Healthtech solutions company Brain+ A/S (Nasdaq First North:BRAINP) announced on Tuesday that Ayla – your CST Assistant has received registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

This registration follows successful certification as a Class I Medical Device Software under UK Conformity Assessment (UKCA) regulations. With the UKCA marking secured, Ayla – your CST Assistant is poised for commercial launch as the only medical device software in the UK providing Cognitive Stimulation Therapy (CST) for dementia patients.

Ayla will become commercially available on various digital distribution platforms within the next few days, facilitating outreach to NHS sites and positioning Brain+ to sign initial sales contracts in Q4 2024. As a pioneering software solution, Ayla enhances the delivery of group-based CST, which is endorsed in NICE guidelines as the primary non-pharmacological treatment for dementia. It allows for tailored CST delivery and minimizes preparation time by providing curated content developed with leading experts.

Upcoming certifications will ensure compliance with NHS data privacy, cyber security and usability standards, including NHS DSPT and NHS DTAC requirements. A CREST-accredited penetration test will also be conducted, enabling Ayla – your CST Assistant to be included in the G-Cloud 14 procurement platform by the end of October, streamlining access for NHS trusts.