Medical technology company CathWorks is making waves in cardiology by leveraging advanced computational science and artificial intelligence to optimize treatment decisions for coronary artery disease (CAD). The company’s FFRangio System, FDA approved in December 2018, uses standard angiogram images and a proprietary series of algorithms to, in about 5 minutes, reconstruct a patient’s coronary tree in three dimensions and provide important physiological measurements that guide physician decision-making.
The new technology is a major advancement in the treatment of CAD, the leading cause of death in the United States. Traditionally, treatment decisions, such as whether to place a coronary stent, are made based on evaluating two-dimensional black and white x-ray images. But two-dimensional angiograms can be misleading because they don’t account for the true functional or hemodynamic significance of a blockage. In other words, a blockage that appears significant on an angiogram may not actually impact to blood flow. In these situations, understanding blood flow and the physiology of the blockage is paramount.
A clinical study published in the New England Journal of Medicine demonstrated an improvement in patient outcomes, a reduction in unnecessary stents and reduced overall costs if stent decisions are based on objective physiological data instead of angiography alone. Guidelines now recommend routine measurement of a patient’s physiology before deciding treatment, typically by inserting an invasive pressure wire into the coronary arteries to measure a value known as Fractional Flow Reserve (FFR).
CathWorks, founded in 2013, is looking to disrupt the current pressure wire FFR market by making objective FFR measurements across the whole coronary tree quick, practical, and non-invasive. And the market is ripe for disruption. Despite the proven benefits, adoption of conventional pressurewire FFR has been slow, likely because the procedure comes with added risk, cost and time, and requires a hyperemic stimulus which leads to patient discomfort. Physicians agree that the ability to derive objective FFR values without the need for an invasive pressure guidewire or drug-induced hyperemic stimulus could have an important impact on daily clinical practice and patient outcomes. A recent international clinical trial proved FFRangio to be just as effective as traditional FFR measurement.
Creating 3D flow information from 2D angiogram images is no easy task. The FFRangio system leverages an advanced artificial intelligence platform designed to automatically recognize and evaluate anatomic information used for the analysis. The system derives flow and FFR measurements using rapid flow analysis algorithms using a supercomputer.
Several major US hospitals are already using the tool, including Hoag Hospital in Newport Beach, Stanford Medical Center in Northern California, Cedars-Sinai in Los Angeles and Sharp Memorial Hospital in San Diego.
With the initial rollout of FFRangio technology, which is aligned with triple aim goal in healthcare – improve quality of care, lower cost of care, and reduce risk–the company was recently named a finalist for OCTANe’s “Best Innovation in Medical Technology” award and OC Business Journal’s“Innovator of the Year” award.
The company’s President & Co-Founder – Guy Lavi, is an accomplished executive with strong technical and leadership experience. Mr. Lavi held previous R&D and leadership positions at Philips, P-Cure, IDF, and Volume Elements. A holder of multiple patents, Mr. Lavi is considered a global subject matter expert in the field of image-derived physiology.
CathWorks’ CEO – James “Jim” Corbett, has over 30 years of leadership experience in the medical device field. Mr. Corbett, over the course of his career, has held the positions of Chief Executive Officer, Alphatec Spine, Vertos Medical, ev3 Inc, Chairman and CEO Microtherapeutics, Home Diagnostics Inc.; President, Boston Scientific International; and General Manager Baxter, Japan, as well as a number of executive roles in his 11 years at Baxter Healthcare.
The company’s executive leadership team is focused on expanding the adoption of non-invasive 3D comprehensive physiology, with plans to launch the FFRangio platform globally in all major regions by the end of 2020. CathWorks envisions a world where non-invasive FFRangio replaces current invasive options, and as a result, comprehensive physiology and FFR-guided decision making becomes the standard of care for every CAD patient.