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 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. The CathWorks FFRangio™ System has already received regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in December 2019 and is also commercially available in the United States and Europe.

“The FFRangio System enables us to quickly identify the physiologic significance of coronary artery disease (CAD) without the need for traditional pressure wires or hyperemic agents, which provides significant benefits to clinicians and patients,” said Hiroyoshi Yokoi, M.D., President of Fukuoka Sanno Hospital and Vice Chairman, Japanese Association of Cardiovascular Intervention and Therapeutics. “The Japan reimbursement approval is an important step to enable more physicians and patients to have access to this innovative technology.”

“When patients present with suspected CAD, it is important that we can quickly and cost-effectively determine the appropriate treatment plan,” said Hitoshi Matsuo, M.D., President of Gifu Heart Center. “Our facility has been able to experience firsthand how FFRangio combines artificial intelligence, machine learning, and a streamlined user experience to improve the way we manage and treat our patients.”

The FFRangio System is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs. Clinical trials have demonstrated the FFRangio system is highly accurate compared to traditional wire based fractional flow reserve (FFR) methods. 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 reimbursement approval in Japan is a significant and important milestone for CathWorks” said Ramin Mousavi, CEO of CathWorks. “We are pleased with the early adoption of FFRangio in Japan, and grateful for the tremendous physician support of the technology. We look forward to expanding our commercial presence to make FFRangio and non-invasive CAD decision-making available to more clinicians and patients in Japan and around the world.”

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. For more information, visit cath.works.

1 Iso H. Changes in Coronary Heart Disease Risk Among Japanese. Circulation.2008;118:2725-2729

Follow CathWorks

Contact Information:

Ben Brockman, 1.949.966.0284, [email protected]

CathWorks FFRangio System Case Review – Highlight from Dr. Rahul Sharma’s CVIT Presentation

The CathWorks FFRangio System is revolutionizing treatment decisions for coronary artery disease with quick, non-invasive, wire-free 3D FFR guidance.

In this excerpt from his webinar presentation at CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, presents a case study that demonstrates the highly accurate multi-vessel FFR insights delivered by the FFRangio System.

The case study demonstrates:

  • Starting the FFRangio analysis
  • Angiogram selection
  • Vessel lumen tracing
  • FFRangio final results with sizing tool
  • Stent placement and post-PCI results*

Watch Dr. Sharma’s full CVIT webinar here

*The diagnostic performance of FFRangio compared to FFR wires has not been established for lesions immediately after PCI.

Introducing the Latest FFRangio System – Video Highlight from Dr. Rahul Sharma’s CVIT Webinar

The latest CathWorks FFRangio System delivers wire-free and drug-free 3D FFR guidance that is practical for every case.

In this video highlight from CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, gives a “live” view of the software interface and details the essential information depicted on screen, including:

  • Accurate multi-vessel FFR
  • 3D model of the coronary tree
  • FFRangio | IMPACT – characterizing overall disease burden
  • Angiograms overlaid with 3D QCA and FFR
  • Sizing tool and 3D QCA – aids in procedural planning

Watch Dr. Sharma’s full CVIT webinar here

How Does FFRangio Work? – Insights from Dr. Rahul Sharma’s CVIT 2021 Presentation

FFRangio is a non-invasive, angiography-based system that provides quick, wire-free, and drug-free assessment of FFR for multiple vessels.

In this video highlight from CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, gives an overview of how FFRangio works.

Topics include:

  • 3D model reconstruction – including 3D QCA from routine angiograms without an invasive wire
  • Resistance analysis and FFR – from resistance mapping and computational FFR modeling
  • 3D physiology – with superimposed, color-coded FFR values in multiple vessels
  • FFRangio system results – highlighting the software interface and the important information depicted on screen at the end of analysis

Watch Dr. Sharma’s full CVIT webinar here

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.

A rising star of the medical device industry, Mr. Mousavi has executive leadership and operational experience in general management, marketing, strategy, product development, and commercialization across multiple market segments. Most recently, Mr. Mousavi led the patient monitoring and digital health portfolio at Baxter International. Prior to Baxter, he held various leadership assignments at Edwards Lifesciences. Mr. Mousavi served as CathWorks Vice President of Global Marketing & Strategy and the company’s Chief Marketing Officer from 2019 to 2020. Ramin holds B.S. degrees in Computer and Electrical Engineering from University of California, Irvine. He also earned an M.B.A. from Paul Merage School of Business at UC, Irvine, and received a Healthcare Executive Leadership certificate for Business Innovation in Global Healthcare from Harvard Business School. 

“On behalf of the Board of Directors, I would like to thank Jim for his leadership and many important contributions to Cathworks and I am very pleased to welcome Ramin back to our company,” said Scott Ward, Chairman of the Board of CathWorks. “Ramin’s extensive knowledge of CathWorks innovative technologies—combined with his proven track record of building high-performing teams that design, develop, and launch breakthrough innovative products and programs that help patients—makes him uniquely positioned to lead CathWorks. The Board is confident that under Ramin’s leadership, CathWorks is well-positioned for our next phase of technology innovation, market adoption, and global commercial growth.”

“I am honored and delighted to have the opportunity to lead CathWorks, a company with a transformational product portfolio, exceptionally talented people, and committed investors as well as strategic partners,” commented Ramin Mousavi. “CathWorks’ innovative FFRangio technology has the potential to become the standard of care, enhancing the diagnostic decision making of cardiologists around the world. I look forward to working with our clinician partners, employees, the executive management team, and the Board in our mission to provide clinicians with practical, objective physiology information for every patient they treat, and to deliver meaningful value to our patients, customers, and shareholders.”

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.

FFRangio in Clinical Practice – CVIT Webinar + Q&A with Dr. Rahul P. Sharma

In this virtual webinar presentation from CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, shares his experience with the latest FFRangio software and discusses important benefits of FFRangio for routine clinical practice.

At the end of the video, there is a question-and-answer session with renowned cardiologists Dr. Hitoshi Matsuo of Gifu Heart Center and Dr. Hiroyoshi Yokoi of Fukuoka Sanno Hospital.

Video topics include:

  • Why do we need image-based FFR?
  • How does FFRangio work?
  • An overview of the latest FFRangio system
  • FFRangio clinical integration, including use at Stanford Medical Center
  • LAD lesion case study
  • Panel question-and-answer session

FFRangio in Clinical Practice – An Interview with Dr. Antreas Hindoyan

An Interview with Antreas Hindoyan, MD Dr. Hindoyan, interventional cardiologist at Keck Hospital of USC, discusses the future of coronary physiology and how the CathWorks FFRangio™ System can provide value for PCI decision-making.

How have you integrated wire-based FFR into clinical practice at Keck Hospital of USC? Why is it important for your practice?

I’ve been using FFR since I was a cardiology fellow, and it has become an integral part of our standard PCI procedure workflow at Keck USC. FFR is now a part of the vernacular among the staff. Whenever we have a questionable lesion, it’s not only the doctor suggesting a physiology assessment—the techs and staff are also vocal about using FFR.

The whole goal of treatment is to make the patient feel better and improve outcomes. For patients with stable CAD and an intermediate lesion, it can be unclear which treatment is best for them. That is where an objective measurement will be most useful. If you have a lesion that is not hemodynamically significant, the data shows that a stent will not provide any extra benefit compared to medical therapy. So FFR really standardized our process of deciding which CAD patients should get a stent and which should not.

Are you seeing more hospitals adopting FFR over time?

Yes. Over the last 10 years FFR utilization has increased steadily, and it’s starting to become standard of care in most hospitals. FFR is very easy to conceptualize and provides a clear benefit, and that’s part of the reason why more physicians are adopting it.

I think we’ll see more growth and adoption going forward. It will continue to be important for physicians to have clear documentation of hemodynamic significance prior to stenting, especially for patients with intermediate lesions. Even if the patient arrives at the Cath lab with a stress test or a nuclear test, there is no substitute for a significant FFR value to determine if the patient needs a stent.

Data continues to support broader use of FFR to guide PCI decision-making, but it’s still underutilized compared to clinical guideline recommendations. What needs to happen to make FFR standard of care for more patients?

Procedure time is a big factor. In the Cath lab, the most important commodity is time. The longer you stay in the Cath lab, the greater the risk of complications, patient discomfort, and other issues. You want to be as efficient as possible.

For pressure wire FFR, you need to consider how Adenosine might affect the patient. Hyperemia causes drops in blood pressure and patients feel flushed, which they don’t like. And if you have a patient with a tenuous blood pressure, you might have some issues.

There’s also a risk of complications, especially with oldergeneration pressure wires that are more difficult to handle compared to standard workhorse wires. It would be horrible to cause a dissection in the vessel during a simple diagnostic test. And if a patient has thrombocytopenia, high INR, or cirrhosis with a low platelet count, you want to avoid heparin and placing a wire unless you really need to.

I think all these factors give pause to the interventionalist, which explains the underutilization we’re seeing. Any new FFR technology that addresses some or all these limitations would be very welcomed in the Cath lab.

You’ve been using the wire-free and drug-free CathWorks FFRangio™ System for about a year now. What was your initial experience like?

As an interventionist, you are generally skeptical of new technology, so we wanted to validate the technology ourselves. Early on, we had a patient with a mild/intermediate lesion that I would have guessed did not need a stent. We decided to run an FFRangio analysis and the results showed FFR was significant at 0.72, which was surprising. So, we ran a wire-based FFR just to be sure and got a very similar result. Clearly, there was correlation between the two technologies, and they both told me something different than what I predicted based on the angiogram. We ended up stenting and the patient did great with a lot of symptom improvement. That was a galvanizing experience for us and the moment we knew the technology worked. And we had several similar cases after that, which gave us a lot of confidence. Once we adopted the technology, we started using it in patients we would not normally use wire-based FFR in. Since it doesn’t require heparin or Adenosine, we can actually apply it to more patients.

What do you think are the main benefits of FFRangio compared to traditional wire-based FFR?

FFRangio has added both benefit and safety to the Cath lab. Getting rid of Adenosine is important, especially for patients with a tenuous blood pressure. But we’ve seen a greater benefit in getting rid of heparin. For some patients, we’re hesitant to use a pressure wire because of the risk of complications and bleeding from anticoagulation. Now we can evaluate these patients with FFRangio and still get an accurate FFR measurement. If the patient has a normal FFR, it’s nice that you can send the patient home with just a diagnostic angiogram, and you would have avoided heparin and Adenosine.

The ability to get results quickly in multiple vessels is another advantage of FFRangio. Sometimes you have multiple lesions, and you need a treatment strategy for each one. With the wire, you would have to do multiple measurements, and you need to be sure the Adenosine has completely left the system before the second injection. With FFRangio, you don’t have to worry about that because the analysis is based on angiogram images.

What has the process been like to integrate FFRangio into practice at Keck USC? Any advice for other physicians considering the technology?

In our lab, our CV techs and nurses run the FFRangio analysis. They get the analysis started while I take some additional images. I assist with selecting angiograms and identifying vessels/lesions, but our staff usually drives the process. Our CathWorks rep was great in helping us get comfortable with the technology and get past the initial learning curve. Speed, accuracy, and ease of use are the most important factors. I’ve now seen a couple product iterations and with every update, it’s become more efficient, faster, and more user friendly. I think FFRangio has been easy to use for our team.

I am very happy I had the opportunity to be one of the early adopters of FFRangio. I’m a firm believer in the technology and think of it as my first-line tool for physiology guidance. My advice to other physicians is to try it. Once you have the proper training, it makes your Cath lab more efficient and safer and takes the guesswork out of some complex patients where the wire may not be the optimal choice.

Now that non-invasive technologies like FFRangio are available, what do you think is the future of physiologybased PCI guidance?

I think use of physiology guidance will continue to increase over time. The patient benefit is clear, and you always want an objective justification for the stenting decision. One area I think we’ll see some growth is evaluating FFR after PCI. There’s value there, but the concept has not yet caught on because interventionalists are hesitant to place another wire and risk a potential complication unless they have to. With a non-invasive technology, you might be more inclined to check FFR after stenting and provide additional treatment if the resulting FFR value is still low.*

Another interesting application: in some hospitals, you may also start to see non-interventional cardiologists adding an FFRangio analysis to their diagnostic angiograms. Since it doesn’t require an additional intervention, it creates an opportunity to assess FFR for cardiologists who wouldn’t normally do a wire-based procedure. I can absolutely see quick, non-invasive FFR technologies like FFRangio replacing wire-based methods and becoming the first option for physiology guidance. Ultimately, by expanding the patients who can get FFR, it should improve outcomes and satisfaction for more patients.

*Diagnostic performance of FFRangio compared to FFR wires has not been established for lesions immediately after PCI.

Learn how the CathWorks FFRangio System can impact your practice.

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