Therma Bright's Venowave VW5 Secures FDA 510K Approval
Rhea-AI Summary
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) has received FDA 510K approval for its Venowave VW5 device, addressing the U.S. Centers for Medicare and Medicaid Services (CMS) requirements. This approval allows the device to be used successively by multiple patients, a key factor for securing permanent CPT® and HCPCS codes. The Venowave VW5 is a compact, battery-operated peristaltic pump that improves vascular and lymphatic flow in lower limbs, targeting conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE).
With this approval, Therma Bright expects imminent issuance of permanent codes, enabling distribution partners to deploy Venowave to Medicare and Medicaid medical practitioners. The company has also engaged Outside The Box Capital Inc. for marketing and investor relations services to enhance communication with investors and expand visibility.
Positive
- FDA 510K approval received for Venowave VW5 device
- Approval addresses CMS requirements for permanent CPT® and HCPCS codes
- Device targets conditions affecting over 900,000 U.S. citizens annually
- Distribution partners ready to deploy Venowave to Medicare and Medicaid practitioners
Negative
- None.
News Market Reaction
On the day this news was published, TBRIF declined NaN%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Toronto, Ontario--(Newsfile Corp. - July 29, 2024) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), a developer and investment partner in a wide range of leading-edge, proprietary diagnostic and medical device technologies, is pleased to announce that the Company has received the U.S. Food and Drug Administration's (FDA) approval on its 510K application request to correct the Venowave VW5 device's intended use, labeling, and description. This approval addresses the U.S. Centers for Medicare and Medicaid Services (CMS) requirement for issuing the Venowave VW5 permanent Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes.
As reported, CMS asked the Company to secure approval from the FDA through an updated 510K application stating that the Venowave VW5 device could be used successively by multiple patients; a key requirement for securing the ten (10) permanent CPT® and HCPCS codes.
"With the FDA 510K application approval, as well as the CMS pricing and new HCPCS Level II code designation recommendations and review process complete, the Company expects the Venowave's permanent codes approval imminently," shared Rob Fia, CEO of Therma Bright. "Our distribution partners are standing ready to begin their work to deploy our Venowave to their network of Medicare and Medicaid medical practitioners to help their patients with a variety of circulatory issues, including deep vein thrombosis (DVT) and pulmonary embolism (PE) that the Centers for Disease Control and Prevention (CDC) estimates over 900,000 U.S. citizens are impacted by every year."
The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a waveform motion. When worn below the knee, strapped firmly to the calf, the device results in compression of the calf and consequently an increased upward volumetric displacement of venous and lymph fluid. The 2-pair unit induces improved vascular and lymphatic flow in the lower limbs. Operating with a single rechargeable 1.5 V NiMh AA battery, this 510K FDA-approved Durable Medical Equipment device enables users to receive treatment anywhere while remaining active. The Venowave VW5 assures it can withstand repeated use by successive patients.
In other news, the Company announces that it has entered into a marketing and consulting agreement (the "OTBC Agreement") with an arm's length marketing firm, Outside The Box Capital Inc. ("OTBC") of Oakville, Ontario, to provide marketing consulting and investor relations services, including marketing services through social media channels and online media distribution.
In connection with the OTBC Agreement, for a term of 3 months starting on July 26, 2024, the Company will pay OTBC a cash fee of
The Company's engagement with OTBC is another step in its efforts to enhance communication with the current investor community and expand visibility to a greater audience. OTBC specializes in various social media platforms and will be able to facilitate greater awareness and widespread dissemination of the Company's news.
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
rfia@thermabright.com
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FORWARD-LOOKING STATEMENTS
Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the commercialization 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.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/218092
FAQ
What is the significance of the FDA 510K approval for Therma Bright's Venowave VW5?
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