Breegi Scientific Granted FDA EUA

Breegi Scientific, Inc. (BSI, Woburn, Massachusetts) has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for their Negative Pressure SteriDome or NPS, a single-use protective barrier on May 6th, 2021.

Negative Pressure SteriDome (NPS) is used and monitored by healthcare providers (HCP) as a protective barrier and patient biocontainment to prevent HCP and surrounding environment exposure to pathogenic biological airborne particulates by providing isolation of the head of hospitalized patients with suspected or confirmed diagnosis of COVID-19. NPS is used at the time of definitive airway management, when performing airway-related medical procedures such as CPAP/BIPAP, receive aerosolized nebulizer treatments or undergo emergent procedures, or during certain transport of such patients during the COVID-19 pandemic.

Breegi Scientific, Inc. has been working for several years to optimize a practical, highly effective and safe a patient biocontainment device that can halt the spread of the aerosolized pathogens and protect healthcare workers from exposure during Aerosol Generating Procedures (AGPs), particularly in the acute care/triage setting. NPS is a single use, lightweight, low cost, easy to setup and safe to dispose containment device that uses negative pressure to vacuum out aerosols emitted around a patient’s head, creating a safe and secure containment bubble adding an extra layer of “active” barrier protection for healthcare workers while facilitating treatment.

Dr. Wisam Breegi, CEO of Breegi Scientific, Inc. (BSI) leads a global and highly experienced team of subject matter experts who pivoted our neonatal intensive care incubator (NICI) when the threat of COVID-19 became clear. BSI took our well-studied and developed platform to create the NPS. The horrifying spread of the virus and loss of lives of our healthcare workers while they fight for the lives of others, pressed us to move quickly and work with the FDA team to deliver a safe and effective device: Negative Pressure SteriDome (NPS). The NPS not only evacuated the virus safely, but also has an airlock system allowing HCP to treat the patient without the need to remove the NPS.

We received overwhelming support from HCP and subject matter experts in the US and globally. A leading authority wrote to Dr. Breegi:

"Congratulations, Wisam!

Thank you for your patience and your thorough research and testing on SteriDome NPS. You and your team set a great example on the importance of patient safety."

There is an urgent need for small capacity self-contained negative pressure environments that utilize existing hospital suction lines and HEPA filtration. BSI is leading the paradigm shift in biocontainment with new opportunities for large hospitals and small clinics alike to control aerosol spread throughout the facility and to other patients and healthcare workers. NPS is a scalable and accessible solution to contain aerosolized infectious agents and provides compact negative pressure units for safer treatment, triage, and patient transport.

About Breegi Scientific, Inc.

Breegi Scientific, Inc. “(BSI)” is an innovative medical device company established in 2013. The Company’s mission is to save lives beyond the paved roads. Breegi Scientific, Inc. is based in Woburn, Massachusetts. For more information, please go to www.breegiscientific.com

CONTACT:

Dr. Wisam Breegi, CEO

Breegi Scientific, Inc.

120 Bedford Road

Woburn, MA 01801

Tel: 1 (781)-258-5297

E-mail: wisam@breegiscientific.com