BiteStrip is a disposable sensor that electronically checks for the widespread syndrome known as Bruxism. This syndrome is characterized by grinding and clenching of the teeth during sleep.How did a small Israeli company emerge as the world’s leading sleep disorder sensors manufacturer?

According to SLP’s CEO Noam Hadas, it was a combination of providing a quality product and being on the crest of a wave.

For SLP, that wave was sleep apnea. Sleep apnea is a serious medical disorder, affecting 4% of men and 2% of women. It is characterized by repetitive reductions or complete obstructions of airflow during sleep due to the collapse of the pharyngeal airway, causing loud snoring, brief awakenings, hypoxemia and elevated blood pressure. Sleep apnea is relatively unknown, with only about 15% of patients diagnosed so far. But according to Hadas, sleep centers have proliferated throughout the U.S. in recent years as the syndrome has become more known.

“There’s much more awareness now of sleep apnea. It’s a whole different ballgame. It used be a small niche market, now it’s a leading medical sector – more than $2 billion worldwide,” Hadas told ISRAEL21c. “When I used to tell people 10 years ago I was working in sleep, they would laugh at me. Now there’s some understanding.”

Hadas’s involvement with sleep disorder diagnosis got its start through a connection with the prestigious Technion Sleep Disorder Center back in 1992.

“Sleep sensors are our franchise product – they are the cables connected to sleep monitoring systems. When you go to a sleep disorder clinic, and they put sensors all over your body, most of them are using our sensors,” said Hadas.

He described how Technion Professor Peretz Lavie, a renowned sleep expert and one of the pioneers of sleep apnea diagnosis approached him back in 1992 about collaboration.

“The Technion sensors were originally developed for internal use. But they discovered there was a market for them as sleep clinics began springing up. Professor Peretz came to me – I had a small R&D company – and asked me to help develop more types of sensors,” Hadas said.

“From that initial momentum SLP was established – with no investment and just a one and half person staff. We had not business plan, other than to just start working and see what happens. Over time, we introduced more and more sensors, and began working with a good distributor in the U.S. And here we are today – with over 20 people and the world’s leading sleep disorder sensors manufacturer.”

But where SLP is really breaking the mold is in its home diagnostic products, where they are attempting to change the standards in the industry.

Its flagship product SleepStrip is a disposable home screening test for sleep apnea.
Several research studies have shown that its indications correlate well with those of formal sleep studies. The FDA and CE approved product is available via prescription through health-care providers worldwide at a low price to the public as a self-administered test. SleepStrip is being sold over the counter in Europe and Israel.

According to Hadas, researchers in the U.S., Germany, Belgium, France, Italy, Israel, and Canada have used SleepStrip to successfully screen patients with sleep apnea after one-night tests.

“We plan on placing the Strip where patients will have easy access – like overweight clinics, impotence clinics and other clinics who treat populations with high incidence of sleep apnea, but who so far do not test or even consider it in their diagnosis and treatment.”

SleepStrip won a Gold Medical Design Excellence Award in an international competition organized by Canon Communications in 2001. The MDEA competition is the premier international awards program for the medical technology community.

And proving it was no fluke, another addition to the SLP diagnostics called BiteStrip just won another MDEA award. The award will be given in New York in June in the framework of a medical product expo.

BiteStrip is a disposable sensor that electronically checks for the widespread syndrome known as Bruxism. This syndrome is characterized by grinding and clenching of the teeth during sleep.

Both SleepStrip and BiteStrip are based on SLP’s ‘smart sensor’ platform, integrating a physiological sensor, real time signal processing and analysis, a permanent digital display and a power source, all on one flexible miniature substrate. This patented and patent pending technology enables SLP to bring forward, in a very short time and relatively small investment, many sensor products for various medical disorders.

“SleepStrip was the first product based on our platform technology,” said Hadas. “We integrate a physiological sensor with real time analysis of signal and electrochemical display. It’s all integrated on one device. The SleepStrip is one manifestation. But you can take this model in many directions.

“We’ve introduced the BiteStrip which follows the same concept. There’s a muscle activity sensor and we analyze in real time every time the subject grinds his teeth. The severity of the disorder is displayed in the morning on a monitor.”

The prevalence of Sleep Bruxism is estimated at 14%-20% in children and 8% in adults. However, few patients are diagnosed, leaving the majority of patients to deal with the consequences of dental problems and pain that can be successfully treated. Diagnosis of SB is usually based on clinical examination and patient history. However, none of the signs and symptoms may be considered conclusive. A definitive diagnosis can be obtained by a formal sleep study, costing anywhere from $600 to $1500

According to Hadas, SLP’s consumer products like SleepStrip and BiteStrip are just beginning to take off in the U.S. So far, since its introduction five years ago, about 30,000 SleepStrips have been sold worldwide in spot sales to clinics. BiteStrip is awaiting FDA approval which is expected in the coming weeks.
Both SleepStrip and BiteStrip will have a consumer price of under $50, according to Hadas.

In another achievement, SLP was recently chosen along with four other Israeli companies to participate in MarketReach America – a project of the The Maryland/Israel Development Center. It brings together promising Israeli companies with life science business experts to provide U.S. market entry consulting and a business support structure in America and Israel to expedite their successful penetration into the American market.

Hadas feels that the right circumstances have fallen together and the time is right for SLP’s products to crack the American market in a big way.

“We’re very close to signing a distribution agreement in the U.S., and when this happens every doctor in the U.S. dealing with sleep disorders will be able to prescribe our diagnostic products,” said Hadas.