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