Who reads the results?
The software will generate a report that compares the baseline scan to the post-injury scan. We leave the diagnosis to the physician. Over time, we believe a critical mass of data will be collected and stored that may allow us to develop some kind of scale that estimates the severity of the concussion. The athlete or patient would be re-scanned every 2 or 3 days until the eyes return to an accepted level of movement.
Do you have to have a baseline to get valuable data?
Having a baseline is ideal and necessary at this time. In Arizona, all High School athletes are already required to take a cognitive baseline concussion test, and watch an informative concussion video about the risks. So our solution will be very easy to implement. The baseline test also allows us to generate revenue on every student who participates in athletics, not just the ones that are injured. Our inventors are very confident that the test will reveal a signature for concussions. They have not worked on this area, however, as they have been focused identifying the signatures for other neurological disorders like Alzheimer’s Disease. When we have done a critical mass of scans, we expect to be able to detect the concussion without the baseline.
Are you distributing the device for free, then charging for tests, or is it the reading of tests?
Our cost on the current device is about $1500 with the tablet. We will charge for Dthe device but keep the cost as low as we can. We will look at a variety of sales or leasing models for the device. Our initial target market is athletic trainers and sports-medicine clinics. The trainer can administer the test, but the report is ideally sent to the M.D. to make the diagnosis. Phase 2 is sales directly to schools. We also like the rural/telehealth angle, so that a school in rural Kansas can have a device on-site, and a local trainer, doctor, or nurse can administer the test, with the report going directly to a neurologist, who may be 100 or 200 miles away. We will have all of the intelligence in the cloud, so we will charge for the test. We will negotiate an annual “site license” for schools that will allow them to test and re-test students without cost concerns. For private practice physicians, it will be a per-test rate. There is a CMS reimbursement rate CPT Code for “neurophysiological testing by computer” that runs about $48-$53 per test, which is about where we expect to be. Maybe more. The physician can also charge for reading and interpreting the report.
Who is qualified to administer the test?
The test is very easy to administer. You sit the patient in a chair, press the start button, and have them stare at a dot in the center of the screen for 20 sec. intervals. It takes less than 5 minutes. I would compare it to an electronic blood pressure tester. You could do it yourself, but you still wouldn’t want to put the kid back on the field until they are cleared by the trainer or physician. We will train nurses, doctors, and certified athletic trainers to administer the test.
Are the licenses exclusive? Is there competing IP? Competing solutions?
The licenses are exclusive. The method can also be used for fatigue and deception, which we do not have license for, due to ongoing research. There is no competing IP that we have been able to find that addresses the measure of involuntary eye movements (microsaccades, fixational eye movements.) Other competing solutions all require voluntary participation in baseline testing, which is easy to fake. If you talk to athletes under age 25 who have taken those tests, they say “those things are a joke.” There are some well-funded competitors using these methods – NeuroKinetics, King-Devick Test, ImPACT, SyncThink, NeuroTrack, and Oculogica are the primary competitors.