Irvine-based Breathe Technologies Inc. is looking to get a boost from new clinical study results and a device that’s scheduled to be introduced this year.
Breathe makes ventilation devices for treating chronic obstructive pulmonary disease, or COPD, which is a combination of chronic bronchitis and emphysema that makes breathing difficult. About 24 million Americans have the disease, according to the Miami-based COPD Foundation.
Breathe at the COPD9 industry meeting in Chicago this month unveiled data showing use of its Non-Invasive Open Ventilation wearable device in lung rehabilitation patients was associated with longer endurance during exercise.
“Patients that are being oxygenated and ventilated at the same time … they are able to have an increased amount of endurance and mobility,” Chief Executive Larry Mastrovich said of the results.
The Non-Invasive Open Ventilation device received Food and Drug Approval in 2010. Breathe is preparing to introduce a new product, the Life 2000 ventilator, at the end of this year, with a full launch expected in 2016.
The Life 2000 is designed for patients who need ventilation delivered through a tube or a mask and can be used in institutional and home settings.
Breathe gets its devices onto the market through a direct sales force made up of registered respiratory therapists. Its customers include home healthcare companies, a field that Mastrovich is familiar with, having served as president and chief operating officer of Lake Forest-based Apria Healthcare Group Inc.
“Our approach is to provide a much higher clinical approach, and it’s been very well-received,” he said of how Breathe’s sales force works.
Mastrovich didn’t give a specific revenue number for Breathe but said the privately held company is in the eight-figure range.
Breathe is planning to build the organization and remain independent as it grows, according to Mastrovich.
There are other companies that produce devices to assist with breathing disorders, but Mastrovich said many are focused on sleep apnea.
“We’re not in the sleep business. We are not competitive in the sleep market. We are in the ventilation market,” he said, later adding that Breathe feels “like we have a product line that is not matched by anybody.”
Silicon Valley
Breathe is backed by venture capital firms and has raised about $38.8 million in its 10-year history.
Investors include Silicon Valley-based Kleiner Perkins Caufield & Byers and New Jersey-based Johnson & Johnson Development Corp.
“We have excellent investors, and they have been very, very supportive of the company,” Mastrovich said, adding that Breathe also has support from Sunnyvale-based Life Science Angels Inc.
Breathe has done nine clinical studies of its products.
Mastrovich shared thoughts on the latest one.
“It’s important for the [whole healthcare system] to provide benefits. What we’ve been focused on is providing benefits that show patients are improving clinically,” he said.
Breathe has “done a lot of work in that area with patients that show there’s an improvement in their clinical outcomes by being put on this device in addition to other therapies,” he said. “If you can get a patient up and exercising for two more hours a week, you can reduce their hospitalizations by 30% to 40%.”
Clinical Study
Breathe will soon launch a tenth clinical study, a follow up to the study presented at COPD9, Mastrovich said. He said the study will show the potential of the Non-Invasive Open Ventilation devices to help control healthcare costs and that it will be presented in October at the American College of Chest Physicians’ meeting in Montreal.
Breathe has 22 workers and manufactures devices locally. Mastrovich said it plans to look at partners as the company’s volume and revenue increase. He said the company plans to do more hiring but gave no specific numbers.
The device maker moved to Orange County in 2011 from San Ramon in the Bay area. Mastrovich, who lives in Coto de Caza, told the Business Journal at the time that the number of medical device workers in South County and northern San Diego County drove the company’s decision to move here from up north.
