NC Startup Awaits FDA OK for ‘Low-Cost’ COVID-19 Ventilator
As the world grapples with a shortage of ventilators for COVID-19 patients, a small North Carolina life science startup has designed a low-cost option.
BioMedInnovations (BMI), headquartered outside Charlotte with a research lab in Research Triangle Park, hopes to get federal fast-track approval this week to manufacture and distribute its uniquely simple device to help people breathe.
Until a few weeks ago, the company was focused on making equipment that helps prolong organ life for transplants.
Then the COVID-19 pandemic struck, and it decided to change tack.
“What we realized 10 days ago is that the core of the technology that we use for [prolonging organ life] can be used for pumping gases like oxygen just as easily as we do fluid,” BioMedInnovations CEO Sherif Gabriel, Ph.D., told the North Carolina Biotechnology Center in a phone interview. “We pivoted in that moment.”
Within 48 hours, the startup’s team of engineers, with Asheville-based partner Equilibar, had designed their first operating model using BioMed’s unique technology.
Gabriel said the design has minimal components and is easy to assemble. Plus, it comes with an attractive price tag.
“Most hospital ventilators run around $25,000,” he said. “Our ventilators are expected to come in around the $5,000 to $6,000 range.”
On Friday, March 27, the firm filed for emergency use authorization from the U.S. Food and Drug Administration.
Gabriel said he hoped approval could come as early as this week. Hospitals across the U.S. are facing shortages of these life-saving machines in the face of a disease that attacks the lungs.
Many medical experts fear these devices won’t be developed and shipped quickly enough in the coming weeks, which could mean the difference of life or death for many patients with COVID-19.
While Gabriel recognized that BMI is not the only company ramping up operations to fill the void (Tesla, General Motors and Dyson are among big players that have retooled factories to make ventilators), he said his company is singular in its effort to bring a low-cost option.
“We're also this small startup company with half a dozen or fewer employees, and our technology is unique.”
Gabriel said most ventilators are built on a concept of delivering flow or volume to the lung.
BMI's ventilators, meanwhile, are based on a “pressure-regulated” system. It is designed to deliver room air and can also be attached to an oxygen supply.
“We are not competing for supplies from typical ventilator makers as we are using a different technology, better in my opinion, so we can increase supply of ventilators globally,” Gabriel added.
Ideally, the ventilator could be used for patients with milder symptoms and in a mobile setting.
The company has partnered with a number of motor sports manufacturing teams to assemble the ventilators, and is getting funding from small business loans and possibly venture capital investors.
He believes they could make around 1,000 devices a week.
“We could definitely be up and running in two to three weeks,” he said.