CathWorks Company Profile

Background

Overview

CathWorks is a medical technology company founded in 2013, specializing in the development of non-invasive diagnostic solutions for coronary artery disease (CAD). The company's flagship product, the FFRangio® System, leverages advanced computational science and artificial intelligence to transform routine coronary angiograms into objective fractional flow reserve (FFR) assessments, thereby enhancing the precision of CAD diagnosis and treatment planning.

Mission and Vision

CathWorks is dedicated to partnering with physicians to improve patient health by revolutionizing the diagnosis and treatment of cardiovascular disease. The company's vision is to provide quick, precise, and objective intraprocedural wire-free FFR guidance that is practical for every case, thereby optimizing clinical decision-making and patient outcomes.

Industry Significance

Operating within the medical equipment manufacturing industry, CathWorks addresses a critical need for non-invasive diagnostic tools in cardiology. The FFRangio System offers a significant advancement over traditional wire-based FFR methods by eliminating the need for invasive pressure wires and pharmacologic agents, thus reducing procedural risks and improving patient comfort.

Key Strategic Focus

Core Objectives

CathWorks aims to enhance the accuracy and efficiency of CAD diagnosis and treatment by providing non-invasive, wire-free FFR guidance. The company focuses on expanding the adoption of its FFRangio System globally, thereby improving patient outcomes and reducing healthcare costs associated with invasive diagnostic procedures.

Areas of Specialization

The company's primary specialization lies in the development of non-invasive diagnostic technologies for cardiology, particularly in the assessment of coronary artery disease through advanced imaging and computational modeling.

Key Technologies Utilized

Artificial Intelligence (AI): Employed to analyze angiographic images and generate FFR values without the need for invasive procedures.

Computational Science: Utilized to model blood flow dynamics and assess the physiological impact of coronary lesions.

Primary Markets Targeted

CathWorks targets hospitals, cardiology centers, and healthcare providers globally, focusing on regions such as the United States, Europe, Japan, and Israel, where the FFRangio System is commercially available.

Financials and Funding

Funding History

As of February 2026, CathWorks has raised a total of $75 million in funding over five rounds. The most recent funding round occurred on July 12, 2022, when Medtronic invested $75 million in the company.

Notable Investors

Medtronic: Invested $75 million in July 2022 and holds a minority stake in CathWorks.

Deerfield Management: Led a $30 million Series C financing round in February 2019.

Corundum Open Innovation: Participated in a $15.8 million Series B financing round in October 2017.

Intended Utilization of Capital

The funds raised have been utilized to support the commercialization of the FFRangio System, expand clinical studies, and enhance product development to meet regulatory requirements and market demands.

Pipeline Development

Key Pipeline Candidates

The primary focus of CathWorks is on the FFRangio System, which has undergone multiple generations of development to enhance its accuracy, automation, and user-friendliness. The fourth generation of the FFRangio System received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in October 2022.

Stages of Clinical Trials or Product Development

The FFRangio System has completed various stages of clinical trials, including the FAST-FFR trial, which supported its FDA 510(k) submission in August 2018. The system has received regulatory approvals in multiple regions, including the United States, Europe, Japan, and Israel.

Target Conditions

The FFRangio System is designed to assess coronary artery disease, particularly focusing on evaluating the physiological impact of coronary lesions to guide treatment decisions.

Relevant Timelines for Anticipated Milestones

CathWorks continues to expand the adoption of the FFRangio System globally, with ongoing efforts to integrate the technology into clinical practice and achieve further regulatory approvals as needed.

Technological Platform and Innovation

Proprietary Technologies

FFRangio System: A non-invasive diagnostic platform that utilizes AI and computational science to derive FFR values from routine angiograms, eliminating the need for invasive pressure wires and pharmacologic agents.

Significant Scientific Methods

Angiography-Derived FFR: A method that computes FFR values directly from angiographic images, providing a comprehensive assessment of coronary physiology without invasive procedures.

AI-Driven Capabilities

Image Analysis: AI algorithms analyze angiographic images to generate accurate FFR measurements across the coronary tree.

Computational Modeling: Simulates blood flow dynamics to assess the impact of coronary lesions on myocardial perfusion.

Leadership Team

Key Executive Profiles

Ramin Mousavi: President & Chief Executive Officer. Ramin brings extensive executive leadership and operational expertise across various domains, including general management, marketing, strategy, product development, and commercialization within diverse market segments.

Dalit Cohen-Shipperman: Vice President, Global Human Resources. Dalit has over 14 years of executive-level experience in Human Resources, contributing to both tactical and strategic growth initiatives across diverse organizations.

Mike Feher: Chief Financial Officer. Mike brings 15 years of seasoned leadership and operational expertise to CathWorks, focusing on financial planning and analysis, process improvement, resource allocation, and investor relations.

Asaf Jazcilevich: Vice President, Research & Development/Site Leader. Asaf has a wealth of experience in R&D management, with a strong record of success in building and leading multi-disciplinary teams across diverse sectors.

Sarita Monico: Senior Director, Global Marketing. Sarita has over two decades of medical device strategic marketing experience, integral to the launch and commercialization of revolutionary therapies.

Leadership Changes

As of February 2026, there have been no publicly disclosed significant changes or appointments within CathWorks' leadership team.

Competitor Profile

Market Insights and Dynamics

The market for non-invasive diagnostic technologies in cardiology is expanding, driven by the demand for procedures that reduce patient discomfort and procedural risks. CathWorks competes with other medical device companies offering diagnostic solutions for coronary artery disease, including those providing wire-based FFR systems and alternative non-invasive imaging technologies.

Competitor Analysis

Philips Healthcare: Offers advanced imaging solutions for cardiology, including non-invasive diagnostic tools.

GE Healthcare: Provides a range of imaging technologies applicable in cardiology diagnostics.

Siemens Healthineers: Develops imaging systems and diagnostic tools for cardiovascular applications.

Strategic Collaborations and Partnerships

In July 2022, CathWorks entered into a strategic partnership with Medtronic, which included a co-promotion agreement for the FFRangio System in the U.S., Europe, and Japan. This partnership has been instrumental in expanding the reach and adoption of CathWorks' technology.

Operational Insights

CathWorks differentiates itself through its non-invasive, wire-free FFR guidance system, which offers a less invasive alternative to traditional methods, potentially reducing procedural risks and improving patient comfort. The strategic partnership with Medtronic has enhanced its market presence and operational capabilities.

Strategic Opportunities and Future Directions

The acquisition of CathWorks by Medtronic, announced in February 2026, presents significant opportunities for the integration of CathWorks' technology into Medtronic's extensive product portfolio, potentially accelerating the adoption of non-invasive diagnostic solutions in cardiology.