The US Patent Office recently granted a patent to Sommetrics for the use of a chin cup feature in the design of its aerSleep collar to maintain positional stability of the device during sleep.
Sommetrics is advancing activities aimed at obtaining US Food and Drug Administration (FDA) market clearance for its flagship product, aerSleep II, which is targeted for the treatment of obstructive sleep apnea in those unable to use CPAP therapy. The self-contained and noninvasive aerSleep device externally applies mild vacuum to the neck to expand the upper airway, eliminating the need for a face mask or tether of any kind.
The newly patented chin cup feature helps to obviate the requirement for a retaining strap, which enhances freedom of movement during sleep. The allowed claims include the use of a fully integrated silent piezoelectric pump as the vacuum source for the aerSleep device. A separate Japanese patent was also allowed and covers methods for avoiding contamination and blockage of the vacuum pump during use.
The approval of these patents in the United States and Japan brings the number of Sommetrics patents approved in key global markets to 36.
In other Sommetrics news, the six-month aerSleep pivotal trial termed the SUPRA study (Study Using Negative Pressure to Reduce Apnea) is now being conducted at university and community-based sleep centers in the United States. The lead SUPRA Investigator, Kingman Strohl, MD, program director, sleep medicine at University Hospital in Cleveland, and professor of medicine at the Case School of Medicine, says in a release, “There is a great deal of excitement at the SUPRA study sites and among study participants about the opportunity to evaluate a much-needed alternative to CPAP. To date, we are pleased with the safety profile of the device and look forward to reporting on aerSleep’s effectiveness when the study is completed at the end of this year.”
SUPRA builds upon favorable clinical study results seen in a previous first generation aerSleep I device, which demonstrated reduction in apnea similar to CPAP in responder subjects, and a favorable safety profile in multiple studies conducted in the U.S. and Canada. These studies were the basis of a Health Canada Medical Device License for aerSleep I, and the Breakthrough Device designation by the FDA of the second generation aerSleep II product.
On the financial side, up to $16 million is targeted for Sommetrics’ Series C Preferred round, of which $11 million has been raised to date from existing shareholders and new investors in the United States and Australia. These funds will be used to support the FDA clearance submission and to support readiness for the commercial launch of aerSleep II.
To facilitate commercial planning efforts, Sommetrics has appointed Scott Wilkinson as an advisor. Wilkinson was most recently president and CEO of Inogen where he developed a direct-to-consumer pull-through marketing program for a portable oxygen concentrator product in the home healthcare segment, leading to an over 40% compounded annual increase in revenue over ten years. Wilkinson says in a release, “I am delighted to become an advisor to Sommetrics where my past experience at Inogen can help shape the commercial strategy for aerSleep—a product which promises to disrupt the treatment paradigm for sleep apnea as well as the business model for treating this common condition.”