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A difficult decision in Q3

We have gotten some very good information so far on our survey and are happy to report that our clinical studies are showing promise in the first few patients.  I have the very difficult decision (Q3 of this year) of determining how much of our budget we can afford to divert to the tinnitus product, as opposed to our wireless neurostimulator for the treatment of chronic pain or urinary incontinence.  I’m hoping to delay having to make this decision by raising more money from non-dilutive sources.  Our investors (quite correctly) have supported the tinnitus research to some degree, but the majority of the investment dollars we have raised have to go into lower risk disease states (easier regulatory pathway, clearer competitive position in an established market etc…).    It will be hard to make the decision to stop funding our PTSD research (a post on this later) and our tinnitus research.

For both PTSD and tinnitus, we have shown very nice results in animal studies.  It has been difficult to convince people who haven’t treated these types of patients, that these sufferers would be willing to have an operation to have their tinnitus reduced.   These surveys are giving me the data to support the position that patients would accept an implantable device.  It looks as if most sufferers would accept a surgery in order to reduce their tinnitus by 50%.   So, my early analyis on this is that if we can get at least 50% of the patients at least a 50% reduction we would likely have a clinical product that investors would be comfortable with.  The difficulty is that getting enough patients with enough data to support this 50/50 metric is expensive.  

The American Tinnitus Association has offered to help us find some support in the military research coffers.  In talking with them, I realized my statistics for the military were out of date.  Here is the 2010 numbers on our wounded warriors:

Most Prevalent Service-Connected Disabilities for Veterans Receiving Compensation at the End of Fiscal Year 2010

Tinnitus 744,871

Hearing loss 672,410

Post traumatic stress disorder 437,310

Scars, general 418,748

Diabetes mellitus 332,065

Hypertensive vascular disease 284,552

Traumatic arthritis 279,402

Lumbosacral or cervical strain 277,417

Impairment of the knee, general 267,049

Most Prevalent Service-Connected Disabilities for Veterans Who Began Receiving Compensation During Fiscal Year

2010

(Disability Number of Veterans Percent of Total)

Tinnitus 92,260 10.7%

Hearing loss 63,583 7.3%

Post traumatic stress disorder 37,263 4.3%

Limitation of flexion, knee 34,456 4.0%

Lumbosacral or cervical strain 31,881 3.7%

Tendon inflammation 25,826 3.0%

Degenerative arthritis of the spine 25,394 2.9%

Diabetes mellitus 24,233 2.8%

Limitation of motion of the ankle 20,623 2.4%

Scars, general 20,562 2.4%

Most Prevalent Disabilities by Period of Service at the End of Fiscal Year 2010

717,463 male veterans and 27,408 female veterans are rated for tinnitus; and 632,627 male veterans and 9,710 female veterans are rated for hearing loss.

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  • AD

    This is upsetting news. I am one of the substantial number of people anxiously awaiting this treatment. To think that, after such initial promise, there is a chance that this project will not progress further is disappointing, to say the least. I suspect that the real reason is that the treatment has been unsuccessful in the initial stages, and Microtransponder are covering that up by citing other reasons for possibly discontinuing research in this area. Given the millions of tinnitus sufferers around the world who live in continual distress I refuse to believe that investors cannot see a large enough market for a an effective final product.

  • http://twitter.com/pissliv Jörgen Levengood

    Actually having a somewhat successful treatment of Tinnitus would give this product 100% of a market covering a large percentage of every nations consumers.
    No intelligent investor would risk losing that, to being just one of many competitors in another arena. This sounds like BS to me. It does indeed seem like the human studies have shown little promise and Will simply wants to divert the anger from the thousands he gave hope just to take it away. I hope you sleep better at night now.

  • JVidueira

    I cannot believe that this is happening. I am one of those pacients that is waiting for this treatment to be implemented. Please continue the research on this area. Millions of tinnitus sufferer are waiting for this.

  • ND

    I speak as one of the millions of people that suffer from tinnitus when I ask you to PLEASE continue to fund and resaerch the cure for tinnitus. We are all awaiting for this treatment. I cannot beleive that investors would not support this research especially knowing that there is a positive result in this treatment

  • Anonymous

     I would suspect that the level of investor interest is largely dependent upon the success of the clinical trial and the finical investment tinnitus suffers are willing to pay for treatment.  Hopefully, the questionnaire issued by Micro Transponder answers the question about the user’s willingness to invest in treatment.  If the clinical trials are successful the finical benefits, I would imagine, would be substantial (if you went public, I would invest in it).   Having said all that, it is sad that considering the level of distress and, I do not believe this to be an exaggeration, suffering experienced by those living with tinnitus experience, compassion does not enter into the equation.  This especially true of the Department of Defense, who will not award Micro Transponder a grant. You would think they would be more willing to step up to the plate considering how many veterans suffer the malady.  
        Please continue this research , your company gives hope to all the tinnitus suffers and represents one of the few legitimate and promising treatments for a problem that so many suffer with.     

  • Hari

    Didn’t some super smart Indian guy tell you this would be the outcome? Nobody ever believes the super smart Indian guy:)

    In defense of Will the big problem in getting military primary devices approved is that it requires the military to:

    A) admit there is a problem which is an inherent liability issue

    B) define the patients and endpoints (ie what is clinically relevant tinnitus) that you need for approval.

    I think will would work on it till he literally ran out of money (a fact I know as he continued to work on the indication despite my insistence of it’s stupidity). He would also be the first to admit it doesn’t work in adults if it didn’t work. Will likes to think and solve big but in devices that usually leaves you in a disadvantageous situation.

    My only recommendation is to pursue this as an HDE. It limits the number of people who get therapy but at least people will get therapy.

    Glad to hear pns and urinary incontinence are working well.