Copenhagen, Denmark, 19 March 2024 - Brain+ A/S (Nasdaq First North: BRAINP)

Brain+ A/S ("Brain+" or "the Company") informs to have made partnership agreements with two local Age UK sites who will each run a usability pilot study on the Company's CST-Therapist Companion. The first agreement has been signed with Age UK Trafford and the second will be signed with Age UK Tameside.

Age UK is the largest and leading charity organization in the United Kingdom (the UK) offering services and support to seniors, and a significant provider of Cognitive Stimulation Therapy (CST) to people with dementia. Age UK also plays a crucial role in the UK tech innovation eco system, often acting as first mover in trialing new product innovations, like CST-Therapist Companion, providing detailed feedback and recommendations that are highly regarded within the country's National Healthcare System (NHS).

Commenting on the partnership agreement with Brain+, Lucy Chidlow, Memory Loss Advisor with Age UK Trafford said: "Age UK Trafford has long commitment to support communities living with memory loss and are excited to collaborate with Brain+ in the evaluation of this new technology in practice."  

From Age UK Tameside, Vikki-Rose Hawkins, Dementia lead, commented: "We are excited about the potential of this product to help us in the planning and execution of CST, and are eager to work with it." 

Brain+' CST-Therapist Companion is targeted to enable cost-effective and high-quality scaling of CST to broaden access to this clinically proven therapy to as many people with dementia as possible. It provides support to and saves time for therapists to conduct CST group sessions, while helping to ensure consistent delivery of the therapy. The product offers readily available digital high quality CST content in the form of expert approved activities, suggested talking points, images, videos and printable material. All in full compliance with the CST manual.  

During the project, the two Age UK sites will each conduct a full CST program using the near-final English version of CST-Therapist Companion v 2.0 and test the use of the product in the preparation and conduct of 14 CST sessions for a group of 7-10 people with dementia. Throughout the CST programs, therapists will provide detailed feedback on the ease of use of the product and the appropriateness of its content after each session, through online questionnaires. The study will end with a detailed interview session with all therapists involved. Under the agreements, Brain+ will provide free access to CST-Therapist Companion, while all costs associated with running the CST sessions will be born by Age UK.

Data and learnings from the study will help to ensure a strong product-market fit of CST-Therapist Companion for the UK market and contribute data that is required for the Medical Device Software Certification 

The UK usability study adds to the data collected in the Danish usability study, which was conducted in Q4 2023, providing valuable feedback from both markets to optimize user experience and data for the Class I Medical Device certification (MDR/EU). The EU-Medical Device certification is also valid in the UK, and the Class I is a self-certification, yielding better control of timelines. 

The usability study is an important milestone in Brain+' plan to enter the UK market in Q3 2024 feeding into the next key milestones for CST-Therapist Companion:  

Q2 Certification as Medical Device (EU MDR Class 1 MDR) 

Q3 Compliance with additional specific UK requirements for health tech products

Q3 Market release of fully UK compliant Medical Device 

Q4 First sales contract(s) with local NHS Trust(s)

About Cognitive Stimulation Therapy (CST)

Cognitive Stimulation Therapy (CST) is an evidence-based therapy for people with mild to moderate dementia. The therapy was developed by Professor Aimee Spector from University College of London (UCL) and is the only non-medical therapy endorsed by UK government guidelines (NICE recommendation) for the cognitive symptoms of dementia. Group CST treatment involves 14 or more sessions of themed activities, which are led by one or two trained CST therapist and typically run twice weekly. The aims of sessions are to actively stimulate and engage people with dementia, whilst providing an optimal learning environment building on the social benefits of a group.

CST has been recommended by the World Alzheimer's Association and the therapy is gaining recognition worldwide with currently around 40 countries implementing it.

For more information about Brain+, please contact:

Kim Baden-Kristensen, CEO
Phone: +45 31 39 33 17
E-mail: kim@brain-plus.com 

www.brain-plus.com