Vision testing that extends
the practice — not around it.

01

The dispensary is the business

Across ~22,900 independent US optometry practices (an ~$18B market), eyewear dispensing is 40%+ of practice revenue at 50–70% gross margin — and that margin is leaking to national online retailers and big-box chains.

02

The patient disappears between exams

Between comprehensive exams the practice has no touchpoint. When vision changes or glasses break, the patient starts wherever is fastest — which today is not their own doctor.

03

DTC alternatives cut the doctor out

Online vision tests built to bypass the practice draw organized optometry into opposition and give the independent OD nothing. Nobody is arming the incumbent.

A mapped Class I pathway

OculiRX is the same device type as the FDA-cleared Visibly Digital Acuity Product (predicate K220090): Class I SaMD, product code QTO, 21 CFR 886.1150 — a 510(k)-exempt category, with a Traditional 510(k) planned and Q-Sub Q261815 filed. The regulatory route is de-risked by precedent.

source · FDA 21 CFR 886.1150 · K220090

DTC backlash opened the channel

Organized optometry has fought direct-to-consumer online vision testing for a decade. A provider-led model inverts the politics: the constituency that opposes DTC becomes the distribution channel.

source · AOA public positions

At-home care is normalized

Patients now expect clinical-grade interactions from home. Practices that offer a supervised at-home touchpoint keep the relationship; practices that do not cede it to whoever is fastest online.

source · telehealth adoption data · TBD sourcing

At-home acuity exam

The patient surface

Calibrated in the browser — ISO ID-1 card screen calibration with a PPI cross-check, continuous camera-based distance monitoring, Sloan optotypes with letter-by-letter logMAR scoring, and a gated outcome state machine that never renders a clinical call.

Provider review portal

The clinical authority

A PHI-minimized review queue with the measured acuity, an exam-integrity report, and distance confidence — closed by a step-up TOTP e-signature. A licensed professional reviews and signs every result.

Practice platform

The tenant boundary

Practice-scoped multi-tenancy enforced at the query layer, an append-only SHA-256 audit chain, encrypted session video, and deterministic anti-cheat rules that flag — never auto-reject — for the provider.

Team

• Founders1
• IC engineers2
• Sales / marketing1
• Ops1
• Total headcount5

Speed

• Validation study completemonth 6
• 510(k) submittedmonth 9
• First paid practicesmonth 15
• First buying-group pilotmonth 18
• Runway46 months

Risk profile

• De-riskedvalidation study + 510(k) funded end-to-end
• Bet remainingpractice conversion post-clearance

Strengths

• ·Shipped SaMD-grade platform — exam engine, review portal, tenancy, audit chain
• ·Channel alignment no DTC player can copy without abandoning their model
• ·Regulatory-first honesty architecture, enforced in CI
• ·Mapped Class I pathway with a named predicate device

Weaknesses

• ·Pre-clearance and pre-revenue — the honest state
• ·Validation study proposed, not yet run
• ·Solo operating founder — bus-factor 1 until seed hires land
• ·No practice pilots signed yet; channel relationships are targets, not contracts

Opportunities

• ·Buying groups and alliances concentrate thousands of practices behind one deal
• ·Every DTC controversy strengthens the provider-aligned position
• ·The platform generalizes: the screening wedge can grow into the practice front door
• ·At-home care expectations keep rising

Threats

• ·FDA Q-Sub feedback could shift the regulatory posture or timeline
• ·The predicate vendor pivots hard into the provider channel
• ·Practice buying groups move slowly; channel deals can stall
• ·Validation results could force a narrower claim set