May 1, 2020 – 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 https://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.
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[1] 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.
†Based on weekly patent counts issued by United States Patent and Trademark Office.
Corporate Contact:
Brian Bell
Chief Executive Officer and Director
First Wave Technologies, Inc.
99 MedTech Dr.
Batavia, New York 14020
Phone: +1 877.784.0269
E-mail: info@firstwavetechnologies.com
Investor Contact:
Jennifer K. Zimmons, Ph.D.
President, Investor Relations
Zimmons International Communications
Phone: +1 917.214.3514
E-Mail: jzimmons@zimmonsic.com
