PLEASANTON, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA), a leading CPAP alternative for the treatment of Obstructive Sleep Apnea (“OSA”), today announced that their precision sleep apnea devices will be prominently featured in the scientific programs at upcoming medical conferences. The new scientific abstracts and podium presentations feature new data and additional data reporting on the efficacy, effectiveness, and safety of ProSomnus devices. The positive data adds to the expanding volume of independent evidence establishing precision oral devices as a leading treatment option for obstructive sleep apnea.
“ProSomnus proudly supports medical grade research that helps physicians select the optimal therapy for each and every patient with Obstructive Sleep Apnea,” said Len Liptak, ProSomnus Co-Founder and Chief Executive Officer. “A growing number of physicians are interested in ProSomnus devices as an alternative to CPAP and Hypoglossal Nerve Stimulation. ProSomnus devices have demonstrated efficacy, safety, adherence, and patient preference in several studies. The additional data reported at these upcoming conferences should further establish precision oral appliance therapy with ProSomnus devices as a consistent, reliable, treatment option.”
ProSomnus clinical data will be presented at the following medical conferences:
6th Two-Day iBEDSSMA Symposium on the Multidisciplinary Treatment of Sleep-Disordered Breathing
Knokke, Belgium
September 29 - October 4, 2023
International Surgical Sleep Society & American Academy of Otolaryngology 2023 Annual Meetings
Nashville, TN
Dr. Edward Sall, MD, DDS, ProSomnus Medical Director, will present:
CHEST 2023 Annual Meeting (The American College of Chest Physicians)
Honolulu, HI
World Sleep 2023
Rio de Janeiro
FLOSAT is an ongoing prospective, independent, head-to-head, crossover 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, with 102 of those patients moving into the analyzed population. The study concluded, among other findings, that precision OAT was effective among 90% of moderate OSA patients and 85% of severe OSA patients.
“The findings from FLOSAT demonstrate that precision oral appliance therapy can be a highly effective therapy for moderate to severe OSA, while being much more comfortable and convenient for the patient,” said Dr. John Remmers, ProSomnus Chief Scientist. “It is a known fact that many patients refuse the CPAP option, putting their health in serious jeopardy, and the ProSomnus device goes a long way to addressing this drawback. Based on both its efficacy and superior adherence, the data shows that precision oral therapy is suited to become a first-line therapy for the widespread health emergency that is Obstructive Sleep Apnea.”
About FLOSAT
Designed and conducted by The Antwerp University Hospital (UZA), the primary endpoints of FLOSAT are to evaluate the overall effectiveness of OAT as a first-line treatment for OSA, compare the overall effectiveness of OAT with that of CPAP and evaluate patients’ preference. ProSomnus devices are being used exclusively for the precision OAT arm of the study. A total of 136 patients enrolled in FLOSAT, all with moderate to severe OSA, body mass index less than 35 kg/m2, and central AHI less than 30% of total AHI, and all of whom had not received any previous OSA therapy and were eligible for OAT. After completing three months of first-line treatment with OAT followed by three months of CPAP, participants are asked which therapy they prefer. More information can be found at www.ClinicalTrials.gov using the identifier NCT05393531.
About ProSomnus
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 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.
Such risks and uncertainties include, but are not limited to: (i) uncertainty of the projected financial information with respect to ProSomnus; (ii) ProSomnus’s limited operating history and history of losses; (iii) ProSomnus’s ability to maintain and grow its profit margin from sales of ProSomnus oral devices; (iv) ProSomnus’s ability to expand internationally; (v) the roll-out of ProSomnus’s business and the timing of expected business milestones; (vi) ProSomnus’s ability to formulate, implement and modify as necessary effective sales, marketing, and strategic initiatives to drive revenue growth; (vii) expectations concerning the effectiveness of OSA treatment using ProSomnus oral devices and the potential for patient relapse after completion of treatment; (viii) the understanding and adoption by dentists and other healthcare professionals of ProSomnus oral devices for mild-to-moderate OSA; (ix) risk related to compliance debt covenants or successfully renegotiating such covenants; (x) ProSomnus’s ability to obtain additional funding and the risk of potential future significant dilution to stockholders resulting from any such financing or from lender conversions under the convertible debt financing; (xi) the viability of ProSomnus’s intellectual property and intellectual property created in the future; (xii) government regulations and ProSomnus’s ability to obtain applicable regulatory approvals and comply with government regulations, including under healthcare laws and the rules and regulations of the U.S. Food and Drug Administration; (xiii) the risk of downturns in the market and ProSomnus’s industry including, but not limited to, as a result of the COVID-19 pandemic; and (xiv) the outcome of any legal proceedings that may be instituted against ProSomnus. 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 Securities and Exchange Commission (the “SEC”) any subsequently filed quarterly reports on Form 10-Q, and other documents that the parties may file or furnish with the SEC, which you are encouraged to read. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. Forward-looking statements do not represent our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements.
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