PLEASANTON, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced that it has contributed two scientific abstracts that have been accepted for presentation at the 2024 American Academy of Dental Sleep Medicine Meeting in New Orleans.
- Abstract #019
“Assessing Health Outcomes When Treating Obstructive Sleep Apnea with Mandibular Protruding Appliances”
Erin Mosca, PhD1; Joshua Grosse, MMath1; John Remmers, MD1
1ProSomnus Sleep Technologies, Pleasanton, CA
Data from three prospective clinical studies with a pooled sample size of 134 were analyzed to assess the relationship between apnea-hypopnea index (AHI), a frequency-based metric, and sleep apnea-specific hypoxic burden (SASHB), a metric that captures the risk associated with obstructive sleep apnea (OSA). Precision oral appliance therapy significantly reduced AHI and SASHB in all severities of OSA. 76% of study participants achieved therapeutic success when it was defined as AHI < 10/h, whereas 94% achieved therapeutic success when it was defined as SASHB < 60% min/h. AHI appears to misclassify some individuals as therapeutic failures to precision oral appliance therapy despite their having an SAHSB below the threshold of increased risk; therefore, SASHB likely provides a more meaningful assessment of OSA treatment response than AHI as it accounts for the risk associated with the disease.
“The research indicates that judging outcome using sleep apnea-specific hypoxic burden reveals that the traditional methods are inappropriately restrictive,” commented Dr. John E. Remmers, MD, Chief Scientist for ProSomnus Sleep Technologies. “Efficacy of oral appliance therapy is higher than that previously understood when a predictor of long-term clinical outcome is used.”
- Abstract #032
“Medical Grade Class VI Devices Demonstrate Statistically Significantly Lower Mean Staining than Other Devices Tested”
Len Liptak, MBA1, Mark Murphy, DDS1,2, ABDSM, Sung Kim1
1ProSomnus Sleep Technologies, Pleasanton, CA, 2Funktional Sleep, Rochester, MI
Data from this investigation evaluates the staining profile of seven sleep apnea devices. Various, previous, independent studies establish material staining as a surrogate for bacteria colonization and health risk. Devices made from medical grade class VI material (ProSomnus EVO® and ProSomnus EVO® [PH]) demonstrated statistically significantly lower staining than the four other oral devices tested and were the only two devices in the study to exhibit less staining than a CPAP mask.
“These two scientific abstracts demonstrate ProSomnus’s commitment to investigating topics, in this case health outcomes and patient safety, that are important to sleep physicians, sleep dentists and, ultimately, patients with OSA,” commented Len Liptak, CEO. “This type of research is intended to help sleep healthcare providers evaluate non-CPAP treatment options for OSA, particularly for those patients who refuse or terminate CPAP therapy.”
About ProSomnus
ProSomnus is the leading non-CPAP therapy 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 the Securities Act of 1933 and the Securities Exchange Act of 1934, both as amended. Statements that are not historical facts, including statements about the timing, outcome and effects from the pilot testing for the RPMO2 OSA Device and the potential impacts of the RPMO2 OSA Device, are forward-looking statements. The words “expect,” “believe,” “estimate,” “intend,” “plan” and similar expressions indicate forward-looking statements, although not all forward-looking statements contain these or similar identifying words.
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: effectiveness of the ProSomnus’s products; ProSomnus’s ability to raise additional funds to continue operating under its existing business plan; ProSomnus’s ability to comply with its debt obligations; changes in the timelines and potential outcomes of regulatory clearance and/or approval processes; securing and maintain regulatory clearances, approvals and compliance in jurisdiction in which the Company intends to offer its products, competitive industries in which the Company operates and variations in operating performance across competitors; changes in laws and regulations affecting ProSomnus’s business; the risk of downturns in the market and ProSomnus’s industry; risks related to ProSomnus’s limited operating history and history of losses; the timing of expected business milestones; ProSomnus’s ability to implement its business plan and scale its business, which includes the recruitment of healthcare professionals to prescribe and dentists to deliver ProSomnus oral devices; the understanding and adoption by dentists and other healthcare professionals of ProSomnus oral devices for mild-to-moderate OSA; the understanding and adoption by dentists and other healthcare professionals of ProSomnus oral devices for severe OSA if clearance for such indication be secured from the FDA; expectations concerning the effectiveness of OSA treatment using ProSomnus oral devices and the potential for patient relapse after completion of treatment; the potential financial benefits to dentists and other healthcare professionals from treating patients with ProSomnus oral devices; ProSomnus’s ability to properly train dentists in the use of the ProSomnus oral devices and other services it offers in their dental practices; ProSomnus’s ability to formulate, implement and modify as necessary effective sales, marketing, and strategic initiatives to drive adoption of its devices; the viability of ProSomnus’s intellectual property and intellectual property created in the future; acceptance by the marketplace of the products and services that ProSomnus markets; 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; the extent of patient reimbursement by medical insurance in the United States and internationally; and the outcome of any legal proceedings that may be instituted against the Company. A further list and description of risks and uncertainties can be found in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 14, 2023. 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. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements relate only to the date they were made, and the Company and its subsidiaries undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made except as required by law or applicable regulation.
Investor Contact
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com
Media Contact
Heather Whalen
ProSomnus
Phone: +1.925.360.2990
Email: HWhalen@ProSomnus.com
