Can Fresca & #039;s Sleep Apnea Device & #039;Curve & #039; the CPAP Compliance Problem?

    SAN CLEMENTE, Calif., June 25, 2018 /PRNewswire/ -- 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 novorequest 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 wit...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news