Middletown-based diving contractor Michael Lombardi is used to solving challenges underwater, immersed in 500 feet of ocean water or a shallow sewer in places as far-flung as Antarctica or closer to home in Rhode Island.
And he has designed custom life-support systems for some of the most difficult tasks that take place under the sea. But more recently, he’s pivoted, using his expertise and an emergency authorization from the U.S. Food and Drug Administration to tackle one of the globe’s most pressing issues during the coronavirus pandemic: a shortage of ventilators.
Lombardi has teamed up with Subsalve USA Corp., a North Kingstown-based manufacturer to produce an oxygen-treatment hood that treats COVID-19-related respiratory ailment without the insertion of breathing tubes required when using a traditional ventilator.
Now the hoods are being dispersed throughout the world, including to Rhode Island hospitals.
“The whole point is to be able to ventilate a patient noninvasively,” said Lombardi, who has operated Lombardi Undersea LLC in Middletown since 1998.
The transparent hoods provide a constant flow of air after they are fixed around a patient’s head and neck. Health care workers can control the air pressure inside the hoods. Lombardi said units have been sent to Rhode Island Hospital, The Miriam Hospital, Boston Medical Center, Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
‘The whole point is to be able to ventilate a patient noninvasively.’
MICHAEL LOMBARDI, Lombardi Undersea LLC owner
Lifespan Corp., the parent company of both Rhode Island Hospital and Miriam Hospital, declined to comment.
Richard Fryburg, who founded Subsalve in 1977, said after significant startup costs, his company is producing about 400 oxygen hood units each day and has supplied more than 20,000 to date worldwide, and more than 2,000 devices within the United States at 50 different hospitals. He said he’s hoping to start producing more than 600 per day shortly and work with distributor The Health Bank.
While the hood hasn’t been a moneymaker yet, Fryburg said he expects to start making a profit soon. And there have been other payoffs.
“What’s monumental is that we are the only company and the only product that has been FDA-approved for a COVID-19 treatment,” he said. “There’s nothing less than enormous gratification and elation knowing we made a difference in helping to save lives and help to boost our local economy.”
In a humanitarian aid push with the Boston-based nonprofit Ventilator Project, Lombardi said units have been shipped to Nicaragua, Honduras, Indonesia, Mexico, Philippines, Bolivia, Nigeria, Costa Rica, Brazil, South Africa and Ukraine, among other countries.
The oxygen-treatment hoods range in price from $125 to $145 each, depending on different features. By comparison, ventilators can cost more than $20,000.
While the hoods should only be used once, Lombardi said that in areas with limited resources, they are being reused on patients.
“We were starting to think about how to address the [poor countries] of the world, and in places where they just don’t have Westernized hospitals. And no one has the resources to ship tens of thousands of $20,000 ventilators to these kinds of places,” said Lombardi.
According to Lombardi, there are many developing nations that have populations exceeding 20 million people but only have five ventilators.
Recent reports by Elsevier Inc.’s health and medical journals said that once a COVID-19 patient is on a ventilator, mortality is around 80%. However, a new study by the University of Chicago says intubations can be reduced by 40% when a patient has access to a helmet-based ventilation system.
“You have to sedate the patient with a tube down their throat; they’re unconscious for potentially several weeks,” said Lombardi. “With the helmets, you don’t have to sedate them; you can start treatment much earlier if you’re proactive, and the whole system is less than $500.”
Fryburg said that because of its intubation reduction, this new invention is here to last past the pandemic and any vaccine that’s developed.
“This product will have future uses for other respiratory conditions and has already proven to be an improved method of treatment to other methods,” said Fryburg.
The hoods are similar to helmet-based ventilation units that have been used in Italy for several decades, but are still new to the U.S.
Unlike products such as oxygen masks, Lombardi said he was inspired to not only help the patient but also ensure that they wouldn’t infect the health care workers providing care for them.
“I recognized very early that diving technology could make a difference for COVID-19 and felt a social responsibility to do what I could,” said Lombardi.
Alexa Gagosz is a PBN staff writer. Contact her at Gagosz@PBN.com.
