FRESCA Medical joins sleep therapy market
By Theresa Flaherty, Managing Editor
Updated Tue June 26, 2018
SAN CLEMENTE, Calif. - The U.S. Food and Drug Administration has granted FRESCA Medical's de novo request to market its CURVE Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea. “FDA clearance of the CURVE System for obstructive sleep apnea is our first step toward becoming a recognized innovator in sleep apnea,” said John Cox, president and CEO. “This market is already one of the largest applications for cloud-based patient monitoring and engagement, and our goal is to leverage the latest connected health technology to treat, delight and engage patients and providers, while reducing healthcare costs.” The key to the Curve System, FRESCA says, is a patented SmartValve technology that allows the treatment of OSA with far less airflow than conventional CPAP systems. The company says the system has the potential to solve many of the complaints that cause sleep apnea sufferers to abandon therapy or refuse to event try it. It says the results from a prospective, controlled, randomized, crossover, evaluator-blinded trial demonstrated that the system was non-inferior to CPAP, the current gold standard in the treatment of sleep apnea. It says patients treated with the system showed significant improvement in baseline values for the Apnea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI), both within the normal range (i.e., AHI 2.9/hr, ODI 1.4/hr).
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