Tinnitus Clinical Trial Update from MicroTransponder

December 19, 2011 in Uncategorized
Tinnitus Clinical Trial Update and Our $2M Investment Round

To the Tinnitus Patient Community,

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. 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. Thus, we are pushing forward on device development and additional clinical trials.

As a company, we are firmly committed to being scientifically rigorous in our clinical trials and research. Our previous tinnitus research was published in the journal Nature in Jan. of 2011 and featured in the New England Journal of Medicine in April, 2011. We intend on releasing the full tinnitus clinical results at the Tinnitus Research Initiative conference in June of 2012. This conference consists of academic tinnitus experts from around the world and our lead clinician will present the clinical results at that time. 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.

As of now, 7 patients have completed the Serenity System™ therapy, and more will finish in the next few months. The trial is being run by a world class tinnitus center in Belgium and our Principal Investigator is Dr. Dirk DeRidder. The trial has completed its enrollment. Each patient is evaluated by the center using a number of standard surveys and tests, so trying to answer the question of “What percent did you reduce the patients’ tinnitus?” is quite complex. 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. The therapy sessions lasted for 2 hours each day (Monday through Friday) and continued for 2-4 weeks, depending on the patient.

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. 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. 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. (simply email tinnitus@microtransponder.com if you have not joined already)

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. 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. The patient wears headphones to listen to a series of tones during therapy. 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.

We have already begun discussions with the FDA in order to begin a tinnitus clinical trial in the U.S. as soon as possible. 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. clinical trial until 2013. The U.S. tinnitus clinical trial will involve multiple sites, but the locations have not been determined at this point in time.

The chief obstacle for our company is that we need to raise additional funds for the next tinnitus trial. We have received some NIH grants, but they have only cover a portion of the clinical trial and device development costs. We have applied for additional grants from both the NIH and U.S. Military, but we have not received results on these grants yet and they will not fund a trial outside the U.S., meaning the tinnitus therapy would still experience a delay of 12 months while we wait for FDA approval. 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.

In order to run our next clinical trial for tinnitus, we need to raise an additional $2 Million in funds. Due to U.S. Government rules, we can only accept investment from “accredited investors” – individuals with $1M in net worth, or those who have earned $200,000 each of the last 2 years. Interested individuals (U.S. or non U.S.) can visit our website www.microtransponder.com to fill out the investor form on the homepage and then we can send investment information to continue our development of this therapy for tinnitus. We need to raise the additional funds by March 2012 to be able to make the proper arrangements for the trial.

Thousands of patients have emailed us and asked what they can do to help. There are 2 ways to help. First, many potential investors do not fully understand the severity of the condition of tinnitus. You are our best advocates to these independent investors. Second, if anyone has any high ranking contacts in the military – U.S. or Europe, you can tell them about our promising clinical studies and they might potentially fund a study out of self interest. 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.

Our CEO Will Rosellini will be continuing to provide more frequent updates on our Tinnitus research at www.willrosellini.com Please check his site for postings on our development.

Here are the links to several of our prominent research papers in academic journals.

Nature – VNS Reverses Tinnitus in Animal Studies (Jan. 2011)

NEJM – Harnessing Plasticity to Reset Dysfunctional Neurons (April 2011)

Neuromodulation – Paired VNS to Eliminate Tinnitus in a Rat Model (May 2011)

Neuroscience – VNS Mechanisms of Action (May 2011)

And lastly, here are 2 videos. The first features our lead PhD Neuroscientist explaining how our therapy treats tinnitus. The second features our CEO discussing the importance of Angel investment to supplement NIH government grants. Both are very informative.

http://www.youtube.com/user/MicroTransponder#p/u/0/yMLbFwltBdc

http://www.youtube.com/watch?v=-VgADxOsJvc&feature=related

We are working diligently to bring our therapy to patients with tinnitus as quickly as possible. We now need your help.

thanks,

the MicroTransponder Team

*Investigational Device, Not for Sale in the United States, limited by Federal law.