Imagine what it would be like if the only way we could treat bacteria was by addressing the risk factors. We would probably devote far more effort to prevention. We would make a point of washing our hands, take plenty of vitamin supplements to strengthen our immune system, constantly check whether our bodies were showing signs of inflammation, and then take drugs to reduce fever and rest when we discovered them. In a situation like this, where we didn't test for the presence of bacteria and didn't take antibiotics to counter them, we would probably live shorter lives.
The same rule applies to the diagnosis and treatment of heart disease. Medical science has only recently made a clear statement on the precise manner of the development of heart disease, which results in hard cholesterol substances (plaques) being deposited in the walls of the arteries, blocking them. As long as we do not understand the exact stages leading up to the presentation of the disease, it is difficult to diagnose it before the more serious symptoms set in and it is sometimes too late do anything by the time this stage is reached. For example, 40% of heart attacks can't be detected even one day before they actually occur.
Accordingly, the disease itself is also not treated directly but by addressing the risk factors that cause it. If a person appears to be at risk of suffering a heart attack, he or she will be asked to exercise more, reduce cholesterol levels and, to be on the safe side, take various drugs. But how much exercise is needed to have an effect? How do we know if the drugs work? In addition, some risk factors such as genetic make-up and mental stress are not quantifiable at all.
Over recent years, a worldwide consensus has emerged that heart disease begins with damage to a thin tissue called endothelium, a thin layer of cells that lie along the interior surface of blood vessels. When the endothelium is damaged, it can result in the creation of a fatty deposit (plaque). This layer can trigger the creation of a thrombus which clots in narrowed areas in the artery, or is released into the blood stream, causing a clot elsewhere, as is the case in an ischemic stroke. "The damage to the endothelium is not a risk factor, it is the disease itself," explains Dr. Giora Amitzur, co-founder and CTO of medical device start-up Lavi Cardiatec Ltd.. "This means that if there is no damage to the endothelium, the other risk factors become less significant - even if your cholesterol is extremely high, you are not at much risk of suffering a heart attack unless the endothelium has been damaged. On the other hand, if you've started treating the risk factors, your cholesterol has dropped, you've lost 20 kilos and the endothelium is nevertheless damaged - the treatment probably isn't effective enough and needs to be more intensive."
According to Amitzur, drug companies are currently working on the development of drugs designed specifically to repair damage to the endothelium. The difference between treating the risk and treating the disease itself is like the difference between taking pro-biotic supplements and antibiotics.
But while treatment is essential, measuring endothelial functioning is also beneficial. One Israeli company already emerging as a specialist in this field is Itamar Medical Ltd. (TASE:ITMR). Lavi carries out the same measurement but with a different method which it claims, not surprisingly, is more accurate than that of Itamar Medical and other competitors in the field.
There are currently two types of tests. A test like the one developed by Itamar Medical measures the blood flow rate to the finger. First the blood flow is stopped, and then released again and allowed to circulate freely. The rate of flow depends on the flexibility and completeness of the endothelium.
But according to Amitzur and Lavi Cardiatec co-founder Dr. Eran Peleg, "When you place a finger on the artery on the inside of your wrist, you can feel the pulse - this pressure actually makes the blood vessels start working, to get the blood flow moving. This pressure is affected directly by the functioning of the endothelium. The healthier it is, the more pressure it will create, which will then translate into faster blood flow. But this is a roundabout method of measurement, while we measure directly." Ultrasound scanning is another alternative to Lavi Cardiotec's method. Lavi Cardiotec's device, which is similar in use to a blood pressure monitor, measures endothelial functioning by analyzing blood flow in the arteries in the arm, not the fingers.
The method of testing is similar to that of a regular blood test. "The aim is to offer the test to family doctors, with nurses the ones actually carrying it out," says Amitzur. "The existing range of tests consists of the ECG, which has often been found to be ineffective, or costly invasive procedures, such as radioactive imaging, or diagnostic angioplasty."
Globes: Aren't cardiologists likely to insist on continuing to carry out diagnostic angioplasties? They are a powerful sector in the medical world, and undoubtedly have an unshakeable belief in the methods they're accustomed to.
Amitzur: "Even if some cardiologists continue to keep faith with angioplasty, they will eventually have to come to terms with the revolution, once they see just how great the saving on costs and prevention of disease complications are."
Lavi Cardiatec was founded on the basis of research conducted at Tel Aviv University by Peleg, Amitzur, and Prof. Shmuel Einav. The company CEO is Avner Amir formerly general manager of Tadiran Lifecare, an independent medical device division of Tadiran Spectralink. The company recently graduated from the Misgav Technology Center incubator, and was named after Lavi Werner, the former manager of the incubator who accepted the company, but later died of a heart attack at the age of just 46.
Do you believe that your product could have saved someone in Werner's condition?
Amitzur: I believe it could have. He did have a number of risk factors that went untreated, and we warned him that he could have a problem at some point, but I believe that had he understood just how serious his disease was, he would have realized a lot sooner that he needed to treat those risk factors urgently."
Upon graduating from the incubator, Lavi raised additional funding, reportedly around $1 million, from a number of private investors and from Misgav's owner Trendlines International Ltd.. It carried out a clinical trial, made improvements to the product, and is currently conducting further clinical trials. Once this is complete, Lavi will adopt a two-track approach - it will sell the product as an accessory to drug companies contemplating the development of cardiovascular drugs, while at the same time, it will begin the application process for approval by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) to market its device, initially to cardiovascular diagnosis institutes, and then, as mentioned earlier, to family doctors.
Published by Globes [online], Israel business news - www.globes-online.com - on April 2, 2008
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