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MEDTECH SPOTLIGHT  |  SEPTEMEBR 2026
GuideAI Health Just Received FDA Clearance for Vascular Assist Occlusion Triage – Targeting a 230 Million Patient Market

When we look for companies with genuine transformative potential in healthcare AI, we look for two things: a proven thesis and an underserved market. GuideAI Health has cleared the FDA, gone public, and set out to prove the market.

We're Looking at GuideAI Health for the First Time — at the Moment It Matters Most

We are covering GuideAI Health CBOE:GDAI for the first time, and the timing is not incidental. In June 2026, the U.S. Food and Drug Administration granted GuideAI Health 510(k) clearance for VascularAssist Occlusion Triage (VAOT), the company’s AI software that reviews routine CT scans of the lower legs and is designed to flag signs of blocked or narrowed arteries aimed at moving the most urgent cases to the front of the radiologist’s queue for review.¹

In clinical performance testing, VAOT correctly flagged up to 95% of patients with significant peripheral arterial disease (95% on 2D analysis, 94% on 3D), where “significant” means at least one artery narrowed by 50% or more.2 The software runs inside the imaging systems hospitals already use, so radiologists do not need to change their tools or workflow to adopt it. It supports the radiologist’s read — it does not replace it.

The company is also already public. GuideAI trades as CBOE:GDAI, following the filing of its Final Prospectus on June 12, 2026.3 This is not a story asking investors to take a private company on faith — it is one they can buy shares in today.

There Is Already a Proof of Concept. It Is Worth $176 Million a Year.

At TheMarketsToday, we have spent considerable time covering the AI diagnostics space — a sector full of bold claims, compelling technology, and, far too often, an absence of real-world validation. That is what makes HeartFlow Inc unusual. It is the rare company that has not only made the case for AI-powered vascular imaging in theory, but has built an actual, reimbursed, scaled clinical business on the back of it.

Founded in 2010 by a Stanford bioengineering professor, and a Stanford vascular surgeon,4 HeartFlow Inc spent years developing and clinically validating a platform that applies artificial intelligence to coronary CT angiography scans — turning existing imaging data into a detailed 3D model of the heart that reveals blood flow dynamics previously only measurable through invasive catheterisation. By 2014 it had FDA clearance.5 By 2017, the UK’s NICE recommended its adoption.6 Today, as a publicly listed company on the Nasdaq (ticker: HTFL),7 HeartFlow generated $176 million in revenue in FY2025 — a 40% year-on-year increase — and is guiding to $246–$250 million for FY2026.8 It has treated over 600,000 patients across more than 1,800 institutions worldwide.9

We reference HeartFlow Inc not to write its story — that story is already well told — but because it provides something extremely rare in the medtech AI space: a real life example of the model working. AI applied to vascular imaging, sold into hospitals, generating reimbursable clinical value at scale. The question we have been asking ourselves at TheMarketsToday is simple: where is the company applying the same playbook to the next large, underserved vascular disease population?

We believe the answer is GuideAI Health — and the disease it is targeting may carry an even larger unmet clinical need than the one HeartFlow addressed.

HeartFlow Solved Coronary Disease. We Don’t Know Anyone that has Solved the Periphery Yet.

HeartFlow’s focus is the coronary arteries — the vessels that supply blood to the heart muscle itself. Coronary artery disease is the world’s leading cause of death,10 and HeartFlow’s technology addresses the challenge of determining, non-invasively, whether a blockage is actually restricting blood flow in a clinically meaningful way. It is a powerful, specific, and now well-validated use case.11

But there is a parallel vascular crisis unfolding in a completely different part of the body — one that receives a fraction of the clinical attention, almost none of the dedicated AI investment, and affects an estimated 230 million people worldwide.12 It is called Peripheral Arterial Disease, or PAD — and it is, in the most literal sense, the disease hiding in plain sight.

Peripheral arterial disease describes the narrowing and hardening of arteries outside the heart and brain — most commonly in the legs and lower extremities. Like coronary disease, it progresses silently. Like coronary disease, it is driven by diabetes, hypertension, obesity, smoking, and aging.13 And like coronary disease before HeartFlow, it is routinely caught too late — at the point where intervention has shifted from preventive to reactive, where limbs are already at risk, where the chance to change the trajectory of the disease has already passed.14

The consequences are severe. Undetected and untreated PAD leads to critical limb ischemia, chronic wounds, non-healing ulcers, and amputation.15 It dramatically elevates the risk of heart attack and stroke.16 It is also expensive at a system level: PAD carries an estimated $233 billion annual healthcare cost burden in the United States alone, with roughly 75% of that spend concentrated in late-stage hospitalizations — the very events earlier detection is designed to avoid.17 Independent analysis reviewed by GuideAI Health CBOE:GDAI indicates that early PAD identification can reduce long-term healthcare costs by up to $25,000 per patient.18 Multiply that across a 230-million-person patient population, and the economic case for getting this right becomes staggering.

THE COMPANY

GuideAI Health: Built by the Clinicians Who Saw What Was Being Missed

What gives us confidence in GuideAI Health’s approach begins, as it does with HeartFlow, with how the company was founded. GuideAI Health CBOE:GDAI was not created by technologists looking for healthcare applications for AI. It was created by interventional radiologists — clinicians who spent years in the room, reviewing imaging, and repeatedly seeing early signs of PAD that were present in scans but going unidentified in the context of busy, high-volume clinical practice.

Co-founders Dr. Raj Shah and Dr. Luke Higgins identified a recurring pattern: the markers of early PAD were distributed subtly across complex vascular anatomy, variable in presentation, and consistently overlooked — not because radiologists lack skill, but because the human visual system, under time pressure, was not optimised to find signals that AI, trained on thousands of cases, could learn to detect reliably. They brought in Dr. Amin Katouzian to build the AI infrastructure and navigate the regulatory pathway.

Since founding, the leadership bench has deepened considerably. Paul More has joined as Chief Financial Officer and Tasheel Jeerh as President, alongside a board of clinical and strategic advisors that includes Dr. James Benenati (interventional radiology; Chief Medical Officer, Penumbra), and Gail Marcus (Natera, Cigna) — a leadership bench whose clinical depth and operating experience is, in our view, one of the most important differentiators GuideAI Health has.

THE TECHNOLOGY

VascularAssist™: Finding What Others Miss, Before It Becomes Irreversible

The core of GuideAI Health CBOE:GDAI platform is VascularAssist™ — an AI-powered image activation system designed specifically to detect and characterise early PAD in standard clinical imaging. Like HeartFlow’s platform, it requires no new imaging hardware, no additional scan protocols, and no disruption to established workflows. It works with the data already being collected — and delivers structured, actionable outputs that radiologists and referring clinicians can use immediately.

The AI models underlying VascularAssist™ are trained through GuideAI’s partnership with vRad — exclusive access to more than 1 billion medical images from 2,100+ hospitals, one of the largest training datasets in peripheral vascular AI.19 The system is designed to mimic the diagnostic approach of expert radiologists — not replace it — acting as a force multiplier that allows clinicians to maintain diagnostic quality even as imaging volumes continue to grow and workforce pressures intensify.

The first product built on this platform, VascularAssist Occlusion Triage (VAOT), received FDA 510(k) clearance in June 2026 and is now commercially available in the United States — turning a research platform into a marketed clinical product.

THE COMPARISON

Two Platforms. Same Thesis. Different Battlegrounds.

When we map GuideAI Health CBOE:GDAI directly against HeartFlow, what emerges is a picture of striking philosophical alignment combined with completely distinct clinical territory. These companies are not necessarily competitors. They are parallel expressions of the same idea — applied to different anatomical regions, different patient populations, and very different stages of corporate and market development.

Category GuideAI Health HeartFlow
Focus Peripheral arterial disease — arteries of the limbs and extremities outside the heart Coronary artery disease — the heart's blood supply and flow dynamics
Core Product VascularAssist™ / VAOT — AI image analysis on existing CT scans; structured PAD-detection reports HeartFlow One — 3D coronary model from CCTA; FFR-CT, plaque characterization
Company Stage FDA-cleared (VAOT, June 2026); publicly listed (CBOE: GDAI); 200+ hospital LOIs; pre-revenue Public (Nasdaq: HTFL); $176M revenue FY2025; 1,800+ institutions globally
Reimbursement First FDA clearance obtained; reimbursement strategy in development Category I CPT code secured for FFR-CT; ~99.5% of US lives covered
Clinical Evidence 95% patient-level sensitivity (VAOT); active hospital pilots; academic validation partnerships 600+ peer-reviewed publications; multiple completed RCTs
Disease Population ~230M people globally with PAD; majority undiagnosed until late-stage ~200M people globally with coronary artery disease
Employees20 Not publicly disclosed; third-party estimate ~6 (likely undercounted) 843 (as of Jul 27, 2026)
Market Cap ~US$38M (~CA$53M) as of Jul 29, 2026d) ~$2.19B (as of Jul 27, 2026)
Revenue $0 — pre-revenue $176M FY2025; $191.4M trailing twelve months
Years Operating 2–4 yrs (2022–23 per company's own founding story; 2024 per corporate registry) 16 years (founded 2010)

The table above illustrates both the gap in maturity and the size of the opportunity. HeartFlow’s achievements in reimbursement, clinical evidence, and commercial scale reflect a 15-year journey. GuideAI Health is very early in that journey — but with one critical advantage HeartFlow did not have when it started: the roadmap already exists, and GuideAI has now converted its first milestone on that roadmap into an actual FDA clearance.

Other AI Imaging Companies We Know of are Focussed on a Different Anatomy

Coronary AI has multiple entrants. Stroke AI has multiple entrants. Acute radiology triage has multiple entrants. Peripheral arterial disease — a 230-million-patient population — currently has – as far as we know – one dedicated public company AI platform.

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

Rather than competing in an established category, GuideAI is helping create one.21

What the Numbers Tell Us About Where AI Vascular Diagnostics Can Go

We think it is worth dwelling for a moment on what HeartFlow’s financial trajectory actually represents — because it is one of the most instructive data points available to anyone evaluating GuideAI Health CBOE:GDAI.

HeartFlow’s growth from early commercial stage to $176 million in annual revenue did not happen overnight. It required among many other steps, FDA clearance, Category I reimbursement codes, the completion of multiple randomised controlled trials, and the gradual accumulation of 600+ peer-reviewed publications. It required building trust with cardiologists, hospital procurement departments, and insurance payers, one account at a time. What it ultimately proved — and this is the critical point — is that AI-powered vascular imaging is not a theoretical clinical benefit. It is a product that hospitals will pay for, that insurers will reimburse, and that generates measurable improvements in patient outcomes.

$936 million in total funding raised.22 A gross margin approaching 80%. A 40% year-on-year revenue growth rate. 340 new institutional accounts added in a single year — described by the company as the strongest new account growth in its history.23 There are obviously substantial differences in the stage of development and maturity of these two companies, and GuideAI would have to achieve a number of significant milestones to follow the same path as HeartFlow — but HeartFlow targeted a disease population of roughly 200 million people, and GuideAI Health is targeting one of 230 million, in a market where the competitive landscape for dedicated peripheral vascular AI is essentially empty.

HeartFlow's climb to $176 million in revenue is reflected today in a market capitalization of roughly $4.25 billion (as of August 26, 2026). GuideAI, still pre-revenue, and with many milestones yet to achieve, but now FDA-cleared and publicly listed, carries a market capitalization of roughly $38 million $38 million (as of July 29, 2026) — pricing in only a small fraction of the trajectory HeartFlow has already proven achievable. That valuation gap — not just the strategic similarity — is where we think the opportunity sits.

Ready to take a closer look at GuideAI Health?
GDAI trades on the CBOE. Contact your broker or financial advisor to learn more about the company.

200+ Hospital LOIs, a Named Health System Partner, and a Business Model That Compounds

GuideAI has assembled more than 200 global hospital letters of intent ahead of its first signed contract. Advocate Health — a 69-hospital system serving 6 million patients annually — has signed a letter of intent and is now conducting a feasibility assessment for clinical integration. Pilots are underway at Boone Heart Institute and Loma Linda University, alongside validation studies at academic medical centers.24

Access the Investor Briefing
Learn how GuideAI is bringing AI-powered early detection to a $200B+ PAD market.
WHY NOW

The Structural Forces That Make This the Right Moment

Beyond the clinical and competitive logic, we see several structural tailwinds that make the current moment particularly favourable for a company like GuideAI Health CBOE:GDAI.

The diabetes epidemic is expanding the patient pool relentlessly. Diabetes is one of the most powerful risk factors for PAD, damaging blood vessels through chronic inflammation and accelerating the atherosclerotic process. The International Diabetes Federation projects global diabetes prevalence to reach 853 million adults by 2050.25 Every new diagnosis represents a patient whose vascular health should be monitored — and who, without early detection tools, is likely to arrive at a clinician’s door only when the disease has already progressed.

The AI in medical imaging market is growing at a rate that surprises even optimistic forecasters. Valued at approximately $2.2 billion globally in 2026, this market is forecast to reach $17.8 billion by 2033 — a compound annual growth rate of 34.8%.26 Healthcare systems that were cautious about AI adoption five years ago are now actively seeking platforms that improve diagnostic accuracy, reduce reporting variability, and help manage the growing radiologist workforce shortage.27

The value-based care transition is creating powerful financial incentives for prevention. As hospitals and health systems are increasingly reimbursed based on outcomes rather than procedure volumes, a platform that prevents amputations, reduces cardiovascular events, and eliminates unnecessary downstream testing is not just a clinical good — it is a financial imperative.

The reimbursement pathway has been charted. HeartFlow’s journey to Category I CPT reimbursement — one of the hardest milestones in US medtech commercialisation — proved that AI vascular imaging tools can navigate this process successfully. The FDA has now approved over 500 AI-enabled medical devices, the majority imaging-focused28 including GuideAI’s VAOT to market.

THE PLATFORM VISION

VascularAssist Gets GuideAI Into the Room. Elevate Becomes the Infrastructure.

The HeartFlow comparison is the right frame for understanding what GuideAI Health CBOE:GDAI is doing today. But the more instructive lesson from HeartFlow’s trajectory is not the imaging algorithm itself — it is what came after it.

HeartFlow did not build a $176 million business by selling a better scan analysis. It built that business by becoming workflow infrastructure — embedded in how cardiologists make decisions, how hospitals bill for diagnostic workups, and how longitudinal cardiovascular care is structured. The imaging model was the entry point. The platform was the moat.

GuideAI Health is building toward the same architecture. VascularAssist™ is the first product and the clinical entry point — now FDA-cleared and ready to generate the institutional relationships and longitudinal patient data that become increasingly valuable over time. Elevate is the platform that is designed to sit above it: a clinical intelligence layer designed to evolve from single-study imaging analysis into longitudinal disease tracking, physician-centred decision support, referral coordination, and structured care pathways for chronic vascular disease management.

GuideAI has now put dates on that ambition. The company is targeting a launch of the Elevate platform at RSNA 2026, and has a second product, CarotidAssist™, on track for application to obtain FDA 510(k) clearance as early as Q1 2027 — a second disease area, and a second revenue layer, on the same infrastructure. An international pilot in India, also targeted for Q1 2027, would mark the company’s first step outside the U.S. market. By the company’s own account, four catalysts move this story next: the VAOT clearance already obtained, the first signed hospital contract, CarotidAssist clearance, and the India pilot.29

The right frame for GuideAI Health today is still the one we have outlined in this report: VascularAssist™ is the HeartFlow of PAD. That comparison is clean, credible, and — as of June 2026 — backed by an actual FDA clearance rather than just a roadmap. What Elevate represents is the potential next chapter: the platform that transforms a strong imaging AI product into a defensible, compounding healthcare business.

OUR ASSESSMENT

The Blueprint Exists. The Clearance Is In Hand. The Stock Now Trades.

We have covered a lot of healthcare AI companies at TheMarketsToday. Many have compelling technology. Fewer have compelling technology applied to a clearly defined clinical need, backed by an actual regulatory clearance. Fewer still have a directly comparable proof point in an adjacent market that confirms the model can work at scale.

GuideAI Health CBOE:GDAI has all three, plus something few pre-revenue medtech companies can claim this early: a green light from the FDA. The clinical need — PAD affecting 230 million people, routinely diagnosed too late — is as clearly documented as any we have seen. The technology VascularAssist™ and its first cleared product, VAOT, validated with 95% patient-level sensitivity is designed specifically for this problem.

The commercial foundation, an exclusive dataset of 1 billion+ images via vRad, and a named health system partner in Advocate Health — is a real pipeline, not a slide. And the proof of concept — HeartFlow’s $176 million business, now valued at roughly $3.02 billion, built on the same fundamental thesis in the coronary space — is as direct a validation of the commercial model as we could ask for.

What GuideAI Health is building is not a replication of HeartFlow. The anatomy is different, the clinical workflows are different, the patient population is different. But the core proposition — that AI can find the signal in existing imaging data that human review misses, earlier in the disease process, in ways that fundamentally change outcomes and reduce systemic healthcare costs — is identical. And that proposition, HeartFlow has now proven beyond reasonable doubt, is one the market will pay for.

For hospital systems evaluating their next generation of AI diagnostic tools, for clinical partners looking to reduce the burden of late-stage vascular disease, and for investors who followed the HeartFlow story and wished they had gotten in earlier — GuideAI Health, now trading as CBOE: GDAI, deserves a very close look.

Ready to take a closer look at GuideAI Health?
GDAI trades on the CBOE. Contact your broker or financial advisor to learn more about the company.
Access the Investor Briefing
Learn how GuideAI is bringing AI-powered early detection to a $200B+ PAD market.

IMPORTANT DISCLAIMER

This is a paid promotion prepared on behalf of GuideAI Health Corp. The Markets Today and its affiliates have been compensated for the creation and distribution of this content and may hold a position in the securities discussed. This content is for informational and promotional purposes only and does not constitute investment advice, a recommendation, or a solicitation to buy or sell any security. Forward-looking statements, including revenue projections and roadmap timelines, are subject to risks and uncertainties and may not be achieved. Past performance, including that of HeartFlow, Inc., is not indicative of future results for GuideAI Health Corp. Market and company data are sourced from public filings and third-party research and are subject to revision. Always consult a licensed financial advisor and conduct independent due diligence, including a review of GuideAI Health Corp.’s Final Prospectus filed on SEDAR+, before making any investment decision.

This content contains forward-looking statements and forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking statements are statements that are not purely historical and include statements regarding expectations, beliefs, estimates, plans, intentions, opportunities, projections, targets, objectives, assumptions, future events or future performance. Forward-looking statements are often, but not always, identified by words and phrases such as “may”, “will”, “would”, “could”, “should”, “expect”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “forecast”, “target”, “project”, “potential”, “designed to”, “aimed at”, “seeking”, “on track”, “roadmap”, “opportunity”, “pipeline”, “catalyst”, “next chapter”, “path”, “trajectory”, “thesis”, “can”, “becomes”, “will pay for”, “deserves”, “we believe” and similar expressions.

Without limiting the generality of the foregoing, the forward-looking statements in this content include statements and implications concerning: (i) GuideAI Health’s potential transformative impact in healthcare AI, its ability to prove or capture an underserved market, and the timing or significance of FDA clearance and public listing milestones; (ii) the potential ability of VascularAssist Occlusion Triage, VascularAssist or related technology to flag signs of blocked or narrowed arteries, prioritize urgent cases, support radiologists, fit within existing hospital imaging systems and workflows, improve diagnostic quality, function as a force multiplier, or identify what may otherwise be missed; (iii) the possible clinical utility, scalability, commercial value or market acceptance of AI-enabled peripheral vascular imaging tools; (iv) the size, characteristics and commercial significance of the PAD population, including statements regarding unmet clinical need, underdiagnosis, disease progression, healthcare cost burden, potential cost savings from early identification, and the possibility that early detection could reduce amputations, cardiovascular events, downstream testing, hospitalizations or other healthcare costs; (v) the assertion or implication that the HeartFlow business model, commercial path, reimbursement journey, market response, valuation or revenue trajectory provides a roadmap, proof of concept or validation for GuideAI Health; (vi) statements comparing GuideAI Health to HeartFlow or other companies, including statements that GuideAI Health may be applying a similar playbook, may have an analogous opportunity in a different clinical territory, may be early in a comparable journey, or may benefit from a valuation gap or strategic similarity; (vii) statements that the competitive landscape for dedicated peripheral vascular AI is limited, empty or favourable, or that GuideAI Health is a first mover, category creator or uniquely positioned public company platform in PAD-focused AI imaging; (viii) statements regarding hospital letters of intent, Advocate Health, feasibility assessments, pilots, validation studies, academic partnerships and the possibility that any such relationships, studies, assessments, pilots or letters of intent may result in definitive agreements, clinical integration, revenue, reimbursement, commercial scale, patient data, institutional relationships or broader market adoption; (ix) statements regarding structural tailwinds, including diabetes prevalence trends, growth in AI medical imaging markets, radiologist workforce pressures, value-based care incentives, healthcare procurement trends, payer behaviour, hospital demand and the potential effect of those trends on GuideAI Health’s business; (x) statements that reimbursement pathways have been charted, that AI vascular imaging tools can navigate reimbursement processes, or that GuideAI Health may obtain reimbursement, coding, payer coverage or commercial acceptance; (xi) statements regarding the Elevate platform, including its expected functions, ability to evolve from single-study imaging analysis into longitudinal disease tracking, clinical intelligence, physician-centred decision support, referral coordination, structured care pathways or workflow infrastructure, and its potential to become a moat, platform, defensible business or compounding healthcare business; (xii) statements regarding anticipated future milestones, catalysts and timelines, including any targeted launch of Elevate at RSNA 2026, any application for or receipt of FDA 510(k) clearance for CarotidAssist as early as Q1 2027, any international pilot in India targeted for Q1 2027, any first signed hospital contract, any second disease area or revenue layer, and any other product, market, partnership, regulatory or commercialization milestone; (xiii) statements regarding GuideAI Health’s business model, product roadmap, revenue potential, market capitalization, valuation opportunity, investor interest, trading opportunity, prospective return profile or reasons investors may wish to evaluate or purchase its securities; and (xiv) any other statements regarding future clinical, regulatory, operational, commercial, financial, market, partnership, technological or investor-related outcomes.

The forward-looking statements in this content are based on assumptions believed to be reasonable as of the date of publication, including assumptions regarding the accuracy and completeness of public filings, company materials and third-party information; the continued availability and usefulness of datasets, hospital relationships, clinical advisors, management, collaborators, vendors and research partners; the clinical performance, safety, reliability, interoperability and scalability of GuideAI Health’s technology; hospital, radiologist, physician, patient, payer and regulator acceptance of AI-enabled imaging solutions; the ability to obtain, maintain, expand and commercialize regulatory clearances; the ability to convert letters of intent, pilot programs, feasibility assessments and validation studies into definitive commercial relationships; the availability of reimbursement, coding, payer coverage and procurement support; the continued growth of relevant healthcare and AI-imaging markets; the continued relevance of PAD as a clinical and economic burden; the availability of capital on acceptable terms; the absence of material adverse changes in law, regulation, competition, technology, public markets, healthcare policy, reimbursement policy, cybersecurity, privacy or data access; and the continued execution of GuideAI Health’s business plan. These assumptions may prove incorrect.

Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results, performance, achievements or developments to differ materially from those expressed or implied by such statements. These risks include, without limitation: risks related to GuideAI Health’s early stage of development, limited operating history and pre-revenue status; the risk that FDA 510(k) clearance for VAOT does not result in revenue, reimbursement, hospital adoption, clinical use, commercial scale, investor returns or clearance of future products; the risk that clinical performance data, validation studies or pilot results may not be replicated, expanded, accepted by clinicians or payers, or sufficient for commercial adoption; the risk that letters of intent, feasibility assessments, pilots, academic collaborations, hospital relationships or strategic partnerships may be non-binding, delayed, terminated, narrowed or never converted into definitive contracts or revenue; the risk that Advocate Health, Boone Heart Institute, Loma Linda University or other named or unnamed counterparties may not proceed beyond exploratory, pilot, feasibility, validation or limited-scope arrangements; regulatory risks, including delays, denials, limitations, withdrawals or failures in obtaining, maintaining or expanding FDA, Health Canada or other regulatory clearances; risks relating to claims about clinical utility, workflow integration, prioritization of urgent cases, diagnostic support, early detection, cost savings and prevention of downstream adverse outcomes; reimbursement, coding, payer acceptance, procurement and billing risks; risks related to product performance, false positives, false negatives, bias, limitation of training data, interoperability, cybersecurity, privacy, medical data access and healthcare information systems; medical device liability, patient safety, professional liability and product liability risks; dependence on key personnel, clinical advisors, technology providers, data providers, hospitals, vendors and collaborators; risks relating to intellectual property, trade secrets, licensing, data rights and exclusivity; competition from existing and future medical imaging, radiology, vascular, cardiovascular, hospital workflow and healthcare AI companies, including better-capitalized or more established competitors; risks that market size, disease prevalence, healthcare cost, cost-saving and market-growth estimates are overstated, outdated, not independently verified or not applicable to GuideAI Health’s products; risks inherent in comparing GuideAI Health to HeartFlow or any other more mature company; risks related to public market volatility, valuation, trading liquidity, analyst or investor interest, financing needs, dilution and capital availability; risks related to operating in Canada, the United States, India or other jurisdictions; risks related to economic conditions, healthcare budgets, hospital procurement cycles, inflation, interest rates and general capital market conditions; and the other risks described in GuideAI Health’s public disclosure record, including its Final Prospectus filed on SEDAR+.

Forward-looking statements should not be read as guarantees of future performance. Actual outcomes could differ materially, and no representation or assurance is made that GuideAI Health will achieve any regulatory clearance, clinical result, product launch, hospital contract, revenue, reimbursement status, payer coverage, market share, valuation, market capitalization, commercial scale, patient outcome, healthcare cost saving, international expansion, investor return or other milestone described or implied in this content. Past performance of GuideAI Health, HeartFlow or any other company is not indicative of future results. The fact that another company has achieved FDA clearance, reimbursement, revenue, market capitalization, institutional adoption or clinical validation does not mean GuideAI Health will achieve comparable results. Readers should not place undue reliance on forward-looking statements.

Market, clinical, medical, financial and third-party data referenced in this content are derived from public filings, company materials, third-party research, websites and other sources believed to be relevant, but they may be incomplete, unaudited, outdated, subject to revision, based on assumptions, not independently verified, or not prepared in accordance with standards applicable to securities disclosure. This content does not constitute medical advice, investment advice, an offer to sell or a solicitation of an offer to buy any security. Readers should conduct their own independent due diligence, including reviewing GuideAI Health’s public disclosure on SEDAR+, and should consult their own legal, financial, tax, medical and other professional advisors before making any investment or other decision. Except as required by applicable law, no obligation is undertaken to update or revise any forward-looking statement after the date of publication, whether as a result of new information, future events or otherwise.

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1 GuideAI Health Corp. — Investors page, “FDA Clears GuideAI’s AI Software for Vascular Disease” (VAOT 510(k) clearance, June 2026; clinical sensitivity data, 95% 2D / 94% 3D). guideaihealth.com/investors
2 GuideAI Health Corp. — Investors page (same source as note 1) — clinical sensitivity data, 95% 2D / 94% 3D. guideaihealth.com/investors
3 GuideAI Health Corp., Final Prospectus, June 12, 2026, SEDAR+. sedarplus.ca
4 HeartFlow, Inc. — “Our Story”: company founded 2010 by Charles Taylor (Stanford bioengineering professor) and Christopher Zarins (Stanford vascular surgeon). heartflow.com/our-story/
5 HeartFlow, Inc., press release, “Heartflow Secures De Novo Clearance from the U.S. Food and Drug Administration for Breakthrough FFRCT Technology,” November 26, 2014. heartflow.com/newsroom
6 National Institute for Health and Care Excellence (NICE), Medical Technologies Guidance MTG32, February 13, 2017. nice.org.uk/guidance/mtg32
7 HeartFlow, Inc., Form 424B4 and Nasdaq IPO overview; began trading August 8, 2025 under ticker HTFL. sec.gov; nasdaq.com
8 HeartFlow, Inc., “Heartflow Reports Fourth Quarter and Full Year 2025 Financial Results,” March 18, 2026 — revenue $176.0M (+40% YoY); FY2026 guidance $218–$222M; 76.8% gross margin; 340 new accounts. ir.heartflow.com. Guidance was subsequently raised to $246–$250 in HeartFlow’s May 14, 2026 – August 13, 2026 Q2 2026 report (sec.gov).
9 HeartFlow, Inc. — About page: 600,000+ patients treated, 1,800+ institutions. heartflow.com/about/
10 World Health Organization, “Cardiovascular Diseases (CVDs)” fact sheet — coronary artery disease as the world’s leading cause of death. who.int
11 HeartFlow, Inc., “Clinical Evidence” — PRECISE trial (2,103 patients, RCT): the CCTA + FFRCT pathway identified 78% more patients with disease and reduced negative diagnostic-only catheterizations by 69% vs. standard care; FFRCT achieved a 0.90 AUC per-patient vs. 0.81 for CCTA alone; backed by 625+ peer-reviewed publications. heartflow.com/ccta-advantage/clinical-evidence/
12 American Heart Association — global PAD prevalence estimates (~230 million) (same underlying source family as note 10). heart.org
13 National Center for Biotechnology Information (NCBI Bookshelf), StatPearls — “Peripheral Arterial Disease”: definition and risk factors (diabetes, hypertension, obesity, smoking, aging). ncbi.nlm.nih.gov
14 Mizrahi et al., “Perspectives on Lower Extremity Peripheral Artery Disease: A Qualitative Study of Early Diagnosis and Treatment and the Impact of Health Disparities” — 64% of patients diagnosed with lower-extremity PAD ulceration had no prior PAD diagnosis. National Library of Medicine (PMC). ncbi.nlm.nih.gov/pmc/articles/PMC10698760/
15 American Heart Association / UC Davis Health Vascular Center — PAD complications: critical limb ischemia, non-healing ulcers, gangrene, and amputation. heart.org
16 American Heart Association, “Understand Your Risk for Peripheral Artery Disease” — PAD increases the risk of coronary artery disease, heart attack, stroke, and death. heart.org/en/health-topics/peripheral-artery-disease/understand-your-risk-for-pad
17 Society for Cardiovascular Angiography & Interventions (SCAI) — PAD annual U.S. healthcare cost burden ($233B+); ~75% of costs from hospitalizations. scai.org
18 GuideAI Health, “The Economic Case for Early Vascular Disease Detection,” February 2026 — up to $25,000 per patient in avoided long-term costs. guideaihealth.com
19 GuideAI Health — VAOT clinical performance data and vRad data partnership (1B+ images, 2,100+ hospitals). guideaihealth.com
20 Employees, market cap, revenue and years-of-operation data: GuideAI Health Corp. — Simply Wall St company profile and GlobeNewswire listing announcement, current as of July 29, 2026; HeartFlow, Inc. — StockAnalysis.com company statistics (S&P Global Market Intelligence data), current as of July 27, 2026. simplywall.st; globenewswire.com; stockanalysis.com
21 GuideAI Health Investor Presentation, July 2026 — hospital LOIs, Advocate Health LOI, competitive landscape, business model, roadmap, and near-term catalysts. guideaihealth.com/investors
22 Tracxn / public records — HeartFlow total funding of $936M across 13 rounds.
23 HeartFlow, Inc., “Heartflow Reports Fourth Quarter and Full Year 2025 Financial Results” (same source as note 8) — 340 new accounts described as strongest new account growth in company history. ir.heartflow.com
24 GuideAI Health Investor Presentation, July 2026 (same source as note 21) — hospital LOIs, Advocate Health LOI, academic validation studies. guideaihealth.com/investors
25 International Diabetes Federation, IDF Diabetes Atlas — 853 million adults with diabetes projected by 2050. diabetesatlas.org
26 Coherent Market Insights, “AI in Medical Imaging Market Share & Opportunities 2026–2033” — $2.2B in 2026 to $17.8B by 2033 at 34.8% CAGR. coherentmarketinsights.com
27 American College of Radiology / Harvey L. Neiman Health Policy Institute, “The Radiologist Shortage: A Workforce Update from HPI,” ACR Bulletin, 2026. acr.org/Clinical-Resources/Publications-and-Research/ACR-Bulletin/2026/radiologist-shortage-work-force-update
28 NEJM AI — 500+ FDA-cleared AI-enabled medical devices. ai.nejm.org
29 GuideAI Health Investor Presentation, July 2026 (same source as note 21) — four forward-looking catalysts including the India pilot. guideaihealth.com/investors