FDA Clearance for Portable Ventilator

Breathe Technologies Inc., a manufacturer of innovative technology solutions for people with respiratory conditions, including chronic obstructive pulmonary disease (COPD), has received FDA clearance for use of the Breathe Technologies BT-V2S ventilator in the home setting. The one-pound portable device provides ventilation assistance to aid select adult patients who suffer from respiratory insufficiency.

"This marks an important milestone not only for Breathe, but for the future of COPD disease management and patient quality of life," remarks Larry Mastrovich, President and CEO. "Patients with advanced COPD frequently suffer a loss of mobility, which may accelerate their respiratory disease progression and lead to decreased functional abilities. We are delighted to be able to offer this technology for patients to use in their homes because it has the potential to significantly improve their ability to perform activities of daily living."

The FDA clearance comes as Breathe prepares for market launch. The company will transfer its operations this year to a new facility in Southern California, where a number of major respiratory and sleep apnea device manufacturers are based. Additionally, industry veteran Rebecca Mabry has joined the Breathe Technologies management team as Senior Vice President of Sales and Marketing. Most recently, Mabry was General Manager at Midmark Diagnostics Group, a manufacturer of cardiopulmonary diagnostic devices. Prior to that, she served as Division President for Sleep Diagnostics and Therapy at VIASYS / Cardinal Health. During her career, she has held marketing positions with leading respiratory companies such as Bird Products, Healthdyne Technologies, Respironics, and SensorMedics.

"Our number one priority is to get this device out into the market where patients can benefit from this innovative technology," comments John Miclot, Chairman of the Board. "Rebecca brings a wealth of experience and expert knowledge to Breathe."