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ensures it won’t fall off when the user rolls over in bed, but also allows for quick detachment. The company tried to make the Reza Band unobtrusive and designed it with “unassuming” colors “so it doesn’t stick out as much,” Maris says. That’s partly because some users might choose to wear it during the daytime, perhaps after meals, when the digestive system is more active. “Our market research said that people wanted this to be discrete, even if they wear it at home in bed,” unlike, for instance, notoriously obtrusive sleep apnea machines, he says.
Next, Somna ran a multi-center clinical trial testing the safety and effectiveness of the device with patients suffering from LPR. The study results have been presented at medical conferences, but have yet to be published in a medical journal, Maris says. Top-line results show that more than 80 percent of the 89 patients who completed the study experienced a meaningful reduction in symptoms within two weeks of wearing the device. This was measured by the change in their industry-standard reflux symptom index score, which improved by an average of 54 percent in device users, Maris says. In addition, 75 percent of patients and 92 percent of doctors said they were satisfied with the device.
The only notable side effect from using the device was a handful of patients who experienced mild skin irritation that typically would subside within an hour, Maris says.
Last spring, the FDA requested additional data before making a decision. Somna then submitted results from some earlier studies Shaker and his colleagues had performed, which involved fiber optic imaging to visually confirm the occurrence of acid reflux and the ability to block it using a device that applies external pressure. Somna also conducted another small safety study confirming that if the band inadvertently shifts during sleep, the device pressure isn’t strong enough to cause any serious issues, such as cutting off circulation through the jugular vein, Maris says.
The FDA eventually signed off on the Reza Band, although it took longer than most medical devices. That’s because the FDA sets a higher bar for clearing devices, like Somna’s, that go through the “de novo” classification process—meaning there isn’t a similar device already on the market with which to compare it. The Reza Band was just the fourth de novo device in 17 years cleared by the FDA’s ear, nose, and throat division, Maris says.
“That’s a big deal,” he says. “It’s a chance to bring a really needed solution to acid reflux sufferers, and to bring a new tool to the toolbox of acid reflux physicians.”
Steve and Cindy Clinch are among the early believers. Cindy suddenly began coughing nonstop last summer, and LPR was believed to be the cause. Steve, a retired cardiothoracic surgeon who lives in Omaha, NE, heard about the Reza Band and bought one in September through Somna’s European sales office to try out while he and his wife were vacationing in Spain.
Steve wasn’t sure the device would work, but he thought the concept had “some validity to it.” The first night Cindy wore it, she enjoyed the best night of sleep she’d had in weeks, he says. “It really saved our trip, and my wife immediately got better.”
During a recent checkup with a gastroenterologist, Cindy’s throat showed no signs of irritation from acid reflux, Steve says. He doesn’t know with certainty if that’s due to wearing the Reza Band, but it seems to have helped. “After putting the Reza band on, I can tell you that her chronic cough quickly subsided. She’s pretty much healed today.”
Steve Clinch, an active angel investor, says he has no financial ties to Somna, but he has expressed interest in investing in the company should it need to raise more funds.
That’s an option, Somna board chair Shannon says, but the company likely won’t need to raise more than $500,000 to tide it over until it reaches profitability—unless it decides to make a national advertising push. “We expect profitability to come within 12 months, and we don’t see a large need for money,” he says.
It will likely take time and a lot of work to win broad adoption by doctors, who are often “resistant to change,” Clinch says.
But Maris has generated early interest in the Reza Band through networking at industry conferences, building a database of about 600 doctors the company could sell to, Shannon says. Somna also intends to grow its staff of five people to nearly 20 by the end of the year, primarily hiring sales employees, Maris says.
“We think we’ll be able to get enough buzz in the marketplace to meet our sales objectives,” Shannon says.
If Somna’s business takes off, don’t expect its backers to quickly flip the company, Shannon says. The goal is to build a thriving business in Wisconsin. “We would like to let this one run,” Shannon says. “I don’t see any expectation of selling the company in the near term.”