Press Release: Medical Device Company MicroTransponder Presents Positive Tinnitus Clinical Trial Results at Tinnitus Research Institute Conference in Europe
Medical Device Company MicroTransponder Presents Positive Tinnitus Clinical Trial Results at Tinnitus Research Institute Conference in Europe
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.