1. Home Tonometer
The University of Arizona
Eniko Enikov - PI
Vasco Polyzoev – EL
Emre Toker - Mentor

3. Here’s What we Thought
• Serial tonometry was exotic and under-utilized
procedure with low volumes
• The market for serial tonometry is negligibly
small
• Drainage of ocular fluid is a new
function/market and of potential interest to
doctors

4. So Here’s What we Did
• Interviewed several ophthalmologists
• Searched FDA data base for predicate
instruments and approved applications
• Searched commercial market study reports
and Medicare re-imbursement data to
identify market size in US

5. Here’s What we Found (Cont.)
Serial Tonometry: Reimbursable
procedure

6. Here’s What we Found (Cont.)
• Only 35,000 claims are filed annually, while there are 5M
patients with glaucoma
• Doctors and patients find serial tonomery impractical and
cumbersome to perform
• Doctors feel that all glaucoma patients should be
undergoing serial tonometry, if there was a practical way of
performing it.
• At $90 per claims the annual revenue to doctors would be
$450 M in US.
• Doctors would like to capture near all of the insurance
revenue and potentially recoup the cost of tonometer
within 1 year (larger sample needed to get more accurate
estimate)

7. Here’s What we Found from FDA
(cont.)
• Is there a defined pathway to FDA approval (predicate 510(k) device
for home use)? YES
• Is the procedure reimbursable? YES
• Do we have enough clinical data to gain physician endorsement?
NOT YET
• Do we know what we need to demonstrate to gain physician
endorsement? YES; +/- 2mm Hg; equal to gold standard
• Do we have an estimate of the potential market? YES; one device
per 5 patients; 5M patients => 1M devices at ~$500 each => $500M
market potential
• Do we know the biggest business risk factor going forward
(assuming technology works as planned)? YES; Medicare cuts
reimbursement for home tonometry.

8. Here’s What we Found (cont.)
Predicate Device (Pro View)
• Low-risk FDA 510(k) route with predicate
device

9. Here’s What we Found (cont.)
Why is Proview not currently in use?
• Mechanical and not accurate.
• Subjective – requires patients to take reading
based on perceived light.
• Doctors need comparison with Goldman and
minimal accuracy of +/- 2 mm Hg.
• Cannot gather data electronically.

10. Here’s What we Found (cont.)
Market Size
• The interviewed ophthalmologist might be able to prescribe 2000
tests per year requiring 40 tonometers for his office assuming the
device is used for 1 week by each patient.
• Based on 5M patients and 20,000 opthalmologists in US, the
average number of patients per doctor seems to be around 250,
leading to each doctor purchasing or leasing about 5 tonometers.
•
• Might be able to get higher reimbursement as “M-code device”
similar to ecocardiography at home (Holter monitor.)
• Serial tonometry might be prescribed once per year per patient
with glaucoma

11. Concerns from Doctors
• Possible damage to the instrument by home
use.
• Acceptance – need a clinical trial
demonstrating efficacy

12. Here’s What we Are Going to Do
• Continue interviewing potential customers to
find out if “M codes” can be used.
• Determine delivery/distribution method, i.e.
lease vs. sale, data collection and processing
• Validate assumption of price point, acceptable
profit margins to doctors.
• Prepare prototype for clinical trials