FDA OKs Garden City-Based Beyond Air’s Clinical Trial For A New COVID-19 Treatment

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A Beyond Air employee demonstrates how the system would be used to treat a patient. Beyond Air photo)

The Food and Drug Administration has approved clinical trials for a new medical device developed by Beyond Air, a Garden City-based biopharmaceutical company, that can be used to treat coronavirus.

The clinical study that Beyond Air is initiating will evaluate the effectiveness of the LungFit™ system to treat COVID-19 patients. The device treats patients with high concentrations of inhaled nitric oxide, which works by targeting the vascular smooth muscle cells that surround the small resistance arteries in the lungs.

“We are pleased with the rapid action taken by the FDA to allow this first step in providing high concentration nitric oxide therapy to COVID-19 patients,” said Steve Lisi, the company’s chairman and chief executive officer. “The Beyond Air team is working tirelessly to initiate this important study, into which we expect to begin enrolling patients within weeks.”

Northwell Health has similarly been conducting a pair of clinical trials studying two coronavirus drug treatments. Long Island is also home to several companies developing rapid COVID-19 tests and a coronvirus vaccine.

Beyond Air additionally has applications pending to conduct its study in Canada and Israel. In the U.S. study, the LungFit device will be used in an open-label study to treat 20 patients between the ages of 22 and 65 years old who are hospitalized with COVID-19. Subjects will be treated with nitric oxide administered over 40 minutes four times per day, in addition to standard care.

The 20-pound device, which is not yet approved for commercial distribution, generates nitric oxide from ambient air that flows through a reaction chamber and filters it to avoid toxic levels in the patient. The company said it is confident that respiratory therapists can easily be trained to use the system, which can treat up to four patients per day.

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