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.