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FDA Clears Breathe Technologies, Inc.'s Sleep System



5/30/2013 6:22:42 AM

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Breathe Technologies Sleep System Receives FDA Clearance

IRVINE, Calif.
, May 30, 2013 /PRNewswire/ -- Breathe Technologies, Inc., a manufacturer of innovative medical devices for people with respiratory conditions today announced the Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its Sleep System (Continuous Positive Airway Pressure, or CPAP & Interface) in the US for treatment of Obstructive Sleep Apnea (OSA). The Breathe Sleep System utilizes miniaturized technologies coupled with user-centric design to provide a new therapeutic solution for patients with OSA.

"Reaching this milestone ahead of schedule is a testament to the expertise of our world-class team," said Larry Mastrovich, CEO of Breathe Technologies. "Our approach to respiratory care is centered on improving patients' quality of life. Based on extensive research with patients and clinicians, we have designed a clinically effective system with unique features."

Breathe's Sleep System is easy to set-up and provides effective CPAP therapy with a comfortable, discrete interface and tubing. Additional advanced features include a redesigned humidification system, an interactive patient touch-screen interface, and a smart pressure ramp function. Breathe Technologies product portfolio will be further enhanced with the addition of the Breathe Sleep System. Breathe Technologies' award-winning Non-Invasive OPEN Ventilation (NIOV) System is a one pound, wearable hospital to home miniaturized ventilation device that facilitates early ambulation in hospital settings and enables patient independence in the home for better quality of life. NIOV is currently in use by clinicians and patients across the country, including public and private hospitals, VA healthcare facilities, pulmonary rehab centers, and with patients at home.

For more information on Breathe Technologies' products visit www.breathetechnologies.com or contact us at info@breathetechnologies.com.

About Breathe Technologies, Inc.

Breathe Technologies, Inc., located in Irvine, California, is a developer and manufacturer of innovative medical technologies for treating respiratory conditions. The company was founded with the goal of transforming the lives of people with respiratory insufficiency by producing innovative therapies that have the potential to dramatically improve quality of life. The Breathe Non-Invasive OPEN Ventilation (NIOV) System, featuring the company's proprietary OPEN-airway platform, is FDA-cleared for use in both the institutional and homecare settings. The Company has received FDA clearance for its Sleep System to address unmet needs in sleep apnea. Breathe has taken an integrated approach focused on an improved user experience, supported by innovative design and best in class therapy. Investors include Kleiner Perkins Caufield & Byers, Delphi Ventures, Johnson & Johnson Development Corporation, Synergy Partners International, DAG Ventures and Morgan Creek. For more information, please visit www.breathetechnologies.com

SOURCE Breathe Technologies, Inc.



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