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Breathe Technologies Receives CE Mark Approval For Non-Invasive Open Ventilation (NIOV) System
Date:9/9/2014

IRVINE, Calif., Sept. 9, 2014 /PRNewswire/ -- Breathe Technologies, a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases, announced today that it received CE Certification for its Non-Invasive Open Ventilation (NIOV) System, enabling the company to market and sell the device in the European Union. In addition, the NIOV System has been recognized by the European Respiratory Society with its Product of Outstanding Interest (POINT) Award for 2014.

The Breathe NIOV System is the first and only wearable, ventilation system for people with respiratory insufficiency to receive a CE Mark. The Breathe NIOV System provides augmented tidal volume, which reduces the work of breathing for people with respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD), including Alpha-1 Antitrypsin Deficiency.

When Breathe Technologies received its first U.S. FDA 501(k) Clearance in 2010 for the NIOV System, it was the first innovation in the ventilation category since 1998. Medical devices must be CE marked before they can be legally used in Europe. The Breathe NIOV System was certified under the European CE Full Quality Assurance System Directive 93/42/EEC for Medical Devices, Annex II excluding (4). The review was carried out by AMTAC Certification Services Limited, Milton Keynes, UK, which authorized Breathe Technologies to use the CE 0473 mark for its NIOV System.

"Receiving a CE Mark for our NIOV System is a significant milestone for Breathe Technologies and we appreciate the concurrent recognition from the European Respiratory Society," said Larry Mastrovich, president and CEO, Breathe Technologies. "We are now exploring potential commercialization partners for the EU and developing a European advisory board."

Receipt of the European Respiratory Society 2014 POINT Award signals the EU healthcare community's esteem for the Breathe NIOV System, and bodes well for the uptake and impact the device will have in European markets. The POINT Award was established by the European Respiratory Society to encourage and reward innovation and application of current ideas to solving the challenges of modern respiratory healthcare.  

"Our experience with the Breathe Non-Invasive Open Ventilation System in the U.S. reaffirms the importance of ventilation with ambulation for people with respiratory insufficiency diseases including COPD," said Larry C. Casey, M.D., PhD, Mayo Clinic Health System, Franciscan Healthcare, La Crosse, Wisconsin.  "I expect that the improvements in exercise duration and reduction in exacerbations seen among patients using the NIOV will resonate with physicians and patients in the EU."

About The Breathe NIOV System
The Breathe NIOV System is a one-pound non-invasive mechanical ventilator that can be used in homecare and institutional settings. The Breathe NIOV System utilizes novel venturi principle technology in a comfortable facial interface that can be worn while talking and exercising. The Breathe NIOV System technology reduces the overall size of the ventilation system and supports patient mobility and independence.

The Breathe NIOV System reduces the work of breathing by unloading the ancillary respiratory muscles.[i] Data from the seven studies that support the efficacy of the Breathe NIOV System demonstrate that the device reduces dyspnea (shortness of breath), increases oxygenation, enhances exercise endurance, and unloads respiratory muscle activity.

About Breathe Technologies
Breathe Technologies, Inc. is a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases. The company is the first provider of lightweight and wearable ventilators that reduce the work of breathing and support improved patient mobility. Breathe Technologies has a robust product pipeline that seeks to address additional unmet needs in respiratory care. Investors include Kleiner Perkins Caufield & Byers, DAG Ventures, Morgan Creek, and Synergy Partners International. Breathe Technologies is located in Irvine, California.

For more information, please visit www.breathetechnologies.com.  

[i] 1Porszasz J, et al. Physiologic effects of an ambulatory ventilation system in COPD. Am J Respir Crit Care Med Vol 188, Iss. 3, pp 334–342, Aug 1, 2013


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SOURCE Breathe Technologies, Inc.
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