Home Tonometer

The University of Arizona

Eniko Enikov - PIVasco Polyzoev – ELEmre Toker - Mentor

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

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

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

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)

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.

Here’s What we Found (cont.)Predicate Device (Pro View)

• Low-risk FDA 510(k) route with predicate device

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.

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

Concerns from Doctors

• Possible damage to the instrument by home use.

• Acceptance – need a clinical trial demonstrating efficacy

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