First Wave Technologies Plans To Work With Canon Virginia, Inc.
To Manufacture Its IsoVENT™ Ventilator During The COVID-19 Pandemic
BATAVIA, New York – First Wave Technologies, Inc. (“First Wave,” “FWT” and “Company”), a medical device company developing products for the acute care and long-term care market has submitted a request with the Food and Drug Administration (“FDA”) for Emergency Use Authorization (“EUA”)1 to manufacture and sell its IsoVENT™ ventilator in the United States during the Coronavirus Disease (COVID- 19) public health emergency. First Wave announced today that, assuming its request for an EUA is granted by the FDA and the ventilators can be made available in the United States for use during the public health emergency, it will work with Canon Virginia, Inc. (”CVI”), a wholly owned subsidiary of Canon U.S.A, Inc. engaged in engineering and manufacturing operations, to manufacture the IsoVENT™ ventilators.
First Wave’s CEO Brian Bell stated, “Working with a manufacturer like CVI will be critical to helping First Wave provide quality products for use in this time of critical need.”
“Canon U.S.A., Inc., acting through its wholly owned subsidiary Canon Virginia, Inc., will be pleased to work with First Wave Technologies to help meet the urgent need for ventilators created by the COVID-19 pandemic,” said Kazuto Ogawa, President and CEO, Canon U.S.A, Inc. “This is a great example of how we are guided by our corporate philosophy of Kyosei – ‘all people living and working together into the future’ -- as we seek to assist people during this crisis.”
About First Wave Technologies
First Wave Technologies, Inc. is a medical device company developing products for the acute care and long-term care market. The focus is to disrupt areas of healthcare with innovative products which have not seen meaningful change historically for the improvement of patient care. Current products are centered around improving the ease and accuracy of pharmaceutical delivery. For more information, please visit http://firstwavetechnologies.com
About Canon U.S.A., Inc.
Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $33 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2019† and is one of Fortune Magazine's World's Most Admired Companies in 2020. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA.
†Based on weekly patent counts issued by United States Patent and Trademark Office.
Chief Executive Officer and Director First Wave Technologies, Inc.
99 MedTech Dr.
Batavia, New York 14020 Phone: +1 877.784.0269
Jennifer K. Zimmons, Ph.D. Investor Relations
Zimmons International Communications Phone: +1.917.214.3514
This press release contains forward-looking information that involves various risks and uncertainties regarding future events related to our IsoVENT™ and our partnership with Canon. Such statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements and are not guarantees of future performance of the Company. No assurance can be given that any of the events anticipated by the forward-looking statements will occur or, if they do occur, what benefits the Company will obtain from them. These forward-looking statements reflect management's current views and are based on certain expectations, estimates and assumptions which may prove to be incorrect. A number of risks and uncertainties could cause our actual results to differ materially from those expressed or implied by the forward-looking statements, including: (1) a downturn in general economic conditions in North America and internationally, (2) the inherent uncertainties and speculative nature associated with the development and commercialization of technology and the practice of medicine, (3) a change in health regulations, (4) any number of events or causes which may delay or cease commercialization and development of the IsoVENT™ device, (5) the risk that the Company does not execute its business plan or that the companies engaged to develop and obtain regulatory approval for the IsoVENT™ device do not execute their plans, (6) inability to retain key employees, (7) inability to finance operations and growth, (8) the IsoVENT™ Ventilator has not been cleared or approved for sale in the United States by the FDA and therefore is not currently available for sale in the United States. Although First Wave has submitted a request for Emergency Use Authorization (“EUA”) to the FDA with regard to the IsoVENT™ Ventilator, there can be no assurance that the EUA will be granted so that the IsoVENT™ Ventilators may be made available for sale in the United States or if granted, the EUA will not be terminated by the FDA and (9) other factors beyond the Company's control. These forward-looking statements are made as of the date of this news release and, except as required by law, the Company assumes no obligation to update these forward-looking statements, or to update the reasons why actual results differed from those projected in the forward-looking statements.