CE Mark for Non-Invasive Open Ventilation (NIOV) System

Breathe Technologies, a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases, has gained CE Mark approval for its Non-Invasive Open Ventilation (NIOV) System.


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

The way it works is by effectively unloading the ancillary respiratory muscles. 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.

The system is the first and only wearable, ventilation system for people with respiratory insufficiency to receive a CE Mark. It 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.

Not only has it gained a CE Mark, but Breathe Technologies’ NIOV System has been recognized by the European Respiratory Society with its Product of Outstanding Interest (POINT) Award for 2014.

Physician comments

“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.”

Company comments

“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.”

Source: Breathe Technologies, Inc., PR Newswire

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