OrSense Ltd. has obtained EU CE Mark certification to market its non-invasive continuous monitoring solution of hemoglobin and oxygen saturation to hospitals. The company plans to launch sales immediately in Europe this week. The company's devices use occlusion spectroscopy technology in the infrared part of the spectrum to continuously monitor various blood variables.
In a few weeks, OrSense plans to apply to the US Food and Drug Administration (FDA) for marketing approval of the device for both uses, which it expects to obtain by year-end.
The products that OrSense is launching reflect a major strategic change at the company in the past year. Until the end of 2007, its flagship product was a non-invasive home measuring monitor of blood sugar levels. The market for such a product amounts to billions of dollars a year, making it the mother lode for non-invasive devices. Many companies have tried and failed to develop such a device due to technological difficulties.
OrSense believes that it can pierce this market soon. However, CEO Lior Ma´ayan says, "We realized that the time had come, after my six years at the company, to put our business on a more practical footing."
The change in concept paralleled a change in the market. Ma'ayan said, "While we were developing the home blood sugar monitoring device, the market recognized the need for continuous non-invasive measurement at hospitals, not only of blood sugar, but also of other variables. The hemoglobin and blood saturation measuring markets are each considered to have the potential of $1 billion."
OrSense faces competition in both markets from medical device giants like GE Healthcare, as well as newer companies, such as Britain's Masimo Corporation (Nasdaq: MASI). OrSense's product will be the first hemoglobin measuring product to be marketed in Europe. The company believes that its blood saturation measuring device is better than current devices on the market, and has conducted the trials to support its claim.
Ma'ayan says, "Current products on the market are inaccurate precisely for the patients who need it the most, those with weak hearts. Our product is also accurate for these patients and is equal to its competitors."
Published by Globes [online], Israel business news - www.globes-online.com - on March 24, 2009
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