COHOES — The U.S. Food and Drug Administration has given a Cohoes firm approval to start selling their newly designed emergency ventilators.
PVA is the first New York firm to get emergency-use approval for the life-saving devices that can help patients with COVID-19 to breathe – though most of their demand is now coming from out of state.
Their “PREVENT” ventilator is a microwave-sized pumping machine sold for $6,000 or less, unlike the large $30,000 to $40,000 units that some hospitals around the globe have been running out of.
“I have never been more proud of the people around me in the 30 years I’ve been doing this, to see everybody pulling together and working as a team to make this happen,” said PVA President Tony Hynes.
Hynes’ company isn’t normally a medical-device manufacturer, but they’ve been supplying components to companies that make ventilators for years. They also make components for the automotive and tech industries. Much of that business has dried up since the COVID-19 pandemic began.
While bad news for revenue, CEO Tony Hynes said it freed up his company to devote most of its energy toward developing an affordable ventilator. Thanks to a $35,000 grant from National Grid, they’ve converted their factory to be able to produce 250 ventilators a day – or one every six minutes.
The project started a month ago, when Gov. Andrew Cuomo described New York’s need for thousands more gloves, masks, ventilators and other equipment. The governor called on local businesses to “get creative” and promised help.
But just as PVA has received approval to sell their ventilator, New York has largely eliminated shortages of the devices in the state. On April 6, Cuomo said “we don’t need any additional ventilators right now.”
And this past weekend, the governor announced he was ready to send 400 ventilators to Massachusetts if they needed them.
“We jumped in this for New York state. We were trying to fill the gap here at home,” said Frank Hart, PVA’s managing director of sales and marketing. “I think we’ve realized that we may be past that peak right now here, but there’s a lot of areas in the world that are not so we’re seeing increased demand from different states, different countries, and also individuals.”
Unlike New York, which has been purchasing medical supplies and ‘surging’ them around the state, many hospitals in other states must compete individually to make sure they have enough supplies. “Right now all our activity has been from out of the state,” said Hart. “I think that’s primarily based on the timing.”
While some states in the U.S. already have enough equipment, nations around the globe may still face critical need. TIME magazine reported earlier this month of the death of Zimbabwe celebrity Zororo Makamba in a hospital with few drugs, scared staff, and no ventilators. Hynes said he hopes his company’s ventilators can help in places like Africa.
Private philanthropists have already shown interest in ordering the PREVENT device to donate, Hart said.
PVA’s emergency ventilator was based off research from Massachusetts Institute of Technology. Managing director of product development Jason Schoen led the team in designing the prototype, which mechanically squeezes a standard hand-operated resuscitation bag. The machines do more than just pump air into a patient’s lungs – the circuitry allows therapists to change airflow, rate, and other settings. The devices also monitor air pressure, a key feature that can notify therapists of possible problems in the system.