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Therma Bright's AI-Powered Digital Cough Technology Being Considered as Partner Technology in New Chronic Cough Drug Clinical Trial

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Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) announced that its AI-powered Digital Cough Technology (DCT) is being considered as a partner technology for a new chronic cough drug clinical trial in the US. The company, in collaboration with AI4LYF, has developed this platform to support healthcare decision-making by improving respiratory data collection and analysis.

Therma Bright is also pursuing FDA classification and regulatory requirements for its DCT as a remote therapeutic monitoring solution. The company has prepared additional materials, including user guides and data capture platforms. Furthermore, Therma Bright is exploring possibilities for CMS reimbursement code designation and federal funding for its DCT platform, while awaiting final approval on permanent CMS reimbursement codes for its Venowave VW5 solution.

Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ha annunciato che la sua tecnologia digitale per la tosse (DCT) potenziata dall'IA è in fase di considerazione come tecnologia partner per un nuovo studio clinico su un farmaco contro la tosse cronica negli Stati Uniti. L'azienda, in collaborazione con AI4LYF, ha sviluppato questa piattaforma per supportare il processo decisionale in ambito sanitario, migliorando la raccolta e l'analisi dei dati respiratori.

Therma Bright sta inoltre perseguendo la classificazione FDA e i requisiti normativi per la sua DCT come soluzione per il monitoraggio terapeutico remoto. L'azienda ha preparato materiali aggiuntivi, inclusi manuali per utenti e piattaforme di raccolta dati. Inoltre, Therma Bright sta esplorando le possibilità di designazione del codice di rimborso CMS e di finanziamento federale per la sua piattaforma DCT, mentre attende l'approvazione finale sui codici di rimborso CMS permanenti per la sua soluzione Venowave VW5.

Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) anunció que su tecnología digital de tos potenciada por IA (DCT) está siendo considerada como tecnología asociada para un nuevo ensayo clínico de un medicamento para la tos crónica en EE. UU. La empresa, en colaboración con AI4LYF, ha desarrollado esta plataforma para apoyar la toma de decisiones en el sector salud, mejorando la recolección y análisis de datos respiratorios.

Therma Bright también está buscando la clasificación de la FDA y los requisitos regulatorios para su DCT como una solución de monitoreo terapéutico remoto. La empresa ha preparado materiales adicionales, incluyendo guías de usuario y plataformas de captura de datos. Además, Therma Bright está explorando posibilidades de designación de código de reembolso de CMS y financiamiento federal para su plataforma DCT, a la vez que espera la aprobación final de los códigos de reembolso permanentes de CMS para su solución Venowave VW5.

Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF)는 자사의 AI 기반 디지털 기침 기술(DCT)이 미국에서 새로운 만성 기침 약물 임상 시험의 파트너 기술로 고려되고 있다고 발표했습니다. 이 회사는 AI4LYF와 협력하여 호흡 데이터 수집 및 분석을 개선하여 의료 의사 결정을 지원하기 위해 이 플랫폼을 개발했습니다.

Therma Bright는 DCT를 원격 치료 모니터링 솔루션으로 분류하고 규제 요구 사항을 충족하기 위해 FDA 절차도 진행하고 있습니다. 회사는 사용자 가이드 및 데이터 수집 플랫폼을 포함한 추가 자료를 준비했습니다. 또한, Therma Bright는 DCT 플랫폼에 대한 CMS 상환 코드 지정 및 연방 자금 지원 가능성을 탐색하는 한편, Venowave VW5 솔루션에 대한 영구 CMS 상환 코드의 최종 승인을 기다리고 있습니다.

Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) a annoncé que sa technologie numérique de toux alimentée par l'IA (DCT) est envisagée comme technologie partenaire pour un nouvel essai clinique de médicament contre la toux chronique aux États-Unis. L'entreprise, en collaboration avec AI4LYF, a développé cette plateforme pour soutenir la prise de décision en matière de santé en améliorant la collecte et l'analyse des données respiratoires.

Therma Bright cherche également à obtenir la classification de la FDA et à répondre aux exigences réglementaires pour sa DCT en tant que solution de surveillance thérapeutique à distance. L'entreprise a préparé des matériels supplémentaires, y compris des guides d'utilisateur et des plateformes de capture de données. De plus, Therma Bright explore les possibilités de dénomination de code de remboursement CMS et de financement fédéral pour sa plateforme DCT, tout en attendant l'approbation finale des codes de remboursement CMS permanents pour sa solution Venowave VW5.

Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) hat angekündigt, dass ihre KI-gestützte digitale Husten-Technologie (DCT) als Partnertechnologie für eine neue klinische Studie zu einem Medikament gegen chronischen Husten in den USA in Betracht gezogen wird. Das Unternehmen hat in Zusammenarbeit mit AI4LYF diese Plattform entwickelt, um die Entscheidungsfindung im Gesundheitswesen zu unterstützen, indem die Erfassung und Analyse von Atemdaten verbessert wird.

Therma Bright verfolgt zudem die Klassifizierung und die regulatorischen Anforderungen der FDA für ihre DCT als Lösung zur Fernüberwachung der Therapie. Das Unternehmen hat zusätzliche Materialien vorbereitet, darunter Benutzerhandbücher und Datenaufnahme-Plattformen. Darüber hinaus erkundet Therma Bright Möglichkeiten für die CMS-Erstattungscode-Zuweisung und die Bundesfinanzierung für ihre DCT-Plattform und wartet auf die endgültige Genehmigung für die dauerhaften CMS-Erstattungscodes für ihre Venowave VW5-Lösung.

Positive
  • AI-powered Digital Cough Technology being considered for use in a US clinical trial with a leading pharmaceutical brand
  • Potential for CMS reimbursement code designation and federal funding for the DCT platform
  • Venowave VW5 solution awaiting final approval on permanent CMS reimbursement codes
Negative
  • None.

Toronto, Ontario--(Newsfile Corp. - August 16, 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 it's AI-powered Digital Cough Technology (DCT), with development partner AI4LYF, is currently being considered as a partner technology for a new innovative, disruptive chronic cough drug US-based clinical trial.

"We're pleased to learn from our development partners at AI4LFY that our AI-power DCT platform is in top consideration for use in a US clinical trial with a new and innovative chronic cough drug with a leading pharmaceutical brand," shared Rob Fia, CEO of Therma Bright. "Our DCT solution and data collection platform is ideally positioned for clinical studies like this one, allowing health practitioners and epidemiologist to make more accurate and informed clinical decisions in order to quickly address a patient's or group of patients respiratory issues."

In addition, and as reported in November 2023, the Company has continued its effort around the U.S. Food and Drug Administration (FDA) 513(g) request to obtain information regarding the classification and regulatory requirements for its acoustic AI digital cough technology as a remote therapeutic monitoring (RTM) solution. Additional materials have been prepared to further this effort, including Patient User Guide and Healthcare User Guide, alongside the DCT's mobile cough collection app and desktop/mobile app data capture and reporting platform.

Furthermore, with the Venowave VW5 solution awaiting final approval on permanent U.S. Centers for Medicare and Medicaid (CMS) reimbursement codes, the Company is investigating the possibilities of its AI-powered DCT platform securing permanent CMS reimbursement code designation and/or qualifying for other federal funding or grant support.

The Company, with partners at AI4LYF, will keep the market up to date on all the above pursuits and opportunity, as discussions continue with its key strategic partners and advisory network.

Therma Bright's AI-powered DCT platform, with partner AI4LYF, is focused to support healthcare decision-making by improving the ability to collect, organize, and display cough and respiratory data for health care providers, as well as epidemiologists who are public health workers that investigate respiratory patterns.

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 DCT 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/220173

FAQ

What is Therma Bright's AI-powered Digital Cough Technology (DCT) being considered for?

Therma Bright's AI-powered Digital Cough Technology (DCT) is being considered as a partner technology for a new chronic cough drug clinical trial in the United States.

What regulatory steps is Therma Bright (TBRIF) taking for its Digital Cough Technology?

Therma Bright is pursuing FDA classification and regulatory requirements for its DCT as a remote therapeutic monitoring solution, and exploring possibilities for CMS reimbursement code designation and federal funding.

What is the status of Therma Bright's (TBRIF) Venowave VW5 solution?

Therma Bright's Venowave VW5 solution is awaiting final approval on permanent U.S. Centers for Medicare and Medicaid (CMS) reimbursement codes.

Who is Therma Bright's (TBRIF) development partner for the Digital Cough Technology?

Therma Bright's development partner for the AI-powered Digital Cough Technology is AI4LYF.

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