The US Food & Drug Administration (FDA) cleared the Somnera System in June of 2020, and Somnera Inc (also known as Fresca Medical Inc) is preparing for high-volume manufacturing to meet increasing demand in respiratory healthcare. The Somnera System will be available exclusively through The CPAP Shop, an online sleep device retailer owned by Agile Medical.
Somnera provides positive airway pressure without the continuous high airflow of CPAP. At 13.3 cm x 8.8 cm x 6.8 cm, it is smaller than many CPAP devices.
Somnera’s recent clinical study demonstrated effectiveness in treating obstructive sleep apnea. “This is the second randomized trial that demonstrates the safety and efficacy of Somnera in treating sleep apnea. Sleep apnea is often tough to treat because some patients cannot tolerate CPAP and many abandon treatment,” says Richard K. Bogan, MD, study investigator, in a release. “There is a vast patient population who could benefit from an additional treatment option.”
The system fits within existing diagnosis, treatment, and reimbursement pathways. It will be sold along with a “SleepBridge Patient Services” program, an onboarding and support program that will be provided at no charge to each new Somnera user.
“As the number of sleep apnea diagnoses grows and reliance on CPAP continues to increase, the number of people who struggle with long-term adherence to CPAP therapy also increases. We are proud to work with Somnera on the launch of this disruptive, low-flow technology that can potentially benefit thousands of CPAP patients who are unsatisfied with traditional CPAP therapy,” says Anthony Zadnik, CEO of Agile Medical, in a release. “Somnera will be available for purchase and supported exclusively at The CPAP Shop.”