Making History

ORGAN PERFUSION

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



Supplevent (TM) Ventilator from BioMedInnovations LLC

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


BioMedInnovations LLC., (BMI) a medical device company, makes precision air and fluid flow devices and products-in-development for lung ventilators and ex vivo tissue perfusion.  BMI has developed an emergency- use lung ventilator for patients and critical care providers in COVID-19 crisis.   These new ventilators are capable of breathing support for patients affected by COVID-19. The BMI ventilators are designed to deliver room air and can also be attached to an Oxygen supply if one is available.  BMI is collaborating with the Lawrence Livermore National Lab, and it’s NC business connections, including motorsports and others, to create rapid response manufacturing capacity of BMI’s designs and feasibility prototypes.

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113000 transplant candidates will die this year if they don't receive an organ
Demand exceed supply because many organs time out before they can be placed in a candidate's body

This is game-changing... It's also life-changing.

BMI challenges the common belief that there are not enough transplantable organs to meet the demand. The Company redefines the problem as a “shortage of confirmed viable organs available for transplant”—not simply a shortage of organ donors. Understanding this distinction inspired BMI to develop CaVESWave®, which we believe is the most significant technological advances in the field of tissue perfusion in the past 40 years!
Pre-clinical testing demonstrated that CaVESWave® preserves organs longer than does current technology, and that it provides real-time organ metrics. Pre-clinical testing also validated that the CaVESWave® system not only keeps organs “alive” and fully-functional after being explanted, but it provides detailed, real-time organ performance and viability data, previously unavailable! This science may help eliminate unnecessary deaths in those patients waiting for organs!

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CaVESWave® is an investigative device in the preclinical stage of development. It has not yet been tested extensively on humans or approved for commercial sale by the FDA or by any other regulatory body. ©BMI Proprietary and Confidential