Brain+ informs of progress on its UK focused proof-of-business strategy plan

Copenhagen, Denmark, 16 May 2024 - Brain+ A/S (Nasdaq First North: BRAINP)

• Supportive early user feedback from the ongoing AgeUK usability study of the CST-Assistant v2.0 to standardize Cognitive Stimulation Therapy (CST)

• Application submitted for the CST-Assistant to be included on G-Cloud, the digital procurement platform for the UK National Health Service, NHS

• Development and UK regulatory compliance of the English CST-Assistant v2.0 as medical software advancing as planned towards UK launch in Q3 2023

• Together with Quiddity, pre-commercial outreach to relevant UK NHS trusts has begun

In March 2024, Brain+ informed that a committed and UK focused strategy plan for 2024-2025 had been set with the aim of obtaining commercial proof-of-business and scalable sales as fast as possible. The plan builds on the UK representing the currently most attractive and accessible market for the company's health tech solutions for better dementia management - an area of very high unmet needs.

The objectives for the strategy plan are to

• get a regulatorily compliant English version of the CST-Assistant v 2.0 ready for market entry in Q3 2024,
• close the first sales with a UK National Health Service (NHS) trust in Q4 2024, and
• reach commercial scale and cash-flow break-even for the UK business in 2025.

Since March, Brain+ has been progressing well on its plan and 1) Started a usability study of the CST-Assistant in collaboration with AgeUK and now obtained the first supportive data on cost effectiveness and performance standardization from using the product to deliver Cognitive Stimulation Therapy (CST) to people with dementia, 2) submitted an application for the CST-Assistant v2.0 to be included on the G-Cloud procurement platform used by NHS entities, 3) advanced the development of the English CST-Assistant v2.0 to the final stage including its compliance with UK requirements for medical software certification, and 4) begun outreach to the most relevant NHS Trusts together with its UK commercial partner, Quiddity Health. Further details on each milestone further below.

The attraction and potential of the UK market for Brain+

The CST-Assistant is a software-based tool that standardizes the CST method and provides the CST Therapists with a means to ensure a cost-effective delivery of high-quality therapy to more people with dementia. CST as a method was developed in the UK, and the therapy is recommended by the UK health standardization body, the National Institute of Health and Care Excellence (NICE) as standard of care for people with dementia. CST is thus an integrated part of the memory service accreditation program offered by the health care professionals who are responsible for diagnosing dementia in elderly and widely acknowledged for its benefits. The main barrier for full penetration of CST in the UK are resource constraints in the healthcare system, and the CST-Assistant can help solve this problem. At a later stage, Brain+ pipeline product, CST-Home Care, has significantly further potential to extend and increase the value of CST to people with dementia.

There are close to one (1) million people with dementia in the UK and the adoption of healthtech solutions in the country is high, based also on established reimbursement pathways for medical software products. The UK National Health Service (NHS) is responsible for about 80% of the delivery of social and medical care to people with dementia, and NHS organizations, primarily NHS Trusts, are the initial main customer target for Brain+. Together with Quiddity Health, a step-wise go-to-market approach, which has already proven commercial success in other disease areas, will be followed for the CST-Assistant. This implies to initially target smaller NHS Trusts for early-adopter contracts of E10,000-25,000 pounds each, while gradually building evidence to support first larger NHS Trust contracts and eventually reimbursed contracts with regional NHS Integrated Care Systems of an 18-24 months' duration and a standard value of around E500.000 pounds. There are 42 Integrated Care Systems in the UK.  

Supportive early user feedback from AgeUK usability study of the CST-Assistant

Brain+ has partnered with AgeUK to run a UK usability study of the CST-Assistant v2.0. AgeUK is the largest charity organization for seniors in the UK and a significant provider of CST to people with dementia. Under the partnership, Brain+ has provided access to a near-final English version of its CST-Assistant v2.0 to two local AgeUK organizations, which each use the product to run a full CST program and provide user feedback and cost-effectiveness data. The study output is important to feed into UK Medical Software certification of the CST-Assistant v2.0 and to provide evidence of UK product market fit. While the study is still ongoing, weekly user feedback is being collected from the CST therapists, who have so far confirmed the value proposition of the CST-Assistant v2.0 to save time and provide for a more efficient delivery in a UK context.

Application submitted to have the CST-Assistant included in the NHS digital procurement framework, G-Cloud

Brain+ recently submitted an application for the CST-Assistant to be included in the G-Cloud procurement framework, which makes it smoother and easier to sell to NHS organizations. The G-Cloud framework is established to simplify the procurement process for government and public sector organisations in the UK. It serves as a digital marketplace where various suppliers, including IT service providers and software vendors, can list their services and products. G-Cloud thus allows public sector organisations to buy services without needing to run a full tender or competition procurement process. Inclusion in the G-Cloud framework is not a prerequisite to sell Brain+ products to the NHS, but it will ease the procurement process in particular for larger contracts which otherwise require tendering. The application will be processed by November 2024, and in the meantime, outreach for early adopter customer contracts has started.    

Development of the CST-Assistant v2.0 for the UK progressing as planned for Q3 launch as a medical software

The product development of the CST-Assistant has two main components: Software backbone development and CST content development. The software development is in the phase of finalizing technological features and quality assurance. The development of validated and customizable English CST content has been completed to provide material for full UK CST programs.

In terms of regulatory standards for certification as medical software in the UK, requirements conform to the previous EU Medical Device Directive. Brain+ has given first priority to ensure compliance of the CST-Assistant under this framework, including also compliance with relevant UK specific requirements. Brain+ is working with a UK regulatory partner, 8fold, towards getting the English CST-Assistant v 2.0 certified as a medical software, including finalizing the clinical evaluation report on the product, design documentation, data privacy and risk assessment.

All development and compliance activities are on track to meet the planned commercial launch of the CST-Assistant as a medical software on the UK market in Q3 2024.

Contact Information

Kim Baden-Kristensen, CEO
Phone: [phone]
E-mail: [e-mail] 

www.brain-plus.com

Brain+ mission:  Become the preferred provider of certified health tech solutions for better dementia management, servicing several million people affected by dementia by 2030.

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