FDA AUTHORIZES FRESCA MEDICAL TO MARKET NEW POSITIVE AIRWAY PRESSURE DELIVERY SYSTEM TO TREAT SLEEP APNEA
Novel Low-Flow Technology Has Demonstrated Efficacy in Obstructive Sleep Apnea Patients
SAN CLEMENTE, CA, – June 25, 2018 – FRESCA Medical, Inc., a privately held sleep solutions and connected health company, announced today that the U.S. Food and Drug Administration (FDA) granted their de novo request to market the CURVE™ Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea (OSA). The de novo pathway is reserved for marketing approval of novel devices of low to moderate risk. The FRESCA system includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and a comfortable nasal pillow patient interface. The key to the system is FRESCA's novel, patented SmartValve™ technology which enables the system to treat OSA with far less airflow than conventional CPAP systems, and has the potential to solve many of the complaints that cause sleep apnea sufferers to abandon therapy or refuse to even try CPAP. Scientific literature reports extremely high rates of patient dissatisfaction with CPAP, and treatment abandonment rates of up to 50%.1 Currently, for every patient in treatment, there are at least four additional sleep apnea sufferers who are undiagnosed or refuse treatment. The World Health Organization estimates that at least 100 million adults suffer from sleep apnea globally, creating a $35 billion market opportunity for a treatment that is both effective and embraced by patients.
An analysis commissioned by the American Academy of Sleep Medicine showed that treating OSA with positive airway pressure has been shown to save healthcare systems money in the first year. Sleep apnea is one of the few chronic diseases where there is such a rapid return on investment in diagnosis and treatment. 2
Results from a prospective, controlled, randomized, crossover, evaluator-blinded trial demonstrated that FRESCA's CURVE system was non-inferior to CPAP, which is the current gold standard in the treatment of sleep apnea. Patients treated with the FRESCA 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). "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."
"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. 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."
About FRESCA Medical, Inc.
FRESCA Medical is a pioneer in sleep apnea treatment and connected health technology. FRESCA's first product, the CURVE™ Positive Airway Pressure System for sleep apnea addresses numerous unmet needs in the $35B available sleep apnea treatment market. For more information, visit: www.frescamed.com. FRESCA anticipates launching the CURVE System in the U.S. in 2019.
Indications for Use: The CURVE™ Positive Airway Pressure System
The CURVE™ Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).
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- Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: implications for future interventions. Indian J Med Res. 2010;131:245–258.
- Watson NF. Health care savings: the economic value of diagnostic and therapeutic care for obstructive sleep apnea. J Clin Sleep Med 2016;12(8):1075–1077.