ProSomnus Contributes Two Scientific Abstracts for Presentation at SLEEP 2024, A Joint Meeting of the American Academy of Sleep Medicine and the Sleep Research Society

Rhea-AI Summary

ProSomnus has contributed two scientific abstracts for presentation at SLEEP 2024, a conference hosted by the American Academy of Sleep Medicine and the Sleep Research Society from June 1-5 in Houston, TX. The first abstract (ID 1262) examines the clinical performance of a novel oral appliance therapy (OAT) device made from USP Class VI material. Data from 91 patients showed that 98% of mild and moderate OSA cases were successfully treated to an AHI < 10 events per hour, with no material-related side effects. The second abstract (ID 0606) reviews post-market surveillance from 10,880 patients and 646 providers over 60 months, indicating high satisfaction rates: 99% of patients and 98% of providers reported satisfaction with the device. CEO Len Liptak highlighted the increasing need for non-CPAP OSA therapies and the importance of these scientific studies in establishing the clinical safety and performance of ProSomnus's precision OAT devices.

Positive

• ProSomnus's novel OAT device demonstrated a 98% success rate in treating mild and moderate OSA to an AHI < 10 events per hour.
• No patients discontinued treatment due to material-related side effects.
• Post-market surveillance showed 99% patient satisfaction and 98% provider satisfaction.
• The studies underline high-quality device manufacturing with a 'first time fit' for 98% of users.
• ProSomnus devices are made from USP Class VI qualified material, ensuring high safety standards.

Negative

• The successful treatment rate was only assessed in mild and moderate OSA cases, leaving severe cases unexamined.
• The studies are based on surveys and may include self-reported biases that could affect objectivity.
• Post-market data, although extensive, spans over a long period (60 months), which may include outdated information.

PLEASANTON, Calif., May 30, 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 SLEEP 2024, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, June 1-5 in Houston, TX.

• Abstract ID 1262
  “Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly from a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea”
  
  E Sall¹; K Smith²; A Desai³; JA Carollo⁴; MT Murphy⁵; S Kim⁶; LA Liptak^{6
  1}GoTo Sleep Center, Glendale, AZ
  ²Star Sleep & Wellness, Frisco, TX
  ³London Bridge Hospital, London, GBR
  ⁴Dental Sleep Medicine of New Jersey, Florham Park, NJ
  ⁵Funktional Sleep, Rochester Hills, MI
  ⁶ProSomnus Sleep Technologies, Pleasanton, CA

This study evaluated the clinical performance of a novel, precision oral appliance therapy (ProSomnus OAT) medical device made entirely from a US Pharmacopeia (USP) medical grade class VI qualified material for the treatment of OSA. Data from 91 patients with OSA found that 98% of patients with mild and moderate OSA were successfully treated to an AHI < 10 events per hour. No patients discontinued treatment due to material-related side effects. The results of the study show that a precision ProSomnus OAT device made from USP Class VI qualified material is safe and efficacious for the treatment of OSA.

• Abstract ID 0606
  “Post Market Surveillance from Precision OAT Cases Indicates High Levels of Patient and Provider Satisfaction”
  
  Len Liptak, MBA¹, Yoann Ojeda, MDT¹, Mark Murphy DDS^{2
  1}ProSomnus Sleep Technologies, Pleasanton, CA
  ²Funktional Sleep, Rochester Hills, MI

Review of post-market surveillance surveys collected from 10,880 patients and 646 providers over a 60-month period showed that 98% of patients and providers reported a ‘first time fit’, indicating a high-quality device made precisely to specification. 99% of patients reported being satisfied with their appliance and 98% of providers reported being satisfied with the device upon delivery to the patient. These results indicate that ProSomnus precision OAT devices are associated with high levels of satisfaction among patients and providers.

“A growing number of physicians are realizing the need for non-CPAP OSA therapy, due to recent research documenting patient preferences, FDA recalls, treatment compliance and treatment effectiveness rates,” noted Len Liptak, Chief Executive Officer. “ProSomnus is proud to be associated with these scientific abstracts which further investigate and establish the clinical safety and performance of precision oral appliance therapy for patients with Obstructive Sleep Apnea.”

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.

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

FAQ

What did ProSomnus present at SLEEP 2024?

ProSomnus presented two scientific abstracts, one on the clinical performance of their OAT device and another on post-market surveillance results.

What are the key findings of ProSomnus's clinical performance study?

The study found that 98% of mild and moderate OSA cases were treated successfully to an AHI < 10 events per hour with no material-related side effects.

How satisfied are patients and providers with ProSomnus OAT devices?

Post-market surveillance indicates that 99% of patients and 98% of providers are satisfied with ProSomnus OAT devices.

What material is used in ProSomnus's OAT devices?

ProSomnus OAT devices are made entirely from USP Class VI qualified material.

When and where is SLEEP 2024 taking place?

SLEEP 2024 is scheduled for June 1-5 in Houston, TX.

What is the significance of ProSomnus's contribution to SLEEP 2024?

ProSomnus’s contributions highlight the clinical safety and efficacy of their non-CPAP OSA therapy devices, aligning with growing patient and provider preferences.