Breathe steps up offerings

IRVINE, Calif. - Breathe Technologies will significantly extend its reach into the vent market on Jan. 1 when it plans to launch Life2000.

The system received 510(k) clearance from the Food and Drug Administration in June and Medicare coverage for invasive and non-invasive ventilators in September. Breathe Technologies' first product, the Non-Invasive Open Ventilation or NIOV system, has broken down barriers as an ultra-lightweight device but only has Medicare coverage under E1352, oxygen accessory, and can't be billed as a standalone vent.

“This ventilator has critical care capabilities and a detachable module that incorporates the wearable technology used in our first device,” said Larry Mastrovich, CEO.

Breathe Technologies had demos of the Life2000 at Medtrade in October.

With clearance and coding for the Life2000, Breathe Technologies has now set its sights on funding studies of the patient and financial outcomes associated with using this type of device.

Fueling Breathe Technologies' recent activities: a sizeable list of investors, including Kleiner Perkins Caufield & Byers, Deerfield Management Co., Roddenbury Foundation, DAG Ventures, Morgan Creek, BioMed Ventures and Synergy Partners International.

To date, the bulk of Breath's customer base has been homecare providers, but Mastrovich says the company is now garnering more interest from the institutional side as hospitals take more responsibility for caring for patients outside their four walls.

“I think there's a number of places where this device fits in, but with the changes that are taking place so quickly, we believe we have a device that can go from hospital to home,” he said. “It fits very well in the ER to the ICU, all through the step-downs to long-term acute care to rehab to home.”