Heartflow (HTFL) announced that the randomized P4 trial met its primary endpoint, supporting CT-guided planning for percutaneous coronary intervention (PCI).The 1,105-patient trial found CT-guided planning non-inferior to intravascular ultrasound (IVUS), imaging performed inside blood vessels. Twelve-month target-vessel failure was 4.1% versus 4.6%. Median procedure time was 46 versus 63 minutes, and median contrast volume was 150 versus 170 mL. P4 used Heartflow FFRCT Analysis and Heartflow Planner, an earlier version of PCI Navigator.In the separate 203-patient NAVIGATE-PCI registry, physicians modified treatment plans in approximately 70% of patients after reviewing PCI Navigator, compared with angiography alone. Changes included stent length in 41% and lesion preparation technique in 12%. Physicians also reported higher confidence in Navigator-based plans.

Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.

Heartflow (Nasdaq: HTFL) reported second quarter 2026 revenue of $64.1 million, up 48% year-over-year, driven mainly by higher U.S. FFRCT and Plaque case volumes. U.S. revenue rose to $59.6 million (+51%), while international revenue reached $4.5 million (+12%). GAAP gross margin expanded to 83.0% from 75.5%, with non-GAAP gross margin at 83.3%. Total operating expenses were $71.1 million (111% of revenue), leading to a GAAP operating loss of $17.9 million and a non-GAAP operating loss of $7.9 million. Net loss was $15.7 million (‑$0.18 per share), while non-GAAP net loss improved to $5.8 million (‑$0.07 per share). Adjusted EBITDA was ‑$6.7 million, and cash, cash equivalents and investments totaled $246.8 million as of June 30, 2026.Heartflow raised its full‑year 2026 revenue guidance to $246–$250 million (40–42% growth) and now expects non‑GAAP gross margin of approximately 82%.

Measured using an artificial intelligence-based imaging tool, reduced coronary blood flow predicted future cardiovascular events in patients with suspected stable coronary artery disease.

This consensus standardizes definitions for bifurcation lesions, lesion classification, relevant side branches, study types, endpoints and follow-up for clinical trials to improve comparability.

The International Journal of Cardiovascular Imaging - Coronary CT angiography (CTA) derived fractional flow reserve (FFRCT) is recommended for physiological assessment in intermediate coronary...

The International Journal of Cardiovascular Imaging - Coronary Artery Disease-Reporting and Data System (CAD-RADS) standardises Computed Tomography Coronary Angiography (CTCA) reporting. Coronary...

The International Journal of Cardiovascular Imaging - Coronary CT angiography (CTA) derived fractional flow reserve (FFRCT) is recommended for physiological assessment in intermediate coronary...

Heartflow (Nasdaq: HTFL) announced two large real-world analyses from FISH&CHIPS (England NHS) covering >90,000 patients, presented at EACVI on Dec 11, 2025. The reports show lesion-specific FFRCT predicts individual outcomes: patients with the lowest FFRCT had a 4× higher MI risk and 3× higher cardiovascular death risk, independent of traditional risk factors. A separate health‑economic analysis found £1,042 GBP ($1,394 USD) per‑patient savings at two years, with modeled system savings of about £25 million GBP ($33.45 million USD) per year and reduced downstream testing and increased appropriate revascularization.Findings support clinical and economic value of the Heartflow One platform and lesion-specific FFRCT in large health systems.

Heartflow (Nasdaq: HTFL) introduced PCI Navigator, an AI-driven CT-guided PCI planning tool that combines patient-specific 3D anatomy, plaque composition and lesion-specific physiology in a single web-based view to help plan stent placement.New PLAN CALCIUM data (TCT 2025) found that adding AI plaque analysis to coronary CTA/FFRCT altered calcium modification plans in >50% of lesions. Heartflow will launch the NAVIGATE-PCI registry in 2026 to enroll ~2,500 patients across ~30 U.S. sites, with broader commercial availability planned later in 2026.

ハートフロー（Heartflow, Inc.）株式の概要です。HTFLの最新終値、チャート、ニュース、分析、アナリストによる評価などをご覧いただけます。

ML-based FFRCT matched CFD specificity but lower sensitivity for coronary stenosis; promising with tweaks. #Cardiology #FFRCT

The International Journal of Cardiovascular Imaging - Coronary CT angiography (CTA) derived fractional flow reserve (FFRCT) is recommended for physiological assessment in intermediate coronary...

The International Journal of Cardiovascular Imaging - Coronary Artery Disease-Reporting and Data System (CAD-RADS) standardises Computed Tomography Coronary Angiography (CTCA) reporting. Coronary...

The International Journal of Cardiovascular Imaging - Fractional flow reserve (FFR) post percutaneous coronary intervention (PCI) is an important determinant of patient outcomes. A new virtual...

The International Journal of Cardiovascular Imaging - Coronary CT angiography (CTA) derived fractional flow reserve (FFRCT) is recommended for physiological assessment in intermediate coronary...

The International Journal of Cardiovascular Imaging - Coronary Artery Disease-Reporting and Data System (CAD-RADS) standardises Computed Tomography Coronary Angiography (CTCA) reporting. Coronary...

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