Alternative Sleep Apnea System Receives FDA Approval to Market

JUNE 26, 2018
Cecilia Pessoa Gingerich
fda, istenti inject trabecular micro-byass system, intraocular pressure, glaucoma, cataractThe US Food and Drug Administration (FDA) has granted a de novo application to market the CURVE Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea (OSA). The FRESCA Medical, Inc system includes a dedicated flow generator, a light and ergonomic hose for air delivery, and a nasal pillow patient interface, and is intended for use by adult patients weighing over 66 lbs (30 kg).

"FRESCA Medical is committed to developing disruptive and effective technologies for sleep apnea sufferers who cannot tolerate the currently available therapies," said John Cox, President and CEO of FRESCA Medical. "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.”

The company’s novel SmartValve technology allows the CURVE Positive Airway Pressure (CPAP) system to treat obstructive sleep apnea with less airflow than conventional CPAP systems. This has the potential to ease many patient complaints about the traditional CPAP issues that lead patients with sleep apnea to abandon or refuse to try the treatment.

"CPAP compliance continues to be a struggle for millions of people," said the largest enroller in the FRESCA study, Gary Zammit, PhD, President & CEO of Clinilabs, Inc., Executive Director of the Sleep Disorders Institute in NY, and Clinical Associate Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai, NY. "Additional options for treating obstructive sleep apnea could ultimately drive improvements in compliance and clinical outcomes."

The de novo permission to market application included data from a prospective, controlled, randomized, crossover, and evaluator-blinded trial that showed that the FRESCA CURVE system was non-inferior to CPAP. Participants treated with CURVE Positive Airway Pressure delivery system showed significant improvement in baseline values for both the Apnea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI).

“Quality sleep is fundamental to good health, and new treatment options are urgently needed in our healthcare armamentarium,” said Cox. “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."

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