Business
Therma Bright Provides 2022 Year End Update
Toronto, Ontario--(Newsfile Corp. - December 21, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: ...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Provides 2022 Year End UpdateToronto, Ontario--(Newsfile Corp. - December 21, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (\"Therma\" or the \"Company\"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide a summary of activities and accomplishments achieved during 2022 as outlined below.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. VenowaveThe FDA-approved Venowave product was previously sold in the US and was reimbursed under Medicare/Medicaid for only one indication. In August 2022, Therma engaged a consulting firm to apply for an expanded number of reimbursement codes for the product. The product received eight new temporary reimbursement codes greatly expanding the market for the product into other therapeutic areas and increasing the reimbursement level. Since receiving the temporary codes Therma has been working with a US distributor to identify the new market opportunities and establish reimbursement levels. The Company expects permanent codes to be issued by early 2023 when the coding committees are scheduled to ...