Breathe BioMedical, a Canadian medical technology company developing a breath test for breast cancer, filed on Friday with the SEC to raise up to $12 million in an initial public offering. The company plans to concurrently list its shares in Canada, though it did not specify which exchange.
Breathe BioMedical is focused on developing a breath test to be used as an adjunctive test to mammography screening to detect early-stage breast cancer in women with dense breast tissue. Over the next two years, the company has verification and validation studies, as well as a large multi-center clinical study planned to evaluate the safety and efficacy, for the various components of its Breast Cancer Breath Test. It is currently conducting a proof-of-concept study, for which data collection will be completed in 3Q24. Breathe BioMedical anticipates the completion of the components, the Breast Cancer Breath Test, and the verification and validation studies in 2025 with a pivotal trial in 2026 to support a marketing authorization application in the US in 2027, subject to discussion with the FDA.
The Moncton, Canada-based company was founded in 2005 and plans to list on the Nasdaq under the symbol BRTH. Breathe BioMedical filed confidentially on March 4, 2024. Maxim Group LLC is the sole bookrunner on the deal. No pricing terms were disclosed.
