ProSomnus, Inc. Enrolls First Participant in Study Evaluating Safety and Efficacy of ProSomnus EVO(TM) in Treating Severe Obstructive Sleep Apnea
December 19, 2022 at 08:00 am
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ProSomnus, Inc. announced the enrollment of the first patient in its Severe Obstructive Sleep Apnea (SOS) study. The SOS study is a prospective, FDA-reviewed, multi-center, single- arm study evaluating the safety and efficacy of precision oral appliance therapy (OAT) with the ProSomnus EVO Sleep and Snore device in individuals with severe OSA. ProSomnus intends to use data from the SOS study to apply for an expanded indication for use with the FDA. If successful, the ProSomnus EVO would be the first intraoral medical device cleared for the treatment of patients with Severe OSA. Efficacy and safety are the two primary endpoints for the study. Researchers in the study will assess the ProSomnus EVO's efficacy by measuring participants' apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) six months after initiation of precision OAT. Investigators will evaluate the safety of the ProSomnus EVO by reviewing all reported adverse events, dental examinations, and safety evaluations. The ProSomnus EVO is an alternative to legacy dental products and CPAP machines, and can result in more effective
treatment and superior patient compliance. Fully customized based on the anatomy and treatment plan for each patient, the ProSomnus EVO precisely repositions and stabilizes the jaw during sleep, improving airflow through a patient's pharyngeal space. The ProSomnus EVO consists of maxillary and mandibular aligners that are precision-manufactured with twin-mated posts, and is digitally manufactured to be patient-specific. Prescribed advancements can be achieved by removing the current upper- or lower-device arch and inserting the next arch in the mandibular advancement series. Participants in the study will receive a custom ProSomnus EVO and be tested using a Type II home sleep apnea test (HSAT) to determine if they have achieved an AHI of less than 15 h(-1) with the device in place. Researchers will administer HSATs at predetermined intervals. To determine the ProSomnus EVO's efficacy, participants will complete a set device advancement and testing protocol and a final HSAT six months after precision OAT begins. During each visit after precision OAT begins, researchers will conduct safety evaluations which, along with dental examinations and adverse event reports, will be used to determine the ProSomnus EVO's safety. After collecting data for the study's primary endpoints for six months after precision OAT begins, researchers will monitor participants for six more months.
ProSomnus, Inc. is a medical technology company. The Company is focused on the development, manufacturing and marketing of precision intraoral medical devices, a novel non-invasive option for treating and managing patients with obstructive sleep apnea (OSA). Its intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. The Company's devices have demonstrated efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. Its precision intraoral devices are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, TRICARE and many Government-sponsored healthcare plans around the world, representing over 200 million covered lives. The Companyâs products include ProSomnus EVO Sleep and Snore Device, ProSomnus EVO SELECT Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus [CA] LP Sleep and Snore Device and ProSomnus [MOG] Morning Occlusal Guide.
PROSOMNUS, INC. 
