Somna Rebrands Acid Reflux Band in Bid to Reach More Patients
There’s a long list of products named after their inventors: everything from the diesel engine to Jacuzzi tubs to the leotard.
For years, the list had also included Reza Band, a medical device co-developed by gastroenterologist Reza Shaker and sold by Germantown, WI-based Somna Therapeutics.
Somna’s medical device is no longer on that list. This week, the company said its device, which is designed to be worn around the neck to stop acid reflux that affects the throat and lungs, is now called Reflux Band.
The name change marks a “major turning point” for Somna, says president and CEO Nick Maris. Having the word “reflux” in the product name better conveys Reflux Band’s purpose to patients and healthcare workers than the previous name, he says.
The switch follows Somna’s announcement, in May, that the FDA had cleared the device to be sold over-the-counter. Around that time, Somna also dropped the price of Reflux Band to $169 from $299. Those two moves, along with the company’s decision to rename the device, are all part of a new strategy of getting more patients to learn about, and consider buying, Reflux Band.
Somna has sold nearly 3,000 of the devices since launching the product in early 2015, Maris says. He declined to share revenue figures, or say whether he expects Somna to turn a profit in 2018.
Reflux Band is designed to combat 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, which occurs most often when the person is asleep, is in large part the result of a malfunctioning upper esophageal sphincter. That’s a group of muscles at the top of the esophagus that functions like a valve, tightening and loosening to allow food and fluids to pass through.
Problems with the upper esophageal sphincter are often associated with weight gain, aging, alcohol and tobacco use, and other factors. When this valve is not able to expand and constrict properly, acid can flow from the esophagus into the throat, voice box, and lungs, Somna says. Symptoms of LPR can include coughing, burning and irritation in the throat, difficulty swallowing, and sleep loss.
LPR is distinct from gastroesophageal reflux disease, though the two conditions are related and can be treated with some of the same medications. Gastroesophageal reflux disease occurs when stomach acid flows back up into the esophagus, and the condition can cause heartburn and chest pain. Somna markets Reflux Band exclusively as a treatment for LPR.
Acid-suppressing drugs such as omeprazole (Prilosec OTC) and esomeprazole (Nexium) can be used to treat both gastroesophageal reflux and LPR. Other treatments for LPR include surgery and wedge pillows that force a person to sleep upright, Maris says. One advantage of Reflux Band is that people who wear the device to fend off symptoms of LPR can sleep lying down, he adds.
Reflux Band works by applying a small amount of targeted pressure just below the Adam’s apple. It’s less pressure than one feels wearing a necktie, and about the same amount of force as you would use to take someone’s pulse, Maris says. The band’s pressure is enough to buttress the valve at the top of the esophagus and help it stop acid from leaking through, Somna says.
While patients no longer need a prescription from a healthcare provider to buy Reflux Band, part of Somna’s long-term strategy is educating more doctors about the device, Maris says.
“We will still be marketing to the physician community,” he says.
Somna had initiated the process of requesting that the Centers for Medicare and Medicaid Services (CMS) cover some or all of the cost of Reflux Band for patients, but scrapped those plans in recent years, Maris says. The company does not plan to petition CMS or other health insurers to reimburse providers and patients for Reflux Band, he says. Instead, patients must purchase the device out-of-pocket.
Maris estimates that Somna would have had to spend five or more years—and millions of dollars—trying to persuade insurance companies to cover Reflux Band. Even if Somna were to spend lots of time and money doing so, there was no guarantee insurers would decide to reimburse for the device, he says.
“It would take way too much time to potentially get reimbursement,” Maris says. “The prospects of actually getting reimbursement are remote. There are tons of products that have died on the vine.”
Somna currently has clearances to market Reflux Band in the U.S., Canada, Australia, and some countries in Europe, Maris says.
The company currently has four employees, he says. Shaker, who works at Froedtert & the Medical College of Wisconsin and the Zablocki VA Medical Center in Milwaukee, advises Somna but is not an employee, Maris says.
Somna has raised about $8 million in outside financing since launching in 2012, Maris says. It’s possible the company will rely only on revenues and retained earnings to continue fueling the growth of Reflux Band, he says. But Maris isn’t ruling out the possibility of bringing in more money from outside investors.
“We may choose as a business to go externally to raise more funds to grow faster,” he says.