Investors

The Investment Case for GuideAI Health

GuideAI Health is building the first AI platform for early detection of PAD—addressing a $200B+ problem with a proven path to clinical adoption and commercial scale.

The Clearance

FDA Clears GuideAI's AI Software for PAD

VascularAssist Occlusion Triage (VAOT) received FDA 510(k) clearance in June 2026 — here's what it means, in plain terms.

  1. 1

    The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to GuideAI Health for its artificial intelligence software, VascularAssist Occlusion Triage (VAOT).

  2. 2

    A 510(k) clearance permits the device to be marketed for its cleared use in the United States.

  3. 3

    VAOT reviews routine CT scans of the lower legs and automatically flags signs of blocked or narrowed arteries.

  4. 4

    It moves the most urgent cases to the front of the radiologist's queue so they are reviewed sooner. VAOT supports the radiologist and does not replace their diagnosis.

  5. 5

    PAD is common, often underdiagnosed, and frequently caught late.

  6. 6

    It is a leading contributor to limb-threatening loss of blood flow. Catching it earlier can speed up diagnosis and treatment.

The Opportunity

230M7

Patients with PAD

$6B8

Addressable medical imaging AI market (28% CAGR)

$20B9

Total AI in medical imaging by 2029

$233B+10

Annual US healthcare cost burden of PAD

GuideAI targets 230M PAD patients in a large, under-served market with no equivalent AI competitor.11

Why Now

Four Forces That Make This the Right Moment

Four independent forces are converging on this moment.

Diabetes Epidemic

IDF projects 853M adults with diabetes by 2050 — the primary risk factor for PAD. Every new diagnosis is a patient whose vascular health needs monitoring.4

AI Imaging Market

$2.2B in 2026, forecast to reach $17.8B by 2033 at a 34.8% compound annual growth rate (CAGR). Deep-learning platforms with clinical validation are the primary growth driver.5

Value-Based Care

Hospitals and payers are increasingly rewarded for outcomes, not volume. Early detection is a financial imperative, not just a clinical good.

FDA Pathway Proven

More than 500 AI-enabled medical devices have received regulatory clearance, reflecting a well-established pathway for clinical AI adoption.6

The Moat

Three Moats That Are Hard to Replicate

Three compounding advantages that get harder to copy over time.

Data

Exclusive access to 1B+ images from 2,100+ hospitals via vRad. More data means better AI — and a dataset that took years to secure can't be replicated quickly.

Clinical Origin

Built by interventional radiologists who saw the problem firsthand — purpose-built for PAD detection, not retrofitted from general-purpose AI.

Workflow Integration

Designed to plug into existing hospital radiology systems. Switching costs rise with every installed contract, creating a durable revenue moat over time.

Why GuideAI

A Proven Blueprint. An Unaddressed Market.

HeartFlow validated AI-enabled imaging in coronary artery disease. GuideAI applies the same approach to PAD — a larger, under-served population with no dedicated AI solution today.

HeartFlow Inc.

A Proven Blueprint

$176M1

Annual Revenue (FY 2025)

  • Built on AI applied to coronary imaging
  • 200M patient population2
  • Market cap ~$3.02B3

GuideAI Health

Early-Stage Opportunity

The same thesis, a larger market

PAD

  • Targeting multiple vascular diseases, starting with PAD
  • Multiple advanced AI models for full vascular analysis
  • Today: pre-revenue, FDA-cleared for VAOT

The Competitive Gap

Every Competitor Is in a Different Anatomy

See where each AI imaging player focuses — and where GuideAI stands alone.

Company Focus Area PAD Coverage
Viz.ai Stroke / brain imaging None
Aidoc Acute radiology triage None
Cleerly Coronary arteries None
HeartFlow Coronary arteries None
GuideAI Health Peripheral Vascular First Mover

The peripheral vascular lane is empty. GuideAI is not competing for market share — it is creating a new category.

What's Next

Four Events That Will Move This Story

The milestones that turn clearance into revenue and scale.

Swipe the roadmap

  1. Obtained

    FDA Approved VAOT — 510k Clearance

    Commercial launch trigger

  2. Post-FDA

    First Signed Hospital Contract

    First revenue visibility

  3. Expected Q1 2027

    CarotidAssist™ FDA Clearance

    Second product, second revenue layer

  4. Q1 2027

    International Pilot — India

    Global expansion signal

Get in Touch

Investor Inquiries

For investor relations, media inquiries, or to request the full investor deck, contact us below.

info@guideaihealth.com
Download Investor Deck Contact Investor Relations

This website contains forward-looking statements. Actual results may differ materially from those projected.

Sources

  1. 1. HeartFlow vs. Novocure: Which Emerging Healthcare Stock Is a Better Buy in 2026? — The Globe and Mail
  2. 2. HeartFlow Reports First Quarter 2026 Financial Results — ir.heartflow.com
  3. 3. HeartFlow, Inc. (HTFL) market capitalization — Yahoo Finance
  4. 4. Diabetes prevalence projections — International Diabetes Federation (IDF Diabetes Atlas)
  5. 5. AI in Medical Imaging Market — Coherent Market Insights
  6. 6. AI-enabled medical device clearances — NEJM AI
  7. 7. Peripheral artery disease overview — American Heart Association
  8. 8. Artificial intelligence in medical imaging market — Grand View Research
  9. 9. AI in medical imaging market — Precedence Research
  10. 10. Peripheral artery disease cost burden — Society for Cardiovascular Angiography & Interventions (SCAI)
  11. 11. Global peripheral artery disease prevalence — The Lancet Global Health