The FDA approval process for the tinnitus therapy tinniwell is continuing.
Roggwil, July 13, 2022 – Due to the COVID pandemic, work on the FDA approval of tinniwell was halted in early 2021. This has now been resumed, and the Chief Medical Officer Thomas Rauterkus has been appointed to lead the project. The aim is to complete this project within 12 months and thus facilitate entry into the medical technology market in the USA.
We currently assess the market environment as very favorable, as the only serious competitor, Neuralink, around investor Elon Musk, has suffered a significant setback in the FDA approval of its solution. In animal trials, monkeys were implanted with brain implants that were supposed to cure tinnitus later on. Many of these test animals have died for various reasons. Elon Musk estimates that the application will still be available in 5 years.
The management of Resaphene Suisse AG considers the timeline and the broad application of the therapy unrealistic. Even in the event of approval of the Neuralink product, we estimate the cost of the therapy to be in the five- to six-figure dollar range. Coverage by health insurance companies is ruled out, as this would overwhelm the insurance budgets due to the large number of tinnitus patients. There will likely only be rare cases of private coverage by the patients themselves, as most simply lack the financial means.
As a result, tinniwell remains the only available tinnitus therapy that can scientifically prove to cure tinnitus. Due to the unavailability of competing products with similar performance characteristics, Resaphene Suisse AG currently holds a monopoly position in tinnitus therapy.
++ 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.
++ Contact for questions:
Resaphene Suisse AG
Mrs. Anke Rauterkus (Chief Executive Officer)
Bahnhofplatz 5
9322 Egnach
Switzerland
T. +41 714500668
a.rauterkus@resaphene.ch
