Therma Bright Inc.

Therma Bright Prepares FDA 513(g) Review Document for its AI-Driven Digital Cough Analyzer (DCA)


Company’s DCA Solution Offers Robust Set of User and Medical Practitioner Features via an Android & iOS Mobile App and a Clinician Dashboard For Monitoring Patient’s Cough

Toronto, Ontario–(Newsfile Corp. – November 29, 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, with its development partner AI4LYF, an artificial intelligence (AI) driven technology firm that operates an ISO/IEC 27001 and ISO: 9001 certified facility, announced today that its AI-driven Digital Cough Analyzer (DCA) is ready for a 513(g) request to the U.S. Food and Drug Administration.

The formal 513(g) request is a means for Therma Bright to obtain information from the FDA regarding the classification and regulatory requirements for its acoustic AI digital cough technology to be used as a remote therapeutic monitoring (RTM) solution.

“Our Digital Cough Analyzer, designed and developed by AI4LYF under exclusive license to Therma Bright, offers a unique set of features not available in today’s market,” shared Rob Fia, CEO of Therma Bright “Not only do we offer key features for patients and users who download the Android and Apple iOS mobile apps to capture and manage their cough data, but the clinician dashboard is a powerful tool for medical practitioners and researchers who are monitoring the health of their patients. The importance of obtaining FDA consent on the proposed RTM classification is that it will allow the Company to immediately initiate its commercialization plans to thousands of health care providers across the United States.”

Therma Bright believes that making its Digital Cough Analyzer available to healthcare providers, to support their patients via a downloadable mobile app, will be an excellent support to a patient’s care. The acoustic AI-driven technology offer numerous Patient/User features through its mobile app and Medical Practitioner features through a computer-based clinician dashboard.

For user’s, the Digital Cough Analyzer (DCA) mobile app features include:

  • Cough Detection: AI-based detection that can distinguish cough sounds from non-cough sounds to preserve patient/user privacy.
  • Continuous Cough Counter: Counts coughs automatically with a continuous recording, saving only cough sounds to protect patient/user privacy.
  • User Controls: Allows patient/users to schedule cough recording times, as well as have complete control over their data – (i) can store date on their own mobile phone or the cloud, (ii) can share all or selected data with doctor for medical and/or research purposes, (iii) can share cough pattern with or without actual cough audio, (iv) can play back recorded cough sounds, retaining or deleting recordings, as desired.
  • Reporting: Users can generate and share a PDF report file that summarizes cough patterns, as well as add notes to the cough recordings, e.g., after taking medicine or a meal.

For medical practitioners and researchers, the Digital Cough Analyzer’s clinical dashboard allows healthcare professionals to review a patient’s cough data, including the cough recording, to better assess the health of their patient. Cough data and recordings are shared by the patient, which makes the solution HIPPA compliant for patient privacy.

As a Time Magazine article on acoustic AI technologies highlighted in April 2023, “Beyond the initial utility that chronicling the frequency of coughs can provide, the ultimate goal is to mine cough data to see if distinct signatures materialize that would distinguish, say, a flu’s cough from a COVID-19 one, or lung cancer from allergies.” With acoustic AI, research suggests that using cough data can possibly help diagnose different health issues or conditions. Therma Bright and AI4LYF see huge benefit for this, and putting this capability into the general public’s hands via their mobile app.

Source: https://time.com/6267654/ai-track-coughing-health/.

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.

About AI4LYF
AI4LYF is an innovative smart-health company with a mission to transform lives through deep intelligence. Having pioneered DCT, it is also working on AI based novel solutions that have potential to change the “Reactive Sick care” into “predictive, preventive, personalized health care” for fuller and longer lives for all.

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 DCA 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.

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