Sleep is a fundamental component of long-term health. Sleep apnea, a condition in which breathing repeatedly stops and starts during sleep, prevents quality sleep, and it’s far more common than most people realize. An estimated one billion people worldwide suffer from obstructive sleep apnea (OSA), in which the throat muscles and soft tissues relax, and physically block the airway. That’s roughly one in every eight people—including 54 million in the United States alone. OSA carries serious health consequences, such as an elevated risk of heart attack, stroke and diabetes.
For most patients, the standard prescription is continuous positive airway pressure (CPAP), which involves a continuous airflow mask worn during sleep. However, nearly half of sufferers find they can’t tolerate the bulky device long-term.
That’s where Somnair, the newest company in Fogarty Innovation’s Company Accelerator Program (CAP), is making a difference, designing what it believes to be the first non-invasive neurostimulation device to treat the condition. The device, which is similar to a retainer, uses gentle electrical stimulation to activate a novel nerve target, which improves the tone of the muscles in the airway and prevents the collapse that triggers OSA events.
A wake-up call for a better solution
Somnair is led by co-founders Mitchell Turley, an MIT-trained engineer with expertise in product development and regulatory pathways, and Anders Sideris, MD, who has trained in ENT and sleep surgery and was mentored by a prominent sleep surgeon, an experience that shaped his clinical and academic focus on OSA.
Sideris and Turley met at the Johns Hopkins Center for Bioengineering Innovation & Design (CBID). “We knew there was a big unmet need for something more comfortable than CPAP and less invasive than surgery,” Sideris said. Together with additional co-founders Phoebe Dijour and Shri Prabha Shivram, they worked through the Johns Hopkins Biodesign process, learning how to integrate the clinical and engineering domains. Sideris and Turley then served as innovation fellows where they incubated the concept alongside a sleep surgeon and sleep medicine specialist at Hopkins.
An early clinical study conducted in more than 40 patients established proof of concept in humans, showing that stimulating the target nerve in this form factor could open the airway and restore airflow without waking patients. Realizing the concept had promise, they incorporated the company.
Backed from early on by two large venture capital firms, Somnair recently closed a $4.3 million seed round, bringing total funding to approximately $5 million. The team is currently formalizing the device design based on clinical data gathered to date. They’ll execute an early feasibility study in Australia as the first clinical trial, and if that goes well, will apply for an Investigational Device Exemption (IDE) in the U.S. and initiate a study here. While they’ve begun early conversations for Series A funding, they’ll start seriously pitching to investors and undergoing diligence as they approach the clinical trial.
Fogarty opens eyes to what it takes to succeed
Somnair’s path to Fogarty Innovation began with a referral from a former Johns Hopkins CBID graduate who later went on to Stanford Biodesign, and was shaped by several years of conversations and relationship-building before the timing aligned for a move west.
The team was drawn to Fogarty because of its proven track record and the desire to learn from people who “have successfully gone through this process countless times,” Sideris said.
Key priorities while at Fogarty include evidence generation, specifically extending their proof-of-concept study in a sleep lab setting. Already, Fogarty CMO Zach Edmonds, MD, has connected the team with local sleep clinicians.
Another is strategic R&D input from advisors who have operated as engineers inside both startups and larger strategics.
“There’s a long history of people within Fogarty who have built, executed and sold medical device companies, and the insights they’ve gained from those experiences are an invaluable resource for us,” said Sideris. “The wealth of knowledge they offer will be game changing.”