Toronto, Ontario--(Newsfile Corp. - November 2, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX) ("Therma" or the "Company"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, announced today the Company has opened its existing and new distribution channels for its Venowave device.
Each channel partner has expressed an interest in the Venowave solution and is eager to evaluate the commerciality of the Venowave device after pilot tests and doctor/patient validation. The Company has shipped pilot units to each channel partner for immediate distribution for these patient pilot tests.
"We are very excited to have existing and new sales distribution partners reach out to us over the last few months about our Venowave device, and their eagerness to implement pilot tests with patients," shared Rob Fia, CEO of Therma Bright. "If these pilot tests are successful, we anticipate these distribution partners will begin securing commercial volumes of our innovative Venowave device."
In addition, the Company is actively engaged with the U.S. Food and Drug Administration (FDA) on its updated 510K application that corrected the Venowave device's intended use, labeling and product description so it will better address the U.S. Centers for Medicare and Medicaid Services (CMS) application for permanent Current Procedural Terminology (CPT®) / Healthcare Common Procedure Coding System (HCPCS) codes. Once the FDA approves the updated 510K application, Therma Bright will re-submit its application for these Medicare and Medicaid permanent codes.
About Therma Bright Inc.
Therma Bright is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright Inc. trades on the (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.
Therma Bright Inc.
Rob Fia, CEO
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Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the regulatory approval, commercialization, and sales of Venowave and related technology as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether such results will be achieved. Actual results could differ materially from those anticipated due to several factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information, future events or otherwise, except as required under applicable securities regulations.
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