Navigation Links
Breathe Technologies Receives CE Mark Approval For Non-Invasive Open Ventilation (NIOV) System

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  

[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

SOURCE Breathe Technologies, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Breathe Technologies Sponsors Veteran With COPD On September Honor Flight
2. Easy Breathe Blog Emerges as the Go-To Resource for Sleep Apnea Sufferers
3. Chicago Man Breathes Again Thanks to Northwestern Medicine Study
4. Breathe Technologies Sleep System Receives FDA Clearance
5. Immortum Breathes Life Into End of Life Care
6. Breathe Technologies Non-Invasive Open Ventilation (NIOV™) System Receives Medical Design Award
7. Zebra Technologies Expands Healthcare Solution Offering and Introduces First-of-its-Kind Desktop Printer for Sterile Environments
8. Palatin Technologies, Inc. Reports Fourth Quarter and Fiscal Year End 2014 Results
9. Global Mobile Health and Fitness Sensor Market 2014-2018: Key Vendors are Abbott, Acute, Bayer, F. Hoffmann-La Roche, Fujitsu, GE Healthcare, Honeywell, LifeScan, Medtronic, OMRON and RF Technologies
10. Stellar Biotechnologies Analyst Report; Early Mover in Fast Growing Immunotherapy Market by BrokerBank Securities, Inc.
11. Palatin Technologies, Inc. To Report Fourth Quarter and Fiscal Year 2014 Results
Post Your Comments:
(Date:5/21/2020)... (PRWEB) , ... May 21, 2020 , ... The COVID-19 ... in March of this year, leadership at SPIRE Institute & Academy (IA) have closely ... and Ohio Governor Mike DeWine’s office to prevent the spread of coronavirus, and keep ...
(Date:5/21/2020)... ... May 21, 2020 , ... ... beginning May 11th. The offices had been closed due to the coronavirus pandemic ... in the dental field. The office has remained open only for emergency needs ...
(Date:5/21/2020)... ... May 21, 2020 , ... Murrieta Genomics has partnered with ... Conference to offer startup companies a special discount rate to the Digital RESI ... series was created by LSN to bring together startups with early-stage investors and strategic ...
Breaking Medicine Technology:
(Date:5/21/2020)... ... May 21, 2020 , ... JNL Technologies Inc. , a manufacturer ... of the SafeHealth screening software. This tool allows companies to create an ... or the cost of additional paperwork management. , SafeHealth allows you to create a ...
(Date:5/16/2020)... , ... May 15, 2020 , ... On May 21, T1V will host a webinar ... Institute of USC, and a contributor to CBS news, as we address COVID-19 and the ... in most parts of the country since March, many questions are left unanswered as we ...
(Date:5/15/2020)... Ill. (PRWEB) , ... May 15, 2020 , ... COVID-19 ... back on their feet by making sure their employees can get back to work ... popular, they have expanded to gyms, restaurants, bars, and countless other settings. , Everyone ...
(Date:5/15/2020)... ... May 15, 2020 , ... On May 17, World NF Awareness ... Where the Heart Is, a benefit to support the Children’s Tumor Foundation and to ... tumors to grow on nerves throughout the body and affects all ethnicities, races, and ...
(Date:5/15/2020)... ... 15, 2020 , ... How do you visit your primary care provider during ... are not set up to see their patients. Telemedicine alone doesn’t solve the problem ... to overcome. Doctors and patients need to connect again for continuity of care. Today ...
Breaking Medicine News(10 mins):