Study to be Presented at European Respiratory Society and European Sleep Research Society’s Sleep and Breathing 2023 Conference Demonstrates Efficacy of ProSomnus Precision Oral Appliances

Rhea-AI Summary

ProSomnus, a leader in precision medical devices for Obstructive Sleep Apnea (OSA), announced findings from a recent study highlighting the effectiveness of its Precision Oral Appliance Therapy (OAT) compared to traditional methods. Presented at the 2023 Sleep and Breathing Conference, the study reveals that Precision OAT demonstrated a 100% efficacy rate in mild OSA cases, outperforming traditional OAT's 85%. For mild to moderate OSA, the median efficacy stood at 92% for Precision OAT versus 75% for traditional OAT. Even in severe cases, Precision OAT led with 59% efficacy compared to 50% for traditional options. ProSomnus continues to lead the market, with over 200,000 devices delivered, offering an effective alternative to CPAP therapy.

Positive

• Precision OAT demonstrated 100% efficacy in mild OSA cases compared to 85% for traditional OAT.
• Median efficacy for Precision OAT in mild to moderate OSA was 92%, outperforming the 75% of traditional OAT.
• Even in severe OSA, Precision OAT showed a median efficacy of 59%, compared to 50% for traditional OAT.
• ProSomnus has delivered over 200,000 devices, positioning it as a market leader in precision OAT.

Negative

• None.

Study data indicates that ProSomnus precision oral appliances appear to be more efficacious than traditional oral appliances for the treatment of mild, moderate, and severe Obstructive Sleep Apnea

PLEASANTON, Calif., April 24, 2023 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (“the Company”) (NASDAQ: OSA), a pioneer in precision medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced the results of a retrospective study demonstrating the efficacy of Precision Oral Appliance Therapy (OAT) compared to Traditional OAT for the treatment of OSA. The study indicates that precision oral appliances by ProSomnus appear to be more efficacious than traditional oral appliances for all severities of OSA. Dr. Shouresh Charkhandeh, DDS, BMedSc shared the data in a poster presentation at the European Respiratory Society (ERS) and European Sleep Research Society’s (ESRS) Sleep and Breathing 2023 Conference, held from April 20-22 in Prague, Czech Republic.

In the study, researchers sought to determine whether Precision OAT has a different efficacy than Traditional OAT. They reviewed the published literature and abstracts presented at scientific meetings that evaluated commercial oral appliances, stratified data by OSA severity, and defined efficacy as a residual apnea-hypopnea index < 10 h^-1. Fifteen sources were identified for mild to moderate OSA and 12 were identified for severe OSA. The total pooled sample size was 1,641 patients with OSA.

Key findings from the study include:

• Precision OAT was efficacious in 100% of individuals with mild OSA, while Traditional OAT was efficacious in 85%.
• Median efficacy for Precision OAT in individuals with mild to moderate OSA was 92%, while that of Traditional OAT was 75%.
• Median efficacy for Precision OAT in individuals with severe OSA was 59%, while that of Traditional OAT was 50%.
  

“Oral Appliance Therapy has been improving over the past two decades and has become a great therapy choice for patients with OSA,” stated Dr. Shouresh Charkhandeh, DDS, BMedSc. “Being preferred by most patients and with very high patient adherence rate, especially compared to traditional CPAP therapy, it could be considered the first line treatment for OSA patients. This can be further improved by increasing the efficacy of treatment and focusing on precision Dental Sleep Medicine. Of course, device design and manufacturing could play a significant role in that.”

“There is a prevalent misconception that all oral appliance therapy devices are equally efficacious because they share the same mechanism of action: mandibular repositioning and stabilization,” said Len Liptak, Co-Founder and Chief Executive Officer of ProSomnus. “The findings of this study, that precision oral appliances are likely more efficacious than traditional oral appliances across all levels of OSA severity, challenge this misconception and should serve as a catalyst for additional consideration and research.”

About ProSomnus
ProSomnus (NASDAQ: OSA) precision intraoral medical devices offer effective, economical, and patient-preferred treatment for patients suffering from Obstructive Sleep Apnea (OSA). ProSomnus is the first manufacturer of mass-customized Precision Oral Appliance Therapy (OAT) devices to treat OSA, which affects over 74 million people in North America and is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes. ProSomnus’s patented, FDA-cleared devices are a less invasive and more comfortable alternative to Continuous Positive Airway Pressure (CPAP) therapy, and lead to effective and patient-preferred outcomes. A growing body of research, including studies published by the Journal of Clinical Sleep Medicine and Military Medicine, suggests ProSomnus’s Precision OAT devices are an effective treatment for mild to moderate OSA. Additional clinical research has shown that ProSomnus’s Precision OAT devices mitigate many of the side effects associated with alternative treatments and improve economics for payers and providers. With more than 200,000 devices delivered, ProSomnus’s devices are the most prescribed Precision OAT in the U.S. ProSomnus’s FDA-cleared devices are authorized by the Department of Defense and the U.S. Army, and are often covered by medical insurance, Medicare, and social health programs in key international markets. 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
Elizabeth Coleman
ICR Westwicke
Phone: +1.203.682.4783
Email: Elizabeth.Coleman@westwicke.com

FAQ

What were the key findings of the ProSomnus OSA study presented in April 2023?

The study revealed that ProSomnus's Precision Oral Appliance Therapy was significantly more efficacious than traditional oral appliances, achieving 100% efficacy in mild OSA cases and 92% for mild to moderate cases.

When and where was the ProSomnus OSA study presented?

The study was presented at the European Respiratory Society and European Sleep Research Society's Sleep and Breathing 2023 Conference held from April 20-22 in Prague, Czech Republic.

What is the efficacy of ProSomnus's Precision Oral Appliance Therapy for severe OSA?

Precision Oral Appliance Therapy demonstrated a median efficacy of 59% for severe OSA cases, compared to 50% for traditional oral appliances.

How many devices has ProSomnus delivered to date?

ProSomnus has delivered over 200,000 devices, making it the most prescribed precision oral appliance in the U.S.