Progressing NilocasPatch coronary artery disease detector: proof of concept to clinical feasibility

RESEARCH QUESTION Can NilocasPatch accurately and cost-effectively identify patients without coronary artery disease (“no CAD”), enabling earlier diagnosis, reducing NHS diagnostic waiting times, and lowering healthcare costs? BACKGROUND Coronary artery disease (CAD) affects over 3 million people in the UK. Diagnostic delays can be up to 18 months due to limited CT coronary angiography (CTCA) capacity. This results in reliance on invasive coronary angiography (iCA), which is more costly and invasive. Additionally, 18% of CAD cases are asymptomatic and there is no mechanism available to detect and diagnose these patients before a major adverse cardiovascular event occurs. NilocasPatch is a non-invasive, low-cost diagnostic device that detects CAD by capturing vibrations from disturbed blood flow through narrowed arteries and using machine learning/artificial intelligence (ML/AI) for analysis. Initially, the technology aims to rapidly identify patients who do not require diagnostic imaging (“no CAD”), significantly reducing wait times for patients who do have CAD. Its small, low-cost, easy-to-use form could eventually allow its use outside of hospitals, including for detection of asymptomatic CAD in primary care. AIM Prepare for a clinical feasibility study called Nilocas-NA to demonstrate NilocasPatch’s non-inferior accuracy to CTCA and its acceptability and inclusivity. Objectives: 1. Design and manufacture the third-generation NilocasPatch prototype optimised for data collection for use in the Nilocas-NA study. 2. With PPI and Inclusion Research, develop a non-functional fourth-generation prototype for usability testing. 3. With PPI and Inclusion Research, prepare and submit regulatory applications (HRA, REC, MHRA) for the clinical study. 4. Complete Nilocas-NA study setup at Barts Health NHS Trust. 5. Conduct budget-impact analysis to inform device pricing. METHODS This 8-month translational project (September 2025-April 2026) includes upgrading NilocasPatch hardware (32-channel sensors, 2kHz sampling rate), setting up an AI architecture for the study data, preparing regulatory and clinical study documentation, and conducting a budget-impact evaluation. Key deliverables include a third-generation prototype capable of high-resolution three-axis data collection and an approved Trial Master File, indicating readiness to commence the Nilocas-NA feasibility study. TIMELINES FOR DELIVERY Project Start: Sep’25 Prototype Development Complete: Feb’26 Regulatory Approvals: Mar’26 Project End (Nilocas-NA Study Ready to Launch): Apr’26 KNOWLEDGE MOBILISATION, DISSEMINATION & IMPACT Guided by the NIHR Cardiovascular Medicine HealthTech Research Centre, a diverse PPI panel and patient co-applicant will co-design the participant-facing study materials and the fourth-generation prototype for usability feedback. Dissemination activities include co-created social media campaigns and newsletters with relevant charities (e.g., British Heart Foundation). Budget-impact modelling will inform a future NICE Medical Technology Guidance submission, supporting NHS adoption by 2029. RESEARCH INCLUSION Barts Health NHS Trust’s highly diverse catchment will support inclusive recruitment into the Nilocas-NA study. The PPI panel, balanced across gender, age, and ethnicity, will advise on recruiting underserved populations and those with conditions like obesity and lung disease, ensuring diverse performance assessment and usability feedback.