CathWorks News
21 articles
CathWorks Announces First Patient Enrolled in Global ALL-RISE Study
CathWorks has announced the enrollment of the first patient in the ALL-RISE Study, a randomized controlled trial aimed at transforming the diagnosis and treatment of coronary artery disease (CAD) by evaluating the clinical and economic benefits of the CathWorks FFRangio® System. The study will enroll 1,924 patients at up to 60 sites in North America, Asia, Europe, and the Middle East. In July 2022, CathWorks entered into a strategic partnership with Medtronic to amplify its efforts in bringing the benefits of FFRangio to more physicians and patients globally.
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Israeli startup is aiming to transform how cardiovascular disease is diagnosed and treated | CTech
Israeli startup CathWorks, co-founded by Professor Ran Kornowski, aims to transform the diagnosis and treatment of cardiovascular disease. Professor Kornowski spoke about the startups innovation at the Mind the Tech conference in London. The conference focused on the changes in the high-tech sector and how they have impacted the economy. CathWorks goal is to revolutionize the way cardiovascular disease is diagnosed and treated.
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Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan
CathWorks has received regulatory approval in Japan for its fourth generation CathWorks FFRangio System. The system allows for a comprehensive physiologic assessment of coronary artery disease without invasive pressure wires or hyperemic agents. The approval offers significant automation and enhancements, simplifying the utilization of the platform. The CathWorks FFRangio System is the first non-invasive device of its kind to receive approval for diagnosis of functional ischemia for patients with ischemic CAD in Japan. The system has a diagnostic accuracy of 93% compared to invasive wire-derived FFR. With this approval and a strategic partnership with Medtronic, CathWorks aims to expand its presence in Japan and make the FFRangio technology available to more physicians and patients.
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Medtronic announces co-promotion agreement with CathWorks, with path toward acquisition
Medtronic has entered into a strategic partnership agreement with CathWorks, a company that aims to transform how coronary artery disease (CAD) is diagnosed and treated. Medtronic will invest up to $75 million and co-promote CathWorks FFRangio System. Medtronic also has the option to acquire CathWorks in the future. The partnership is expected to be neutral to Medtronics earnings in fiscal year 2023 and accretive thereafter. The FFRangio System combines artificial intelligence and advanced computational science to obtain quick and reliable FFR values from routine angiograms, eliminating the need for invasive measurements with wires and stimulation with hyperemic agents. The partnership aligns with Medtronics commitment to investing in innovative technologies for the healthcare industry.
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CathWorks and Quest International Announce Global Post-Sales Technical Service Support Partnership
CathWorks and Quest International have signed a post-sales technical service support agreement, making Quest International the preferred technical service delivery partner for CathWorks customers globally. This partnership will help CathWorks accelerate its commercial operations and expand its geographic footprint. Both companies have their US headquarters in Irvine, California, and see this partnership as a commitment to local economic growth. CathWorks is a leader in digital health innovations, providing physicians with advanced computational science and artificial intelligence tools for diagnosing and treating cardiovascular disease. Quest International is a global post-sales service support partner for original equipment manufacturers (OEMs) in various industries.
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CathWorks Presents New Data and Latest Innovations at ACC 2022
CathWorks announces the completion of more than 5,000 FFRangio cases globally. The results of its outcomes study on the CathWorks FFRangio™ system will be presented at the annual American College of Cardiology (ACC) conference. The study examined the 1-year clinical outcomes of 492 patients. CathWorks FFRangio has become the standard of care in their cath lab. CathWorks has surpassed a major milestone with more than 5,000 patients benefiting from their FFRangio technology. They will have a prominent presence at ACC 2022 and their technology will be showcased at the Future Hub. Several scientific sessions at ACC will focus on the growing adoption of angio-based FFR and its role in managing cardiovascular disease.
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CathWorks Announces Appointment of Ramin Mousavi as Chief Executive Officer and Board Member
CathWorks has announced the appointment of Ramin Mousavi as Chief Executive Officer and member of the Board of Directors. Mousavi has extensive experience in the medical device industry and previously led the patient monitoring and digital health portfolio at Baxter International. CathWorks is a global leader in digital health innovation focused on helping patients with cardiovascular disease. The companys innovative FFRangio technology has the potential to become the standard of care in enhancing diagnostic decision-making for cardiologists. With Mousavis leadership, CathWorks aims to drive technology innovation, market adoption, and global commercial growth.
Management Changes
Israeli angiography co CathWorks raises $30m
Israeli non-invasive diagnostics company CathWorks has completed a $30 million Series D financing round. The funds will be used to expand the commercialization of the companys FFRangio system, a non-invasive diagnostic technology used during routine angiography. The CEO of CathWorks expressed excitement about the clinical value of the FFRangio system and stated that the funding will support continued commercialization and expanded access to the technology for physicians, hospitals, and patients.
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Can 3D Modeling Replace a Guidewire-Based Cardiac Procedure?
CathWorks FFRangio™ System Receives Regulatory Approval in Japan
CathWorks has received approval from Japans Ministry of Health, Labour and Welfare (MHLW) for its CathWorks FFRangio System, a non-invasive diagnostic technology used during routine angiography. The system provides objective and comprehensive physiology information, including 3D renderings of blood flow in the hearts arteries, to help physicians make decisions about coronary artery disease treatment. The approval allows CathWorks to expand its presence in Japan, where heart disease is a leading cause of death. The CathWorks FFRangio System is already available in the United States and Europe. This milestone is expected to positively impact the companys growth.
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Medtronic signs marketing agreement with CathWorks
Medtronic has signed a marketing agreement with Israeli medical device company CathWorks for the marketing of its products in Europe. This is Medtronics third marketing agreement this year with an Israeli medical technology company. The agreement allows Medtronic to gain ownership of the marketing of imaging products used to direct its medical devices. This strengthens Medtronics connection with Israel and signifies a new attitude by the corporation towards signing agreements with young companies. The article suggests that this approach may lead to future acquisitions, as happened with Medtronics acquisition of Mazor Robotics. The article also mentions Medtronics previous marketing agreements with Israeli companies Mazor Robotics and Alpha Omega.
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CathWorks Appoints Chief Financial Officer
CathWorks has announced the appointment of Mike Feher as Vice President of Finance and Chief Financial Officer. This appointment coincides with the US commercialization of the CathWorks FFRangio System. Feher will focus on developing financial and operational capabilities and executing the companys strategy. CathWorks CEO, Jim Corbett, expressed confidence in Fehers ability to lead the finance organization. The CathWorks FFRangio System provides non-invasive, objective FFR guidance during coronary angiography. CathWorks received FDA clearance for the system in December 2018.
Management Changes
CathWorks Adds Vice President of Global Marketing to Leadership Team
CathWorks has announced the appointment of Ramin Mousavi as Vice President of Global Marketing & Strategy. Mousavi will be responsible for the U.S. clinical and commercial launch of the CathWorks FFRangio System and expanding into other global markets. His experience in cardiovascular marketing and successful device launches will be beneficial for the companys growth. The CathWorks FFRangio System provides objective FFR guidance for optimizing PCI therapy decisions. CathWorks received FDA clearance for the system in December 2018.
Management Changes
CathWorks Announces Completion of $30 Million Financing
CathWorks has completed a $30 million Series C financing round led by Deerfield Management. The funding will support the acceleration of the companys clinical and commercial activities in the United States. CathWorks FFRangio System, which received FDA 510(k) clearance, provides objective FFR guidance for optimizing PCI therapy decisions. The system is non-invasive and performed intra-procedurally during coronary angiography. Deerfield Management believes there is tremendous clinical and economic potential for the technology. CathWorks is focused on bringing the FFRangio System to market to provide quick, precise, and objective intraprocedural FFR guidance for every case.
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CathWorks Names Paul Kapsner as Vice-President of Sales
CathWorks has appointed Paul Kapsner as Global Vice President of Sales to accelerate the clinical and commercial organization in the United States. The appointment coincides with the FDA clearance of CathWorks FFRangio System. Kapsner brings 27 years of experience in commercial sales and marketing in the medical device industry. CathWorks FFRangio System provides non-invasive, intraprocedural FFR guidance to optimize PCI therapy decisions for patients with coronary artery disease. The system received FDA 510(k) clearance on December 19, 2018.
Management Changes
CathWorks FFRangio™ System Receives U.S. FDA Clearance
CathWorks FFRangio System has received FDA 510(k) clearance, allowing for non-invasive evaluation of coronary artery disease. The system provides objective FFR guidance during Percutaneous Coronary Intervention (PCI) assessment, eliminating the need for invasive procedures. The FAST-FFR study, involving over 380 patients, demonstrated the clinical predictive value of the FFRangio system. CathWorks CEO, Jim Corbett, sees this FDA clearance as a significant milestone for interventional cardiologists and the healthcare system. The company was founded six years ago by Dr. Ifat Lavi, Guy Lavi, and Prof. Ran Kornowski. The CathWorks FFRangio System aims to optimize PCI therapy decisions and elevate coronary angiography to an objective FFR-based decision-making tool.
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CathWorks FFRangio™ Trial Meets Primary Endpoint and Exceeds Performance Goals
CathWorks, a medical technology company, published trial results for their FFRangio System in the journal Circulation. The results showed high sensitivity and specificity, exceeding the trials goals. The system has the potential to improve patient outcomes and increase physiologic coronary lesion assessment. The trial was rigorous and involved multiple hospitals and operators. The CathWorks FFRangio System is still in development and not yet FDA-cleared.
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CathWorks FFRangio™ System Files FDA 510(k) Submission
CathWorks has submitted its CathWorks FFRangio System to the FDA for review and market clearance. The system is a non-invasive FFR platform that provides objective physiologic measurements to optimize PCI therapy decisions. The company expects market clearance by the end of 2018 and anticipates the system to benefit physicians and patients soon. The CathWorks FFRangio System is still in development and not yet available for sale in the United States.
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CathWorks Appoints New CEO
CathWorks Ltd. has appointed James M. Corbett as its Chief Executive Officer. Corbetts experience in global commercialization will help the company in its efforts to globally commercialize the FFRangio technology. CathWorks recently closed a Series B financing round of $15.8 million and announced the first enrollment of its FDA Clinical Trial, FAST-FFR. The company believes that the FFRangio technology has the potential to become the standard of care in the cath lab.
Management Changes
CathWorks Announces FAST-FFR Pivotal Clinical Trial
CathWorks Ltd. has enrolled the first patient in the FAST-FFR clinical trial, which aims to assess the efficacy of FFRangio in measuring FFR derived from coronary angiography. The trial outcomes will support CathWorks submission to the FDA for 510K clearance. FFRangio is a non-invasive software device that provides physicians with clinical information to determine whether an intermediate coronary artery blockage requires treatment. The device has the potential to disrupt and expand the existing FFR market. The trial is considered critically important and could have broad implications for diagnosing ischemic heart disease. CathWorks will hold a Breakfast Meeting during the Transcatheter Cardiovascular Therapeutics (TCT) conference to share investigators experiences with the FFRangio technology.
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Cathworks Announces Completion of $15.8M Series B Financing
CathWorks Ltd. has announced the completion of a $15.8M Series B round of financing led by Quark Venture and Triventures. The funding will allow the company to conduct a global pivotal trial to support FDA approval. CathWorks has developed a real-time digital platform for determining FFR in the catheterization laboratory during procedures. The companys technology has the potential to disrupt the existing FFR market and integrate coronary images with lesion physiology in real time. CathWorks received a CE Mark on its lead product earlier this year. The investors in this funding round also include Planven Investments, Pontifax, Corundum Open Innovation, and BioStar Ventures.
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