The Winnipeg Ventilator design from Cerebra is proven worldwide to provide full functionality to address COVID-19 patient needs as well as the necessary fast, low cost, local production needed

Cerebra Health Inc. (“Cerebra”) is pleased to announce the Winnipeg Ventilator has been selected as the ventilator of choice by Next Generation Manufacturing Supercluster (“NGen Canada”), the organization leading Canada’s Advanced Manufacturing Supercluster, to fund and facilitate the rapid response to COVID-19. The Winnipeg Ventilator was chosen for design and manufacturing by a national consortium of leading engineers and manufacturers. The first phase of the project is being led by Canada’s largest medical device design company, Starfish Medical, with the goal to provide a quick solution for Canada’s shortage of ventilators.

“Canada needs a solution to bring ICU standard ventilators to the market fast, economically and at a scale to meet the needs of this crisis,” says Jay Myers, CEO, NGen Canada. “The Winnipeg Ventilator has proven worldwide to meet those requirements as seen through its broad use and validation by the scientific community.”

Developed by Cerebra’s Scientific Founder, Dr. Magdy Younes, the original Winnipeg Ventilator was licensed to a major manufacturer and used as the basis for commercial ventilators deployed in tens of thousands of machines in ICUs globally during the 1990s and 2000s. These units were used extensively during the SARS epidemic in 2003.

“The nature of respiratory distress in patients with COVID-19 requires different approaches to ventilatory support in different patients, and in the same patient at different times,” explains Dr. Younes. “This means the ventilator must be able to deliver a range of ventilator modes and oxygen concentrations of up to 100%. While all standard commercial ICU ventilators meet these requirements, it is very difficult to manufacture such ventilators at the scale and speed required for the COVID-19 pandemic and they are very expensive. The Winnipeg Ventilator is the exception.”

Cerebra is working directly with Starfish Medical and other consortium members to update the Winnipeg Ventilator design for broad distribution and manufacturing at a low cost. Cerebra will play a key role in supporting the design phase as well as setting up the transfer of design to qualified manufacturers and clinical testing of the final product.

“Now is the time for Canadian companies to work together,” says Earl Gardiner, Executive Chairman, Cerebra. “We’re proud to bring Dr. Younes’ innovation to meet this urgent need and to do so with the support of NGen and some of Canada’s leading medical device manufacturing companies. The project scope and timelines would not have been possible without NGen funding.”

About the Winnipeg Ventilator

The original Winnipeg Ventilator was used on a research basis in several hospitals in the United States, Canada, and Europe. The system was used in care for hundreds of patients and resulted in 15 publications. The updated Winnipeg Ventilator system is purposely designed to meet Canada’s regulatory requirements for pandemic response ventilators, in addition to delivering full functionality for use in the Intensive Care Unit (ICU) and aims to be among the easiest designs in the world to bring into high volume production. Chosen for Canada’s response to the COVID-19 crisis, The Winnipeg Ventilator is:

Reliable and Proven – This is a medical device with full ICU functionality, and one which does not require the hospital’s delivery of air pressure in order to function, with predecessor models in use globally.

Simple means scalable – It’s easy-to-use design, facilitates straightforward use by technicians and also supports low-cost manufacture (most parts pre-exist in local supply chains). Most ventilators utilize “Blower” based technology and therefore compete for parts within the same limited supply chain whereas, The Winnipeg Ventilator utilizes “Piston” based technology with widely available parts.

Fast and Cost-Effective – Assemblies are simplified, allowing faster production cycle times and much lower costs. Localized production eliminates logistical risks, reduces costs, improves speed of delivery, and ensures access to care for local interests.

The original Winnipeg Ventilator was used on a research basis and was not an approved Medical Device under Health Canada. The updated Winnipeg Ventilator design has been accepted and is being developed under the NGen Canada COVID-19 Response Project in accordance with Health Canada Ventilator Review Elements under section 4 of the Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19.

About Next Generation Manufacturing Canada

NGen leads Canada’s Advanced Manufacturing Supercluster, managing $230 million in funding from the Government of Canada to leverage Canada’s manufacturing and technology strengths to build world-leading advanced manufacturing capabilities. There is no more important priority for manufacturers across Canada today than to respond to COVID-19. NGen is targeting enhanced funding for companies that can scale-up production of critical supplies in response to the COVID-19 crisis and secure their supply chains given the likelihood of future global disruptions.

For more information about NGen COVID-19 funding initiative, please visit www.ngen.ca/covid-19-response

About Cerebra

Cerebra Health Inc. is a Canadian medical device and digital health company co-founded by Dr. Magdy Younes and is a global leader in digital sleep analysis. Cerebra’s sleep study services provide unmatched capabilities for in-home sleep analysis, with a focus on improved user experience, state-of-the-art technology, and increased operational efficiency. Cerebra is expanding its focus to include Dr. Younes earlier innovation in ventilator design & technology with the Winnipeg Ventilator in response to the COVID-19 response to meet the needs of Canada and countries around the world.

Cerebra Medical, a wholly owned subsidiary of Cerebra Health, operates an ISO 13485:2016 certified Quality Management System for the design, development, and manufacture of EEG sleep monitoring systems and medical device software for collection and analysis of physiological data recorded during sleep. Cerebra Medical holds an MDSAP certificate in conformance with the requirements of Health Canada and the FDA.

For more information, please visit www.thewinnipegventilator.com

Contact:

Mary Fearon or Lindsay Glasspoole

289-440-2654 / 416-738-9506