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, Ph.D., president & CEO of Clinilabs Inc., Executive Director of the Sleep Disorders Institute in N.Y., and Clinical Associate Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai, N.Y. "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."
1 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.
2 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.