of certified healthtech solutions for better dementia management, servicing one million people affected by dementia in 2030.
