BreathDirect, a California-based medical device company, is developing a low-cost, critical care ventilator with a comprehensive set of operating modes and ranges designed in response to COVID-19.

The BDR-19 (BreathDirect, COVID-19) ventilator is part of the company’s goal to build an affordable critical care device that can deliver a full continuum of ventilatory support to patients and be produced at high-volume for rapid global deployment.

The device has not yet received FDA approval or FDA emergency use authorization, but the company says an EUA is “expected very soon.” Once received, the BDR-19 ventilator will be readily available as hospitals and healthcare systems around the world stockpile their ICUs to meet a projected demand of up to 900,000 ventilators worldwide in 2020, according to BreathDirect.

The company, which was formed earlier this year by Nectar Product Development, is working with Evolve Manufacturing Technologies and Hubbell Inc to develop and produce the BDR-19.

This week BreathDirect appointed Anthony Wondka as chief operating officer. His previous experience includes time as general manager at Capnia Inc, where he led the development, manufacturing and commercialization of an important new neonatal breath test product that will help prevent newborns from getting bilirubin related brain damage. Wondka also served as VP of R&D, Technology and Clinical at Breathe Technologies.

“As the need for critical care ventilators grows in the United States and internationally, including developing countries, we’ll be at the ready, with affordable, US-made, life-saving equipment,” said Wondka, a 30-year veteran of respiratory and ventilator device development and production. “The BDR-19 will be an important solution and resource to help hospitals address COVID-19-related ventilator shortages in the United States and worldwide.”