ProSomnus, a leader in patient-preferred medical devices for the treatment of Obstructive Sleep Apnea (OSA), today announced the results of three studies evaluating its FDA-cleared Oral Appliance Therapy (OAT) devices in the treatment of OSA. ProSomnus will share data in three poster presentations at SLEEP 2022, the Annual Meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held from June 4-8 in Charlotte, North Carolina.
The data to be presented demonstrate the efficacy and performance advantages of precision oral appliance therapy, a new option for the treatment of OSA. ProSomnus is a pioneer in precision oral appliance therapy. OSA is the recurring collapse of the airway during sleep resulting in oxygen shortages and abrupt awakenings accompanied by gasping or choking. In addition to daytime sleepiness, OSA is associated with comorbidities such as heart failure, stroke, hypertension, morbid obesity and type 2 diabetes. Patients with untreated OSA are 23 times more likely to suffer a heart attack and four times more likely to have a stroke. It is estimated that approximately one billion people worldwide and over 74 million people in North America suffer from obstructive sleep apnea, with approximately 56 million of those 74 million people in North America undiagnosed.
“OSA is severely undertreated; changing that will require collaboration and innovation from the sleep medicine community at large,” said John E. Remmers, MD, Chief Scientist of ProSomnus. “We believe these data continue to validate ProSomnus’s oral appliance therapy devices and suggest that OAT has the potential to improve treatment, and we look forward to sharing them at SLEEP 2022.”
The abstracts to be presented include:
- Preliminary Efficacy of a Novel Iterative Device and Material
Data showed that 94.7 percent of patients with mild or moderate OSA were successfully treated to an Apnea Hypopnea Index (AHI) below 10 when treated with a ProSomnus EVO precision oral appliance therapy device. The data from a cohort of 55 patients – 15 of whom had mild OSA, 23 moderate and 17 severe – showed an average pretreatment AHI of 26.4 and a 75 percent improvement when treated with precision oral appliances. 85 percent of all patients, including those with severe OSA, achieved an AHI below 10 with treatment. 65 percent of severe patients attained an AHI below 15 with treatment, a success rate on par with other CPAP alternative treatments.
- Use of a Precision Oral Appliance Therapy Device in the Treatment of Severe OSA
Data from two studies find ProSomnus’s precision oral appliance therapy devices effective for severe OSA patients. Of 41 patients with severe OSA, 73.2 percent achieved a respiratory event index decrease from a baseline of at least 50 percent after treatment with ProSomnus’s oral appliance therapy. 68.3 percent achieved a respiratory event index decrease of less than 15 h-1, demonstrating improvements on par with other alternatives to CPAP therapy for patients with severe OSA.
- Performance Testing of a Novel Oral Appliance Material; A New Standard for OAT
A performance evaluation of the first FDA-cleared, precision oral appliance therapy device made from medical-grade class VI polymer demonstrated positive results. According to US Pharmacopeia, Class VI designated materials are those that pass the most stringent toxicity and biocompatibility tests. In colorimetry graded stain testing alongside legacy oral appliances and positive airway pressure mask materials, the polymer showed a stain delta of 3.06, the lowest of all materials tested. The precision oral appliance with class VI polymer also passed a military drop test in which 40 cases were dropped six times each, as well as tests for skin sensitization, acute oral mucosa irritation, acute systemic toxicity, in vitro cytotoxicity by agar diffusion method, in vitro cytotoxicity by filter diffusion method, and in vitro cytotoxicity by elution method.
“Many patients with OSA and their healthcare providers are seeking treatment alternatives because patients often refuse or fail CPAP, or cannot access CPAP due to supply constraints,” said Len Liptak, Co-Founder and Chief Executive Officer of ProSomnus. “The data presented at this conference further establish ProSomnus precision, FDA-cleared, intraoral devices as a safe, effective, affordable and comfortable treatment option.”