The ETT-PAT 2000 System identifies disruptions in cardiac activity during stress tests.An Israeli medical devices company has developed a new non-invasive diagnostic tool that can help doctors detect heart problems more accurately and earlier than existing devices on the market, helping to save thousands of lives every year.

In the US, one million people die of heart attacks every year, making it the number one cause of death, greater than both cancer and AIDS deaths combined. A further four to five million patients in the US suffer from congestive heart failure, while millions more suffer a range of other cardiac conditions.

At present the first line of diagnosis for heart problems is an EKG. Some 12 million EKGs are carried out in the US every year. The EKG, however, fails to diagnose about 40-50 percent of heart patients.

“There have been cases where a patient carries out an EKG, is given a clean bill of health, and then dies of a heart attack on their way out,” says Israel Schreiber, the CEO of Caesarea start-up Itamar Medical. “It’s like playing with dice. Some 50% of men, and 63% of women die of a heart attack without even realizing they had heart problems.”

Schreiber’s company has developed a device called the ETT-PAT 2000 System, which can identify disruptions in cardiac activity during stress tests. The device, which includes a specially developed finger probe, records measurements of the blood volume in a patient’s finger during exercise and mental stress tests. In a healthy patient one would expect to see the blood volume rise as they undergo the exercises because the heart is working harder to pump blood to peripheral areas to help cool the body. If a person suffers from a cardiac problem, however, the heart prefers to pump blood to internal organs rather than peripheral areas. As a result the signal from the finger probe will be lower.

The ETT-PAT is a simple test designed to be used in tandem with an EKG. “It increases the sensitivity and accuracy of the EKG by 35% making it a reasonable medical test,” explains Schreiber. The initial hardware costs $5,000, but the probes are disposable and cost just $25 each.

Itamar’s technology can also be applied to the diagnosis of sleep apnea, a condition where people stop breathing for short periods during sleep. Many people suffer about 10 sleep apnea episodes an hour without any negative results. Only once the episodes increase to over 15 an hour do doctors actually diagnose it as a problem. In extreme cases a patient can suffer from 500 sleep apnea episodes a night – 60 to 70 an hour.

While this is not a life threatening condition because the body’s sympathetic nervous system wakes a person to ensure he continues breathing, it causes snoring, fatigue, and in some cases impotence. In 70% of cases it is also an indication of more serious heart problems.

In the US, 18 to 20 million people are thought to suffer from this condition, making it as widespread as asthma. Despite this, only 10% of these patients are diagnosed, because current testing is intrusive, uncomfortable, and time-consuming. Patients have to attend a sleep laboratory at a hospital for one or two nights. Electrodes are hooked up all over their bodies and they are monitored throughout the night. About 1.5-5 million sleep tests are carried out a year in the US, and some 75-80% of patients who undergo the test are diagnosed with sleep apnea.

Itamar’s new device, the Watch-PAT 100, is worn on the wrist and uses a non-invasive finger probe to measure blood volume. The signals are stored in a removable memory card in the device, which can then be downloaded to a computer for analysis. The company says this test is so simple it can be carried out by the patient himself in his home environment, causing minimal interference to sleep.

Both the Watch-PAT and the ETT-PAT tests have received FDA approval in the US and CE approval in Europe. Watch-PAT went on sale in the US in 2002. It is being distributed by Respironics, the largest US company in the field of sleep medicine.

The ETT-PAT will go on sale in the US in the second half of this year. Itamar is now looking for a suitable US distributor.

Itamar was founded in 1997 by heart surgeon Prof. Danny Goor, Prof. Peretz Lavie, Giora Yaron and Martin Gerstel, former CEO and chairman of pharmaceutical company ALZA. The team approached US medical technology company Metronic, which agreed to finance the company with a $1m. loan. To date Medtronic has invested a total of $20m. in Itamar, and owns 24 percent of the company. Since the first seed investment the company has held two other fund-raising rounds. The latest was held in July 2002 when the company raised $8m. US life sciences company, Bay City Capital invested $1m. in this round.

With the backing of Medtronic, Itamar has tested its devices on some 3,500 to 4,000 patients in clinical trials at the Mayo Clinic, Yale, Stanford and Columbia universities. Over the next year Itamar plans to increase its marketing presence and look for new distributors. Schreiber said he expects sales of the new devices to begin properly in about a year to 18 months. He also anticipates that the company will reach profitability at this time.

Itamar is now working on new technologies, including a device that will be able to indicate cardiac problems two to three decades before a person has a heart attack. This device is at an advanced stage of development and has already been tested in clinical trials at the Mayo Clinic.

“We have overcome a lot of obstacles and hurdles and I think this market has great potential,” says Schreiber. “There is a great need for our products.”