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Sep 21, 2024
The Memo: AccuLine Preventing the Next Heart Attack
The Memo: AccuLine Preventing the Next Heart Attack

Newsletter - AccuLine

Under the direction of CEO and Co-Founder Moshe Barel, AccuLine is working to realize its vision of saving millions of lives by “preventing the next heart attack.” The company is developing a non-invasive, cost-effective solution to assess a patient’s risk of severe coronary artery disease (CAD).

Origin Story

As an expert in cardiology, Barel recalls being asked by a VC to do due diligence on the technology of the three other founders: a cardiology professor, a computer science professor, and a technologist. He explained, “As I reviewed their work, I realized I didn’t just want to assess the technology—I wanted to be a part of the team and help build the company with them.”

Interestingly, the original VC chose not to invest, but that didn’t stop the momentum. “Another VC saw the potential and decided to back us,” Barel said.

Beyond the professional aspect, Barel’s decision to join the company had deep roots. He recalled, “When I was just 15 years old, I experienced my father having a heart attack. I had first-hand experience of what happens to a healthy person getting a heart attack in midlife. It was close to my heart.”

The Current Landscape

The current landscape for early detection of CAD reveals significant gaps in accessible and accurate screening methods. Heart attack is the number one cause of death globally—yet, as Barel explained, “Doctors don’t have a frontline tool for early detection of CAD that is accurate, non-invasive, risk-free, sedentary in office, and low-cost. There’s no solution like that.”

He noted that there are other modalities in the market, such as the ECG stress test, but they are highly inaccurate. In fact, there are guidelines against using it for low- and moderate-risk patients for CAD. Barel continued, “There are other minimally invasive exams, like nuclear stress tests and coronary CTAs, but these are not exams that you could use as a general screening tool for the general population or even symptomatic patients. There’s radiation. There are radioactive agents.” It’s time-consuming. It’s labor intensive. You have to go to the hospital. There’s risk involved.”

Inside the Innovation

AccuLine is developing CORA, an accurate, non-invasive, and cost-effective exam for early detection of CAD. The device is a tabletop touchscreen with five ECG electrodes and one SpO2 sensor. It is cloud-connected and can be operated from any computer or the touchscreen.

Through a brief four-minute evaluation of three vital signs—the heart’s electrical activity, oxygen saturation levels, and respiratory phase—CORA automatically generates results. The technology is based on detecting two novel biosignals combined with AI-powered signal processing and proprietary augmented waveform display. The biosignals are voltage spread, the inter-cycle variability of the voltage, and VCG, a 3D image of the heart’s electrical activity.

Barel explained the simplistic process: “You hook up these sensors for a four-minute sedentary exam, and we provide you with a report on that patient’s risk level for having significant CAD.”

Progress and Milestones

AccuLine has made substantial progress in its mission to detect CAD to prevent the next heart attack. One of the company’s pivotal milestones was the completion of an initial proof-of-concept clinical study, demonstrating that its algorithm can “accurately differentiate between patients with and without significant CAD.” 

AccuLine also attracted serious attention from investors and received multiple grants, further propelling its momentum. Barel shared, “We received investments after due diligence from very serious entities like the Israel Innovation Authority, Google, Mayo Clinic, and the second-largest healthcare organization in Israel, Maccabi. Within two years, we completed a clinical study with 300 patients and a prototype.” 

The company is currently working to complete the product’s final design. Next year, AccuLine will launch its IDE study for FDA approval in the United States. While currently based in Israel, the company has plans to expand. Barel explained, “In the next 12 months, we plan to open our US subsidiary, which will be the ‘mother company,’ fully owning the Israeli company.”

Market Insights

According to LSI’s Surgical Procedure Volumes database, 5.9 million PCIs (to treat infarctions) were performed in 2023. This will increase at a CAGR of 6.2% from 2023 to 2028, reaching 8.0 million procedures by 2028. The growth of these procedures is indicative of the continued increasing prevalence of CAD, as PCI is used to treat stable and acute (heart attack) blockages of the coronary artery.

Despite technological advances and initiatives to improve access to healthcare, more people are dying of ischemic heart disease than they were in the year 2000. According to the latest data from the World Health Organization, 9.1 million people died of ischemic heart disease in 2021. Based on WHO data, ischemic heart disease has remained the number one cause of death worldwide for over two decades. This signifies a serious unmet need to identify heart disease earlier and take steps to reduce the risk of the disease progressing to more severe stages. 

Barel at LSI Europe ‘24

Barel was selected to present at Europe ‘24 this past week (September 16th-20th) in front of hundreds of global medical technology companies. The full presentation from the event will be available to watch on our website in the coming weeks.