Speak And Be Saved: App Detects Heart Failure Weeks Before Attack Cordio Medical’s HearO designated as FDA Breakthrough Device as pilots run across US, Europe
Jerusalem, Israel
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February 05, 2024 08:45 AM Eastern Standard Time
By Jeremy Ruden
“The puppy sat on the ship.”
That was one of five potentially life-saving sentences that heart patients spoke into their smartphones during a US trial for HearO, the groundbreaking app that detects signs of congestive heart failure (CHF) simply by monitoring a person’s voice.
Created by startup Cordio Medical, the system’s artificial intelligence algorithms detect voice changes that indicate fluid accumulation in the lungs before any symptoms surface. When changes are noticed, the system alerts the patient’s doctor of an imminent risk that might require medication, IV therapy or hospitalization, allowing intervention before the condition deteriorates.
The company is currently raising a funding round via OurCrowd, the Jerusalem-based investment platform that allows accredited investors to access privately held startups.
In trials, the HearO app successfully predicted heart failure in 81% of cases, about three weeks before heart failure actually occurs, giving physicians time to intervene and scale back expensive and traumatic hospitalizations. The condition develops when the heart muscle is too weak to pump all the blood the body needs. Fluid builds up in the extremities and lungs as a result.
“This approach has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes,” says William T. Abraham, MD, of Ohio State University Wexner Medical Center in Columbus, who reported the trial findings at the 2023 Scientific Sessions of the American Heart Association.
The app functions by having patients record a baseline of phrases when their lungs are clear, then repeat them daily so algorithms can detect any changes.
Saving lives
With over 26 million people in the Western world suffering from CHF, the need to monitor patients is growing quickly. About half are at high risk of a fatal incident within five years of diagnosis. CHF patients generally require timely, personalized medical attention to avoid episodes that demand immediate medical care or hospitalization. Prevalence of CHF in the US alone is projected to increase by nearly 50% by 2030, while direct medical costs – predominantly hospitalization – are forecast to more than double between 2012 and 2030. The annual burden of CHF on the US healthcare system is some $18 billion.
“The holy grail” of the heart failure monitoring industry “is to find a solution that will help a patient know in advance when they’re deteriorating so they can change their diuretics and hopefully avoid hospitalization,” says Tamir Tal, CEO of Cordio Medical.
In the long run, Cordio plans to use the technology to detect other conditions such as chronic obstructive pulmonary disease, Tal says. The company is initially targeting heart failure, which frequently causes patients to return to the hospital for lengthy, expensive stays.
“Speech carries a lot of personal information about us. When you talk to your mom, just one sentence is enough for her to know how you feel,” says Tal. “We might not be giving the same kind of support as a parent, but we are using speech to give the physician something they can objectively use to determine a patient’s medical condition, helping them avoid serious health episodes.”
AstraZeneca partnership
In the US, Cordio Medical’s DETECT-HF pivotal study is fully operative, with data collected from dozens of patients in 38 centers. As a result of the clinical collaborations with the centers, the company has already received commercial interest from participants.
This extensive collaboration with renowned medical centers has the potential to establish a smooth pathway for future commercial traction. Some of the largest US providers and payers are among the members of the pivotal steering committee, a further sign of their faith in HearO’s clinical significance and business potential.
In Europe, Cordio found a partner in pharma giant AstraZeneca. In Q3 2023, the two companies began a second pilot program in Spain at the General Hospital of Valencia in conjunction with the Valencian Society of Cardiology. The first ongoing pilot is being conducted at Bellvitge University Hospital.
“AstraZeneca is committed to advancing digital tools to diagnose, monitor and treat high-impact pathologies such as heart failure,” says César Velasco, director of Innovation and Digital Strategy at AstraZeneca. “Thanks to the collaboration across Spanish hospitals and health professionals, we are closer to making life-saving digital health tools a reality for millions with chronic diseases.
FDA approval
The HearO system received a prestigious and coveted Breakthrough Device designation from the FDA, with approval for the CHF indication forecast in Q1 2025, around 6 months after the company is expected to complete and publish the data from the US pilot. In the EU, Cordio obtained the CE certificate for HearO’s software application. The system was also approved by the Israeli Health Ministry.
Cordio has several key investors including Peregrin, Ceros, Aegis Capital and Super-Pharm. They are all participating in the company’s current SAFE, which is available to accredited investors via OurCrowd.
For more information about investing in Cordio Medical via OurCrowd, click HERE.
OurCrowd was started in 2013, driven by the idea that the business of building startups grows bigger and better when the global ‘crowd’ gains access to VC-level investment opportunities.Today, OurCrowd is a global venture and alternative investing platform that empowers institutions and individuals to invest and engage in emerging companies. OurCrowd vets and selects companies, invests its capital, and provides its global network with unparalleled access to co-invest and contribute connections, talent and deal flow. OurCrowd builds value for its portfolio companies throughout their lifecycles, providing mentorship, recruiting industry advisors, navigating follow-on rounds and creating growth opportunities through its network of multinational partnerships.
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