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 In talking with them, I realized my statistics for the military were out of date.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
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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.

May 5, 2011 











