Hogan Lovells advises Vayu Global Health Innovations in obtaining Emergency Use Authorization for bCPAP device to alleviate ventilator shortage due to COVID-19
Washington D.C., 8 May 2020 – International law firm Hogan Lovells advised Vayu Global Health Innovations in obtaining an Emergency Use Authorization (EUA) from the Food and Drug Administration that allowed its bubble CPAP (bCPAP) device to be used to help alleviate the ventilator shortage associated with COVID-19. Vayu is a non-profit company supported by the Gates Foundation and the National Institutes of Health (NIH), and collaborates with thought leaders and faculty from Harvard, MIT and the Massachusetts General Hospital.
The COVID-19 crisis has led to a nationwide shortage of ventilators, and many of those life-saving devices are reserved for neonatal ICUs (NICU’s) where they are used not for mechanical ventilation, but rather to provide non-invasive breathing support, or continuous positive airway pressure (CPAP). It was a novel idea: the simple, ultra-low cost bCPAP invented by Vayu Global Health Innovations founder Dr. Thomas Burke, Director of the Global Health Innovation Lab at Massachusetts General Hospital, could replace some of these ventilators, allowing them to be freed up immediately to treat adult COVID-19 patients and thus save lives. The company was fielding daily requests for the device from local governments, hospitals, and aid organizations in the U.S. and around the world.
With the help of Hogan Lovells attorneys, the company was able to secure EUA approval for the device on 5 May, which allows it to be immediately distributed to hospitals where it is needed. In addition to freeing up ventilators, the EUA also authorizes the bCPAP device to treat certain infants with COVID-19 who require breathing support and to be used in community settings where more women are giving birth as they avoid hospitals during the crisis.
The Hogan Lovells team was led by partner Jonathan Kahan and counsel Kristin Zielinski Duggan, with help from partners Lina Kontos and Mike Heyl, and senior associate Arthur Kim.