Breathe Technologies, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved its critical care Breathe Technologies Life2000 Ventilation System. The device is designed to provide both continuous and intermittent ventilatory support to care for patients who need mechanical ventilation.
Breathe Technologies is a manufacturer and developer of medical technologies designed to address patients who suffer from respiratory insufficiency and neuromuscular diseases. The company announced that the FDA has granted 510(k) clearance for their Breathe Technologies Life2000 Ventilation System as indicated for those in need of positive pressure ventilation delivered invasively (through ET tube) or non-invasively (through mask). The ventilator can be used at home and under institutional settings, but the company notes that it should be administered by qualified and trained personnel under a physician’s supervision.
The company expects the Breathe Technologies Life2000 Ventilation System to be available and commercialized in the United States starting in late 2015.
“We are pleased to announce the FDA clearance of the Breathe Technologies Life2000 Ventilation System. This clearance underscores our commitment to providing healthcare providers and patients with another therapeutic option for critical care ventilation,” said Larry Mastrovich, CEO and president of Breathe Technologies.
In addition to this respiratory system, Breathe Technologies also manufactures the Non-Invasive Open Ventilation (NIOV) System, which is the first wearable and lightweight ventilator available on the market to reduce the effort of breathing that assists in patient mobility. The company is developing a strong product pipeline whose goal is to address unmet needs for respiratory care. Kleiner Perkins Caufield & Byers, Deerfield Management Company, L.P., Roddenbury Foundation, DAG Ventures, Morgan Creek, BioMed Ventures, and Synergy Partners International are main investors.
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The Non-Invasive Open Ventilation (NIOV) System to improve pulmonary rehabilitation in patients with respiratory insufficiency diseases and neuromuscular diseases was shown to be effective, according to data presented at the biennial COPD9USA meeting, which took place last weekend in Chicago. The study was pivotal in the device’s recent acceptance.
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