Orsense’s non-invasive glucose monitor that allows a diabetic patient to test his or her blood glucose levels without spilling a drop of blood.

Doctors agree that the most essential way to treat diabetes and prevent long-term health complications is for every patient to manage their disease carefully by testing glucose levels regularly. Sounds easy right? But the majority of diabetic patients are doing no such thing. Instead of testing themselves the recommended four to seven times a day, many diabetics are testing themselves just once a day, while some are not bothering with testing at all.

So why would anyone want to risk a whole list of health problems ranging from impotence, blindness, kidney failure, nerve degeneration, cardiovascular malfunction, amputation, and even death just to avoid a test? The problem is the test itself – a painful pinpick of blood from the finger. Not only is it an unpleasant experience, especially when repeated month after month, year after year, but also it is also cumbersome, and unsafe.

Now an Israeli company, OrSense, has come up with a solution – a non-invasive glucose monitor that allows a diabetic patient to test his or her blood glucose levels without spilling a drop of blood.

Diabetes is a devastating disease with no known cure. In developed countries it is the fourth leading cause of death, and has now been recognized as a global epidemic, with the potential to cause a worldwide healthcare crisis. Currently some 200 million people worldwide suffer from diabetes, and the International Diabetes Federation estimates that this figure will rise to 333 million by the year 2025.

America now has over 21 million diabetics – some seven percent of the total population. Of this an estimated 14.6 million have been diagnosed with the condition, leaving well over six million unaware that they are suffering from the disease. A further 41 million Americans suffer from impaired glucose intolerance, a condition that leads to diabetes. In many of these people, the complications of diabetes may already be occurring, causing long-term damage to the body.

The result of this is that in the US one of every ten healthcare dollars is spent on treating or managing diabetes. In 2002, the total economic cost for the year of diabetes healthcare was estimated at $132 billion.

Decades of research confirm that obesity is an important contributing factor in diabetes. Eighty percent of Type 2 diabetics are also obese or overweight. The health care community forecasts that if the obesity epidemic in the US continues unchecked, the diabetes epidemic will continue to grow at an alarming rate.

OrSense’s monitor, the NBM-200G, is based on “Occlusion Spectroscopy”, OrSense’s proprietary measurement technology and is designed to non-invasively measure multiple significant blood parameters such as glucose, hemoglobin, SpO2, etc.

A ring-shaped probe is applied to the patient’s finger, gently stopping the flow of blood. The device generates a strong optical signal across the finger yielding a high blood driven signal-to-noise ratio. Analysis of this signal provides the sensitivity necessary to measure blood glucose and other analyte concentrations without the need to draw blood with a fingerstick test. Results are available within 30 seconds, and the measurement can be repeated painlessly and rapidly any number of times, and even continuously.

“OrSense stands out from competitors in this arena in because it does not try to measure blood in its natural state of circulation,” says Lior Ma’ayan, the CEO of OrSense. “Our technology is based on creating a new dynamic in the blood – looking at it, not in its normal behavior, but abnormal behavior.”

Over the last 24 months, OrSense has carried out four clinical trials in five different locations across Israel. Over 300 patients were involved in the trials, and over 100,000 measurements were taken. The study consisted of three phases: one focused on low glucose levels and two additional trials that simulated home use, including nighttime measurements.

Results show that readings obtained by the OrSense device were as accurate as those obtained using regular invasive testing of type I and type II diabetic patients under home conditions. The device was also found to offer very good quality of performance in the low glucose range.

The results of these trials were presented to the European Association of Diabetes, the International Symposium on Intensive Care and Emergency Medicine, and the American Diabetes Association’s 66th Scientific Sessions which was held in Washington DC in June. This is considered to be one of the most important conferences in the field, and OrSense was one of only two companies to present clinical results in non-invasive blood sugar testing at the event.

In his presentation to the Washington conference, Professor Avraham Karasik, director of the endocrinology institute at the Sheba Medical Center, Tel Hashomer, and the principal investigator of the study, said, “We believe that OrSense’s glucose monitoring system is set to become the system for real-time blood sugar monitoring of diabetes patients under home conditions.”

The device is already well advanced in the regulatory process in both Europe and the US. “We are in the final stage of data collection for CE approval,” Ma’ayan told ISRAEL21c.

The company also plans to carry out a pivotal trial in order to receive FDA approval.
Ma’ayan says he believes the device will reach the European and US markets early in 2008. Though there are a number of companies, including other Israeli companies, in the race to produce the first non-invasive glucose monitor, Ma’ayan feels confident that he is in the front of the pack.

While the glucose monitor is OrSense’s main product, the company has also developed the NBM-100, a non-invasive hemoglobin/hematocrit monitor. The NBM-100 has already been granted CE approval and goes on sale in the UK and Europe this year. It is now in trials in the US and the company expects it to win FDA approval soon.

The hemoglobin monitor can detect anemia and gives an early diagnosis of blood loss in ER or operating room environments. “This is a life-saving tool,” says Ma’ayan. “Studies have shown that doctors are waiting for a device like this because in the past they have lost patients due to hidden bleeds.”

The device can also be used before blood donation to painlessly check hemoglobin levels in potential donors. “Today the test for hemoglobin levels is often more painful that the donation itself because there are more nerves in the tip of the finger than in a venous location,” admits Ma’ayan.

OrSense was founded in 1996 by Dr. Alex Sternberg and Dr. Ilya Fine. Until now the company has raised $28 million. It’s last round, of $6.2 million, was held in February this year.

Principal investors in the company include Israel Healthcare Ventures, the Lewis Trust Group, STAR Ventures, Carlo Salvi and other individual investors. The Office of the Chief Scientist also invested $4 million in the company. OrSense employs 30, and is based at the Weizmann Science Park in Ness Ziona. The company has 20 granted patents worldwide, and over 25 additional applications in the process.

“Glucose monitoring is the essential tool for diabetics to control and regulate their illness, but the one clear barrier to this is the current mode of monitoring,” says Ma’ayan. “OrSense’s non-invasive blood glucose monitor holds out the promise of a dramatic improvement in the quality of life of millions of diabetics worldwide.”

(See Exclusive Video on Orsense from IsraelHighTech.TV).