U.S. Food and Drug Administration Grants Emergency Use Authorization to Manufacture and Distribute SuppleVent™

06/09/2020

Press Release:

BioMedInnovations LLC Announces U.S. Food and Drug Administration Has Granted Emergency Use Authorization to Manufacture and Distribute SuppleVent™, a Unique and Value-Added Ventilator Technology

~ BioMedInnovation Aims to Address Global Shortages of Life-Saving Machines Due to COVID-19 via Manufacturing Process Independent of Commercial and Other Ventilator Supply Chains

~~ Collaborations with Several Motor Sports Manufacturing Teams Allows for Immediate Assembly of Up to 1,000 Ventilator Machines Per Week

~~ BioMedInnovation's Back-Pressure Regulator (BPR) Based Ventilator Technology, Which Can be Used in Mobile Settings, Prevents Against High Pressures that Could Damage the Lung

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Lawrence Livermore National Laboratory and BMI pursued a reversed design approach, a methodology guided by anticipated supply chains and ease of assembly. With this mindset, the partnership brought a design forward to full test spanning clinically relevant PIP, PEEP, I:E, RR and FiO2. The machine is a simple assembly of components with an intuitive and clinician-friendly interface that includes full alarms and low power operation from a compressed gas source. Forward flexibility is included in the system architecture to add additional displays, data logging, wireless communication, closed loop control and other features, if desired.

"BMI is pleased with the FDA's decision, which underscores the applicability of the core technology in our organ perfusion system. In partnership with Lawrence Livermore National Laboratory, we were able to quickly design a machine with minimal components that is easy to assemble in an effort to help COVID-19 patients and healthcare providers who are in need of highly efficient, value-added ventilators," said Sherif Gabriel, chief executive officer of BioMedInnovations LLC.

"This effort has been truly collaborative, and we are honored to have partners such as Roush Yates Manufacturing Solutions ready to quickly manufacture as many as 1,000 of these potentially life-saving machines per week," said Carrie DiMarzio, chief operations officer of BioMedInnovations LLC.

Full Press Release:
https://www.prnewswire.com/news-releases/biomedinnovations-llc-announces-us-food-and-drug-administration-has-granted-emergency-use-authorization-to-manufacture-and-distribute-supplevent-a-unique-and-value-added-ventilator-technology-301072540.html