The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks.

The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic. Saravis, who is Breath Direct’s CEO, had prior experience with ventilator design and engineering as the head of Nectar Product Development, a position he still holds.

“When COVID-19 hit, our team saw that ventilators currently on the market were not designed for mass production using local supply chains. There was going to be a great need for quality ventilators in the coming months, and our team mobilized to develop a critical care ventilator designed for rapid production and deployment,” Saravis told BioWorld.

The EUA comes as hospitals and public health agencies are reassessing the adequacy of their ventilator inventories. According to Breath Direct, only 10% of stockpiled ventilators are suitable for full ICU critical care.

Competitively priced

Darren Saravis, CEO, Breath Direct

The company says that the BDR-19 pairs full functionality with ease of operability, an intuitive interface and the ability to rapidly mobilized and learned. It can be used for both invasive and noninvasive ventilation and stored for long periods without regular maintenance. Roughly the size of a toaster oven and lightweight for portability, the BDR-19 is designed to squeeze into the tight spaces of the intensive care unit and emergency department. “All in all, it fits on a bedside table or on our optional compact rolling stand,” Saravis said.

Breath Direct is targeting a per unit price of $15,000 or less, compared with $20,000 to $50,000 for most hospital-grade ventilators.

“We designed the BDR-19 as a continuous use, critical care ventilator, built primarily for intensive care units and capable of a full continuum of respiratory support,” Saravis said, adding the company worked with the FDA for months as new knowledge was acquired from ERs and ICUs on the treatment of COVID-19 patients requiring ventilatory support and as new care protocols evolved.

“The result is a machine that addresses the broad range of clinical needs while hitting the highest bar of safety and efficacy that the FDA demands,” he said.

Breath Direct is currently pursuing 510(k) clearance from the FDA, as well as the CE mark, with a 10-month timeline in mind.

“Looking ahead, we expect to see a steady demand for more capable, multifunctional ventilators from hospitals in the U.S. and abroad – including those in developing countries,” said Saravis.

All U.S.-sourced

Buzz about the ventilator has sparked interest, and the company’s clinical sales director, Cecil Jennings, is reaching out to consolidate that interest. In the meantime, the company has locked in its supply chain channels and procured enough components and raw materials – all U.S.-sourced and built – to ensure uninterrupted manufacturing and assembly as it scales production this spring.

“We’re optimistic, given its competitive price point, that procurement managers will see the BDR-19 as a viable, strategic acquisition – helping them be at the ready for whatever lies ahead,” Saravis said.

Breath Direct has partnered with Evolve Manufacturing Technologies Inc. to produce the ventilator. The Fremont, Calif., company can roll out a machine every 15 minutes and, at full capacity, every 90 seconds, for a maximum capacity of 40,000 units per month, depending on demand.

The first units are expected to begin shipping in mid-April.