Israeli company Elfi-Tech hopes to do away with blood tests to check blood coagulation levels and replace them with a non-invasive test that uses light to come up with the same readings.A heart attack or stroke is a life-changing event. It’s not just a new diet; it’s a new way of life. Patients have to quit smoking, start exercising, and they also have to visit the doctor once a week to check blood coagulation levels (PT/INR levels).
This weekly visit to the doctor can quickly become a hassle and studies show that once a patient starts to feel better, many drop out of the program. If they are lucky, they won’t have another attack, but the studies suggest that many patients end up right back where they started, or sometimes in a worse situation than before.
Now an Israeli company, Elfi-Tech has developed a device that could make blood coagulation checkups less irksome. The technology not only checks coagulation levels without drawing blood, but it also lets patients do the test at home.
Strokes and other heart diseases are often caused by blockages of arteries, with blood unable to reach the brain. Thrombosis and embolism, two of the main causes of stroke, are associated with blood coagulation. When the blood vessels have become too narrow to allow clots or coagulated blood to pass (due to arteriosclerosis, hardening of the arteries), strokes and heart attack risk rises significantly. Once an attack occurs, the cardiovascular system is weaker – and in many cases, the heart can’t handle a second one.
For doctors, the immediate need is to prevent another attack, and since repairing the arteries takes much time and effort, most doctors go with a treatment that will yield immediate results – prescribing blood thinning drugs such as Warfarin, Plavix, Comadine, and others. Using these drugs, doctors can help prevent repeat – and possibly fatal – strokes or heart attacks due to coagulations that block the blood vessels.
But blood thinning is a tricky business. If the dose is insufficient, the blood will still be too thick, meaning that a thrombotic event could still occur; too thin, and excessive internal bleeding could occur. So, keeping an eye on the patient’s blood coagulation level is essential.
Stick to the program
That’s where Elfi-Tech’s blood coagulation monitor comes in. Dr. Ilya Fine, CEO of the company, says that home checking of PT/INR levels is the wave of the future. “Patients will be far more willing to stick with the treatment routine if they feel more comfortable with it.
Elfi-tech’s device solves two major issues for patients – enabling them to undergo their test at home, and saving them from having to have their blood drawn.”
Instead of blood, Elfi-tech’s monitor uses light to determine coagulation levels. Using a method called Circulation Pattern Recovery, the Elfi-tech monitor uses Laser Speckle Contrast Imaging (LSCI) to determine the velocity at which the blood flows through the vessels – essentially using color to figure out whether the blood needs to be thinned.
After being analyzed by sophisticated algorithms unique to the Elfi-tech monitor, the information is then transmitted to the patient’s caregiver (via Wi-Fi and/or cell phone connections). The doctor can then make a determination on whether the dosage should be changed, or remain as is.
The Elfi-tech monitor saves lives in more ways than one, says Fine. “Many patients are evaluated once a month, but the body can change much more quickly. Studies have shown that if coagulation levels were checked once a week, repeat thrombotic events could be reduced by 70 to 90 percent.
“While some more serious patients get that kind of attention, most doctors and hospitals are too swamped to provide that kind of routine. But with our monitor, patients can do the checkup themselves, with doctors getting the analysis directly on their computers – enabling them to make a diagnosis without further cramping their schedules.”
A real-time test
In addition, the blood flow is checked in “real time,” while it is actually flowing – making the examination far more accurate than the results yielded by a blood sample, Fine says.
Eventually, Fine believes that home checkups of blood coagulation will become as common as home blood pressure tests, or even self-administered insulin shots.
“At one time, both those procedures could only be done by doctors, but after some pilot programs, it became clear that public health was advanced when patients were able to manage those procedures themselves,” he explains.
Health officials in the US and European Union are now studying the effects of home administration of blood coagulation levels, according to Fine. “Our system not only enables patients to do the check at home, but also answers public safety concerns, since there is no need to draw blood, and the information is sent to their doctors,? thus preventing possible abuse by patients tempted to “self-medicate” using the information provided by the monitor, Fine says.
The Elfi-tech monitor is in its final stages of development, and the company is set to submit the device for approval by EU medical authorities in the coming months (FDA approval will be tackled later on, says Fine).
The company has raised about $1 million since it was founded in 2006, with about $350,000 coming from the Chief Scientist’s Office. In fact, Elfi-tech was named Israel’s “most promising medical device start-up for 2008” by the Chief Scientist’s LifeScience Accelerator, ILSI (Israel Life Science Industry), and the Israeli Export Institute.
Despite the tough economy, Fine is convinced he will be able to raise the money necessary to continue the product’s development. “Bad economy or not, nobody wants to get a stroke or heart attack. Our monitor will be able to help patients live longer, and that’s an idea that ‘sells,’ regardless of the economy,” he explains.
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