Discover Medical Devices announces additional intermediate results of its second clinical trial with the revolutionary self adaptable intra oral CPAP mask – the SomnuSeal

Discover Medical Devices SomnuSeal masks line are the first CPAP masks that successfully address the problem of non compliance in Obstructive Sleep Apnea patients. The revolutionary SomnuSeal mask has 90% compliance among current users of traditional masks and 26% compliance among non compliant OSA patients that refuse to use any traditional mask.

The novel SomnuSeal masks do not suffer from the side effects of traditional masks and therefore will allow many millions of OSA patients that currently refuse treatment to receive an effective treatment.

Eran Lavi, founder and CEO of Discover Medical Devices comments on the new clinical data: “Today more than 2 million patients are diagnosed each year as OSA patients that require CPAP treatment. Unfortunately 50% of them refuse to receive the necessary treatment exposing them to increase morbidity.

The SomnuSeal mask can be chosen by more than 60% of newly diagnosed patients in comparison to the current 10% of the most successful masks.

Another very interesting result of the SomnuSeal mask usage is a substantial reduction in required air pressure needed to provide a very good therapeutic result. In fact the SomnuSeal masks line requires only 53% of air pressure that is required by traditional masks. This is a huge difference that has many consequences like more compliance in general and specifically better cardiac output for patients after congestive heart failures that require CPAP treatment.

Clinical trial summary:

The SomnuSeal oral mask is tolerated by otherwise CPAP non compliant patients with OSA.

By Giora Pillar, Adi Segev, Eytan Kurtz.

Feb 2011

Background: Compliance with CPAP is the major limiting factor in treating patients with OSA. Nasal masks may cause skin abrasions or eruptions, mask pressure on the ridge of nose, air leaks (eye discomfort), claustrophobia and nasal stuffiness. The novel SomnuSeal mask (Fig 1) is an oral self-adaptable mask located between the teeth and the lips, ensuring no air leaks or skin abrasions. It is more comfortable, adjusts

better to the patient’s specific anatomical structure, and potentially reduces rejection by claustrophobic patients. In a previous study, a mixed sample of 20 patients with OSA had slept with the SomnuSeal oral mask for an average of 1 week. Compliant patients slept for an average of 4.5 hours per night.

Aim: To evaluate the efficacy and compliance/tolerability of the SomnuSeal oral mask for a one month treatment period in otherwise non-compliant (untreated) patients with moderate-severe OSA.

Methods: So far, 35 patients with RDI>20 had tried the mask for one month. In all patients the mask was connected to an AutoPAP machine with a heated humidifier. Efficacy (respiratory indices), convenience (questionnaire) and compliance (usage meter) were monitored in all patients.

Results: Thirty five patients (28 males and 7 females, mean age 56±12 years, BMI 33.7±4.9 Kg/m2, RDI 45±20/h) have tried the treatment so far. Of them, 9 were satisfied and complied well with it (for an average of 26 nights, 4.7 hours per night), 4 struggled with it (used it for an average of 15 nights, 3 hours per night), and 22 could not comply with it. In all patients who slept with it, the efficacy (assessed by residual RDI derived from the CPAP device) was good, with an RDI of less than 5/hour. Interestingly, the required optimal pressure decreased from an average of 9.4cmH2O to 4.7cmH2O.

Conclusions: The SomnuSeal oral interface is effective, and may result in converting non-compliant untreated patients with OSA into well treated ones. In the current study so far, 9 of 35 patients (26%) who were CPAP non-compliant and remained otherwise untreated, were satisfied and well tolerated the SomnuSeal mask, while additional 4 patients (11%) struggled with it and may have ended up being treated. These results are encouraging to offer this mask and reduce the currently high prevalence of CPAP non-compliant untreated patients with OSA.