Sources inform ''Globes'' that OrSense Ltd. has obtained US Food and Drug Administration (FDA) approval for its noninvasive hemoglobin and oxygen saturation monitor. The device is already sold in Europe.
The sources added that Germany's largest blood bank, one of the largest in Europe, has recently decided to use OrSense's monitors on potential donors, and that the companies signed an agreement worth an estimated few million dollars over several years.
OrSense CEO Lior Ma'ayan says that 400 million hemoglobin tests are conducted annually in the US alone, and the price of test is $1-4 for the patient. The test is currently carried out invasively by drawing blood. It is therefore painful, requires a skilled nurse, and is liable to infect both the patient and the nurse with infectious diseases. As a consequence, fewer tests are carried out than the medical market needs.
Hemoglobin tests have a range of applications. Blood donors are tested to ensure that the donation will cause no harm. Another application is to test for anemia among healthy patients, as it is a symptom of many severe chronic diseases, including heart problems, cancer, and diabetes, and can worsen these diseases. Anemia is also prevalent among 15% of young children, 10% of adult women, and 75% of patients who underwent major surgery, during and immediately after the procedure.
OrSense's monitor can monitor hemoglobin in the doctor's office to monitor patients who complain of fatigue; and to monitor groups, such as vegetarians, pregnant women, malnourished individuals, and hospitalized patients.
The device can also continuously monitor patients undergoing surgery, women with high-risk pregnancies and afterwards to quickly indicate internal hemorrhaging, which immediately affects hemoglobin levels, and to confirm internal hemorrhaging in patients arriving at emergency rooms.
"Our challenge is to decide what not to do," says Ma'ayan.
OrSense is most developed in the blood bank market. It is targeting hospitals and surveys, and its ultimate target is the home hemoglobin monitoring market. It has conducted about one million tests to date, and is growing rapidly, suggesting that its current annual revenue is a few million dollars. The company recently obtained marketing approval in China, and its local distributor, Sinopharm Ltd., has already placed its first order.
Since it was founded in 1996, OrSense has raised more than $40 million from Israel Healthcare Ventures Ltd., Star Ventures, Tamar Technology Investors (Israel) LP, QVentures, Madison Technology, the Lewis Trust Group, and Sicor founder Carlo Salvi.
Published by Globes [online], Israel business news - www.globes-online.com - on November 4, 2013
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