Israel Company Develops Painless Glucose Monitor
portable GlucoTrack can accurately measure glucose
In 2002, diabetes cost the US an estimated $132 billion. Direct medical expenditures totaled $92 billion (compared to $44 billion in 1997), while indirect costs resulting from lost workdays, disability and mortality, totaled $40.8 billion. In 2002, diabetes alone represented 11% of the US health care expenditure.
Integrity-Applications was founded in 2001 by four men, Gal, David Malka, the VP of operations; Zvi Cohen, and Dr. David Freger, the company's former CTO. Freger suffered from type 2 diabetes and in December 2004, died of a stroke connected to his illness, at the age of just 48.
The founders came up with the idea because Freger was sick of having to prick his finger every time he had to check his glucose levels, and dreamed of finding a non-invasive alternative.
"We realized there was an urgent need for such a product, and that it was a very large market, giving us all the reason in the world to work on it," says Gal.
The expertise of the founders was in measurements, rather than medical devices, so they approached the problem from this perspective. One of the difficulties with creating a non-invasive glucose monitoring device, they realized, was accuracy. "The human body is very complex and the accuracy levels required from blood glucose measurements must be very high," explains Gal. "A single technology was not enough to create the necessary accuracy."
The answer was to use three independent technologies to monitor blood glucose levels and then correlate the results. "Developing the three different technologies was relatively easy," says Gal. "The hard part was combining them into a single device with a single interface and point of communication between them. It took quite a lot of effort to overcome this problem, but eventually we did."
Initially the team invested their own money in the project, but afterwards raised $2 million in money in four rounds of fund-raising from angel investors. The product was patented in the US last year and will be patented through Europe and the rest of the world in the coming months. Gal admits he is proud of how much Integrity-Applications accomplished with so little money.
Today the company is in the midst of raising a further $1.5m., from private investors. The company plans to use this money to put the device through Phase 2 clinical trials and to start marketing it worldwide. (Phase 1 clinical trials were held at Soroka Medical Centre in Beersheva). If all goes well in these new clinical trials, CE approval should be approved in the second half of this year, while FDA approval should take a further year. Gal expects the device to reach the US market in the second half of 2007.
Gal says the company is now in negotiations with major European distributors. It plans a step by step introduction to the European market. The UK will be one of the first markets, according to Gal.
In Europe, the GlucoTrack device should cost around 2,000 Euros. Initial outlay is more expensive than traditional invasive methods of blood glucose monitoring, but since the unit is not disposable, and the ear-clip must only be replaced every six months, Gal says the price is cheaper in the long run. A leasing alternative is also considered seriously. The company plans to create a series of versions of GlucoTrack for different types of personal use.
Currently there are about 10 companies worldwide developing non-invasive methods to monitor blood glucose levels. Gal insists, however, that Integrity-Applications stands out from its rivals not only for its accuracy, but also because it only needs to be recalibrated once a month. "Other devices must be recalibrated every few hours or days. This is time-consuming and annoying. Our system only needs to be recalibrated every month and the process is very simple," he says.
In addition, he believes that GlucoTrack will be first to market.
The real advantage of GlucoTrack, Gal believes, is that diabetics will start to monitor their condition more closely and more effectively, leading to improved health care, lower health risks, and lower health costs. "The diabetes market desperately needs a non-invasive glucose level monitor," says Gal. "A non-invasive device approved by CE and the FDA will be easily sold in very large quantities worldwide."
Reprinted courtesy of Israel21c.