Egnach, December 8, 2025 – Resaphene Suisse AG announces that the start of patient recruitment for a clinical pilot study as part of the development of the company's own Digital Health Application (DiGA) is planned for the first quarter of 2026 (Q1/2026).

With the commencement of the pilot study, a central value driver in product and business development will be achieved. The results will serve as a scientific and regulatory basis for the subsequent pivotal study aimed at obtaining DiGA approval in the German healthcare system (BfArM).

The pilot study aims to:

• validate its applicability in everyday healthcare,

• measure user acceptance and Patient-Reported Outcomes,

• generate initial effectiveness signals.

Recruitment will be carried out in collaboration with medical facilities and study partners. The study data will form the basis for the transition to the regulatory relevant main study.

"The planned start of recruitment in Q1/2026 is a significant operational and entrepreneurial milestone. It marks the transition from the development to the clinical validation phase of our DiGA and is therefore a central step towards market approval and scaling," explains the Board of Directors of Resaphene Suisse AG.

With the successful DiGA approval, Resaphene gains access to the reimbursable healthcare market with structural revenue potential via the statutory health insurance system.

++ About Resaphene Suisse AG

Resaphene Suisse AG, based in Egnach, Switzerland, is a medical technology company founded in 2015 and has been selling a tinnitus therapy device under the name tinniwell since 2016.

++ Contact for inquiries:

Resaphene Suisse AG

Ms. Anke Rauterkus (Chief Executive Officer)
Bahnhofplatz 5
9322 Egnach
Switzerland