MicroTransponder, Inc. of Dallas, TX has raised $3.4 million to carry out clinical trials of its Vivistim System to help restore functionality in the upper limbs of stroke patients, and its Serenity System designed to “rewire” the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S.
According to the company’s website, the Serenity System™ pairs Vagus Nerve Stimulation (VNS) with listening to tones. VNS is approved by the FDA and has been used to treat over 60,000 patients for epilepsy and depression, but has not yet been evaluated for safety or efficacy to treat tinnitus. The device is fully implantable and can easily be used at home. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation, which activate the vagus nerve. UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”