AHA Highlights Pediatric Hypertension in Scientific Statement

This AI Startup Aims To Predict Heart Failure Before It Happens

Cordio CEO Tamir Tal

Cordio Israeli-based health tech company Cordio has developed machine learning software that can be downloaded to a smartphone and help keeps cardiac patients out of the hospital.

One day in the future, a patient at risk for heart failure may find themselves waking up in the morning, opening up his smartphone and uttering these words: "The cat sat on the ship. David is a big chef. Jeff plays the guitar."

It's a simple daily habit that could save their life, because one day after repeating their daily refrain, their doctor might be notified that a patient is at risk of heart failure without immediate care.

That's the dream of Tamir Tal, the founder of Israeli-based artificial intelligence startup Cordio. Its app, HearO, uses machine learning algorithms to detect changes in a patient's voice that suggest there's fluid accumulation happening in the lungs before a patient even notices any symptoms. By catching it early, doctors can intervene with medicine and prevent a patient's condition from deteriorating to a point where they need to go to the hospital.

"This situation became the Holy Grail of the remote monitoring industry," says Tal, 50. "To find a way to identify patients when they're getting close to hospitalization because the patient doesn't feel it."

Millions of Americans are at risk for congestive heart failure, a condition in which the heart muscle is too weak to pump all of the blood the body needs. The result is that fluids build up in the extremities and lungs which, if left untreated, can lead to serious complications that require hospitalization. If caught early, patients can avoid a trip to the hospital but it's often hard to diagnose until the heart failure is serious.

"There certainly are unmet needs for heart failure," says William Abraham, a cardiologist at Ohio State University's Wexner Medical Center. "And one of them is to closely monitor our heart failure patients remotely and know when they're accumulating fluids in their lungs and at risk for hospitalization."

So far, clinical studies have shown that the app can predict such events in patients about 80% of the time. Those studies, conducted in Israel, have gained the app marketing authorization from regulators in Europe and Israel, the company says. The company says it's pursuing marketing authorization with the FDA as a breakthrough device after its current U.S.-based clinical trial, which features a larger, more diverse population, is complete.

Abraham, who's currently conducting the company's trial, says that if the results bear out and the app goes on the market, it offers a unique solution in the market for heart failure patients. "What's exciting about this one is its simplicity, its elegance, and that's it's ready to be universally deployed to our heart failure patients," he says. "It doesn't require any hardware or devices in the home–all you need is a smartphone."

"Everyone talks about artificial intelligence, machine learning and remote diagnostics and this company had it all."

Mark Goldwasser, CEO of Ceros Financial, an investor in Cordio

Born in Israel, Tal began his career as an attorney focused on financial transactions such as M&A and venture capital investments, and joined Peregrine Ventures as a partner in 2005, a position he still holds. He began serving as COO of Neovasc, which makes medical devices for cardiac patients, in 2007. That position, he says, inspired his fascination with medical devices.

In 2010, left his role at Neovasc when the company was acquired by Medical Venture Corp. In 2017, he joined Cordio as the CEO. The company was founded in 2013 by Aviv Lotan, Sigal Kremer-Tal, Ze'ev Schlik, Chaim Lotan and Shelley Lotan and went through the Incentive Incubator program, which is operated by the Israeli government.

The inspiration for the Cordio app, Tal says, came from cofounder Chaim Lotan, who is a cardiologist. He and his colleagues had noticed that when a patient had too much fluid in their lungs, it was actually audible in their voice. But generally by that point it was too late to prevent a trip to the hospital. So the idea behind Cordio's app is to see if software could detect those vocal changes earlier.

One of the key features of the machine learning aspect of the app is that the patient is recording a baseline of phrases when they're known to be clear of fluid, using phrases featuring a wide range of sounds. That baseline makes the changes easier for algorithms to detect, and they're spoken in the morning because fluid accumulation is easier to detect when a patient has been horizontal for several hours sleeping.

After coming on as CEO, Tal hired Ilan Shallom as the company's Chief Technology Officer. Shallom has been doing speech recognition research since the 1980s and founded speech recognition company NSC in 1993, which was later acquired by AudioCodes in 2010. "I courted him for a long time," Tal says. "Longer than my wife–it took about a year."

So far the company has raised about $25 million in capital from Peregrine Ventures, Ceros Financial Services and other investors. Tal says that the company will likely do another round of fundraising this year to carry it through the FDA approval process and the beginning of commercialization of its product.

For Mark Goldwasser, CEO of Ceros Financial, his company's investment was its clear vision for how to implement its technology in a way that wasn't just hype. "Everyone talks about artificial intelligence, machine learning and remote diagnostics and this company had it all," he says.

The company's currently finalizing recruitment for its final U.S. Clinical trial, which it expects to have at 30 sites around the country, which will give it a chance to see how the app works with a diverse range of patients. Assuming good results from those trials, Tal says that his company is aiming for FDA clearance by the second quarter of 2024.

Once the technology proves out for congestive heart failure, the company intends to expand its voice recognition technology to apply to other diseases. For example, it's testing predictive software for Covid and COPD patients who might be at risk for hospitalization to catch potential issues before they require a visit. But he sees each as a separate challenge, not something that's necessarily just another line of code in an app, and is planning his company's strategy accordingly.

"I think the biggest difference between us and other digital health companies is that we're thinking like a medical device company," says Tal. "We started working with physicians early on in the game to develop the product and understand what they need."

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Herbal Extract Shows Some Benefit For Heart Failure

Mar. 23 --

TUESDAY, March 27 (HealthDay News) -- An herbal preparation derived from tree leaves offered some benefits to patients being treated for congestive heart failure, according to a new German study presented to American cardiologists Tuesday.

But at least one U.S. Heart expert said the substance needs far more study before it can be deemed of any value to patients.

The substance, dubbed Crataegus Extract WS 1442, is an extract of the leaves of the Crataegus, or hawthorne, tree, and is a natural antioxidant. It's currently approved for use in some European countries as a treatment for early congestive heart failure, which is the heart's inability to adequately pump blood throughout the body.

"This is the first heart failure trial conducted with an herbal product," lead researcher Dr. Christian J.F. Holubarsch, of the Median Kliniken Hospitals in Bad Krozingen, said during a teleconference Tuesday at the American College of Cardiology's annual meeting in New Orleans.

In the trial, called the SPICE study and conducted at 156 centers in Europe, Holubarsch and his colleagues randomly assigned 2,681 patients with advanced congestive heart failure to receive either WS 1442 or a placebo for two years. All the patients were already receiving medications for heart failure.

The researchers wanted to see if WS 1442 could extend the time to a first cardiac event, including sudden cardiac death, death due to progressive heart failure, fatal heart attack, non-fatal heart attack or hospitalization because of heart failure, Holubarsch said.

The researchers found that for patients taking WS 1442, there was a 20 percent reduction in cardiac-related death. The lives of these patients were extended by four months in the first 18 months of the study. But after two years, about the same number of people in both groups had died. This was a secondary endpoint, Holubarsch said.

However, WS 1442 was not effective when it came to death due to progressive heart failure, fatal heart attack, non-fatal heart attack and hospitalization because of heart failure.

"We did not meet the primary endpoint," the researcher said.

Holubarsch cautioned that the findings were preliminary. "We cannot prove that the compound extends life of these patients, but I think it's promising," he said.

One heart expert said he thought that because the study failed to meet the primary goal, it raises a red flag.

"If the specified primary endpoint did not have a significant impact, any observation from a secondary endpoint should be considered hypothesis-generating, rather than evidence that this therapy is beneficial," said Dr. Gregg Fonarow, a cardiologist at the University of California, Los Angeles.

"As this is a single, modestly sized trial, these finding will require confirmation in other independently conducted, randomized, double-blind, placebo-controlled trials," he said.

More information

For more information on heart failure, visit the American Heart Association.

SOURCES: Christian J.F. Holubarsch, M.D., Median Kliniken Hospitals, Bad Krozingen, Germany; Gregg Fonarow, M.D., professor of clinical medicine, University of California, Los Angeles; March 27, 2007, presentation, American College of Cardiology annual meeting, New Orleans

Treating A Sick Heart

From: "Heart Disease," by Robert Soufer, M.D., in The Yale University School of Medicine Heart Book, edited by Barry L. Zaret, M.D., Marvin Moser, M.D., and Lawrence S. Cohen, M.D. Copyright 1992 by Yale University School of Medicine. Reprinted by permission of William Morrow and Company. To order, call 800-843-9389.Overview The heart's primary function is to pump blood to all parts of the body, bringing nutrients and oxygen to the tissues and removing waste products. When the body is at rest, it needs a certain amount of blood to achieve this function. During exercise or times when greater demands are placed on the body, more blood is required. To meet these variable demands, the heartbeat increases or decreases, and blood vessels dilate to deliver more blood or constrict during times when less blood is required.

When a person is diagnosed with heart failure, it does not mean the heart has stopped working, but rather that it is not working as efficiently as it should. In other words, the term "failure" indicates the heart is not pumping effectively enough to meet the body's needs for oxygen-rich blood, either during exercise or at rest. The term congestive heart failure (CHF) is often synonymous with heart failure but also refers to the state in which decreased heart function is accompanied by a buildup of body fluid in the lungs and elsewhere. Heart failure may be reversible, and people may live for many years after the diagnosis is made.

Heart failure may occur suddenly, or it may develop gradually. When heart function deteriorates over years, one or more conditions may exist. The strength of muscle contractions may be reduced, and the ability of the heart chambers to fill with blood may be limited by mechanical problems, resulting in less blood to pump out to tissues in the body. Conversely, the pumping chambers may enlarge and fill with too much blood when the heart muscle is not strong enough to pump out all the blood it receives. In addition, as the architecture of the heart changes as it enlarges, regurgitation of the mitral valve may develop, making the heart failure even worse.

Who develops heart failure? There are an estimated 2 million people in the United States with heart failure. The incidence of chronic congestive heart failure—the number of new cases developing in the given population each year—has increased in recent years. This is possibly a result of the overall decline in deaths from coronary (ischemic) heart disease, an improvement attributed to medical advances and the fact that people are living longer.

The most common cause of congestive failure is coronary artery disease—narrowing of the arteries supplying blood to the heart muscle. Although coronary disease often starts at an early age, congestive failure occurs most often in the elderly. Among people more than 70 years old, about 8 out of 1,000 are diagnosed with congestive heart failure each year. The majority of these patients are women, probably because men are more likely to die from coronary artery disease before it progresses to heart failure.

Heart failure is also associated with untreated hypertension, alcohol abuse, and drug abuse (primarily cocaine and amphetamines) at any age. Hyperthyroidism and various abnormalities of the heart valves (particularly aortic and mitral) are among the other disorders that can cause heart failure. In addition, viral infection or inflammation of the heart (myocarditis) or primary heart muscle disease (cardiomyopathy), and in rare instances, extreme vitamin deficiencies, can result in heart failure.

Treatment Whenever possible, the best treatment of congestive heart failure is one of prevention. This includes diagnosing and treating high blood pressure and attempting to prevent atherosclerosis. Other important preventive steps include not smoking, using alcohol in moderation if at all, and abstaining from cocaine and other illicit drugs. A prudent diet, regular exercise, and weight control are also important.

When a patient is diagnosed as having heart failure, the first treatment is often restriction of dietary sodium. Drugs may be prescribed as well. Diuretics, available since the 1950s, are often used to help the kidneys get rid of excess water and sodium, thereby reducing blood volume and the heart's workload.

Digitalis, a drug that has been used since the 18th century, is still a component of modern therapy. It is prescribed to strengthen the heart's pumping action. Patients taking both diuretics and digitalis may need to supplement their levels of potassium.

Newer drugs for the treatment of heart failure include vasodilators, which cause the peripheral arteries to dilate, or open up. This reduces the work of the heart by making it easier for blood to flow. Among the newest vasodilators used for heart failure are the angiotensinconverting enzyme (ACE) inhibitors, which may be used, along with diuretics, in patients with mild-to-moderate or severe congestive failure. ACE inhibitors, which include captopril (Capoten) and enalapril (Vasotec), block the production of a substance called angiotensin II, a potent constrictor of blood vessels. If blood vessels are dilated, the amount of work needed for the heart to pump blood forward is decreased.

Other drugs used in the treatment of heart failure include calcium-channel blockers, which dilate blood vessels; beta blockers, which slow the heart (used only in unusual circumstances); and medications that affect various heartbeat irregularities. Most cases, however, respond to diuretics and digitalis, especially when ACE inhibitors are added.

Sometimes, surgery proves effective. When heart failure is due to valvular disease, surgical implantation of an artificial heart valve or valve repair may alleviate the problem. Surgery may also be helpful in correcting congenital heart defects that can lead to heart failure. Coronary artery bypass graft surgery and catheterization using a balloon to flatten fatty deposits (called angioplasty) are among the therarpeutic techniques used to prevent and treat heart failure caused by occluded, or blocked, arteries.

Heart transplants are a last resort in treating severe heart failure caused by diseased heart muscle. Although the success rate of heart transplants has significantly improved, the cost of the operation and shortage of donor organs makes it impractical except as a last resort.

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