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Fresca Medical

San Clemente, California, United Statesaccessdata.fda.gov ↗

Ownership: Private
Development stage: Commercial

Overview

The company’s CURVE™ and Somnera™ systems are FDA-cleared positive airway pressure devices for obstructive sleep apnea. Clinical trials demonstrated non-inferiority to CPAP with significant improvements in Apnea-Hypopnea Index and Oxygen Desaturation Index. The system uses a novel low-flow approach that may improve patient adherence compared to traditional CPAP. The Somnera System was cleared by the FDA in June 2020 and launched commercially through exclusive distribution channels.

Therapeutic areas: Pulmonology
Modalities: DeviceNon-pharmacological therapyDigital health technology
Industry: Therapeutic Medical Devices

Partnerships

Agile Medical/The CPAP Shop (exclusive distributor of the Somnera System)

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