Resaphene Suisse AG: FDA Approval Process for Tinnitus Therapy Tinniwell Continues

ROGGWIL, Switzerland--(BUSINESS WIRE)--Due to the COVID pandemic, work for the FDA approval of the tinniwell was stopped at the beginning of 2021. This has now been resumed and Chief Medical Officer Thomas Rauterkus has been commissioned to manage the project. The aim is to complete this project within 12 months and thus gain entry into the medical technology market in the USA.

We currently assess the market environment as very favorable, since the only serious competitor, Neuralink, led by the investor Elon Musk, suffered a serious setback in the FDA approval of its solution. In animal experiments, brain implants were implanted in monkeys, which, among other things, were later to cure tinnitus. Many of these experimental animals have died for a variety of reasons. Elon Musk estimates that the application will still be available in 5 years.

The management of Resaphene Suisse AG sees the time estimate and the widespread use of the therapy as unrealistic. Even if Neuralink's product were approved, we estimate the cost of the therapy to be in the five to six-digit dollar range. A reimbursement by health insurance companies is excluded, as this would completely overwhelm the budget of the insurance companies due to the large number of tinnitus patients. A private assumption of costs by the patients themselves will probably only occur in isolated cases, since most of them simply do not have the financial means.

This means that tinniwell remains the only available tinnitus therapy that has been proven 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.

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