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Brownie’s Marine Group’s BLU3 Submits Emergency Use Authorization

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bman   Friday, 05/22/20 01:26:40 PM
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Brownie’s Marine Group’s BLU3 Submits Emergency Use Authorization Request for BLU3 Vent to the FDA as a Top-5 Finalist in DoD Hack-A-Vent Challenge
GlobeNewswire GlobeNewswire•May 22, 2020
Pompano Beach, Florida,, May 22, 2020 (GLOBE NEWSWIRE) -- Brownie’s Marine Group, Inc. (OTC Pink: BWMG) a leading developer, manufacturer and distributor in the marine industry, today announced that it has been named a Top 5 Finalist in the U.S. Department of Defense (DoD) Vulcan “Hack-a-Ventilator Challenge.” The DoD released a website dedicated to sharing information about the Hack-a-Ventilator project on May 20th, 2020, with the link here: https://www.vulcan-v.com.

In March 2020, the DoD announced the Vulcan Hack-a-Vent Challenge to address the projected ventilator shortage as a result of the Covid-19 global pandemic. Clinicians and engineers at the DoD received 172 submissions and began a rigorous process that within 60 days yielded 5 different scalable ventilator designs that can resuscitate a non-compliant lung. The group of finalists was named the “Vulcan-5” and includes the BLU3 Vent by BLU3, a division of Brownie’s Marine Group, Inc, as well as Corvent by Coridea, i3 Breather by L3 Harris, FieldVent by Northrup Grumman, and NAVSEA PRE-Vent by the U.S. Navy as reported by the DoD. BLU3 has now requested approval for BLU3 Vent from the U.S. Food & Drug Administration (FDA) under the Emergency Use Authorization (EUA). BLU3 submitted their Pre-EUA form to the FDA on May 14, 2020 and received initial feedback from the FDA four days later. The feedback includes requests for additional information such as specific graphical test data and descriptions of manufacturing quality systems, among other items. BLU3 is working toward fulfilling the FDA’s request for additional information with the assistance of the Wright Brothers Institute (https://www.wbi-innovates.com) and regulatory compliance consultants from TAMM Net (https://www.tammnet.com).

“We are so proud of our team’s accomplishment to be esteemed with some of the most innovative engineering companies and groups in the world. We entered the Hack-A-Vent challenge to answer a call-to-action from our military to address critical ventilator shortages. Our team of engineers worked tirelessly to reimagine our existing core technology to meet the challenges laid out before them.” said Robert Carmichael, Chairman & CEO of Brownie’s Marine Group, Inc. “BLU3 Vent has been designed to be low-cost and highly manufacturable so that it is feasible for governments to stockpile as Emergency Use Ventilators. We believe that governments should favor a just-in-case stockpiling approach opposed to the traditional just-in-time approach which lead to the ventilator shortages in the first place.”

About Brownie’s Marine Group

Brownie’s Marine Group, Inc., is the parent company to a family of innovative brands with a unique concentration in the industrial, military, and recreational diving industry. The Company, together with its subsidiaries, designs, tests, manufactures, and distributes recreational hookah diving, yacht-based scuba air compressors and nitrox generation systems, and scuba and water safety products in the United States and internationally. The Company has three subsidiaries including Trebor Industries, Inc., founded in 1981 and dba as “Brownie’s Third Lung,” BLU3, Inc., and Brownie’s High-Pressure Services, Inc., dba LW Americas. The Company is headquartered in Pompano Beach, Florida.

For more information, visit: www.BrowniesMarineGroup.com.

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