Work has started on the FDA approval of tinniwell
Roggwil, May 15th, 2020 – To bring the tinniwell to the market 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. The designated US Agent and deputy contact person for the FDA (Official Respondent) is Resaphene US LLC in Delaware.
Upon completion of the first phase of the project in 4 weeks, an approval process according to 510(k) is to be initiated. This should then successfully conclude after another 2 months.
++ About Resaphene Suisse AG
Resaphene Suisse AG, based in Roggwil, Switzerland, is a medical technology company founded in 2015 and has been marketing a tinnitus therapy device under the name tinniwell since 2016. Other sales companies include Resaphene Deutschland GmbH in Constance, Resaphene UK Ltd. in London, and Resaphene US LLC
in the USA.
++ Contact for inquiries:
Resaphene Suisse AG
Bahnhofplatz 5
9322 Egnach
Switzerland
Investor Relations Contact:
Ms. Anke Rauterkus (Chief Executive Officer)
a.rauterkus@resaphene.ch
