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Therma Bright Inc V.THRM

Alternate Symbol(s):  TBRIF

Therma Bright Inc. is a Canada-based company, which is a developer and partner in a range of diagnostic and medical device technologies. It focuses on providing consumers and medical professionals with solutions that address medical and healthcare challenges. It is involved in developing, acquiring, manufacturing, and marketing proprietary healthcare and medical devices for the consumer and institutional marketplace. Its product offerings include Covid-19 diagnostic test product line, such as AcuVid COVID-19 Rapid Antigen Saliva Test and AcuVid COVID-19 Rapid Antibody Test; Sores & Bite Inflammation Therapy product line, such as InterceptCS Cold Sore Prevention System and TherOZap, and Muscle Pain & Blood Circulation Health Therapy product line, such as Venowave, which is a circulation booster designed to improve circulation in the lower extremities. Its products include Benepod, Inretio, AI4LYF, Invixa and Instatin, and others.


TSXV:THRM - Post by User

Post by AveragePennyon Dec 21, 2022 10:49am
223 Views
Post# 35184569

Therma Bright Provides 2022 Year End Update

Therma Bright Provides 2022 Year End Update

AcuVid™

Health Canada continues to provide constructive feedback as the submission progresses through their approval process.

Due to shifting market dynamics and changing FDA requirements in the US, the Company is currently evaluating its options for US regulatory approval in discussions with the FDA and its FDA consultants.

Therma is evaluating several pathways available for US regulatory approval and market penetration including: applying under a breakthrough designation application, partnering with a diagnostic company to assist with regulatory approval, conduct additional clinical studies for in-home use, filing a full 510(k) application for AcuVid™ and develop sales relationships post approval.

AcuVid™ currently has an EU-CE mark, enabling Therma to market and sell the product in 31 countries. Therma is collaborating with an established partner to identify customers in these nations. Since the COVID-19 outbreak in 2020, the market for Covid-19 diagnostic tests has undergone a major shift. In the future, corporate buyers for employee-based testing, governments that are introducing updated testing standards, and consumers will be the key emphasis for AcuVid™ sales and marketing efforts.

https://www.newsfilecorp.com/release/148972

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