Withers helped a Boston-based medical device innovator secure Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for a product that helps protect health care professionals amid the ongoing COVID-19 pandemic.
John Serio, a partner in Withers’ Boston office, advised Dr. Wisam Breegi, CEO & Founder of Breegi Scientific, Inc., on securing the authorization for the product Negative Pressure SteriDome (NPS). NPS is a single-use barrier protection product intended for health care professionals to use in addition to personal protective equipment when handling hospitalized patients with a suspected or confirmed diagnosis of COVID-19.
Following the declaration of the public health emergency by the Department of Health and Human Services, Dr. Breegi realized that a device he had been developing for many years had applications to protect frontline workers exposed to COVID-19. NPS prevents exposure to pathogenic biological airborne aerosols by providing temporary isolation of hospitalized patients with suspected or confirmed diagnosis of an illness. Given the product’s ability to protect healthcare professionals from COVID-19 exposure, EUA was identified as a regulatory pathway to secure interim FDA approval for the product.
The initial application prepared on behalf of Breegi Scientific was denied, requiring Breegi Scientific to redesign features of the device. Navigating shifting guidance from the FDA on how to approach applications for EUA, Withers successfully argued for an interpretation of the guidance that allowed Breegi Scientific to secure approval utilizing the accelerated review of the EUA pathway for the redesigned device. According to the FDAapproval letter, there are no other FDA-approved or -cleared devices for use as an extra layer of barrier protection in addition to PPE to prevent health care professional exposure to pathogenic biological airborne particulates from patients during the COVID-19 pandemic.
Dr. Breegi commented on the approval of the Negative Pressure SteriDome saying, “I am thrilled to announce that our company, Breegi Scientific, Inc., has been granted Emergency Use Authorization (EUA) for our Negative Pressure SteriDome. With our negative pressure protective barrier enclosure, we will give frontline clinicians a powerful and straightforward tool containing the spread of aerosolized infectious diseases like COVID-19 in healthcare settings and during airway procedures. We look forward to the applications of our platform beyond COVID-19 with several patents filed, and we are honored to have international interest in the form of funding, manufacturing, and government support for our biocontainment platform.”