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12.08.2014
We have had numerous requests from various tinnitus patients asking for an update on the results of our tinnitus clinical trial that began earlier this year in Belgium. As a company, we are firmly committed to being scientifically rigorous in our clinical trials and research. As of now, 7 patients have completed the Serenity System™ therapy, and more will finish in the next few months. This study focused on patients with tonal tinnitus; it is too early in the process to determine which types of tinnitus will respond best to the therapy, but the intent is to help a large percent of the tinnitus patient population. Our initial clinical trial uses a prototype device, so we are now developing a fully implantable version for the larger tinnitus clinical trial in the EU, scheduled to begin in late 2012. We have already begun discussions with the FDA in order to begin a tinnitus clinical trial in the U.S. The chief obstacle for our company is that we need to raise additional funds for the next tinnitus trial. In order to run our next clinical trial for tinnitus, we need to raise an additional $2 Million in funds. We are working diligently to bring our therapy to patients with tinnitus as quickly as possible. Community Upcoming EventsMay 2016NCIEC - Interpreting Immersion Program - May 31-June 9 Gallaudet University, Washington, DC.
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We are pleased to be able to announce that at this point in the trial, our Serenity System™* therapy has been able to help a majority of the patients reduce their tinnitus by a clinically meaningful amount. The trial is being run by a world class tinnitus center in Belgium and our Principal Investigator is Dr. It is also too early to be able to know which exact criteria will be used by the sites to determine eligibility for the upcoming trials. The Serenity System™ features both an implanted device, similar to a neurostimulation device used in over 65,000 patients for the past 15 years to treat epilepsy; as well as external controller which wirelessly turns the device on and off. We have received some NIH grants, but they have only cover a portion of the clinical trial and device development costs. We will announce the opening of enrollment for the next clinical trial via our website, on clinicaltrials.gov, and through our tinnitus update email list. Due to FDA regulatory requirements for extensive materials testing prior to a human trial, we will not be able get approval to begin a U.S. First, many potential investors do not fully understand the severity of the condition of tinnitus. The second features our CEO discussing the importance of Angel investment to supplement NIH government grants.
We intend on releasing the full tinnitus clinical results at the Tinnitus Research Initiative conference in June of 2012. Both the headphones and external controller connect to a single laptop computer which runs software that coordinates both the stimulation and the tones in a paired manner.


This conference consists of academic tinnitus experts from around the world and our lead clinician will present the clinical results at that time. We do not want to wait the 12 additional months until 2013 to treat patients with the therapy in the clinic, so we are raising an additional round of funding right now. We plan to submit the data to a peer reviewed clinical journal for publication as well to maintain our high scientific standards for research and clinical trials. Using standard definitions of clinical response on common measures of tinnitus used in clinical trials, between 50% and 75% of the patients were defined as responders. We need to raise the additional funds by March 2012 to be able to make the proper arrangements for the trial. The therapy sessions lasted for 2 hours each day (Monday through Friday) and continued for 2-4 weeks, depending on the patient. Tinnitus is the #1 disability from soldiers for all nations returning from Iraq and Afganistan and they spend $1.2 Billion each year in tinnitus related disability payments.



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