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

Pompano Beach, Florida,(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.

Safe Harbor Statement

This press release may contain forward looking statements which are based on current expectations, forecasts, and assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors. Stockholders and potential investors should not place undue reliance on these forward-looking statements. Although we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statements in this report are reasonable, we cannot assure stockholders and potential investors that these plans, intentions or expectations will be achieved. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including, without limitation, statements made with respect to the development, production and marketability of our development stage BLU3 Vent. Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the Securities and Exchange Commission (the “SEC”) and our other periodic and quarterly filings with the SEC.

The post 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 appeared first on Civil + Structural Engineer magazine.



source https://csengineermag.com/brownies-marine-groups-blu3-submits-emergency-use-authorization-request-for-blu3-vent-to-the-fda-as-a-top-5-finalist-in-dod-hack-a-vent-challenge/

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