The Swedish startup, led by CEO Filip Peters, has developed the SAVE Sensor System, aiming to revolutionize the management of heart failure by providing accurate, non-invasive intracardiac pressure monitoring.
The best ideas often come from cross-pollination between industries. In the case of Filip Peters, CEO and Co-Founder of Acorai, it was applications of machine learning in the financial sector that sparked Acorai’s founding to tackle unmet needs in healthcare. "My background is in machine learning," Peters explains. "I was working in finance and seeing advanced techniques being used in time series data, and I thought that this should be possible to apply to different fields.” With his expertise and passion for computers and hardware, Peters began exploring spaces within healthcare where machine learning was poised to have the biggest impact. "We looked at various possibilities and ultimately focused on heart failure due to the immense unmet need and the promising commercial case," Peters explains. "Heart failure affects over 60 million patients worldwide. We saw a significant opportunity to address this worldwide issue."
The challenge of managing heart failure stems from the shortage of reliable, scalable tools for effective patient monitoring. "Heart failure management is incredibly complex because existing tools either lack accuracy or are too expensive and invasive," says Peters. Traditional methods like right heart catheterizations provide valuable hemodynamic assessments but are invasive, costly, and unscalable for widespread use.
Non-invasive methods, while safer, often fail to deliver the precision needed for effective patient management. "Studies show that over 40% of heart failure patients in the US are discharged with residual congestion, leading to high readmission rates," says Peters. "We're changing the game by making intracardiac pressure monitoring non-invasive," Peters emphasizes. This shift aims to reduce hospital readmissions and improve patient outcomes, addressing the high costs and complexities associated with current heart failure management practices.
Acorai’s breakthrough technology, the SAVE Sensor System, provides a non-invasive method for monitoring intracardiac pressures, crucial for effective heart failure management. This hardware-enabled software solution integrates seismic, acoustic, visual, and electric sensors into a compact, handheld device. "The SAVE System detects chest wall vibrations, listens to specific frequencies, captures visual signals from PPG sensors, and synchronizes data collection with the cardiac cycle,” Peter explains.
The technology leverages four sensing methods:
Seismic Sensors: Detect minute chest wall vibrations on the skin surface.
Acoustic Sensors: Function as electronic stethoscopes to capture specific frequencies.
Visual Sensors: Use PPG technology to assess blood flow characteristics.
Electric Sensors (ECG): Synchronize data collection with the cardiac cycle.
This multi-sensor approach allows the proprietary system to collect comprehensive raw data, which is then analyzed by Acorai’s advanced machine-learning engine. "We feed this raw data into our machine learning engine, trained on thousands of right heart catheterization measurements, to accurately estimate intracardiac pressures non-invasively," Peters adds.
The workflow is straightforward. The device is placed on the patient's chest, and within seconds, it records and analyzes the data, presenting intracardiac pressures and hemodynamic parameters on the screen. "For the first time, we can measure these patients accurately on a longitudinal basis, which will greatly improve heart failure management," says Peters.
Acorai is advancing through its global clinical study, CAPTURE-HF, involving over 1,500 patients across 14 hospitals in six countries. "This is the largest study of its kind, comparing our device to the gold standard right heart catheterization," Peters highlights. The study’s findings will support regulatory submissions in the US and Europe. "We’re submitting to the FDA by the end of this year, aiming to commercialize in the US by late next year," Peters states.
To support these efforts, Acorai has raised $14 million to date, including a $9 million seed round closed in early 2024. "Building a device that integrates hardware with software and machine learning is not cheap. We’ve been fortunate to attract stellar investors from heart failure pharma, hospital systems, and medtech-focused VCs from both the US and Europe," Peters shares. This funding is crucial for advancing their technology and preparing for commercialization.
Heart failure (HF), which is itself a progression of cardiovascular disease, is a progressive disease. Improper management of the condition can lead to a worsening of symptoms, leaving traditional treatment ineffective. The limited data available on the prevalence of advanced HF suggests that 0.2% to 5.0% of HF patients have advanced HF. In these patients, surgical interventions become the primary means to treat these patients. Mechanical circulatory support and heart transplantation are common interventions for the most advanced of HF patients.
According to LSI’s Market Analysis and Projections (MAP) database, which provides historical and forecasted projections for over 200 device markets, the market for artificial hearts and left-ventricular assist devices (LVADs) is projected to increase at a CAGR of 12.0% from 2023 to 2028. This nearly $2 billion market is one of the fastest growing markets within the wider cardiovascular disease devices market.
While the incidence rate of HF is decreasing, continued support is needed to ensure quality of care for patients living with the disease. There is no cure for HF, so finding effective and accessible solutions to manage these patients is crucial.
Filip Peters has been selected to present at LSI Europe ‘24 this September 16th-20th. Join us in welcoming him to the event in Sintra, Portugal, where he will share the latest updates on Acorai’s technology, clinical data, and development.
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