Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan

Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan

KFAR-SABA, ISRAEL & IRVINE, CA (October 6, 2022) CathWorks announced today the approval of the fourth generation CathWorks FFRangio® System by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The FFRangio System is also commercially available in the United States and Europe.

Continue reading “Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan”

CathWorks Announces Key Events for TCT 2022

KFAR-SABA, ISRAEL & IRVINE, CA (September 15, 2022) CathWorks announced today the schedule of key events for the company during Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) 2022 conference taking place September 16 to 19 at the Boston Convention and Exhibition Center in Boston, Massachusetts.

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CathWorks and Quest International Announce Global Post-Sales Technical Service Support Partnership

 

 

CathWorks and Quest International Announce Global Post-Sales Technical Service Support Partnership

CathWorks, an original equipment manufacturer (OEM), and Quest International, a global service support provider to the OEMs, announced today they have signed a post-sales technical service support agreement that Quest International becomes the preferred technical service delivery partner for end-to-end service support of CathWorks’ fast-growing install-base of customers globally. CathWorks plans to leverage Quest’s capabilities to accelerate its commercial operations and expand its geographic footprint.

“In pursuit of our mission of partnering with physicians to transform how cardiovascular disease is diagnosed and treated, we have become partners with Quest International because of their deep industry expertise and their ability to provide comprehensive services including depot repairs, field services, supply-chain logistics and other professional services. Quest’s global coverage and scalable resources will augment CathWorks’ growing global commercial footprint while enhancing our customers’ overall experience,” said Ramin Mousavi, President and CEO of CathWorks.

“Having served Fortune 500 companies since 1982, Quest is dedicated to meeting the needs of its OEM customers with a comprehensive suite of services and solutions. Partnering with CathWorks perfectly fits our OEM services offering and provides CathWorks and its end-users a global and reliable one-stop shop for all the CathWorks FFRangio™ System service needs,” said Shawn Arshadi, President and CEO of Quest International.

In addition to growing global presence, both companies have their US headquarters in Irvine, California, an unmatched strategic destination for technology and life science companies. Quest and CathWorks see this partnership as their continued commitment of local economic growth. Both organizations have a long history of partnership with local organizations such as the Greater Irvine Chamber of Commerce and Octane Orange County.

ABOUT CATHWORKS
CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio™ System combines advanced computational science and artificial intelligence, transforming how cardiovascular disease is diagnosed and treated. It provides physicians access to objective drug-free and wire-free intraprocedural multi-vessel physiology guidance that is practical for every patient. For more information, visit cath.works and follow us on Twitter @CathWorks.

ABOUT QUEST INTERNATIONAL
Quest International is a leading global post-sales service support partner for original equipment manufacturers (OEMs) across multiple industries including healthcare, industrial, aviation and government as well as IT Solutions provider for large and small enterprises. Having served Fortune 500 companies since 1982, Quest offers a robust suite of new services and solutions throughout its three business units: OEM Services, IT Services and Technology Solutions. Quest is ISO 9001, 13485, 14001, and ANSI/ESD S20.20 Certified with over 30 operation centers worldwide.

Corporate headquarters are located at 60-65 Parker, Irvine, CA 92618. For more information call 800-231-6777 or visit www.questinc.com.

Quest International and the Quest logo are registered trademarks of Quest International Inc.

Contact CathWorks
Media: Natalie Sickler [email protected]
Investors: Mike Feher [email protected]

Quest International Inc. Brian Grotz [email protected]

CathWorks Presents New Data and Latest Innovations at ACC 2022

CathWorks FFRangio™ System outcomes study to be presented at ACC 2022…
CathWorks announces the completion of more than 5,000 FFRangio cases globally.

CathWorks announced today that the results of its most recent outcomes study on the CathWorks FFRangio™ system will be presented by Dr. Guy Witberg from Rabin Medical Center, Petah Tikva, Israel on Sunday, April 3 at the annual American College of Cardiology (ACC) conference in Washington, DC.

Dr. Witberg and his co-investigators in Israel and Japan examined the 1-year clinical outcomes of 492 patients whose treatment decision was based solely on the CathWorks FFRangio™ System results. “FFRangio has been in use in our cath lab since 2016 and we have taken part in several studies demonstrating its excellent diagnostic performance compared to the gold standard wire-based FFR, culminating in the pivotal FAST-FFR trial and our leading role in conducting a pooled analysis that compared FFRangio to wire-based FFR. Based on the results of these studies, we have been using FFRangio as a standalone tool for physiologic assessment in patients undergoing coronary angiography, and it has become the standard of care in our cath lab replacing wire-based FFR. The data we present at ACC will be the first to examine the clinical outcomes of FFRangio-guided treatment in this population. We are happy to add this outcomes study to the growing body of evidence supporting the broad application of FFRangio in the intraprocedural assessment of patients with coronary artery disease,” said Dr. Witberg.

“CathWorks is grateful for the partnership with the study investigators as we continue to broaden the global clinical adoption of FFRangio and work towards our mission of transforming how cardiovascular disease is diagnosed and treated. We are proud to also announce that we surpassed a major milestone for CathWorks this month with more than 5,000 patients having benefited from our FFRangio technology, and we are determined to help many more,” said Ramin Mousavi, President and CEO of CathWorks.

Not only will CathWorks have a prominent presence in the exhibit hall at ACC 2022 where healthcare professionals can get hands-on experience with the latest generation of the CathWorks FFRangio™ System, its technology will also be showcased at the Future Hub for the duration of the conference. Several scientific sessions at ACC will focus on the growing adoption of angio-based FFR and its role in the management of patients with cardiovascular disease.

ABOUT CATHWORKS

CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio™ System combines advanced computational science and artificial intelligence, transforming how cardiovascular disease is diagnosed and treated. It provides physicians access to objective drug-free and wire-free intraprocedural multi-vessel physiology guidance that is practical for every patient. For more information, visit cath.works and follow us on Twitter @CathWorks.

Contact CathWorks

Media: Natalie Sickler [email protected]

Investors: Mike Feher [email protected]

Mike Feher Appointed as CFO of CathWorks

Mike Feher Appointed as CFO of CathWorks Mike Feher Appointed as CFO of CathWorks

 

KFAR-SABA, ISRAEL & ALISO VIEJO, CA (October 4, 2021) – CathWorks, a global leader of digital health innovation focused on helping patients with cardiovascular disease, announced today that Mike Feher was appointed Chief Financial Officer, effective immediately. 

An energetic and results-driven executive, Mr. Feher brings comprehensive strategic and operational finance experience to his role, including expertise in financial planning and analysis, strategy, investor relations, operational execution, and much more. Most recently, he was Vice President, Business Planning & Development at Allied Universal, the largest private security firm in the world. Before his work at Allied Universal, Mr. Feher held various leadership roles at Edwards Lifesciences, Volcom, and Deloitte. He served as CathWorks Vice President of Finance and CFO from 2019 to 2020.  Mr. Feher holds a B.S. degree in Accounting and Business Administration, with an emphasis in Finance and Economics, from Chapman University and is a licensed CPA. He also earned an M.B.A. in Corporate Finance from Marshall School of Business at the University of Southern California.

“Mike is an exceptional executive and a great partner with a unique ability to toggle between creating value through long-term strategic planning and optimizing resource allocation through disciplined financial execution,” said Ramin Mousavi, Chief Executive Officer of CathWorks. “His fundamental financial knowledge, medical device industry expertise,  strong investor relationships, and ability to analyze, plan, and execute will strengthen our leadership team and will drive our continued execution of our strategic vision.”

“I am thrilled at the opportunity to join the dynamic leadership team at CathWorks and help implement its mission of transforming the diagnosis and treatment of patients with coronary artery disease,” noted Mike Feher. “CathWorks has significant momentum towards its vision of establishing FFRangio as the new standard of care, and I look forward to working with Ramin and the entire organization to deliver meaningful value to patients, our customers, and shareholders every day.”  

About CathWorks

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers. The company’s focus today is specifically on bringing the CathWorks FFRangio™ System to market to provide quick, precise, and objective intraprocedural wire-free FFR guidance that is practical for every case.

CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan

FFRangio System Receives National Reimbursement Approval in Japan

CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System, making it more broadly available for coronary artery disease decision-making in Japan. Continue reading “CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan”

CathWorks Announces Appointment of Ramin Mousavi as Chief Executive Officer and Board Member

Ramin Mousavi appointed as CEO of CathWorks

KFAR-SABA, ISRAEL & ALISO VIEJO, CA (June 14, 2021), CathWorks , a global leader of digital health innovation focused on helping patients with cardiovascular disease, today announced that Ramin Mousavi has been appointed Chief Executive Officer, effective June 21, 2021. Mr. Mousavi has also been appointed to the company’s Board of Directors. Mr. Mousavi succeeds Jim Corbett, who served as the company’s CEO since October 27, 2017.

Continue reading “CathWorks Announces Appointment of Ramin Mousavi as Chief Executive Officer and Board Member”

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.”

CathWorks Appoints Chief Financial Officer

KFAR-SABA, ISRAEL and ALISO VIEJO, CA (March 4, 2019) — CathWorks announced that Mike Feher has joined CathWorks as Vice President of Finance and Chief Financial Officer. His appointment coincides with US commercialization of the CathWorks FFRangio™ System. Mr. Feher will initially focus on the development of financial and operational capabilities, as well as creating value for the organization through the execution of company’s strategy.

Mike joins CathWorks with over 13 years of finance and strategy experience in companies such as Edwards Lifesciences, Volcom and Deloitte. That experience includes deep understanding of investor relationships, strategic planning and financial operations. Mike is a certified public accountant. He earned his B.S. in Accounting, Finance and Economics from Chapman University and his MBA from University of Southern California.

Jim Corbett, CathWorks CEO, said of Mike’s appointment, “I am very excited to have Mike join our leadership team. Mike’s strategic mindset and broad financial acumen will be a significant addition to our team. The CathWorks System represents a tremendous opportunity for interventional cardiologists to improve the quality of care and lower costs in the treatment of multi-vessel coronary artery disease. I am confident in Mike’s ability to lead our finance organization as we continue to work towards achieving our strategic plan.”

Mr. Feher said, “I am excited about joining CathWorks and its dynamic leadership team. We look forward to the US commercialization of the CathWorks FFRangio in the next few weeks and cannot wait to see the impact of this transformational technology on patients, physicians, and health systems.”

The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions for every patient. It is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per-procedure costs. The company received U.S. FDA 510(k) clearance for the CathWorks FFRangio Coronary Vascular Physiologic Simulation Software on December 19, 2018.

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

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