Fresca Medical said today it won FDA de novo approval for its Curve positive airway pressure delivery system designed to treat obstructive sleep apnea.
The Curve CPAP system includes a flow generator, air delivery hose and nasal pillow patient interface, the San Clemente, Calif.-based company said. The system also features the company’s SmartValve technology which it claims allows the system to treat OSA with less airflow than conventional CPAP systems.
“Fresca Medical is committed to developing disruptive and effective technologies for sleep apnea sufferers who cannot tolerate the currently available therapies. FDA clearance of the Curve system for obstructive sleep apnea is our first step towards becoming a recognized innovator in sleep apnea. Our breakthrough technology provides physicians the opportunity to offer a new breathing experience for patients who don’t want or cannot tolerate CPAP therapy. Quality sleep is fundamental to good health, and new treatment options are urgently needed in our healthcare armamentarium. 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,” prez & CEO John Cox said in a press release.
Approval came based on results from a prospective, controlled, randomized, crossover, evaluator-blinded trial which showed that the Curve system was non-inferior to traditional CPAP machines.
Results from the trial indicated that patients treated with the Curve system showed significant improvements in baseline values for the Apnea-Hypopnea index and the Oxygen Desaturation index.
“CPAP compliance continues to be a struggle for millions of people. Additional options for treating obstructive sleep apnea could ultimately drive improvements in compliance and clinical outcomes,” study investigator and Clinilabs prez & CEO Gary Zammit of New York’s Icahn School of Medicine at Mount Sinai said in a prepared statement.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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