Leadership: Nick Maris, president and chief executive officer
Headquarters: W175 N11081 Stonewood Drive, Germantown
What it Makes: Medical device to prevent acid reflux
Founded: February 2012
Next goals: Rebrand device; Complete $1.3 million funding round; Ramp up marketing.
Funding: Has raised more than $7 million in three funding rounds.[caption id="attachment_352434" align="alignnone" width="770"] Nick Maris, president and CEO of Somna Therapeutics.
Six years, 10 clinical studies and mounds of paperwork later, Germantown medical device startup Somna Therapeutics has hit a key milestone: The U.S. Food and Drug administration has given approval for its Reza Band device to be sold over the counter.
Consumers can now buy the Reza Band, which is worn around the neck to reduce acid reflux symptoms, directly off the company’s website for $169.
Acid reflux results in the regurgitation of stomach contents from the esophagus into the larynx, pharynx and lungs and can cause chronic sore throat, cough, hoarse voice, sleep disruption and other symptoms.
Launched in 2012, Somna received FDA approval to offer the Reza Band by prescription in 2015.
The device, which is contract manufactured in Minnesota and Texas, was named after its inventor, Dr. Reza Shaker, chief of Gastroenterology and Hepatology at the Medical College of Wisconsin. Somna now plans to rename the Reza Band to “Reflux Band” to better inform consumers of what it does, and add a smartphone connectivity feature and symptom-tracking app for version two of the device, said Nick Maris president and chief executive officer.
There are no competitors to the Reza Band, Maris said, since it is a brand new medical device. Somna has two issued and three pending patents.
Somna serves a large addressable market, and now can do so without Somna or the patient having to convince the doctor to write a prescription for the Reza Band, Maris said.
“Acid reflux is a huge market,” he said. “Many millions of people in the U.S. and around the world have terrible acid reflux every day.
“In the one month since it’s gone over-the-counter, our sales have more than doubled from any month we’ve ever had. And we haven’t done any marketing yet.”
But Maris plans to ramp up marketing, and double Somna’s employee count to eight this year to aid in that effort. The company is bringing in between $500,000 and $1 million in annual revenue, but he expects its first 12 months with OTC sales to top $2 million.
Somna has raised a total of $7 million in funding to date, and Maris is working to raise another $1.3 million round this summer.
The Reza Band works by applying pressure to the cricoid cartilage area at between 20 and 30 milliliters of mercury.
“It’s about half the pressure of a tie,” Maris said.