Somnics Inc. announces that the U.S. Food and Drug Administration (FDA) has granted clearance for the company’s groundbreaking capability to change the negative pressure setting of the iNAP Sleep therapy device. This innovative feature will significantly enhance the success of OSA treatment and empower physicians to titrate the device using the user-friendly iNAP Lab+ App, available for both iOS and Android devices.
With this FDA clearance, Somnics has achieved a remarkable advancement in improving patient adherence and expanding the range of patients successfully treated for OSA. The ability to adjust the negative pressure settings of the iNAP Sleep therapy device between -27 cmH2O and -122 cmH2O will revolutionize the way physicians provide personalized care to their patients, ensuring optimal treatment efficacy and comfort.
The iNAP Sleep Therapy system, cleared by the FDA for all severities of OSA, utilizes negative pressure in the oral cavity delivered by its embedded suction pump to position the tongue and oral soft tissues forward and upward, enabling the opening and stabilization of the upper airway passage while allowing patients to breathe freely through their nose. Previously, the iNAP Sleep Therapy device was dispensed with a fixed pressure setting at 53 cmH2O. While this pressure worked well for many patients, certain cases would benefit from different, sometimes deeper, pressure settings to maintain airway patency. Data on seal time are collected through the iNAP Lab+ App, with the information available to healthcare providers on a secure online portal. This comprehensive interface enables physicians to make real-time adjustments, monitor patient progress, and provide personalized care from anywhere, at any time.
The iNAP Sleep Therapy device, combined with the advanced capabilities of the iNAP Lab+ App, caters to a wider range of patients, ensuring that more individuals can benefit from successful OSA treatment. By expanding the scope of personalized therapy management, Somnics aims to improve patient outcomes, enhance quality of life, and offer one of the best alternative treatments to continuous positive airway pressure (CPAP) for OSA patients of all severities.
“We are extremely proud to have received FDA clearance for the pressure titration capability of our iNAP Sleep therapy device,” said Olivier Lauzeral, General Manager of Somnics Health, the US branch of Somnics. “This innovation marks a significant milestone in PAP alternative treatments for all severities of Obstructive Sleep Apnea, allowing physicians to provide tailored care to their patients. Our ultimate goal is to make OSA therapy more patient-friendly, comfortable, and effective. This titration capability, combined with the small form factor, excellent battery life, silence and comfort of iNAP, brings us closer to realizing that vision.”
Somnics is actively collaborating with healthcare professionals and sleep clinics to integrate iNAP into their OSA treatment protocols as a first line of treatment, ensuring seamless adoption and facilitating improved patient outcomes. The company is committed to ongoing research and development, continuously advancing OSA therapy technology to benefit all individuals suffering from this chronic disorder.
For more information about Somnics, the iNAP Sleep therapy device, and the iNAP Lab+ App, visit inapsleep.online.
Source: Somnics
