Acorai Heart Monitor - Non-invasive multi-sensor device for heart failure monitoring

Introduction

Heart Failure is a progressive clinical syndrome with multiple etiologies. It is associated with nearly three million hospitalizations in the EU annually, representing 30% of all readmissions, and accounts for up to 5% of the entire healthcare expenditure. Despite modern medical treatment, HF is a life-threatening and debilitating condition with a poor prognosis.

Acorai Heart Monitor (AHM)

The Acorai Heart Monitor (AHM) is a monitoring device designed to detect and estimate hemodynamic parameters non-invasively. AHM is a handheld electronic device that features multiple sensors to collect data from four sensor types based upon the patented SAVE sensor system to estimate the absolute pressure of the heart failure patient's cardiac system.

Data Processing

The sensor data are processed within the medical device using machine learning (ML) methods. The results are then displayed to be read by a qualified healthcare professional (HCP).

Benefits of AHM

Delivering intracardiac pressure to HCPs to guide the treatment of patients with HF leads to improved quality of life. Key benefits include:

• Lowering the frequency of hospital admissions
• Providing a non-invasive alternative to current tools, which require invasive procedures

AHM is a multi-patient non-invasive device that would dramatically disrupt the paradigm of HF treatment and lead to significant cost savings in the EU while improving the overall prognosis of patients who suffer from HF. With the growing prevalence of HF globally, the AHM is a tool with applicability in multiple workflows and represents a first-of-its-kind device to revolutionize HF management.

Validation and Market Readiness

AHM has already been validated in 300 patients in a Swedish proof of concept study and now needs support to bring this device to market. Additionally, it aims to collect data via a large multi-national study to prove its effectiveness.

Intellectual Property Protection

The AHM is fully patent protected with three granted patent families and four patents pending, covering the core components of the device and its clinical application. This is additionally protected by large proprietary datasets and a unique ML model.