Journal of Clinical Sleep Medicine Publication Shows Efficacy of ProSomnus® Precision Oral Appliance Therapy Devices in Treating Obstructive Sleep Apnea

Study finds that ProSomnus Precision Oral Appliance Therapy Devices Provide Efficacy Comparable to CPAP for Mild and Moderate OSA

Precision Oral Appliance Therapy Devices Represent a New Category of Intraoral Medical Device for the Treatment of OSA

San Francisco, California – April 5, 2022 – ProSomnus Sleep Technologies (“ProSomnus”), the leader in patient-preferred medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced the results of a peer-reviewed study published by the Journal of Clinical Sleep Medicine (JCSM), which found that ProSomnus’s precision Oral Appliance Therapy (OAT) devices successfully treated most patients’ OSA.

In a prospective, blinded study of 58 individuals with OSA, researchers sought to determine the predictive accuracy of Zephyr Sleep Technologies’ MATRx plus™ mandibular repositioning test, as well as the therapeutic efficacy of the ProSomnus precision OAT device and its ability to resolve OSA symptoms.

The ProSomnus precision OAT device uses proprietary technologies to replicate the bite position provided by the MATRx plus test.

Key findings from the study include:

• 94 percent of patients with mild and moderate OSA were successfully treated with ProSomnus Precision OAT (based on a success criterion of oxygen desaturation index < 10 h-1)
• 81 percent of patients of all severities were successfully treated with ProSomnus Precision OAT
• 97 percent of patients reported a reduction in snoring (median reduction of six points on a 10-
  point scale)
• 69 percent of patients reported experiencing an improvement in sleep quality (median
  improvement of four points on a 10-point scale)
• 85 percent of patients reported achieving their treatment goal

“OSA continues to be a major unmet medical need worldwide. Standard therapies such as CPAP often result in low compliance due to their invasive nature,” said John E. Remmers, MD, Chief Scientist of ProSomnus Sleep Technologies. “This study indicates that ProSomnus’s precision, mass-customized Oral Appliance Therapy devices are highly efficacious in treating mild to moderate OSA and can greatly benefit patients and offer a less invasive solution for those suffering from OSA.”

“Healthcare providers cite poor and uncertain efficacy as a reason they are reluctant to prescribe traditional OAT devices, even for patients who refuse or fail CPAP,” added Len Liptak, CEO of ProSomnus Sleep Technologies. “This investigation adds to a growing body of clinical data indicating that precision OAT devices, a new category of intraoral medical devices that reposition and stabilize the patient’s mandible with greater precision, mitigates these concerns by delivering more predictable, consistent, efficacious treatment.”

About OSA

OSA is the recurring collapse of the airway during sleep, resulting in oxygen shortages and abrupt awakenings accompanied by gasping or choking. In addition to daytime sleepiness, OSA is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes. Patients with untreated OSA are 23 times more likely to suffer a heart attack and four times more likely to have a stroke. It is estimated that more than one billion people worldwide and over 74 million people in North America suffer from OSA. Approximately 56 million of those 74 million people in North America are undiagnosed.

About ProSomnus Sleep Technologies

ProSomnus is the first manufacturer of precision, mass-customized Oral Appliance Therapy (OAT) devices to treat Obstructive Sleep Apnea, which affects over 74 million Americans and is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes.

ProSomnus’s patented devices are a more comfortable and less invasive alternative to Continuous Positive Airway Pressure (CPAP) therapy, and lead to more effective and patient-preferred outcomes.

With more than 135,000 patients treated, ProSomnus’s devices are the most prescribed OATs in the U.S.
To learn more, visit www.ProSomnus.com.