Therma Bright Inc (TSX-V:THRM, OTC:TBRIF), the developer of the smart-enabled AcuVid COVID-19 rapid antigen saliva test, has released an end-of-year shareholder update with comments from CEO Rob Fia.
"2022 was a busy year for Therma Bright with many accomplishments and new endeavors,” Fia said in the update. ‘However, there were many challenges during the year due to the aftermath of the Covid-19 pandemic and the changing local and global economic environments and regulatory requirements.”
Among those accomplishments was the first sales of its Venowave product, a compact and lightweight deep vein thrombosis (DVT) prevention pump specifically designed for use at home.
READ: Therma Bright invests in novel treatment using inhaled statins to treat respiratory conditions
“During the year, we made our first significant sales of the Venowave product in the US and expect substantially increased sales next year because of the new reimbursement codes,” Fia said.
Looking ahead, Therma said it will focus on increasing penetration for Venowave in the US and elsewhere. The global compression therapy market is estimated to be valued at over US$ 3.3 billion in 2022 and is expected to surpass US$ 5.2 billion by 2030, according to Coherent Market Insights.
“We look forward to an exciting 2023 as we move our existing and new products forward. We want to thank our shareholders, employees and partners for their patience, support and efforts during an exciting year," Fia added.
Meanwhile, citing shifting market dynamics and changing US Food & Drug Administration (FDA) requirements, Therma said it is currently evaluating its options for US regulatory approval for its AcuVid test. The product currently has an EU-CE mark, enabling Therma to market and sell the product in 31 countries.
The company is considering applying under a breakthrough designation application, partnering with a diagnostic company to assist with regulatory approval, conducting additional clinical studies for in-home use, filing a full 510(k) application for AcuVid and developing sales relationships post-approval, the company said.
The full Therma Bright letter can be read here.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel