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Can Fresca's Sleep Apnea Device 'Curve' the CPAP Compliance Problem?

Fresca Medical said FDA granted its de novo request to market the Curve positive airway pressure system for the treatment of obstructive sleep apnea.

People who suffer from obstructive sleep apnea (OSA) generally hate wearing their CPAP (continuous positive airway pressure) mask. Many refuse to even give it a try. Even some doctors have a love-hate relationship with this standard sleep apnea therapy.

The good news is that device makers are well aware of the patient compliance problem that plagues sleep apnea treatment, and many have been actively trying to combat the problem through innovation. Case in point, Fresca Medical. 

The San Clemente, CA-based company scored permission from FDA through a de novo request to market the Curve positive airway pressure delivery system for the treatment of OSA. According to the company, the system has the potential to solve many of the complaints that cause sleep apnea sufferers to abandon or refuse to even try CPAP therapy.

The device includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and the company's SmartValve technology, which is designed to enable the system to treat OSA with far less airflow than conventional CPAP machines. 

To support its de novo request, Fresca submitted data from a prospective, controlled, randomized, crossover, evaluator-blinded trial that demonstrated the Curve system was non-inferior to CPAP. In the trial, patients treated with Fresca's system showed significant improvement in baseline values for the Apnea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI), both within the normal range,  the company noted.

"Our breakthrough technology provides physicians the opportunity to offer a new breathing experience for patients who don't want or cannot tolerate CPAP therapy," said John Cox, president and CEO of Fresca Medical. "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."

Indeed, digital health technology has already shown promise in the sleep apnea space. Caesarea, Isreal-based Itamar Medical introduced its SleePath monitoring system in May at Heart Rhythm 2018, the annual meeting of the Heart Rhythm Society. The SleePath system was designed to give cardiologists a way to monitor patients with atrial fibrillation who also suffer from sleep apnea and allows them to see how compliant the patient is with their prescribed CPAP device.

Philips Respironics, a division of Royal Philips that makes CPAP devices, has also turned to digital healthcare to address the CPAP compliance problem.

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