Medical Device Daily Executive Editor

Sleep labs aren't particularly easy places to get a good night's sleep in, says Allan Brack, VP of sales for the Americas for Somnomedics U.S. (Cooper City, Florida).

First of all, "you're not at home," he told Medical Device Daily. "You're in a room in a lab, or in a doctor's office, or a hospital. Obviously, when you put somebody in that environment, it's strange to begin with."

Then, you're hooked up with a bunch of wires — collecting information via channels — all these wires attached to a nearby "head box" for collecting data, the box then attached to a computer, nearby or in another room, for collection and analysis.

And since you have trouble sleeping, well, it's likely that you're going to wake up once during the night — or twice, or more — perhaps to go to the bathroom.

So all these wires have to be "unhooked, rehooked," Brack says, "and then you have to go back to sleep. It's all complicated and uncomfortable," and those complications make the sleep lab analysis less than precise.

All of this is what he calls "the biggest issue" in sleep studies and an issue that is addressed by Somnomedics and its device for getting around these complications and discomforts by actually making the sleep study accurate.

FDA 510(k)-cleared just last week, the company's Somnoscreen is a lightweight handheld device — somewhat shaped like, and somewhat smaller than, the typical video cassette — that allows the person being tested to avoid the unhooking and rehooking process. Belted to the body, the person can wake up, go to the bathroom or get up to take medicine and immediately return to sleep while the device is collecting data.

"All of the data collection is completely self-contained on the patient," Brack says.

The parent company of Somnomedics is Somnomedics GmBH (Kist, Germany), which has been selling the device in Europe since 2005 and is "just starting" sales in India and Asia, Brack says. He notes that the Somnoscreen will be introduced "literally this week" at a sleep congress in Bangkok.

Over the past two-and-a-half years, he says that the company has sold 800 units, making Somnomedics "the fastest-growing sleep apnea diagnostic company in the world."

And he doesn't see that growth slowing down.

"Ten years ago, sleep studies were minimal, at best," he says. "Now they are exploding as people become aware of the effects of lack of sleep" — ranging from serious traffic mishaps to psychological problems and the whole range of physical ills in between. Concerning the multiple impacts of poor sleep, lack of sleep, "There's no end," according to Brack.

Currently, he says the company is "literally starting" to look at a variety of options for distribution of the Somnoscreen in the U.S., from signing on a third-party distributor to developing its own sales force.

Cost of the device, he says, is "competitive," ranging from $9,000 to $12,000, on up to as much as $30,000, given the accessories that can be added, and matching the particular applications and testing methods desired by the user. At the high end this can range to the addition of digital video and audio options, with built-in infrared light source and radio transmitter for a complete sleep lab operation. The system is also modular, for later upgrading.

Brack notes that the device can be used to track a person's sleep either in real-time, "literally scoring various parameters as the patient sleeps," or collected on a flashcard and then plugged into a computer for later analysis.

Besides the ease of use, he says, Somnomedics "has some things no one else has" — primarily a continuous blood pressure collection system, thus adding in checking on possible cardiovascular co-morbidities.

The icing on the marketing cake is reimbursement coding well in place for such studies.

Parent company Somnomedics GmBH develops other types of sleep study devices, and some of these will be presented to the FDA for clearance, as early as this year, Brack said, including smaller devices with similar features.

The portable Somnoscreen will be shown at the "Focus on Respiratory Care & Sleep Medicine Conference" at the Opryland Hotel in Nashville, Tennessee, April 19 to 21.