MicroTransponder: Latest News and Research

MicroTransponder - Vagus nerve stimulation therapy

Only 10 patients but encouraging.


DALLAS, Texas – MicroTransponder, Inc., (www.microtransponder.com) a privately-held medical device company, presented data from the initial 10-patient tinnitus clinical trial during on June 15th at the Tinnitus Research Initiative conference in Belgium.

Patients with tinnitus were treated using a novel paired vagus nerve stimulation therapy which pairs listening to tones with small bursts of stimulation to the vagus nerve in the neck. The results for this initial trial were positive and many of the patients experienced a reduction in the severity and perception of tinnitus. The principle clinical investigator, Dr. Dirk De Ridder said, “The results from this initial clinical trial are promising, this therapy may be the first operative neuromodulation treatment capable of targeting the brain changes related to tinnitus in a controlled way. We look forward to additional longer term clinical trials.” MicroTransponder also recently reached another milestone, raising $2 Million in angel funding to continue its development of the Serenity System™, the commercial neurostimulation system designed to deliver the tinnitus therapy at the home of the patient.

Tinnitus is the annoying perception of sound in the ears or head where no external source is present, commonly referred to as “constant ringing in the ears”. The American Tinnitus Association estimates that as many as 2 million Americans currently suffer from severe debilitating tinnitus that prevents them from functioning on a daily basis. It has become an especially common problem in soldiers returning from Iraq and Afghanistan with over 850,000 Veterans currently having tinnitus and the Veterans Administration spending over $1.5 Billion annually in disability payments. There is currently no cure for tinnitus and while some technologies try to mask the sound of tinnitus, none has shown significant long term clinical success.

Patients in the pilot clinical trial did not experience severe adverse effects during surgery or during the course of the therapy. Weekly assessments were made using standard tinnitus questionnaires and a measure called the minimum masking level (MML). Several patients reported that their tinnitus improved after just one month of treatment when evaluated on the questionnaire scores. Some patients showed very robust responses in MML reduction from baseline. This is in line with our VNS pairing hypothesis that aims to reverse the underlying tinnitus pathology thereby reducing the intensity of tinnitus. Moreover, the improvement lasted at least 2 months and in some patients the improvement lasted for 6 months to a year. However, some patients had no improvement in their tinnitus.

MicroTransponder is in the final stages of development for the Serenity System™ and is preparing for additional clinical trials in both Europe and the U.S. Tinnitus patients will be able to enroll in those trials by visiting www.clinicaltrials.gov and can visit www.MicroTransponder.com to get the latest updates. MicroTransponder continues to seek additional angel funding to increase the number of patients that can be included in the additional clinical trials.

The Serenity System™ is a neurostimulation based system with a small implanted battery and wires that internally connect to the vagus nerve in the neck. As part of the therapy, the patient also wears headphones and every time they hear a tone, they also receive a small burst of neurostimulation to their vagus nerve. The paired stimulation treatment method is based on decades of neuroscience research.

The aim of the neurostimulation therapy is to reverse this maladaptive plasticity by retraining the brain to “shrink” the abnormal representation of the phantom sound. To do this, the researchers targeted the vagus nerve in neck that stimulates other brain structures to release neuromodulators such as acetylcholine and norepinephrine. “By precisely pairing the release of these powerful neuromodulators with simultaneous delivery of sounds, we were able to reduce this abnormal brain activity and eliminate the tinnitus perception” said lead researcher Navzer Engineer, MD, PhD. “Conditions like tinnitus need to be tackled in a powerful and precise manner. Our technique provides that precision by rewiring damaged neural circuits in auditory cortex and reversing the spontaneous activity that generates the phantom sound” Engineer said. “We hope that this therapy is effective in eliminating tinnitus suffering”.

Dr. Engineer recently conducted a research study, which examined the willingness of tinnitus patients to undergo invasive surgery to treat their tinnitus condition. The results of this study have been accepted for publications by the peer reviewed journal, Neuromodulation. Of the tinnitus patients surveyed, 85% were willing to have an invasive surgery with a permanent implant if it could reduce their tinnitus by 1/2.

This announcement of funding is another important milestone for the Company, which has continued its pursuit of a novel therapy for the treatment of tinnitus. Will Rosellini, CEO of MicroTransponder, stated, “The continued focus on the neuroscience related to the condition of tinnitus has allowed MicroTransponder to develop a novel therapy with great promise. Paired vagus nerve stimulation therapy appears to be able to treat the root cause of the problem instead of just temporarily masking it.”

About MicroTransponder, Inc.
MicroTransponder Inc. (www.microtransponder.com) is a medical device development company with a strong neuroscience research focus. An experienced team of scientists and engineers is developing neurostimulation technology platforms to treat various forms of neurological disease, including tinnitus and post stroke motor rehabilitation. MicroTransponder has a substantial neurostimulation focused R&D program which is able to quickly translate scientific discoveries into clinical therapies. MicroTransponder has raised more than $19M in private investment and grants, including several NIH grants.

 

Sure. Yes, small sample size, invasive surgery and no results from some- prob not for me.

 

I just ordered some Magnesium Chloride so I'll give that a whirl. Thanks

 

Karl, it is kinda interesting they just raised $2 million in funding but only have done a trial with 10 people. Either they are great marketers or this product works....only time will tell.

 

This is interesting but still very experimental and looks like it is still much testing needs to still be done. Results of the next clinical will be telling since the original was only done with 10 people.

 

I am interested in seeing the results of the new clinical trials set up for later this year but prob no results until 2013....waiting is the hard part

 

Must be promising treatment if they are getting all this funding......


MicroTransponder has received notice of a $2.65 Million grant from the National Institutes of Health (NIH) – National Institute on Deafness and Other Communication Disorders (NIDCD). This grant will fund a 30-patient clinical trial in the U.S. starting in 2013. The research team at the Company is grateful to the U.S. academic research community for the support of our efforts to develop a novel treatment for tinnitus. We will be using our Serenity™ System in the clinical trial to deliver Paired Stimulation Therapy, where small bursts of stimulation are applied to the vagus nerve in the neck as the patient hears non-tinnitus tones via headphones. Additional information will be published on our websitewww.microtransponder.com and www.clinicaltrials.gov in the coming months.

U.S. Military 30-patient Trial Contract Awarded $3M (est.)
We have been informed that we are scheduled to be awarded a BAA 12-1 contract from the United States Army Medical Research and Materiel Command (USAMRMC) for a 30-patient tinnitus trial with active Department of Defense (DoD) members including the Army, Navy, and Air Force personnel. Tinnitus is currently the #1 disability in the U.S. Military with over 840,000 Veterans listing tinnitus as a disability. We are honored to be working with these American Heroes who have sacrificed so much for our Country.

UT Dallas / UT Southwestern Grants for U.S. Tinnitus and Stroke Trials
MicroTransponder will be receiving two grants from UT Dallas (UTD). Funding for these grants comes from a UTD fund designated to support translational research, bringing therapies from the University Lab into the clinic. Pursuant to these grants, UT Dallas/Southwestern will become a 4th site for the NIH 30-patient trial and will become the site for a standalone 10-patient stroke trial.

MicroTransponder Presents Positive Tinnitus Clinical Data at TRI Conference
The Company presented data from the initial 10-patient tinnitus clinical trial in June at the Tinnitus Research Initiative conference in Belgium. Patients with tinnitus were treated using a novel paired vagus nerve stimulation therapy which pairs listening to tones with small bursts of stimulation to the vagus nerve in the neck. The results for this initial trial were positive and many of the patients experienced a reduction in the severity and perception of tinnitus. The principal clinical investigator, Dr. Dirk De Ridder stated, “The results from this initial clinical trial are promising, this therapy may be the first operative neuromodulation treatment capable of targeting the brain changes related to tinnitus in a controlled way. We look forward to additional longer term clinical trials.”

Tinnitus Therapy featured in the American Tinnitus Association’s magazine –Tinnitus Today (Summer 2012 Research Edition)
It was an honor to be selected by the American Tinnitus Association (ATA) for a story in their annual research issue of their magazine Tinnitus Today. The ATA is the largest tinnitus patient group in the U.S. The article discussed the clinical success in the European trials and the new U.S. studies that will begin in 2013. The full article can be found at the following link on the ATA website: MTI in ATA Magazine.

Additional Grants Require Additional Angel Funding – $1.2M
The Company is pleased to announce that on May 31, MicroTransponder closed on $2 Million of angel funding. This funding was designed to enable the Company to support 2 smaller trials in tinnitus and stroke. The grants from the NIH, UTD, and U.S. Army are large in fiscal size, but the funds are primarily earmarked for the clinical trial sites and supporting staff. The Company has the prospect of having 4 clinical trials with 90 patients (60 for tinnitus and 30 for stroke) all running simultaneously in 2013 and 2014.
MicroTransponder needs to raise an additional $1.2 Million in order to allow our team to support these clinical trials uninterrupted through the end of Q1 2015. We sincerely hope that additional accredited investors will consider investing at this important juncture. Please email jordan@microtransponder.com for more information on investing or click here.

Management Team Members Switching Roles as Company Shifts Focus from Research to Clinical Trials
Note from Jordan Curnes – President, COO: MicroTransponder’s Co-Founders, CEO Will Rosellini and Chairman Frank McEachern have decided to switch their titles at MicroTransponder as a result of the Company’s recent transition to being fully focused on clinical trials. McEachern and Rosellini both founded MicroTransponder in 2007 and have been involved in all areas of the Company. McEachern has been taking the lead in directing the work of the engineering, regulatory, clinical, and legal teams in the past 2 years and will continue this work as CEO of MicroTransponder. Rosellini will continue to provide strategic input to the Company and will continue to be intimately involved in the day to day research and grant efforts of the Company. Rosellini is also taking a position with another non-competitive company focused on patent monetization.

Scientific Publications
We continue to publish research on our neuroscience-based therapies. The following articles were published in peer reviewed academic journals:
1) Rosellini, W., Casavant, R., Engineer, N., Beall, P., Pierce, D., Jain, R., Dougherty, P.M., 2012. Wireless Peripheral Nerve Stimulation Increases Pain Threshold in Two Neuropathic Rat Models, Exp Neurology 235, 621 – 625
2) Engineer N. 2012Willingness to Accept and Pay for Implantable Tinnitus Treatments: A Survey, Neuromodulation: Technology at the Neural InterfaceVol 15, Issue 4
Closing
The entire MicroTransponder team is very encouraged by our clinical results and eager to begin trials for the stroke therapy and prepare for our US tinnitus clinical trials.
The Company continues to execute its strategy to take products through clinical trials and to approval using an outsourcing model that allows the Company to reach the same clinical and regulatory endpoints at significantly less cost than more traditional brick and mortar neurostimulation companies. Besides operating on a lean budget, approximately 70% of the funding for the Company through Q1 2015 is coming through non-dilutive grant funding. The combination of low overhead and non-dilutive funding will drive shareholder return.
The Company potentially will be managing 2 tinnitus and 2 stroke trials over the next 24 months – this will be an exciting time for the Company, requiring the full commitment and attention of our employees and management. We hope you can assist us in raising additional funding to provide salary support for the team through Q1 2015 so that we can focus on these critical operations. Please let us know if you are interested.

 

The Texas Biomedical Device Center at UT Dallas has agreed to partner with neuroscience-based medical device company MicroTransponder to conduct one of the first U.S. clinical tests of a novel tinnitus therapy developed by the University’s researchers.

The therapeutic approach developed at UT Dallas pairs audible tones with brief pulses of electrical stimulation to the vagus nerve. Preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. No device-related adverse events were seen in the initial human safety study conducted in Belgium, and the initial results were encouraging.

Many patients describe tinnitus as a persistent, annoying and painful ringing in the ears. Tinnitus causes mild irritation for some people, but is severely disabling for many others. Nerve damage or trauma to the cochlea – the portion of the inner ear that converts sound waves into electrical signals in the brain – can result in a loss of input to the brain. This lack of input can result in changes to the auditory system, which is believed to be responsible for some forms of tinnitus.

According to the U.S. Department of Veterans Affairs, tinnitus is the number one military service disability, affecting more than 850,000 U.S. veterans.
“In tinnitus, the areas of the brain that previously received signals from the damaged area of the cochlea are now just sitting there with nothing to do,” explained Dr. Robert Rennaker, interim director of the Texas Biomedical Device Center and an associate professor of electrical engineering and neuroscience at UT Dallas. “The lack of input causes the brain to reorganize, and some portions become hyperactive and generate the perception of sound known as tinnitus. By shrinking the hyperactive pathways, we hope to be able to alleviate symptoms.”

In cooperation with MicroTransponder and UT Dallas’s Callier Center for Communication Disorders, the Texas Biomedical Device Center plans to support a small cohort of subjects in a clinical trial designed to evaluate the effectiveness of the novel tinnitus therapy. The trial is expected to commence in 2013.

MicroTransponder’s CEO Frank McEachern added, “It is crucial for these novel scientific discoveries in the University lab to be quickly translated into therapies in the clinic for patients. This can be an expensive and onerous process. But the Texas Biomedical Device Center is an incredible resource, helping small companies like ours collaborate with the world-class medical and engineering talent in North Dallas.”

The Texas Biomedical Device Center was established at UT Dallas in the spring of 2012. Faculty members from the School of Behavioral and Brain Sciences, the Erik Jonsson School of Engineering and Computer Sciences, and the School of Natural Sciences and Mathematics contribute to the center’s interdisciplinary research efforts to create new biomedical technology and therapies.

MicroTransponder was founded in 2007 as an outgrowth of neuroscience research at UT Dallas. The mission of the company is to develop neurostimulation device platforms to treat neurological diseases including tinnitus, chronic pain and stroke.

 

Now, this really makes sense! I hope the clinical trials begin in early 2013. Maybe with the partnership of these two organizations, there will be enough funding to get the trials underway quickly, so that they can get something out there as a therapy soon. I believe that a cure will more likely come from research such as this (neuroscience), rather than from a wonder drug.

 

Yes, Karen, this seems to be the direction most of the T research is heading and I also believe successful treatments will come from this Neuroscience. Though sometimes on those "bad" days, it would be nice to be able to pop a pill and make it go away....

Karen, I know you suffer from pulsatile tinnitus and I believe Calin does too, not sure if you are aware of Whoosers but they are the largest site in the world dedicated to this type of tinnitus http://www.whooshers.com/ and they talk about many different theories and treatments. You might find some answers there.

 

Yes, I think it has to do with the brain more than anything else. I've been going to a chiropractor who specializes in what is referred to as "functional neurology". He is working with me to try to calm down the areas of my brain that are misfiring. He had been working with me on vertigo issues that I was having along with this, and I am feeling so much better now. The out-of-balance feeling I had in my head is virtually gone! He had me doing eye exercises, etc., which somehow corrected the area of the cerebellum that was out of balance. I don't totally understand it, but so far I've had good results.

Yes, I am aware of Whooshers.com, and have read a lot of the success stories and possible causes for pulsatile tinnitus on that website. I've been to three neurotolgists, though, and had tests (CT scan, MRI/MRA, carotid artery scan), and nothing so far has been found that might be a possible cause. But, I'll keep searching, and maybe some day I'll find some answers. In the meantime, the supplements I'm taking have seemed to help take the edge off, and I'm functioning much better these days!

 

How it works:
How Stimulating a Nerve in the Neck can Treat Tinnitus

MicroTransponder’s approach to treating tinnitus is based on decades of scientific research. The innovative approach pairs a well-known treatment called vagus nerve stimulation with listening to specific tones. Using this method, the researchers were first able to eliminate tinnitus in a rat model and then adapted the therapy to be used in human trials.
One might ask the question, “How can a nerve in the neck cause changes in the brain?” The vagus nerve is unlike any other nerve in the body. It directly connects to the brain and sends important signals to tell the brain what to learn. For example, when someone is exposed to a stressful event, a hormone called epinephrine is released into the bloodstream, which activates the vagus nerve. The vagus nerve then sends a signal to the brain to release the neurotransmitter norepinephrine in a region called the amygdala, which strengthens memory storage for the emotional feelings during that specific time. This is why people often vividly remember traumatic events in great detail. The vagus nerve is sending a signal, telling the brain what to learn and when to learn it.
The MicroTransponder team utilizes this natural response system by directly stimulating the vagus nerve while playing a sound, which tells the brain to “pay attention” to that sound. This simultaneous pairing of a specific tone with vagus nerve stimulation (VNS) strengthens auditory neurons representing that tone. Consistently pairing VNS with all other tones except the tinnitus tone, reduces the expanded representation of the tinnitus tone. Over time, the brain learns to ignore the tinnitus tone. Pairing several of these tones (except the tinnitus tone) helped subdue the abnormal hyperactivity and restored the auditory cortex activity back to normal in a rat model of tinnitus. These changes persisted for several weeks after stopping the treatment. This study was published in the journal Nature.
In the image below, the components of the Serenity System™ are labeled. The patient is sitting comfortably in a chair at home, wearing a pair of headphones to hear the tone series. The laptop is running MicroTransponder’s clinical therapy software, which simultaneously pairs each tone with a small burst of neurostimulation. The software on the laptop is controls the implanted VNS device via the wireless transmitter.

 

Ellen,
To answer your question about supplements, there are no supplements that help pulsatile tinnitus that I know of. If there were, I know I'd be taking them!! I'd give anything if I could find something that makes the feeling of constant motion, like distant thunder (you know what I mean, I'm sure!) settle down a bit.

To help with tinnitus, some of the supplements that seem to help are: Magnesium, zinc, vitamin B12, systemic enzymes, GABA (I take PharmaGABA twice a day), fish oil, vitamin D3, and melatonin. I also am still taking Newton Ear Ringing Formula, and moringa oliefera.

 

Hi, Nookie,

I'm glad my list was helpful to you! These supplements certainly don't take the ringing/pulsating away (at least not for me), but they seem to help soften it a bit.

As for your high-pitched, white noise sound --- I don't know if that would be the same thing as pulsatile tinnitus. Mine is very rhythmic, never stops, and sounds just like my heartbeat. I don't hear it so much when I'm up and around, but there is still a rhythmic undertone, sort of like distant thunder, that never stops. Some things I've read say that these are "head noises" (the sound of the pulse near the eardrum) that we can hear when the ear is sensitized by hearing loss or damage.

Does that sound like what you are hearing?