Roggwil, May 15, 2020 – In order to launch tinniwell in the USA, Resaphene Suisse AG, ISIN CH0367465439, WKN A2JG91, has now officially started the FDA approval project. In the first phase of the project, a regulatory pathway will be created to explore the approval options. Resaphene US LLC in Delaware has been designated as the responsible US agent and deputy contact for the FDA (Official Respondent).
After completing the first phase of the project in 4 weeks, an approval procedure according to 510 (k) is to be started. This should then end successfully after another 2 months.
++ About Resaphene Suisse AG
Resaphene Suisse AG, based in Roggwil, Switzerland, is a medical technology company that was founded in 2015 and has been selling a tinnitus therapy device under the name tinniwell since 2016. Resaphene Deutschland GmbH in Constance and Resaphene UK Ltd. in London and Resaphene US LLC in the US act as further sales companies.
++ Contact for questions:
Resaphene Suisse AG
Investor Relations contact:
Ms. Anke Rauterkus (Chief Executive Officer)