BioMedInnovations Lands FDA OK for New SuppleVent COVID-19 Ventilator
Half a year into a global pandemic, a small North Carolina life sciences startup has gotten fast-track approval to start producing “low-cost, high-value” ventilators.
Meet BioMedInnovations (BMI), headquartered outside Charlotte with a research lab in Research Triangle Park. This week, it received emergency use authorization from the U.S. Food and Drug Administration for its device called the SuppleVent, a back-pressure regulator-based ventilator.
Now, the 12-year-old “startup” is joining the ongoing global effort to increase the supply of these lifesaving devices in the age of coronavirus. To date, roughly 7.1 million COVID-19 cases have been reported, with 407,145 deaths and counting.
“There is going to be global demand,” BMI’s CEO Sherif Gabriel said in a video interview with the North Carolina Biotechnology Center this week, shortly after receiving the final FDA go-ahead on the application he submitted in late March.
Consider the price tag: BMI’s ventilators cost around $10,000, while most hospital ventilators cost around $25,000 and up.
Already, Gabriel says BMI has a number of pre-orders from several countries in South America -- including Chile, Panama, Peru -- and as far afield as Rwanda and Uzbekistan. Orders are for “several thousand ventilators.”
“We're hearing from a lot of countries that maybe can't afford the $25,000 to $50,000 ventilators,” Gabriel said. “We also know that there are some smaller regional hospitals and counties, even in the U.S., that don't have as many ventilators as they would like. Those areas would also benefit from having a high-value, lower-cost ventilator.”
Partnering with NASCAR, Indy racing teams
Interestingly, the startup also has some unlikely partners: the world of motor sports.
Through BMI’s relationship with Industrial Hard Carbon (IHC), the startup is collaborating with Roush Yates Manufacturing Solutions, a division of Roush Yates Engines and NASCAR racing teams Joe Gibbs Racing, to build components for the ventilator.
Indy Car engine designer Honda Performance Development is also assisting with testing and engineering expertise.
Gabriel admitted it’s “exceptionally unusual” to see a life sciences company partnering with a motor-racing manufacturer, but these are also unique times.
“We leveraged the relationship well and they were all very, very supportive,” he said.
Production starts this week. They will start by making a few prototypes at Roush’s 88,000-square-foot facility in Mooresville, and then ramp things up fairly quickly, said BMI’s chief operating officer Carrie DiMarzio, who happens to be the former CEO at Industrial Hard Carbon.
She says they expect to produce 1,000 ventilators by the end of the month.
“Depending on the orders that we get, we have the capacity fill orders up to 10,000 per month,” she said.
A sudden pivot
The “startup,” founded around 2005 by George Barr, didn’t start out making ventilators. Its original mission is focused on making equipment that helps prolong organ life for transplants.
NCBiotech helped support the company’s perfusion technology development with a $250,000 loan in March. Now the small fast-moving BMI team is on a roll.
Shortly after COVID-19 struck, its CEO Gabriel, who joined BMI a year earlier, said he and his team realized the core technology behind its device for organ perfusion could also be used for ventilation. In other words, it could pump gases like oxygen just as easily as fluid to keep a person breathing and alive.
Within 48 hours, BMI’s small team of engineers, with Asheville-area partner Equilibar, had designed their first operating model using BMI’s unique technology. Through different iterations, they also collaborated with the renowned California federal research institution, Lawrence Livermore National Laboratory.
The result: a ventilator with minimal components that is easy to assemble -- and affordable.
While Gabriel recognized that BMI is not the only company ramping up operations to fill the void (Ford, Tesla, General Motors and Dyson are among big players that have retooled factories to make ventilators), he said his small 12-person company is singular in its effort to bring a low-cost option.
Its technology is also unique, he added. 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. They’re designed to deliver compressed room air or an oxygen mix and can also be attached to an oxygen supply.
Ideally, the ventilator could be used for patients with milder symptoms and in a mobile setting like a field hospital. It could also be deployed to any hospital intensive care unit and outfitted with either a mask or endotracheal tube.
Jack Kotovsky, a Lawrence Livermore engineer who spearheaded this ventilator effort, said the device could prove to be instrumental during this COVID-19 global pandemic.
“All of us want to contribute and help individuals in all dimensions of this global pandemic and being able to produce a piece of durable equipment that will directly benefit human life is very exciting,” he said. “There is still a significant need for ventilators globally. Knowing that we are providing a buildable and scalable design for a high-functioning and value-added ventilator is very gratifying and there is important work to continue to help patients and hospital systems in need.”