FFRangio in Dual/Triple Vessel Disease

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.”

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.

CathWorks Adds Vice President of Global Marketing to Leadership Team

KFAR-SABA, ISRAEL and ALISO VIEJO, CA (February 25, 2019) — CathWorks announced that Ramin Mousavi has joined CathWorks as Vice President of Global Marketing & Strategy. Mr. Mousavi, an experienced cardiovascular marketer, will take responsibility for the CathWorks FFRangio™ System U.S. clinical and commercial launch and direct future expansion into other global markets.

Mr. Mousavi has over 15 years of global marketing, strategy, product development and general management expertise and is widely recognized for leading one of the most successful cardiovascular device launches of the past decade. Prior to joining CathWorks, Ramin was the head of marketing for Transcatheter Heart Valves in the U.S. at Edwards Lifesciences. Ramin earned B.S. degrees in both computer- and electrical engineering from UC, Irvine. He also earned an M.B.A. from UC, Irvine and received a Healthcare Executive Leadership certificate for Business Innovation in Global Healthcare from Harvard Business School.

Jim Corbett, CathWorks CEO, said of Ramin’s appointment, “I could not be more excited to have Ramin join our leadership team. His analytical and strategic thinking combined with his experience in launching transformational and innovative technology utilizing advanced digital platforms to raise awareness and increase adoption, will be very beneficial as we launch and grow the adoption of the CathWorks FFRangio System in the United States and globally. The CathWorks System represents a tremendous opportunity for interventional cardiologists to improve the quality of care and lower costs in the treatment of multivessel coronary artery disease.”

Mr. Mousavi said, “I am excited to join CathWorks and I know that physicians and patients will greatly benefit from having an objective, non-invasive platform to routinely support PCI (percutaneous coronary intervention) decision-making during the coronary angiogram. Our goal is to ensure that the CathWorks FFRangio system is clinically and economically beneficial for interventional cardiologists, their patients, and the healthcare system overall.”

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.

CathWorks Announces Completion Of $30 Million Financing

Deerfield Management Leads Series C Financing

KFAR-SABA, ISRAEL and ALISO VIEJO, CA (February 4, 2019) — CathWorks announced the completion of a $30 million Series C financing round led by Deerfield Management.

Jim Corbett, CathWorks CEO stated, “We are delighted to have such a notable investor leading this round and for the continued full participation of our existing syndicate of investors. Our company was fortunate to have tremendous excitement around the CathWorks FFRangio™ System following release of the FAST-FFR clinical study results. This funding, coupled with our recent FDA 510(k) clearance, paves the way for acceleration of our clinical and commercial activities in the United States.”

Deerfield Management Principal, Andrew ElBardissi, MD added, “The CathWorks FFRangio platform technology has the potential to become standard of care in PCI [percutaneous coronary intervention] and other interventions where physiologic assessment is critical to determining which patients would benefit from revascularization. We believe there is tremendous clinical and economic potential for all stakeholders, including clinicians, patients, and payors.”

The CathWorks System received United States Food & Drug Administration 510(k) clearance on December 19, 2018. The predicate used for demonstrating substantial equivalence was conventional invasive FFR as demonstrated during the FAST-FFR clinical study. The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions for every patient across the full coronary tree. It is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or perprocedure costs.

CathWorks co-founder, Guy Lavi commented, “We are excited for the investment to support FFRangio market entry and continue with technical and clinical acceleration. As always, we want to thank our clinical development partners in Israel, the United States, and Europe for enabling us to reach this exciting milestone.”

CathWorks Names Paul Kapsner as Vice President of Sales

Provides Experienced Commercial Leadership For CathWorks FFRangio™ System U.S. Launch

KFAR-SABA, ISRAEL and ALISO VIEJO, CA (December 27, 2018) — CathWorks announced that Paul Kapsner has been named as Global Vice President of Sales. His appointment coincides with recent United States FDA clearance of the company’s CathWorks FFRangio™ System. His initial focus will be on accelerating the clinical and commercial organization in the United States.

Paul joins CathWorks with 27 years of commercial sales and marketing leadership experience in marketleading medical device companies. That experience includes deep engagement in the coronary diagnostic market. He earned a B.S. in Engineering from The United States Military Academy—West Point and an M.B.A. from Oklahoma City University.

Jim Corbett, CathWorks CEO, said of Paul’s appointment, “I have worked with Paul previously and am confident in his ability to develop and lead our commercial sales and customer support organization. The CathWorks FFRangio System represents a tremendous opportunity for interventional cardiologists, their hospitals, and patients to improve the quality of care and lower costs in the treatment of multi-vessel coronary artery disease. Paul understands how to develop a team to provide the clinical and technical support our customers need. We could not be more excited to have Paul on board.”

Mr. Kapsner added, “I know from experience how much interventional cardiologists will benefit from having a non-invasive, intraprocedural platform to provide objective FFRangio guidance. We look forward to equipping health systems with an objective resource to aid in PCI decision-making.

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.

CathWorks FFRangio™ System Receives U.S. FDA Clearance

Enables non-invasive, objective functional evaluation of multi-vessel coronary artery disease

KFAR-SABA, ISRAEL and ALISO VIEJO, CA (December 20, 2018) — CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial equivalence of the FFRangio system.

The CathWorks FFRangio™ System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions. FFRangio is derived from routine X-rays acquired during a diagnostic angiogram procedure, is non-invasive and performed intra-procedurally during coronary angiography, eliminating additional clinical risk, time and cost associated with invasive FFR. FFRangio provides a 3D reconstruction of the entire coronary tree with FFR values along each vessel.

Jim Corbett, CathWorks CEO said, “The FDA clearance of CathWorks FFRangio is a significant milestone for interventional cardiologists and the healthcare system overall. It is the first non-invasive device of its kind to receive FDA clearance for use during Percutaneous Coronary Intervention (PCI) assessment. The FAST-FFR study was carried out at 10 centers world-wide and evaluated more than 380 patients. The study demonstrated the clinical predictive value across a full range of coronary physiology, including complex lesion assessment in bifurcations and calcified lesions. FAST-FFR also demonstrated that the FFRangio system could perform non-invasive, objective, multi-vessel, physiologic measurements to support PCI decision making.”

Dr. Ifat Lavi, CathWorks Chief Technology Officer, Guy Lavi, CathWorks President, and Prof. Ran Kornowski, Chairman of Cardiology at Rabin Medical Center in Israel, invented the CathWorks technology and founded the company six years ago. Following the 510(k) clearance, Dr. Kornowski commented, “When we first collaborated, we were trying to solve a real dilemma that interventional cardiologists faced. Doctors knew that conventional FFR provided valuable objective data, but that came with the cost, risk, and time, that ultimately restricted adoption. With the FDA clearance of CathWorks FFRangio, we believe that we have accomplished our goal of providing doctors with objective data to inform their clinical decision-making without an additional intervention. We want to express our deep appreciation for the support of our clinical development partners in Israel, the United States, Europe and Japan in realizing this goal.”

Learn how the CathWorks FFRangio System can impact your practice.

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