The Latest in BioMedInnovations News
U.S. Food and Drug Administration Grants Emergency Use Authorization to Manufacture and Distribute SuppleVent™
BMI Supplevent(TM) Production Emergency Ventilator
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
BMI Prototype Supplevent(TM) Emergency Ventilator
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.
Full Press Release:
"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.
LLNL Links Up with Industry to Produce FDA-Approved Emergency Ventilator
9-Jun-2020 6:05 AM EDT - LLNL and North Carolina-based medical device startup company BioMedInnovations (BMI) have reached an agreement to develop a commercialized ventilator — a machine that helps patients breathe when they are unable to do so on their own — that can be easily built from readily available parts. The U.S. Food and Drug Administration on June 8 approved the ventilator for emergency use, making it particularly useful for COVID-19 patients in places where ventilators are in short supply, such as underdeveloped countries or hospitals in rural areas, or in the event of a sudden resurgence of disease transmission.
On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
Link to: FDA Website and Announcement
"This is a truly unique system which, importantly, was designed with the provider experience in mind. All of the external components can be quickly sterilized, and internal components have been sourced to ensure biocompatibility with oxygen concentrations," said Jhamyie Cappiello MS RRT-ACCS RCP, an educator in Respiratory Care Services at Duke University Hospital. "It requires little maintenance, can be rapidly deployed, and is operated following very simple inputs for inhalation and exhalation pressures. The user-interface is a robust touch screen that reports pressure settings and tidal volume, displays waveforms and safety alarms."
The SuppleVentTM ventilator is
designed to accept 50psi compressed air or oxygen mix and is
powered by a standard 110V/220V AC outlet or an optional DC
battery supply. The device is designed to accommodate a
standard 22 mm ventilator circuit outfitted with either a mask or
ROUSH YATES COLLABORATES WITH
BIOMEDINNOVATIONS ON VENTILATORS
MOORESVILLE, NC – April 16, 2020 – Roush Yates Manufacturing Solutions, a division of Roush Yates Engines, is proud to be working in collaboration with BioMedInnovations LLC and their partners Equilibar on the development and production of specialized ventilators to help address the mounting need for life-saving health care equipment.
BioMedInnovations (BMI) was founded in 2005 to commercialize a highly controllable, low flow, low pressure fluid technology primarily targeting organ transplantation, working on how to keep an organ “alive” outside the body and to assess organ health prior to implantation in a recipient. BMI has been engaged in research and development and recently received a small-business award from the North Carolina Biotechnology Center for assistance in pivoting toward commercialization of BMI’s fluid perfusion technology.
First Demo of BMI SuppleVent ™ ventilator technology
by Chantal Allam, NCBiotech Writer — March 30, 2020
RESEARCH TRIANGLE PARK —
As the world grapples with a shortage of ventilators for COVID-19 patients, a small North Carolina life science startup has designed a low-cost option.
Until a few weeks ago, the company was focused on making equipment that helps prolong organ life for transplants.
Then the COVID-19 pandemic struck, and it decided to change tack.
(WCNC) Medical device company working overtime to make ventilators to help save coronavirus patientshttps://www.wcnc.com/article/tech/medical-device-company-working-overtime-to-make-ventilators-to-help-save-coronavirus-patients/275-993930ae-0d3e-4b89-bb15-a899b5463ff8
In the interview Sherif Gabriel, CEO of BioMedInnovations, states:“Seven days ago we realized that the core technology in our perfusion system could be utilized to make highly effecient, low-cost ventilator, and ideally help COVID-19 patients.”
Prototyping the Technology
Some of the on-going bench prototyping of equipment for the BMI SuppleVent™ COVID-19, Low-Cost, Rapidly-Manufactured ventilator.
As depicted in the CBS article BioMedInnovtions is hard at work in battling the COVID-19 virus:https://www.cbs17.com/news/local-news/wake-county-news/2-bio-med-companies-at-research-triangle-park-join-fight-against-covid-19/
“So what we thought is we could provide a ventilator that could support the rest of the population at a level of airflow oxygen flow to the lungs that was sufficient to maintain their needs before they needed to go to the more extreme measure of the hospital ventilator,” said CEO BioMedInnovations CEO Sherif Gabriel.
Chief Executive Officer
I’m excited to be guiding the efforts of BioMedInnovations. BMI is developing a novel perfusion device to 1) preserve donated organ quality and 2) provide metrics for the transplant community to effectively determine organ health. Using a programmable physio-mimetic waveform (PPW) we are able to more consistently and effectively perfuse organs to the capillary bed. We are committed to significantly reducing the number of deaths of patients waiting on organ transplant lists.
BioMedInnovations LLC welcomes Sherif Gabriel as Chief Executive Officer at BioMedInnovations LLC.
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