Sommetrics has launched a pivotal clinical trial of its aerSleep II device for the treatment of obstructive sleep apnea (OSA). This study is being conducted at 10 university and community-based sleep centers in the United States under an Investigational Device Exemption approved by the Food and Drug Administration.
Termed the SUPRA study (Study Using Negative Pressure to Reduce Apnea), the trial will evaluate the treatment benefits and safety of applying mild external vacuum over the upper airway with the aerSleep II device in subjects with moderate and severe OSA who are unable to use standard therapy with CPAP. Subjects who exhibit an initial response to aerSleep II will be evaluated over 24 weeks of home use. The primary effectiveness endpoint is evidence of continued treatment response at the termination of the study.
SUPRA builds upon favorable clinical results seen in previous studies with the first generation aerSleep (aerSleep I), which demonstrated reduction in apnea similar to CPAP in responder subjects and a favorable safety profile in multiple studies conducted in the United States and Canada. These studies were the basis of a Health Canada Medical Device License for aerSleep I and the designation of the second generation aerSleep II as a Breakthrough Device by FDA.
“SUPRA is an important study for both patients and physicians,” says Kingman Strohl, MD, the lead SUPRA investigator and program director, Sleep Medicine, University Hospital, Cleveland, and professor of medicine, Case School of Medicine, in a release. “AerSleep II could become another approach for many people with sleep apnea who are unable to tolerate CPAP. It is a noninvasive therapy, intuitive to apply and comfortable. I look forward to aerSleep II having a significant role in managing this common and frequently undertreated life-threatening disease with important comorbidities.”
AerSleep II applies negative pressure over the external surface of the neck to hold the airway open during sleep. It is a self-contained unit with an integral vacuum pump. The unit is held in place without the need for a retaining strap and does not generate aerosols during use. In previous clinical studies, participants voiced a strong preference for aerSleep over other therapies like CPAP and oral devices. The aer+ technology utilized in the aerSleep devices is protected by 33 issued patents, with additional patents pending that include a proprietary skin-friendly interface material that has been incorporated into the second generation aerSleep device.
Andre Puleo, Sommetrics’ vice president for clinical affairs, says in a release, “We are ramping up enrollment in the study quickly to meet the tremendous interest in testing aerSleep II at the study sites. There is a pressing need for new approaches to OSA in the many patients unable to use CPAP. We expect aerSleep II to address this large unmet need.”
Sommetrics has also raised $11 million in its Series C Preferred round of financing. Investors in this round included existing shareholders and new investors in the United States and Australia. Funds will be used to support the pivotal trial and to support readiness for commercial launch. Up to $16 million is targeted for this round which is expected to close in early 2022.