Four Independent Scientific Abstracts at the American Academy of Dental Sleep Medicine Annual Meeting Feature ProSomnus Intraoral Medical Devices

/EIN News/ -- PLEASANTON, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced that four independent scientific abstracts accepted for the 2024 AADSM Annual Meeting contain scientific data utilizing ProSomnus precision devices, with one abstract winning the prestigious Clinical Excellence Award, and another featuring over 1,200 patients.

• Abstract #018 (Winner of the 2024 AADSM Clinical Excellence Award)
  “Overall Clinical Effectiveness of Oral Appliance Therapy as a First-Line Treatment Option Compared with Continuous Positive Airway Pressure in Patients with Moderate to Severe Obstructive Sleep Apnea: The FLOSAT Study
  Marijke Dieltjens^1,2, Shouresh Charkhandeh¹, Karlien Van den Bossche², Sanne Engelen², Dorine Van Loo², Renilde Goossens³, Johan Verbraecken³, Marc J. Braem², Olivier M. Vanderveken^{1,2
  1}Translational Neurosciences, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium; ²Department of ENT, Head and Neck Surgery, Antwerp University Hospital, Belgium; ³Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital, Belgium.

• Abstract #021
  “Incidence of Adverse Effects with Mandibular Advancement Device Therapy and Impact on Treatment Modality Choice in Patients Diagnosed with Severe Obstructive Sleep Apnea”
  Shouresh Charkhandeh^{1, 2}, Marijke Dieltjens^1,2, Olivier M. Vanderveken^{1,2
  1}Translational Neurosciences, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium; ²Department of ENT, Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.

Data from the First Line OSA Treatment (FLOSAT) study, a comparative study evaluating the clinical effectiveness of mandibular advancement therapy (MAD), reported that custom-made, titratable MAD devices (ProSomnus EVO^®) have significantly higher patient preference and at least non-inferior overall clinical effectiveness to CPAP therapy.

Analysis of a subset of the FLOSAT study data found comparable rates of adverse effects and levels of mandibular protrusion in patients with moderate and severe OSA. The findings underscore the significance of exploring safe and effective alternatives to CPAP for severe OSA and debunking myths surrounding the efficacy of MAD in this patient population.

The data from the FLOSAT study indicate that OSA therapy with ProSomnus EVO devices is safe, effective, and better adhered to than CPAP.

• Abstract #022
  “Efficacy of Oral Appliance Therapy for Obstructive Sleep Apnea in a Virtual Workflow. A Review of 1,242 Cases.”
  Jordan Stern, MD¹; Alessandro Pezzella², Alicia Jackson, DDS^{1
  1}BlueSleep, New York, NY; ²Boston University, Boston MA

• Abstract #023
  “Comparison of Telemedicine Versus In-Office Delivery of Mandibular Advancement Devices. A Review of 757 Cases.
  Jordan Stern, MD¹; Alessandro Pezzella², Alicia Jackson, DDS^{1
  1}BlueSleep, New York, NY; ²Boston University, Boston MA

BlueSleep, the leader in virtual diagnosis and treatment of sleep apnea, is presenting results of two studies at the 2024 AADSM Annual Meeting. In the first study, the effectiveness of ProSomnus oral appliance therapy (OAT) was evaluated in 1,245 patients with a mix of mild, moderate, and severe sleep apnea. Patients obtained same day online appointments with BlueSleep and received a home sleep test by mail. Patients inserted their ProSomnus devices at home with virtual assistance from BlueSleep’s dentists. Effectiveness was evaluated with post treatment home sleep tests. There was an overall improvement of the AHI by more than 50% for all severity categories.

In a second study, BlueSleep compared the initial fitting of ProSomnus devices either in a virtual or in-person workflow. There were no significant differences in outcomes in the two patient groups, confirming that the virtual delivery of ProSomnus oral appliances is feasible and desirable to improve accessibility to treatment for sleep apnea.

"We have successfully treated over 1,800 patients with ProSomnus oral appliances using our digital care platform," stated Dr. Jordan Stern, MD, CEO and Founder of BlueSleep. "Results of these studies confirm that the BlueSleep virtual workflow using the most advanced oral appliance therapy from ProSomnus can help increase availability of treatment to the one billion globally suffering from obstructive sleep apnea, including those who cannot tolerate or have failed treatment with CPAP."

“ProSomnus is proud that our precision devices have been included in high quality, scientific, research that buttresses the rationale for non-invasive, non-CPAP treatment options for patients with OSA,” commented Len Liptak, Chief Executive Officer for ProSomnus Sleep Technologies. “Research and clinical practice demonstrate that ProSomnus precision oral devices are highly effective, associated with high levels of adherence, have an excellent safety record, and are covered by most medical insurances and Medicare.”

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

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ProSomnus
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Email: HWhalen@ProSomnus.com