Sommetrics, a private company developing products and services to improve sleep health, released an update on its key accomplishments during the first quarter of 2022. Chief among these accomplishments was the Company’s advancing clinical activities aimed at obtaining FDA market clearance for its flagship product, aerSleep® II, that is targeted for the treatment of obstructive sleep apnea in those unable to use standard therapy with continuous positive airway pressure (CPAP) therapy. The self-contained and non-invasive 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 six-month aerSleep pivotal trial termed the SUPRA study (Study Using Negative Pressure to Reduce Apnea) is now being conducted at leading university and community-based sleep centers in the U.S. The lead SUPRA Investigator, Dr. Kingman Strohl, Program Director, Sleep Medicine, University Hospital, Cleveland, and Professor of Medicine, Case School of Medicine, had these comments:
“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. More information about the SUPRA trial may be found at clinicaltrials.gov.
An important patent was allowed by the U.S. Patent Office in the past month. This patent covers the use of a chin cup feature in the design of the aerSleep collar to maintain positional stability of the device during sleep. This feature helps to obviate the requirement for a retaining strap, which enhances freedom of movement and comfort 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 covering methods for avoiding contamination and blockage of the vacuum pump during use. The approval of these patents in the U.S. and Japan brings the number of Sommetrics patents approved in key global markets to 36 and supports the company’s commitment to building a robust intellectual property portfolio.
As the Company seeks to complete its Series C Preferred round of financing, Sommetrics has continued to host informational webinars with investors. In one presentation, Sommetrics and the inventor of CPAP, Dr. Colin Sullivan, discussed options for treating sleep apnea and the role aerSleep can play in the future. Up to $16 million is targeted for the Series C Preferred round, of which $11 million has been raised to date from existing shareholders and new investors in the U.S. 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, the Company is pleased to announce the appointment of Mr. Scott Wilkinson as an Advisor to the Company. Mr. Wilkinson was most recently President and CEO of Inogen (NASDAQ: INGN) where he developed an innovative 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. His extensive experience in marketing and establishing sales teams to promote new product launches makes him ideally suited to help guide the entry of aerSleep® II into the U.S. and global markets. To this end, Mr. Wilkinson commented:
“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.”