The CER of the CST-Assistant validated for UK regulatory compliance, documenting the product’s clinical performance

Copenhagen, Denmark, 27 August 2024 – Brain+ A/S (Nasdaq First North: BRAINP)

• The Clinical Evaluation Report (CER) documents the safety and clinical performance of the CST-Assistant for dementia management
• The validation of CER compliance with UK Regulations is an important step towards UK certification of the CST-Assistant as a Medical-Device-Software
• Aimee Spector, Professor of Clinical Psychology of Ageing at UCL, UK and the creator of Cognitive Stimulation Therapy (CST), has reviewed the CER and endorsed the clinical relevance of the CST-Assistant
• Brain+ is on track for release of the CST-Assistant in the UK as a certified Medical-Device-Software by end Q3 2024  

Brain+ A/S (“Brain+” or the “Company”) informs that the Clinical Evaluation Report (CER) of the CST-Assistant has now been validated for UK regulatory compliance by the Company’s regulatory advisor in the UK, 8FoldGovernance. Compliance validation of the CER is an important milestone towards certification of the CST-Assistant under the UK Medical Device Regulations (UK MDR). Brain+ expects to release the CST-Assistant as certified as a Class I Medical-Device-Software in the UK by the end of September 2024.

The CST-Assistant is the most commercially mature product in Brain+’ pipeline of health tech solutions for better dementia management. It is an innovative software-based offering that enables more effective and scalable high-quality delivery of Cognitive Stimulation Therapy (CST), a clinically proven non-drug therapy for people with mild- to moderate dementia. The CER comprises a structured analysis of all available clinical evidence on the CST-Assistant, documenting its safety and performance in clinical use.

The CER, including the clinical relevance of the CST-Assistant, has been reviewed and endorsed by the creator of CST, Prof. Aimee Spector, Clinical Psychology of Ageing at University College London (UCL), UK, who commented: “I find the CER to be precise, and of high scientific quality. The literature and theory around CST is accurate, as is the description of the CST-Assistant. I am happy to endorse the report and agree that the CST-Assistant is likely to result in similar clinical outcomes to CST if used correctly, with support.”

Nahid Zokaie, Chief Scientific Officer at Brain+, added on the news of the CER validation:

“Demonstrating the clinical relevance of the CST-Assistant has been a key scientific and commercial objective of ours, and with the Clinical Evaluation Report now validated for compliance and importantly, endorsed by Prof. Spector, we have met that objective.”

The CER ties the performance of the CST-Assistant to the clinically documented benefits of the CST method on cognition and behavior for people with mild to moderate dementia, comparable to 6 months delay in cognitive decline. This supports the soft claims for the CST-Assistant as a Medical Device Software to provide benefits equivalent to those reported for traditional CST alone.

The CER is a major component of the Technical File required for Medical Device certification of the CST-Assistant. Obtaining Medical Device status for the CST-Assistant will uniquely document the product’s clinical relevance for people with dementia, while instilling trust with healthcare systems and payers that the product meets the highest quality and safety standards. The validation and the clinical endorsement of the CER also demonstrates the clinical benefits of the CST-Assistant as well as the cost benefits of the product to healthcare systems and practitioners as a key step towards enabling UK reimbursement. This will in turn open for larger access to the therapy for patients and healthcare systems and strengthen the competitive and commercial position of Brain+.

Brain+ will now focus its efforts on finalizing the remaining steps towards UK certification of the CST-Assistant as a Medical-Device-Software. These include UK regulatory compliance of the Company’s Quality Management System, upgrade and implementation of design control procedures and compliance with the stringent UK requirements on Data Privacy and Cyber Security and Digital Technology Assessment Criteria (DTAC).    

Contact Information

Kim Baden-Kristensen, CEO and Co-founder: + 45 31 39 33 17 (SMS), [email protected]

Hanne Vissing Leth, CFO: + 53 88 99 02, [email protected]

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