Somna Makes Case for Simple Device Before Drugs, Surgery for Reflux

Xconomy Wisconsin — 

Somna Therapeutics has just completed a three-year push to bring its medical device from prototype to marketable product, culminating this month with the FDA clearing it for sale.

That’s got Somna’s small team in Germantown, WI, feeling good, but they’re not pausing to celebrate for long. Now, they must quickly turn their attention to the startup’s most important obstacle to date: convincing doctors and patients nationwide that Somna’s surprisingly simple product, called the Reza Band, should be considered one of the main options for fighting acid reflux that affects the throat and lungs.

Somna co-founder and CEO Nick Maris is confident they’re ready for the challenge.

“So far, we’ve been able to tiptoe through the minefield of product development and clinical trials and FDA clearance, and we’re still intact,” Maris says. “We’re kind of battle-tested to go forward.”

Somna says millions of people suffer from laryngopharyngeal reflux (LPR), a condition in which acid and other stomach contents are regurgitated back up the esophagus and into the throat and lungs. The reflux often happens while the person is sleeping, and is largely a result of a malfunctioning upper esophageal sphincter—the band of muscles at the top of the esophagus that acts as a valve, tightening and relaxing to allow food and liquids to pass through.

Smoking, obesity, aging, and injury are among the factors that can contribute to problems with that valve, Maris says. When it isn’t working properly, it can allow acid to escape the esophagus. The results can include scarring, constant coughing, problems with swallowing, a hoarse voice, sleep interruptions, and the aggravation of conditions like bronchitis and asthma. In more serious cases, it can contribute to the onset of throat cancer.

It’s worth noting that LPR is not the same as gastroesophageal reflux disease (GERD), although the two are related and the terms are sometimes used interchangeably. GERD occurs when stomach acid washes back into the esophagus, and it’s typically associated with heartburn and chest pain. Somna is marketing its device solely as a remedy for LPR.

Currently, LPR treatment options include dietary changes, wearing loose clothing, sleeping in an upright position to keep acid from backing up into the throat, taking drugs to suppress gastric acid, and surgery.

Somna is positioning the Reza Band as a first line of defense against LPR, a simple treatment that allows patients to sleep lying down. The device is a band worn around the neck that applies slight, targeted pressure—roughly as much as you might use to take someone’s pulse—just below the Adam’s apple. That pressure is enough to buttress the valve at the top of the esophagus and help it prevent stomach contents from getting through, Somna says.

“Why would a patient go with an invasive surgery or a pharmaceutical that has the potential for side effects and additional costs, when they could try this first, at the very least?” says Somna co-founder and early investor Tom Shannon.

If the device is successful, it could also help save money. Acid reflux disease costs the U.S. healthcare system billions each year, Maris says, driven in part by medications that can cost more than $2,000 per patient per year. The Reza Band, meanwhile, costs $300. Somna intends to apply next year for reimbursement by the Centers for Medicare & Medicaid Services, he says.

The device was born through a moment of frustration-turned-inspiration by Somna co-founder Reza Shaker, a gastroenterologist at the Medical College of Wisconsin (MCW). He was trying to treat a patient with a particularly vexing case of acid reflux. The reflux constantly woke her up at night, and it had damaged her vocal cords to the point that she could no longer sing in her church choir, Somna says. After several remedies failed, Shaker was stumped, and told her that “the only thing left for me to do is to put my hands around your neck and press your esophagus closed,” according to the Reza Band website.

The light bulb went off, and he stitched together the Reza Band’s crude prototype using a rubber band, gauze wrapped in tape, Velcro, and staples, Somna says. The patient went home and started seeing results right away: She slept soundly through the night while wearing the contraption, and it eventually reduced her symptoms enough that her voice recovered and she could sing in her church choir once more, Somna says.

The Reza Band is one of those ingenious ideas that are so simple that doctors unaffiliated with Somna can hardly believe no one thought of it before. Part of the reason might be that doctors treating patients with acid reflux are so focused on treating the issues inside the throat that they don’t consider seeking solutions involving the neck, Maris says. “We’re looking at trademarking ‘Think outside the throat’ as the tagline for this,” he adds.

Milwaukee-area investors Shannon and Jeff Harris joined Shaker to form Somna and were its first two investors. They recruited Maris from nearby Serigraph to run the company, which licensed the technology from MCW in 2012. Somna raised about $3.4 million from angel investors to bring the device to market, Maris says.

The first year was dedicated to evolving Shaker’s prototype into what it looks like today (see picture above). Engineers came up with new features, like a dial to adjust the band’s tightness and a magnetic clasp that 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.”

Cindy Clinch wearing the Reza Band. Photo courtesy of Somna Therapeutics and Steve Clinch.

Cindy Clinch wearing the Reza Band. Photo courtesy of Somna Therapeutics and Steve Clinch.

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.”