Press Release

16 Million People, One Underserved Disease: The AI Imaging Push to Close the Congenital Heart Gap

Issued on behalf of Ventripoint Diagnostics Ltd.

As the number of people living with congenital heart disease climbs and most patients in poorer regions go without timely care, a Toronto-based AI imaging company is joining a new global alliance built to close that gap.

TORONTO, ON, June 16, 2026 /PRNewswire/ — Equity Insider News Commentary — Congenital heart disease is the most common birth defect in the world, and the population living with it is growing, not shrinking. According to the World Heart Federation’s World Heart Report 2026, congenital heart disease now affects roughly 2% of live births globally, and the number of people living with the condition has climbed to an estimated 16 million worldwide — up from 11.8 million three decades ago. Yet the same report found that more than 90% of children in lower- and middle-income countries lack timely access to congenital heart disease care. It is a paradox at the heart of modern medicine: better treatment is keeping more patients alive and aging into adulthood, even as access to the diagnostics and monitoring they need remains deeply unequal.

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Companies mentioned: Ventripoint Diagnostics Ltd. (TSXV: VPT) (OTCQB: VPTDF), HeartFlow, Inc. (Nasdaq: HTFL), Butterfly Network, Inc. (NYSE: BFLY), Tempus AI, Inc. (Nasdaq: TEM), iRhythm Technologies, Inc. (Nasdaq: IRTC)

Into that gap steps a coordinated industry response — and a company positioning its technology at the center of it. On June 15, 2026, Ventripoint Diagnostics Ltd. (TSXV: VPT) (OTCQB: VPTDF), a pioneer in advanced AI-assisted cardiac imaging, announced its support for the newly forming Global Congenital Heart Disease Alliance (GCHDA), an industry alliance dedicated to accelerating the development, commercialization, and global adoption of congenital cardiovascular technologies. As part of its initial efforts, the alliance said it would help fund and place four of Ventripoint’s VMS+â„¢ cardiac imaging units to directly support the congenital heart disease community and expand access to advanced diagnostic care.

Why Congenital Heart Disease Is a Uniquely Hard Problem

Congenital heart disease is not a single condition but a broad family of structural heart defects present from birth, ranging from minor to life-threatening. What makes it uniquely challenging from a diagnostic standpoint is twofold. First, it is a lifelong condition: thanks to decades of surgical and medical advances, the vast majority of children born with congenital heart defects now survive into adulthood, creating a large and growing population that requires structured, individualized follow-up for the rest of their lives. Second, the anatomy is often complex and irregular — hearts that have been surgically reconstructed or that developed abnormally do not conform to the neat geometric assumptions built into many conventional imaging tools, making accurate measurement genuinely difficult.

That combination — a lifelong need for precise, repeated monitoring against anatomy that resists easy measurement — is exactly where imaging technology matters most. The European Society of Cardiology’s guidelines for adult congenital heart disease identify the condition as a chronic illness requiring lifelong individualized follow-up, and affirm echocardiography as the key modality for longitudinal assessment of heart function. The problem is that the gold standard for the most accurate measurements, cardiac MRI, is expensive, slow, and scarce — especially in the underserved regions where the access gap is widest. The field has long needed a way to get high-accuracy cardiac measurement to the point of care, without an MRI suite.

Ventripoint’s Approach: MRI-Level Accuracy From a Standard Echo

Ventripoint’s flagship platform, VMS+â„¢, is built squarely around that need. The technology uses artificial intelligence to transform standard 2D echocardiograms — among the most widely available imaging exams in the world — into highly accurate 3D models of all four chambers of the heart, delivering what the company describes as cardiac-MRI-level measurement accuracy at the point of care. For congenital heart patients, whose complex anatomy often defeats traditional imaging, that capability is especially relevant. The platform is powered by Ventripoint’s proprietary Knowledge-Based Reconstruction technology, the product of roughly a decade of development, and is designed to run on existing ultrasound systems from any vendor — meaning hospitals and clinics can expand advanced cardiac imaging without buying new scanners.

Crucially for a company addressing a global access gap, VMS+â„¢ carries regulatory clearances in the United States, Europe, and Canada, and beyond congenital heart disease it supports applications including pulmonary hypertension and cardiotoxicity monitoring in oncology patients. The technology has been recognized with a Gold Medal at the 2026 Edison Awards in the Precision Health Technologies category, and has been implemented or evaluated at leading institutions including the Peter Munk Cardiac Centre in Toronto and in clinical studies at the Mayo Clinic. “Congenital heart disease affects patients across every stage of life, from infancy through adulthood,” said Joe Hostetter, Director of the CHD Program at Ventripoint, framing accurate, accessible imaging as a necessary part of closing the global care gap.

What the GCHDA Membership Signals

The alliance itself is a notable development for a field that has historically been fragmented. The GCHDA describes itself as a hybrid industry association and innovation consortium, bringing together industry partners, clinicians, researchers, regulators, investors, and patient communities to accelerate congenital cardiovascular technologies through membership and advocacy programs, multi-center research collaboration, and a convening platform of summits and innovation showcases. “We exist to bring focused attention and determined project execution to the congenital heart disease community,” said Julia Friesen, Executive Director of the alliance, noting that its initial efforts include funding and placing four VMS+ units to expand access to advanced diagnostic care.

For Ventripoint, the value is twofold: a direct commercial signal in the planned placement of four units, and a strategic position inside a consortium that could shape how congenital cardiovascular technologies are researched, validated, and adopted worldwide. The company plans to participate in the alliance’s programming, including its annual summit and innovation showcases. It is the kind of ecosystem play that, if the alliance gains traction, could give a small-cap imaging company outsized visibility among the clinicians and institutions that drive adoption — though, as with any newly forming organization, the alliance’s ultimate impact remains to be proven.

A Booming Market for Smarter Cardiac Imaging

Ventripoint is operating in one of the fastest-growing corners of medical technology. The market for artificial intelligence in cardiology has been projected to grow from roughly US$2.78 billion in 2026 to as much as US$14.2 billion or more by the mid-2030s, reflecting compound annual growth rates north of 20%. Echocardiography — the single most widely used cardiac imaging modality in the world — is itself forecast to expand to around US$2.64 billion by 2030, and portable, point-of-care ultrasound is pushing cardiac assessment out of dedicated imaging labs and into clinics and remote settings. The through-line across all of these trends is a demand for technologies that deliver clinical accuracy and economic value at once. Looking at a few of the public companies attacking adjacent parts of this market helps frame both the opportunity and the competitive landscape.

HeartFlow, Inc. (Nasdaq: HTFL) is among the clearest public proxies for AI-driven cardiac imaging. The company’s technology uses AI to create personalized 3D models of a patient’s coronary arteries from standard CT scans to help diagnose and manage coronary artery disease non-invasively. Having gone public in 2025 and built a multibillion-dollar market capitalization, HeartFlow demonstrates the commercial scale that AI-based cardiac imaging can reach — and, like Ventripoint, it is built on the premise of replacing or deferring more invasive or expensive procedures with smarter software-driven imaging.

Butterfly Network, Inc. (NYSE: BFLY) maps most directly to Ventripoint’s point-of-care thesis. Butterfly makes a handheld, semiconductor-based ultrasound probe paired with AI software, pushing cardiac and other imaging out of the lab and into emergency, primary-care, and remote settings. As a company explicitly focused on democratizing access to ultrasound imaging, Butterfly illustrates the same core idea animating Ventripoint — bringing advanced imaging to wherever the patient is — albeit through hardware rather than vendor-agnostic software.

Tempus AI, Inc. (Nasdaq: TEM) represents the scaled, AI-driven diagnostics platform end of the market. While best known for precision oncology, Tempus has expanded into cardiology — including an FDA-authorized ECG algorithm that has drawn CMS reimbursement — and exemplifies how richly investors are valuing AI-enabled diagnostics with reimbursement pathways and large data ecosystems. It is far larger and broader than Ventripoint, but it underscores the market’s appetite for AI that turns routine tests into higher-value clinical insight.

iRhythm Technologies, Inc. (Nasdaq: IRTC) rounds out the group as an established success story in AI-driven cardiac diagnostics. Its Zio platform pairs wearable ECG monitors with AI analysis to detect arrhythmias, and the company has built a substantial commercial franchise around turning continuous cardiac data into actionable diagnoses. iRhythm shows that a focused, AI-centric cardiac diagnostics company can scale into a major player — a potential template for what a technology like VMS+™ might aspire to in its own niche. These companies are referenced to illustrate the sector and do not imply any partnership, endorsement, affiliation, or comparable financial performance; they differ widely in size, technology, and stage, and Ventripoint is among the smaller, earlier-stage names.

The Investment Lens: Promise and Caveats

The appeal of Ventripoint’s positioning is easy to see. It has a regulatory-cleared, vendor-agnostic technology that addresses a real and growing clinical need; recognition from clinicians and awards bodies; implementations at respected cardiac centers; and now a seat inside a global alliance with a concrete near-term order for four units. In a market racing toward AI-enabled, point-of-care cardiac imaging, those are meaningful assets, and the congenital heart disease angle gives the company both a humanitarian narrative and a defensible clinical niche where its accuracy advantage matters most.

The caveats are equally important. Ventripoint is a small-cap company in the capital-intensive, slow-moving world of medical technology, where adoption cycles are long, hospital procurement is deliberate, and revenue can take years to scale even for clinically validated products. The GCHDA is newly forming, and the placement of four units — while a positive signal — is modest in absolute terms; the alliance’s broader promise is, for now, potential rather than proven. The company competes, directly or indirectly, against far larger and better-funded players, and like most small-cap medtechs it faces ongoing financing needs and the risks that come with them. Investors should weigh the genuine clinical merit and strategic positioning against the realities of commercialization at small scale.

Why the Trajectory Still Matters

Step back, and the larger picture is compelling regardless of any single company’s fortunes. The global population living with congenital heart disease is growing, the need for lifelong monitoring is intensifying, the access gap in much of the world remains vast, and the technology to deliver accurate cardiac measurement at the point of care — without an MRI suite — is maturing rapidly. The formation of a dedicated global alliance to coordinate the field’s fragmented efforts is itself a sign that the problem is finally drawing focused, cross-sector attention. Ventripoint has placed itself, and its AI imaging platform, squarely inside that movement.

Whether the company can convert clinical validation, awards, and alliance membership into durable commercial scale is the question that will define its future, and the path for any small-cap medtech is rarely smooth. But the direction of the field is unmistakable: toward smarter, cheaper, more accessible cardiac imaging, and toward coordinated global efforts to bring it to the millions of congenital heart disease patients who currently go without. For investors tracking where AI meets the future of cardiac care, Ventripoint’s latest move is a small but telling marker of that broader shift.

CONTINUED … Learn more about Ventripoint Diagnostics Ltd. at: https://usanewsgroup.com/vpt-landing/

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SOURCES:

[1] Ventripoint Diagnostics Ltd. — “Ventripoint Diagnostics Announces Support for the Global Congenital Heart Disease Alliance” (TheNewswire, June 15, 2026; primary source for the GCHDA support, four VMS+ units, VMS+â„¢ description, WHF 2026 data, management quotes):
https://www.ventripoint.com/news

[2] World Heart Federation — World Heart Report 2026 (CHD ~2% of live births; ~16 million people living with CHD, up from 11.8 million; >90% of children in LMICs lack timely CHD care):
https://world-heart-federation.org/world-heart-report-2026/

[3] Investing News Network — “Cardiac AI Diagnostics Stack Validation Wins Across Regulatory and Commercial Fronts” (AI-in-cardiology market ~US$2.78B 2026 to ~US$14.22B; echocardiography ~US$2.64B by 2030; 2020 ESC ACHD guidelines; peer context):
https://investingnews.com/cardiac-ai-diagnostics-stack-validation-wins-across-regulatory-and-commercial-fronts/

[4] Ventripoint Diagnostics Ltd. / Providence Health Care Ventures — St. Paul’s Hospital VMS+â„¢ validation collaboration (FDA-cleared and Health Canada-licensed; runs on existing ultrasound; Peter Munk and Mayo Clinic implementations):
https://phcventures.ca/phc-ventures-ventripoint-ai-cardiac-imaging/

[5] HeartFlow, Inc. — Nasdaq listing and AI coronary imaging overview (peer context: HTFL, BFLY, TEM, IRTC public cardiac-imaging / cardiac-AI names):
https://www.nsf.gov/science-matters/heartflows-ai-powered-medical-technology-debuts-nasdaq

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