CathWorks Adds Vice President of Global Marketing to Leadership Team

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.”

CathWorks FFRangio™ Trial Meets Primary Enpoint and Exceeds Performance Goals

KFAR-SABA, ISRAEL (September 24, 2018) — The journal Circulation published results from the CathWorks FFRangio™ FAST-FFR clinical trial in an article titled Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. The publication and trial results were announced today at the 2018 TCT (Transcatheter Cardiovascular Therapeutics) annual meeting in San Diego, California.

The FAST-FFR trial demonstrated that the sensitivity and specificity of the CathWorks FFRangio System were 93.5% and 91.2%, respectively, both of which exceeded the trial’s pre-specified performance goals. The diagnostic accuracy was 92% overall, and remained high when considering only FFR values in the critical zone between 0.75 and 0.85. As a result, the trial concluded that the CathWorks System has the promise to substantially increase physiologic coronary lesion assessment in the cath lab, potentially leading to improved patient outcomes.

The CathWorks FFRangio System is a non-invasive FFR platform that quickly and precisely delivers objective multi-vessel physiologic measurements to cost-effectively optimize and confirm intraprocedural percutaneous coronary intervention (PCI) therapy decisions. It is designed to deliver the objective FFR guidance needed to optimize PCI therapy decisions for every patient.

Stephan Achenbach, MD, FSCCT is Chairman of Cardiology and Professor of Medicine at the University of Erlangen, Germany, and was the leading enroller in the FAST-FFR trial. Dr. Achenbach explained the importance of the clinical findings in this trial; “Guidelines mandate that revascularization decisions are based on the presence of ischemia. However, not every stenosis or invasive angiography, even if perceived as ‘severe,’ causes ischemia. Equally important, lesions that do not appear severely stenotic may cause ischemia at times and may hence benefit from revascularization. Invasive angiography in such cases is incomplete without assessment of ischemia. Invasive FFR is considered the standard of care in these situations but adds cost and a significantly higher level of invasiveness to the angiogram, leading to pronounced under-use in clinical reality. Enrolling many patients in the FAST-FFR trial, my team and I experienced how easily the CathWorks FFRangio System can be added to the angiogram. The published trial results convincingly demonstrate the clinical benefit that may be derived. The CathWorks System may turn out to be disruptive technology that changes the workflow in the cath lab – to the benefit of our patients.”

The FAST-FFR trial was rigorous. CathWorks FFRangio System data was measured by 19 on-site cath-lab clinicians blinded to the invasive FFR measurements. Angiograms were acquired by dozens of operators at ten hospitals using all four of the major angiography systems (Siemens, Phillips, Canon, and GE). In addition, a majority of subjects were overweight or obese, and 20 percent had calcified lesions. In the presence of all of these real-world conditions, CathWorks FFRangio accuracy was still very high.

William Fearon, MD, Professor of Cardiology at Stanford Medical Center in Palo Alto, California, was the Principal Investigator of the trial and lead author. Dr. Fearon pointed out that “The results of the FASTNEWS RELEASE Contact: Jim Corbett, CEO +1 949.395.1214 jim.corbett@cath.works Rapaport Street Kfar-Saba 4465141, Israel | www.cath.works FFR trial demonstrate a very high accuracy and strong correlation between the reference standard, pressure wire-derived FFR and FFRangio. Based on these findings, FFRangio has the potential to substantially increase physiologic coronary lesion assessment in the catheterization laboratory, thereby leading to improved patient outcomes.”

The CathWorks FFRangio System is in development and is not yet FDA- cleared.

CathWorks FFRangio System delivers objective measurements to confirm PCI decisions.
CathWorks FFRangio System delivers objective measurements to confirm PCI decisions.

CathWorks FFRangio™ System Clinical Review Featured in TCT 2018 Program

KFAR-SABA, ISRAEL (September 12, 2018) — The CathWorks FFRangio™ System will be featured in a TCT Lunch Presentation Theater Program held during the 2018 TCT (Transcatheter Cardiovascular Therapeutics) annual meeting in San Diego. The event titled “FFRangio for PCI Guidance: A Clinical Review”, will be presented on September 24, 2018 at 1:00 PM in Presentation Theater 5.

The program will feature a panel of experts discussing their experiences with the CathWorks FFRangio System. Presentations will include: 1) In-depth review of FAST-FFR pivotal trial results, 2) Deep dive into FAST-FFR subgroups and secondary endpoints, 3) The benefits of the CathWorks FFRangio System in multi-vessel disease, and 4) How daily use of the CathWorks FFRangio System can change clinical practice in the future.

Program presenters feature leading interventional cardiologists from around the globe: William F. Fearon, MD – Stanford University Medical Center in Palo Alto, CA; Nils P. Johnson, MD, MS – McGovern Medical School at UT Health in Houston, TX; Hitoshi Matsuo, MD – Gifu Heart Center in Japan; and Peter Fitzgerald, MD – Stanford University Medical Center in Palo Alto, CA.

The program is free of charge, open to all registered TCT attendees, and lunch will be served. Seating is limited. You can register online at www.crf.org/tct/agenda/satellite-programs. For more information about the course content and presenters, visit www.cath.works.

CathWorks also announced that the FAST-FFR pivotal trial has been added to the late-breaking clinical science program during the 2018 TCT annual meeting. FAST-FFR trial data will be presented in the Main Arena during the late-breaking clinicals session that begins at 12 noon on Monday, September 24. The FAST-FFR pivotal trial was designed to evaluate the efficacy of the CathWorks FFRangio System in terms of sensitivity and specificity when compared to conventional invasive FFR.

The CathWorks FFRangio System is not FDA-cleared and is not yet available for sale within the United States.

FAST-FFR Pivotal Trial Added To TCT 2018 Late-Breaking Clinical Trial Program

KFAR-SABA, ISRAEL (August 29, 2018) — CathWorks announced that the FAST-FFR pivotal trial has been added to the late-breaking clinical science program during the 2018 TCT (Transcatheter Cardiovascular Therapeutics) annual meeting in San Diego. FAST-FFR trial data will be presented in the Main Arena during the late-breaking science session that begins at 12 noon on Monday, September 24.

The FAST-FFR pivotal trial was designed to evaluate the efficacy of the CathWorks FFRangio™ System in terms of sensitivity and specificity when compared to conventional invasive FFR. Trial enrollment began September 27, 2017 and the final patient was enrolled just eight (8) months later on June 7, 2018. The FAST-FFR pivotal trial was performed at ten leading cardiovascular centers including University of Erlangen in Germany, Stanford University, Columbia University, St. Francis Hospital, and University of Pennsylvania in the United States; Rabin Medical Center, Share Zedek Medical Center and HaSharon Medical Center in Israel; OLV Aalst in Belgium; and Rigs Hospital CPH in Denmark.

In addition to inclusion in the late-breaking clinical trials program, the CathWorks FFRangio System will also be featured in a TCT Lunch Presentation Theater program titled “FFRangio for PCI Guidance: A Clinical Review”. The program will be presented on September 24, 2018 at 1:00 PM in Presentation Theater 5 during the conference.

The program will feature a global panel of experts discussing their experiences with the CathWorks FFRangio System. Presentations will include: 1) In-depth review of FAST-FFR pivotal trial results, 2) Deep dive into FAST-FFR subgroups and secondary endpoints, 3) The benefits of CathWorks FFRangio in multivessel disease, and 4) How daily use of CathWorks FFRangio System can change clinical practice in the future.

The Presentation Theater Program is free of charge, open to all registered TCT attendees, and lunch will be served. Seating is limited. You can register online at www.crf.org/tct/agenda/satellite-programs. For more information about the course content and presenters, visit www.cath.works.

The CathWorks FFRangio System is not FDA-cleared and is not yet available for sale within the United States.

CathWorks FFRangio™ System files FDA 510(k) Submission

KFAR-SABA, ISRAEL (August 22, 2018) — CathWorks announced that it has submitted its CathWorks FFRangio™ System to the United States Food & Drug Administration (FDA) for review and 510(k) market clearance.

The CathWorks FFRangio System is the non-invasive FFR platform that quickly and precisely delivers objective multi-vessel physiologic measurements to cost-effectively optimize and confirm intraprocedural PCI therapy decisions. It is designed to deliver the objective FFR guidance needed to optimize percutaneous coronary intervention (PCI) therapy decisions for every patient.

The FDA 510(k) submission was filed on August 7, 2018. This submission was made possible following early, full enrollment of the FAST-FFR trial.

CathWorks CEO Jim Corbett said, “The FAME trials clearly demonstrated the clinical and economic value of FFR in PCI decision-making. We are confident that the CathWorks FFRangio System meets a real need for patients and physicians, and we expect the system to make non-invasive, wire-free FFR possible in coronary angiograms; reducing wire-related risks and costs.”

Corbett went on to add, “We anticipate 510(k) market clearance by the end of 2018. Given the CathWorks System’s compatibility with major coronary angiogram platforms and a clear CPT code, we expect the system to start benefitting physicians and their patients very soon.”

The CathWorks FFRangio System is in development and is not yet FDA cleared or available for sale within the United States.

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