Breathe Technologies - 2014 Fierce 15

CEO: Larry Mastrovich
Based: Irvine, CA
Founded: 2005

The scoop: Ventilators aren't exactly a hotbed of innovation. But Breathe Technologies is doing its best to rethink the space. It's introduced a 1-lb. miniaturized version of a large ventilator, dubbed Niov, which would typically be in a hospital setting. The idea is to allow patients with respiratory insufficiency--in the hospital and at home--to be more mobile, thereby aiding in the recovery process.

What makes Breathe Technologies Fierce: Making healthcare more effective and cheaper for an aging population is an ever-popular theme that Breathe Tech hits upon squarely. Its Niov system is effective as a portable ventilator that can attach to a belt, much easier to carry than the typical "portable" ventilator, which weighs in at 10 to 12 lbs and is the size of a laptop, notes Breathe Technologies President and CEO Larry Mastrovich.

Prior to Breathe, Mastrovich was the president and COO of Apria Healthcare. Apria is the largest home care provider of respiratory and medical equipment in the U.S. It sold for $1.6 billion to private equity firm The Blackstone Group in 2008.

In addition to being small, this ventilator works via two tiny silicon pillows placed in the nostrils; it doesn't require that a patient is intubated or has a full face mask.

"That doesn't provide an opportunity for rehabilitation or the activities of daily living," Mastrovich said in an interview with FierceMedicalDevices. The innovation in the Niov comes from "shrinking it and using engineering principals in the interface to provide more patient comforts. Innovation in this space has been very slow, haven't really seen any since 1998. We have something very unique, very useful and very new."

The device has been in 7 clinical studies that looked at more than 130 patients, Mastrovich said. "The consistent theme is that the device helps to reduce difficulty of breathing and shortness of breath," he noted.

In one study, Niov was compared with a traditional nasal oxygen cannula in 30 pulmonary rehabilitation patients. The exercise distances increased for the Niov for 25 out of the 30 subjects, with a mean improvement on a 6-minute walk test of 57 meters ± 54 meters. The additional exercise allows patients to improve respiratory capacity faster, enabling a quicker rehabilitation in the hospital and at home.

"Hospitals have found value in putting the device on patients for early mobilization all the way through to early rehabilitation. In long-term care or pulmonary rehabilitation, this device follows the patient all the way through," said Mastrovich.

What to look for: Niov cleared FDA in 2010 and about 400 units are in use in hospitals and homes, according to the company. Breathe Tech is looking to further improve its reimbursement; currently, several large and regional U.S. payers as well as the Veterans Administration and a few state Medicaid systems reimburse for Niov. The company's also focused on continuing ex-U.S. expansion and recently received a CE mark. It's working to find distribution partners there.

Despite a revenue-generating product and a focus on market expansion, Mastrovich said the startup's backers, which include major venture and strategic names, aren't in any hurry for an exit. Most recently, Breathe Tech raised $7.3 million in June, according to an SEC filing. Among its investors are Kleiner Perkins Caufield & Byers, Johnson & Johnson Development Corporation, Delphi Ventures, DAG Ventures, Morgan Creek and Synergy Partners. -- Stacy Lawrence (email | Twitter)

For more:
Breathe Technologies looks to move HQ to OC
Breathe Technologies secures $23M in financing

Breathe Technologies - 2014 Fierce 15