-->

Tinnitus Update

September 19, 2011 15 Comments

I presented the Microtransponder story to the Institute for Innovation and Entrepreneurship at UT-Dallas and once again I had a number of tinnitus sufferers approach me about our progress in translating the therapy.   My heart goes out to these patients, as every story I hear about their symptoms are worse than the last.  I also have to give credit to the Tinnitus chat rooms/message boards… apparently the results are being actively discussed there…albeit the information is sometimes wildly inaccurate, perhaps due to my deficiencies as a writer (the proofreader blows up when I try to post)…I learned as a baseball player not to follow the message boards, so I won’t spend time correcting/addressing issues there.  I need all of my energy and confidence focused on moving the therapy forward.

The good news is that we have a very compelling story coming together in the clinic.  We expect to need to show a 50% response rate (meaning 4 out of 8 patients) that have shown substantial relief (we are currently 5 out of 7).  We would expect this number to get better as we get better at selecting patients for the trial (there is potentially a very interesting method we discovered to do this).   However, it is challenging to find objective imaging or diagnostic tools that can measure the changes occurring in the brain. More on this here (luckily the lead author Rich Tyler is consulting on our current trial design and how best to design our next trial).

http://www.ncbi.nlm.nih.gov/pubmed/17956814

http://www.ncbi.nlm.nih.gov/pubmed/17114142

We met with a number of experts at the Buffalo Tinnitus workshop in August, who were very impressed with the data and our scientific team.  This input has lead to a fairly major shift in our strategy as our Board of Directors (BOD) has decided to focus our remaining investment dollars for a commercial device for tinnitus.  This is in part due to the clinical signal we have observed, but also due to the overwhelming survey results demonstrating a significant unmet need for an implantable solution (everyone would take a pill that costs a dollar, but the question for our BOD was whether they would have surgery).

Our tasks now are to wrap-up the feasibility study in Belgium and begin planning a larger overseas study.  We also plan to put a grant request in to the NIDCD to support a US, multi-center study.  My task now is to coordinate our clinical trial designs with the sites and the FDA.  I’m also tasked with raising a small supplement to our current round of funding.  We are targeting a $3M extension of our current round, which should be enough (if we get the grant) to get a CE Mark for the tinnitus product and begin sales of the Tinnitus therapy in Europe.  The U.S. approval will be after Europe due to FDA regulatory requirements.

We expect to present our data at a conference soon, along with a peer reviewed publication in 2012.

 

 

Twitter Digg Delicious Stumbleupon Technorati Facebook Email
blog
  • Alex George

    I don’t have $50K but I would like to donate what I can, so how do I do that?

    It would be fantastic if you could make the results available in some way to the public either after the conference or the peer reviewed publication. You have a much larger following than you know.

    Also, what happened to the other 4 patients who were not responsive? Are
    you making modifications to the treatment to accommodate them or are
    they simply not responsive for reasons outside of your control?

  • Vajora

    Dear Will,

    If I had that money I would handover to you personally. Until now I spent some 20k in total for all of my trials to get relief,
    Your research sounds promising and I hope you will have much more success with time. To get more funds or some investment of privat people you should do much more public your investigations by this new and innovative treatment possibility.

    I can imagine there are a lot of people out there, who have the money and the willingness to spend money to such a research program, if they would know that. The problem what I see is, that Microtransponder is not much know for the Tinnitus Field, even you presented in Nature etc.

    Most people with tinnitus are old and if they ask their doctors or ENT´s for some cure or treatment, they get message “You have to live with it, no Cure for future” and thats what all people do – no motivation for progress and research.

    Mr. Matteo de Nora as maybe know is not like that! He is a very professional man with vision. I hope that you can find more people like him.

    Regards,SiSKO

  • DavidMolyneux

    Dear Mr. Rosellini,

    Many thanks for the work that everyone at Microtransponder and other clinical organisations are undertaking to try to provide effective treatment or even cure for tinnitus.

    As someone who has experienced this condition for almost 12 months now I can honestly say for me it has been my most difficult personal challenge in my entire life. At age 42 I just hope that an effective treatment or cure comes along sooner rather than later.

    Whilst I dont know any business angels to generate funding I would gladly make a personal donation to your research as other posters have also mentioned if you could make this a possibility.

    Good luck to everyone working towards a tinnitus cure.

    David.

  • Jan Berlin

    thank you, will. this sounds very encouraging and promising.

    I really hope you can continue your research as soon as possible, not “loosing” to much time with fundraising.

    the followoing questions strike my mind when i read your update

    1. what do you consider as “significant relief”?
    2. what are the selection criteria of tinnitus patients for treatment success?
    3. do you “only” expect success rate to improve by improving selection criteria or do you also an improvement potential in the methodology/aprroach/technology?

    Please let us know at what conference you will present your data as soon as you know. We are longing for more (positive) news.

  • Nicolas houart

    Dear Mr Rossellini,

    I came back from Antwerp this monday 19 september and the director of the clinical study told me he had five successes over the seven patients he implanted. Four whose answer on questionnaires show an improvement and one whose tiinitus had nearly dissapeared.

    You say four over eight. Why the difference ?

    Anyway these are good news.

    Regards

    • Will Rosellini

      I corrected this, as my language was unclear…we are hoping to get 4 out of 8 response rate once we finish enrollment…you are correct that we are currently at 5 out of 7.

  • Lucas

    Keep up the good work, we need a cure soon !!

  • Todd Walker

    Will,
    I have some nerve deafness due to blowing a whistle for 30 years, and the resulting tinnitus suffered gets progressively worse as time goes by. This particular treatment approach strikes me as extremely promising, and I hope that you receive FDA approval for clinical trials in the U.S. shortly. People who do not suffer from this condition have no idea just how debilitating it can be at times, and since insurance does not recognize that it exists at all, how costly it can be to chase possible cures/treatments. Best of luck!

  • Martin

    Hi Will,

    Congradulation on your progress!

    You should put a list of potential clients,…I am sure you will be surprise
    of how many people are counting on you and are waiting for the chance to
    get the treatment.

    Keep us informed,

    Thanks.

  • Jin_sora

    i hope there’s a cure for this soon! thank god!

  • http://twitter.com/CurtisR765 Curtis Robertson

    I am very interested in this therapy. So much so that my wife has even suggested I contact you about being a candidate for the clinical trials. I am a volunteer firefighter in rural East Texas and know that the elimination of tinnitus would be a blessing for me as well as the communities that we serve.

  • http://profile.yahoo.com/VTB7YYWQGHHFMLWU2ZEEXREBOQ david

    dear will ,

    i am very glad for your project , i have been suffering for as long as i can remenber and i am just 19 years old . i have a suggestion that may be stupid but i am going to share  : why you guys do not ask for donation , let say 2 or 5 dollars per person i am pretty sure that at least 3 millions people will donate the money , including myself. please keep the good work up

  • Hugh

    I’m following news reports on the study published in Nature, and press reports from Britain. I can only hope there will be clinical trials in the US, and if so I would be first in line to participate. I’m 57 years old and have been suffering from tinnitus for many years. I’d love to at least tone it down if not eliminate it altogether. Good luck with this!

  • joris

    dear mr rosselini,
    my name is joris im 19
    ive been suffering from tinnitus a couple months now and it has changed my live completly im am depressed and i gave up al my dreams i cant live like this i really hope one day you can cure us because we suffer all day long . good luck

  • Helen J. Gwynne

    Dear Mr. Rosselini:  I am 58 years old and have suffered w/ Tinnitus most of my adult life…but the past 6 months it has become increasingly unbearable and depressing as you cannot escape the noise.  I cannot sleep due to the very high pitched sounds and the brain zaps I get once in bed.  Without getting any sleep every night makes me unable to function at work and in my personal life.  Please find a way to help everyone who suffers from this horrible infliction.  Thank you.  Helen.