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ProSomnus Comments on Insurance Coverage Policy Update for Obstructive and Central Sleep Apnea

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ProSomnus, Inc. (OSA) welcomes UnitedHealthcare's updated medical policy for obstructive and central sleep apnea, which establishes oral appliance therapy as a prerequisite for Implantable Hypoglossal Nerve Stimulation. Recent research and data show that modern, precision oral appliances are effective, safe, and non-invasive, with a high level of patient satisfaction.
Positive
  • UnitedHealthcare's updated medical policy acknowledges the role of oral appliances in the continuum of care for obstructive sleep apnea.
  • Recent research demonstrates that modern, precision oral appliances are effective, safe, and non-invasive.
  • Data presented at the November 2023 World Sleep Congress reported that treatment with ProSomnus Precision OAT devices was at least non-inferior to CPAP in a prospective, cross over clinical trial.
  • Data published in the medical journal Cureus reported that 89% of patients with OSA of all severities were successfully treated to an AHI of < 10 with ProSomnus devices.
  • 96% of patients were confirmed to be in active treatment at a one-year follow up.
Negative
  • None.

Insights

The adoption of UnitedHealthcare's updated medical policy, which now includes oral appliance therapy (OAT) as a prerequisite for Implantable Hypoglossal Nerve Stimulation, has significant implications for ProSomnus, Inc. and the broader sleep apnea treatment market. This policy change may lead to an increased demand for ProSomnus's Precision OAT devices, as they become part of the standard treatment protocol for moderate to severe Obstructive Sleep Apnea (OSA) cases covered by UnitedHealthcare.

Considering the market size, the prevalence of sleep apnea in the adult population is substantial and insurance coverage is a critical factor in treatment accessibility. With UnitedHealthcare being one of the largest health insurers in the United States, this policy update could serve as a bellwether for other insurers, potentially leading to broader market adoption of OAT solutions. The move towards non-invasive therapies before surgical options reflects a trend in healthcare towards cost-effective and patient-friendly treatments.

From a market perspective, ProSomnus could see a notable uptick in sales, with the possibility of securing a larger market share if other insurers follow suit. The company's stock could react positively to this news, as investors often look for changes in healthcare policies that can open up new revenue streams for medical device companies.

The clinical data presented at the World Sleep Congress and published in the medical journal Cureus provide a strong foundation for the efficacy of ProSomnus's Precision OAT devices. The reported success rate of 89% in treating patients to an Apnea-Hypopnea Index (AHI) of < 10 is significant, as AHI is a critical measure used to diagnose the severity of OSA and the effectiveness of treatment. Moreover, the 96% active treatment rate at one-year follow-up suggests a high level of patient adherence, which is often a challenge with Continuous Positive Airway Pressure (CPAP) therapy.

These findings may encourage other healthcare providers and insurers to consider OAT as a viable first-line treatment, potentially expanding the patient base for ProSomnus's devices. The absence of exclusions due to inadequate dental anatomy could indicate that ProSomnus's devices are suitable for a broader patient demographic compared to traditional OAT solutions. The impact on the company's research and development trajectory could be significant, as further innovation and product refinement may be warranted to meet the anticipated increase in demand.

The update to UnitedHealthcare's medical policy represents a strategic inflection point for ProSomnus, potentially affecting the company's financial performance. The policy change can be expected to directly increase the volume of ProSomnus's Precision OAT devices prescribed, which should reflect positively on the company's revenue and earnings. This update could also lead to an increase in market valuation, as the healthcare sector is particularly sensitive to policy-driven demand shifts.

Investors will likely monitor the company's quarterly financials closely for signs of growth in sales and market penetration post-policy implementation. Long-term, the company's ability to scale production and maintain quality in the face of increased demand will be critical for sustaining growth. Additionally, the company's margins could improve if economies of scale are realized and if further insurance companies adopt similar policies, the upside could be substantial. However, investors should also be aware of the risks, such as potential competition from other OAT device manufacturers and regulatory changes that could affect market dynamics.

PLEASANTON, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, welcomes the adoption of UnitedHealthcare’s updated medical policy (#2024T0525NN) for Obstructive and Central Sleep Apnea, effective March 1, 2024. The updated policy will establish oral appliance therapy (OAT), such as ProSomnus’s Precision OAT devices, as prerequisite therapy for Implantable Hypoglossal Nerve Stimulation in adult patients with moderate to severe OSA. Specifically, the policy states, “Failure of adequate trial of Oral Appliance therapy,” as the new medical policy of UHC.

“I am pleased to see this policy update acknowledging the role of oral appliances in the continuum of care for Obstructive Sleep Apnea,” commented Edward T. Sall, MD, DDS, MBA. “Recent research has demonstrated that modern, precision oral appliances are effective and safe. It is good medical practice to exhaust the available, non-invasive, reversible treatment options before moving to surgical options.”

“Our review of patient chart data shows that recently 60% of all of our sleep apnea patients receive oral appliance therapy as a first line treatment for OSA of all severities,” stated Jordan C. Stern, MD, Founder and CEO of BlueSleep. “At BlueSleep we have treated over 5,500 patients with oral appliances over the years. Modern, precision oral appliances are different from the oral appliances of ten years ago. Modern oral appliances are safe, effective, comfortable, and easy for the patient to insert, remove and keep clean. Compared with the oral appliances of ten years ago, we can achieve consistent, predictable results and a high level of satisfaction for our patients.”

Data presented at the November 2023 World Sleep Congress reported that treatment with ProSomnus Precision OAT devices was at least non-inferior to CPAP in a prospective, cross over clinical trial, and data published in the medical journal Cureus, “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,” reported that 89% of patients with OSA of all severities were successfully treated to an AHI of < 10 with ProSomnus devices. 96% of patients were confirmed to be in active treatment at a one-year follow up. No patients were excluded due to inadequate dental anatomy.

Link to UnitedHealthcare’s updated medical policy: https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/obstructive-sleep-apnea-treatment-03012024.pdf

About ProSomnus
ProSomnus (NASDAQ: OSA) 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

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Elizabeth Coleman
ICR Westwicke
Phone: +1.203.682.4783
Email: Elizabeth.Coleman@westwicke.com


FAQ

What is the company name and ticker symbol of the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy provider?

The company is ProSomnus, Inc. and its ticker symbol is OSA.

What is the effective date of UnitedHealthcare's updated medical policy for Obstructive and Central Sleep Apnea?

The updated policy is effective from March 1, 2024.

What therapy does the updated policy establish as a prerequisite for Implantable Hypoglossal Nerve Stimulation in adult patients with moderate to severe OSA?

The updated policy establishes oral appliance therapy (OAT), such as ProSomnus’s Precision OAT devices, as a prerequisite therapy.

What percentage of all sleep apnea patients receive oral appliance therapy as a first-line treatment at BlueSleep?

Recently, 60% of all sleep apnea patients receive oral appliance therapy as a first-line treatment at BlueSleep.

What did the data presented at the November 2023 World Sleep Congress report about the treatment with ProSomnus Precision OAT devices?

The data reported that treatment with ProSomnus Precision OAT devices was at least non-inferior to CPAP in a prospective, cross over clinical trial.

What percentage of patients with OSA of all severities were successfully treated to an AHI of < 10 with ProSomnus devices?

89% of patients with OSA of all severities were successfully treated to an AHI of < 10 with ProSomnus devices.

What percentage of patients were confirmed to be in active treatment at a one-year follow-up?

96% of patients were confirmed to be in active treatment at a one-year follow-up.

Where can the link to UnitedHealthcare’s updated medical policy be found?

The link to UnitedHealthcare’s updated medical policy can be found at https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/obstructive-sleep-apnea-treatment-03012024.pdf

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