CathWorks Announces $30 Million in New Financing

FFRangio Pooled Analysis from 5 Prospective Cohort Studies

Excellent diagnostic performance: 91% sensitivity, 94% specificity, and 93% diagnostic accuracy

This lesion-level pooled data analysis of 588 patients and 700 lesions represents the “largest and most diverse cohort of any single angiogram-based FFR technology reported.” Results indicate FFRangio has excellent diagnostic performance, strong correlation, and that results were robust across a wide spectrum of patients and lesion characteristics.


PCI in patients with FFR ≤ 0.80 reduced clinical events by 66% compared to medical therapy alone at 1 year.

The FAME II Trial randomized stable CAD patients with FFR ≤ 0.80 to PCI + medical therapy or medical therapy alone. Enrollment was halted early after 1,220 patients because of a significant between-group difference in the events, driven by a lower rate of urgent revascularization in the PCI group than in the medical therapy group. Continue reading “FAME II Trial”

FAME Trial Economic Analysis

14% reduction in overall costs at 1 year.

Economic analysis of the FAME Trial revealed that PCI guided by FFR saves costs and improves health outcomes at 1 year compared with angiography guidance. Cost savings are driven by a decrease in stent use during the initial procedure, a decrease in rehospitalization and fewer major adverse cardiac events. Continue reading “FAME Trial Economic Analysis”

FFRangio in Dual/Triple Vessel Disease

Excellent diagnostic performance, with sensitivity, specificity and accuracy all above 92%; FFRangio was 40% faster that wire-based FFR

This prospective clinical study conducted at Gifu Heart Centre, Japan—evaluated the diagnostic performance of FFRangio in 50 patients with dual or triple vessel CAD compared to wire-based FFR. Continue reading “FFRangio in Dual/Triple Vessel Disease”

FAST-FFR Pivotal Trial

92% Diagnostic Accuracy, 94% Sensitivity, and 91% Specificity

The FAST-FFR pivotal trial was a prospective multicenter, international trial designed to determine the accuracy of FFRangio in clinical practice compared to traditional wire-based FFR. The trial included 301 patients and 319 vessels at 10 clinical sites. The results demonstrated excellent diagnostic performance, including in the grey zone between FFR values of 0.75 and 0.85. Continue reading “FAST-FFR Pivotal Trial”

CathWorks FFRangio™ System Receives Regulatory Approval in Japan

KFAR-SABA, ISRAEL & ALISO VIEJO, CA (December 10, 2019) — CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW).

The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, including color-coded 3D renderings of blood flow in the heart’s arteries to help physicians optimize coronary artery disease decision making, including whether a stent is needed.

The CathWorks FFRangio System is also commercially available in the United States and Europe. It is noninvasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs. The technology has the potential to positively impact a significant patient population in Japan, where heart disease is the second leading cause of death and coronary artery disease accounts for approximately half of these deaths.1

“The MHLW’s approval of The CathWorks FFRangio System is another important milestone for CathWorks, physicians and patients. It is the first non-invasive device of its kind to receive Japan MHLW approval for use during Percutaneous Coronary Intervention (PCI) and to determine the optimal treatment for patients with coronary artery disease” said Jim Corbett, CEO of CathWorks. “With this approval in Japan, we are positioned to significantly expand our ability to help more clinicians optimize coronary artery disease therapy decisions non-invasively while reducing unnecessary invasive catheterizations and saving costs.”

Learn how the CathWorks FFRangio® System can impact your practice.


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