Prathamesh Prabhudesai, MD
“We are developing a cost-efficient accessory that will make the bag (valve mask) closer to that of a mechanical ventilator,” safeBVM COO Prathmesh Prabhudesai told the 4thEst8. “We had a prototype. We did some testing with the grant. Now we are refining it… it is an FDA Class 2 regulated device, so we are working on compliance.”
Last fall the Chesterfield, Mo.-based Arch Grants finalist landed a $255,999 Phase 1 grant from the National Science Foundation, Directorate for Engineering. The company was incorporated in 2019 and has two full-time employees.
The bag valve mask, or manual resucitator, is a medical device commonly used by first-responders in emergencies to manually deliver air to patients who are unable to breathe on their own. SafeBVM says their research shows that about 13.1 million BVMs are used annualy in the United States. The problem with the standard device, according to CEO Haris Shekhani, is that first responders under high levels of stress can squeeze the bag too hard and damage the lungs of their patient. The safeBVM prototype has a regulator that prevents that.
Haris Shekhani, MD
“We are in (FDA) Emergency Use Authorization, because of Covid 19,” Shekhani said. “We took that pathway first, but are submitting our 510K so things should be taking off soon. We are in the final stages of Emergency Use Authorization with the FDA.
A 510K is a premarket submission made to the FDA to demonstrate that the device to be marketed is both safe and effective.
Up next:
The startup has applied for a Phase 2 grant to help fund clinical trials to show safety and efficacy. That would likely involve partnering with a university, and hopefully lead to proof of improved patient outcomes.
“Our goal is to make the device a standard of care,” Prabhudesai said, when asked about ‘exit plans’. “So, whether that is partnering with another medical device company, or partnering with a distributor, or scaling the business and hiring a lot of sales people – we are open to all of these.”
“Right now we might be a little early for the venture capital,” Shekhani added. “But we are looking for angel investment, like really small venture groups. The moment we have FDA clearance and are scaling business and hiring a lot of folks, that would be an optimal time to raise venture funding.”
