Updated Clinical Trial Data Indicates Precision Oral Appliance Therapy with ProSomnus Devices is Non-Inferior to CPAP Therapy for the Treatment of Moderate to Severe Obstructive Sleep Apnea
Precision oral appliance therapy effective among 90% of moderate and 85% of severe OSA patients
In an Intent-to-Treat analysis, precision OAT demonstrated twice the mean disease alleviation as CPAP
Results for treating Severe OSA patients with precision oral appliance therapy establish rationale for head-to-head clinical trial with hypoglossal nerve stimulation
FLOSAT is an ongoing, prospective, independent, head-to-head study comparing the effectiveness of precision OAT as first-line treatment versus CPAP therapy. ProSomnus EVO® devices are being used exclusively for the precision OAT arm of the study. A total of 136 patients with moderate and severe OSA were included in the study.
Key findings to date include:
- Precision oral appliance therapy is effective, and non-inferior to CPAP, as a first-line treatment for moderate to severe OSA
- Precision OAT was effective among 90% of moderate and 85% of severe OSA patients
- Precision oral appliance therapy was preferred by patients, with 98% continuing therapy at three months versus 22% discontinuing CPAP therapy over the same period of time
- In an intention to treat analysis factoring efficacy and adherence, precision OAT (ProSomnus) demonstrated twice the mean disease alleviation as CPAP
“The FLOSAT study was designed to evaluate whether precision Oral Appliance Therapy could be utilized for the very practical and emergent issue of patients with OSA who could not access CPAP due to the recall,” commented Prof. Dr.
An additional observation from FLOSAT is the performance of precision OAT among severe OSA patients, in the context of data reported for hypoglossal nerve stimulation (HNS). Using the same criteria for efficacy – an AHI < 20 and a 50% improvement – 85% of severe OSA patients were successfully treated with non-invasive precision OAT. Clinical studies for the surgically implanted HNS devices, such as the STAR trial, report success in the range of 66% even with patient selection and the exclusion of concentric collapse patients. In July, ProSomnus announced plans to design a head-to-head clinical trial comparing precision OAT and HNS in treating patients with severe OSA.
Patients are actively being enrolled in the Severe OSA Study, a multi-center, prospective, clinical trial designed to demonstrate the safety and effectiveness of ProSomnus devices for the treatment of severe OSA and apply for FDA label expansion.
“The updated data and analysis from FLOSAT is validation that precision oral appliance therapy with ProSomnus devices is an effective front-line treatment for moderate to severe OSA,” said
Data from FLOSAT will also be presented at the iBEDSSMA Symposium, taking place in Knokke-Heist,
Designed and conducted by
ProSomnus (NASDAQ: OSA) is a leading CPAP alternative for the treatment of Obstructive Sleep Apnea, a serious medical disease affecting over 1 billion people worldwide, that is associated with comorbidities including heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes. ProSomnus intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. Non-invasive, patient preferred and easy to use, ProSomnus devices have demonstrated excellent efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. ProSomnus 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. To learn more, visit www.ProSomnus.com.
Important Notice Regarding Forward-Looking Statements
This press release contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E the Securities Exchange Act of 1934, both as amended. Statements that are not historical facts, including statements regarding ProSomnus’s or its management’s intentions, beliefs, expectations and strategies for the future, including those related to ProSomnus’s clinical trial plans and the stated or implied preliminary results, results and data of future and ongoing studies involving the use of ProSomnus’s products and therapies, ProSomnus’s labeling expansion, the outcome and timing for ProSomnus’s trials, ProSomnus’s future growth, expenses and margins, and the growing markets for its devices, are forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “plans,” “may,” “will,” “potential,” “projects,” “predicts,” “continue,” or “should,” or, in each case, their negative or other variations or comparable terminology. The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects on us. These forward-looking statements are not guarantees of future performance and are subject to various risks and uncertainties, assumptions (including assumptions about general economic, market, industry and operational factors), known or unknown, which could cause the actual results to vary materially from those indicated or anticipated. A further list and description of risks and uncertainties can be found in ProSomnus’s most recent annual report on Form 10-K filed with the
Source: ProSomnus Sleep Technologies, Inc.