DELFT, Netherlands – NightBalance BV plans to use a recent EUR $12.5 million round of financing to bankroll a U.S. launch into the alternative sleep therapy market.
NightBalance makes the Sleep Position Trainer, a device worn around the upper body that, once users turn onto their backs, gives them a gentle vibration, reminding them to change sleeping positions. The company says the device alerts users during lighter sleeping stages, minimizing disruption to their “natural sleep architecture.”
Founder and CEO Eline van Beest says the Sleep Position Trainer targets the 56% of those with sleep apnea whose condition is triggered by sleep position.
“They can use the Trainer instead of more invasive measures (like CPAP and dental devices),” she said. “In the Netherlands, 95% of hospitals are prescribing the Trainer for people with positional sleep apnea.”
NightBalance will use the financing to conduct clinical studies in the U.S., guided by leading sleep specialist Dr. David White, a professor at Harvard Medical School and former chief medical officer for Philips Respironics, and to file for 510(k) clearance with the U.S. Food and Drug Administration.
Additionally, NightBalance will use the financing to intensify and expand existing commercial efforts in Europe, where it’s available by prescription in 10 countries and counting.
While the Trainer has gotten good traction in Europe, it’s a cash product and NightBalance wants to make it a reimbursable one.
“We’re working with insurance companies in the Netherland on that right now,” van Beest said. “It’s looking positive.”
In the U.S., NightBalance has hired John Lipman, formerly vice president of marketing and commercial development for Apnicure, maker of the Winx oral pressure therapy device to treat sleep apnea, as COO. One of his first tasks: determining the best business model in the U.S.
“John has been doing it differently with different companies, and he’s seeing what’s best for us,” van Beest said. “We’re looking at all possible models—it could be through docs, through DMEs or directly to users.”
NightBalance is working toward a target commercial launch in the U.S. in late 2017.
The company’s recent round of financing, announced July 5, was led by INKEF Capital and Gilde Healthcare Partners. Existing investors Thuja Capital, Health Innovation Fund and Van Herk Ventures also participated.