Cardiometer’s test, which takes just 90 seconds, is non-invasive and completely painless, and tests the functionality of three main physiological functions of a patient’s cardiovascular system.About nine months ago, Ronen Arbel, the founder and CEO of medical devices start-up CardioMeter, met Shiri, an old friend of his in the street. Shiri, who is 40, had just come out of hospital having suffered a heart attack.
Shiri, (not her real name), had been feeling extremely tired before she had the attack, but at three months pregnant did not consider this a particularly unusual or noteworthy condition.

When she arrived at the hospital in Tel Aviv, the staff – noting her pregnancy – automatically took her to the maternity unit. On the way back to the heart unit, Shiri suffered a cardiac arrest and had to be resuscitated with a defibrillator.

In the wake of this, she was taken to surgery, where doctors carried out balloon angioplasty, and inserted a stent into one of her arteries.

“I should have checked the condition of my heart on your device,” Shiri, who has now given birth, told Arbel the moment they met.

Arbel’s company, CardioMeter, has developed an innovative diagnostic tool, also called CardioMeter, which can evaluate a person’s cardiovascular system in minutes, and assess the risk of a cardiovascular event such as a stroke or heart attack.

The test, which takes just 90 seconds, is non-invasive and completely painless, and tests the functionality of three main physiological functions of a patient’s cardiovascular system – arterial flow, which gives an indication of how well blood is flowing through the arteries; autonomic nervous system, which gives a picture of how the heart’s control system is functioning; and arterial stiffness, which shows the flexibility of arteries. Low flexibility indicates high cholesterol levels, or high blood pressure – both high-risk factors.
Together these indicators enable the calculation of a risk factor for future cardiovascular events.

“Our test does not examine statistics, it examines a specific person,” Arbel tells ISRAEL21c. “We check the function of your system.”

The CardioMeter, which has not yet reached commercial stage, is cheap, and easy to operate. It can be connected to a PC, laptop, or even a pocket PC. In years to come, users will also be able to connect it to a mobile phone. The test is carried out by clipping a device probe onto a person’s finger. The tested person must then carry out a number of simple and relaxing deep-breathing exercises. During these exercises pulse waveforms are optically measured by the probe.

The CardioMeter software then analyzes the recorded data and obtains diagnosis by examining the response of the cardiovascular system to the breathing exercise.

A device like this is extremely significant for women like Shiri. In recent years, there has been increasing concern about the growing number of women who suffer from heart disease.

Recent figures indicate that one in four women will die of coronary heart disease, making it the number one killer in North America and Europe today. As the number of men dying from cardiovascular events has declined, the number of deaths among women has risen dramatically. Heart attacks are twice as deadly for women as they are for men. According to statistics from the American Heart Association, every year about half a million American women die of heart disease, and it has claimed the lives of more women than men each year since 1984.

“Women suffer heart attacks about 10 years later than men do on average, but when they have them, they are far more likely to die of it than men are,” admits 38-year-old Arbel.

One of the difficulties in identifying heart problems in women is that there are often no specific symptoms before some kind of event. “Often the first real indication that there is a problem is a sudden death,” says Arbel. “About two-thirds of women who have a heart attack die as a result.”

Fatigue is probably the most common symptom of cardio-vascular problems in a woman, but as Arbel points out, this could relate to virtually any kind of illness and can be easily overlooked by a doctor. Other symptoms include breathlessness, lightheadness, nausea, unexplained anxiety and paleness. In comparison, men often experience chest pain.

As a result, doctors often mistake heart related complaints in women as anxiety, depression, or even indigestion.
The other problem is that many of the diagnostic tools available today do not give accurate answers. One of the most common ways to check the cardio-vascular health of a patient is an ECG connected to a treadmill. According to Arbel, in 40% of the cases, the results of this test are wrong. “It’s like throwing a coin,” he explains. “You might be told that you are sick when you are healthy and vice versa.”

CardioMeter was founded by Arbel in November 2003. Arbel, the former COO for ophthalmic company, Visionix, set up the tiny five-man start-up with research carried out by cardiologist Prof. Amos Katz, the director of the clinical electrophysiology laboratory at the cardiology department of Soroka University Medical Center.

The company, which is based in the Georges Leven High-Tech Management School, at Tel Aviv University where Arbel studied for his MBA, was set up as a garage operation. So far, no-one in the company has taken a salary for the work they do.

Work on the technology behind the CardioMeter is now completed, and the company has already carried out a number of clinical trials on patients at the diabetic clinic in Soroka Hospital in Tel Aviv. Results have so far proved encouraging. One of the subjects of the monitoring program is Isaac Landau, a diabetic, who is now the company’s business development director.

Landau, who is 57, suffered a heart attack over five years ago. When Arbel first began monitoring him, his results indicated that he still had a problem, particularly with his arterial flow. “It was the worst we had ever seen,” admits Arbel.

During a meeting at CardioMeter, Landau received news that his son had been injured in a car crash and became stressed. That night Landau had a heart attack and shortly afterwards explorative surgery revealed that one of his arteries was almost completely blocked. A stent was inserted, and the company monitored Landau throughout his recovery process. At several points, results from the CardioMeter device indicated that though Landau’s arterial flow was improving dramatically, and his arterial stiffness was also beginning to improve after he received aggressive anti-cholesterol drugs, the state of his autonomic nervous system was deteriorating and he was in danger of having another cardiac event.

The only answer for this, Arbel told him, was exercise. Landau began to exercise regularly, and within two weeks, his results began to show an improvement, and he was no longer in the danger zone.

Landau’s story shows just how effective constant monitoring can be. “It gives you great motivation because improving your health is no longer a theoretical thing. Doctors talk about improving your diet and exercise all the time, but here you can actually see the results,” says Arbel.

He admits that the monitor acts as a catalyst for many people. Landau’s 29-year-old son for example, never exercised and tests showed that though he was not in immediate danger, his heart was not as healthy as it could be. He took up sports, and three months later his results showed a great improvement.

The company is now planning to start a Phase III clinical trial of one thousand people with a large HMO in Israel in a bid to receive FDA approval. The study will follow patients in the wake of a cardiac event to see whether the device accurately indicates continuing heart problems. If the study goes well, the company hopes to expand it to the US. The study should be completed by 2005.

CardioMeter plans to penetrate the noninvasive cardiology monitoring and screening market with three different applications. The first is aimed primarily at cardiologists, and focuses on secondary prevention. The second market is clinics and GPs. Arbel believes this product will focus on primary prevention. Both these markets are potentially huge. More than $3 billion is spent in the US every year on ECGs. The last market is the homecare, or consumer, market. Arbel foresees two homecare monitoring products in this market, one for patients who are already at high risk of a cardiac event, and the second – a lifestyle monitor – for people who want to monitor the general condition of their heart. This lifestyle monitor will cost in the region of $99.

Currently some two million blood pressure monitors are sold in the US every year, these cost in the region of $50 to $100 each.
Interest in the consumer device is already high, and the company is now negotiating with a large US distributor that specializes in electrical consumer goods. The company hopes to introduce the consumer product to market in 2005, before clinical trials have been completed.

Entering the medical market will be a challenge. “The whole concept is very new and innovative. The medical community takes time to adopt these things,” admits Arbel.

Arbel is very well aware that CardioMeter is a small start-up with virtually no funding, and not much clout. To enter each of its chosen markets, the company must find serious partners. “A start-up cannot educate the market,” admits Arbel. “We plan to build our business in stages, and are looking for partners in every market we go.”

Aside from the US distributor, CardioMeter is now in talks with a large healthcare fund in Israel. The company is also looking for investment of about $5 million.
“The feedback from the market is very good,” says Arbel. “People want these machines. They don’t want to wait for the medical community, they want these devices now.”

(CardioMeter can be reached at ronen.arbel@cardio-meter.com)