Constriction, Pathologic

HeartFlow's non-invasive AI driven FFRCT predicts patient outcomes as effectively as the gold-standard invasive FFR out to 10 years MOUNTAIN VIEW, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that 10-year follow-up data from its DISCOVER-FLOW study were published in the Journal of Cardiovascular Computed Tomography. At 10 years, HeartFlow’s FFRCT Analysis, a non-invasive test for coronary artery disease (CAD), showed strong long-term risk stratification and displayed the risk continuum as effectively as invasive fractional flow reserve (FFR).1 DISCOVER-FLOW was the first trial evaluating the HeartFlow FFRCT Analysis and the new analysis aimed to determine the long-term prognostic implications of lesion-specific FFRCT in patients with suspected or known CAD. Key Takeaways from the study: FFRCT was as predictive of patient outcomes through 10 years as invasive FFRLesions with lower FFRCT values were associated with ever-higher rates of cardiovascular death, heart attack, or a need for revascularization (stenting or bypass surgery) over the 10-year periodFFRCT was superior to CCTA stenosis severity alone for diagnosis of lesion-specific flow impairmentFFRCT is a critical part of the CAD diagnostic toolkit, equivalent to invasive FFR “It’s rare to have the opportunity to follow patients for 10 years in clinical trials and we are delighted to confirm the long-term prognostic value of FFRCT through the DISCOVER-FLOW study,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “These data are a reflection of our commitment to providing comprehensive clinical evidence on the diagnostic accuracy, safety, efficacy, and utility of the HeartFlow Analysis.” The data build on HeartFlow’s extensive body of clinical evidence supporting AI-powered non-invasive diagnostic testing for patients with CAD. The company has spent the last decade working with clinicians to improve CAD diagnosis, making significant progress validated by high quality clinical evidence. HeartFlow’s approach is centered around scientific rigor with peer-reviewed publications to provide confidence and certainty to clinicians and the patients they serve. HeartFlow is committed to elevating the standard for AI technologies entering the healthcare space. HeartFlow is the first company to offer a suite of technologies to help clinicians non-invasively identify and quantify narrowings in the coronary arteries (RoadMap™Analysis), assess the impact of each specific narrowing on coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Together, this comprehensive solution offers valuable data not currently available with other non-invasive diagnostic tools or CTA-based AI analyses. HeartFlow remains dedicated to reshaping cardiovascular care and was recently selected as a winner of the Fierce MedTech’s Fierce 15 award for moving the CAD diagnostics field forward with AI-powered analyses. The Fierce 15 spotlights the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in healthcare. About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guidelines, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com and connect on Twitter and LinkedIn. About DISCOVER-FLOWDISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional FLOW Reserve), an international, multicenter, prospective study, followed 156 vessels in 102 adults aged 18 and up with suspected or known CAD who underwent CCTA, FFRCT, ICA, and invasive FFR. Vessels were examined to determine the correlation between Target Vessel Failure (TVF) and FFRCT / invasive FFR. The study compared the diagnostic performance of FFRCT with CCTA stenosis for the diagnosis of lesion-specific ischemia, as determined by FFR performed at the time of ICA. DISCOVER-FLOW was conducted at four sites in three countries, Korea, Latvia, and the U.S. and was funded by HeartFlow, Inc. (Mountain View, California). 1 Yang, et al. Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study. JCCT 2024. DOI: 10.1016/j.jcct.2024.01.016 Media contactLinly Kulku@heartflow.com

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract. This new worldwide license marks a significant step forward in EVerZom's mission to bring innovative exosome-based therapeutic solutions to patients suffering from serious digestive diseases. EVerGel ™ has demonstrated promising efficacy in 8 animal models, paving the way for entry into regulatory preclinical studies by the end of 2024 and clinical trials in early 2026. EVerZom participated in the 19th ECCO (European Crohn's and Colitis Organization) Congress, held in Stockholm in February 2024, and presented its advances to clinicians and experts in the field. Paris, March 5, 2024 - EVerZom, a CNRS/Université Paris Cité spin-off specializing in exosomes, has announced the signature of a second exclusive license agreement with Erganeo for the development of EVerGel ™, a drug candidate tailored for the healing of digestive tissues. EVerGel ™ is the first therapeutic program developed by EVerZom in collaboration with Professor Gabriel Rahmi, hepato-gastroenterologist and endoscopist at the Georges Pompidou European Hospital in Paris, andAmanda Silva Brun, winner of the 2021 CNRS innovation medal and director of research at the CNRS Matter and Complex Systems Laboratory at Université Paris Cité. EVerZom initially focused its efforts on the development of an innovative platform, protected by several patents, covering the entire value chain: cell selection, production of high-yield exosomes, their modification and formulation. With the invaluable support of Erganeo, which oversaw the final developments required for these new production methods, the intellectual property was transferred to EVerZom in 2019 and a second exclusive license agreement was signed today. Leveraging these innovative technologies, EVerZom's goal is to demonstrate the therapeutic potential of its exosome platform to address a variety of diseases with significant unmet medical needs. The credibility of this platform has been further strengthened by validation from both national and European innovation ecosystems, in particular through the i-lab innovation contest and the EIC Accelerator program. EVerZom's first clinical application focuses on digestive tissue regeneration using naive exosomes derived from stem cells encapsulated in a gel called EVerGel ™. EVerGel's lead indication is the healing of complex ano-perianal fistulas induced by Crohn's disease. In addition, EVerZom has identified several other indications in its pipeline, all of which have demonstrated proof of concept in vivo. These include stenosis, the healing of surgical anastomoses following tumor resection of the digestive tract, including the investigation of post-operative adhesions (esophageal, rectal and colon cancers). EVerGel ™ can be delivered endoscopically or injected directly into the fistula. "Preclinical studies have demonstrated the efficacy of EVerGel™ in 8 animal models, including three porcine models. The results are very encouraging, with over 85% complete closure of fistulas treated by endoscopic injection, compared to only 12% in the control group. These results are particularly promising for patients suffering from complex digestive fistulas or stenosis, who require innovative treatments to improve their quality of life. I am convinced that EVerGel™ will meet this need", says Prof Gabriel Rahmi, clinical hepato-gastroenterologist at the HEGP and co-inventor of EVerGel ™. In February 2024, EVerZom participated in the 19th Congress of the European Crohn's and Colitis Organization (ECCO) in Stockholm to share with clinicians and innovation experts the latest preclinical data on its exosomes-based therapies, in particular EVerGel ™, and their clinical prospects. *** About exosomes Exosomes are one of the main communication pathways between the body's cells, via lipids, proteins, and nucleic acids, among others. The size of these biological nanoparticles is about 150 nm, and these particles are found everywhere in our body and fluids (blood, urine, saliva) by 10 times more in the body compared to cells. Acting as FedEx for cells, exosomes have amazing properties: they have a low immunogenicity (i.e. they don't trigger immune system reactions) and have a strong natural capacity for cell uptake enabling strong targeting. The high interest in exosomes research and applications is leading to an explosion in the number of publications, with more than 8500 in 2022, and an increase in the number of clinical trials in which their safety, and first signals of efficacy have been demonstrated. Last but not least, over the last 5 years, exosomes have been the focus of a sharp increase in partnerships between Big Pharma and innovative biotechs. Leveraging its innovation platform, EVerZom’s ambition is to develop its pipeline of proprietary biotherapies in regenerative medicine, while building partnerships in several other indications. About EVerGel ™ EVerGel ™ combines exosomes derived from stem cells with a heat-sensitive gel, enabling targeted and precise delivery. Preclinical studies have demonstrated promising efficacy in 8 animal models, paving the way for regulatory preclinical entry scheduled for the end of 2024 and entry into clinical trials at the end of 2026. Crohn's disease is a chronic inflammatory disease of the digestive tract that affects approximately 2 million people worldwide. More than 50% of these patients will develop ano-perianal fistulas during the course of their disease, and in more than one-third of patients, ano-perianal lesions will be at the origin of the diagnosis. The persistence of fistulas tracts is a marker of the severity of Crohn's disease and has a significant negative impact on patients' quality of life and functional prognosis. This complication requires complex, multidisciplinary treatment (surgery and biological drugs), the results of which are still unsatisfactory, with only 40% of patients achieving complete healing of the complex fistula. EVerGel ™ is expected to enter regulatory preclinical trials by the end of 2024, with first-in-man administration within 2 years. About EVerZom – everzom.com EVerZom, a CNRS/ Université Paris Cité spin-off dedicated to exosomes, was created in 2019 with the aim of becoming a leader in exosome biotherapies. To this end, the company has developed a proprietary platform that covers the entire technological value chain: cell sourcing, exosome generation, engineering, and formulation. Winner of numerous awards and programs, including the i-Lab program and the prestigious EIC Accelerator for its technological innovation platform, EVerZom is developing a pipeline of proprietary drug candidates in regenerative medicine, while leveraging on partnerships in many other indications. Press contact: Marie Puvieux, presse@atcg-partners.com, +33 6 10 54 36 72 About Erganeo - Erganeo is a French technology transfer company specializing in disruptive innovations (DeepTech) with a high societal impact. We invest as early as possible to secure researchers' new inventions, before they are transferred to industry or start-ups are created, in a wide range of scientific fields: Biotech (health, agrifood, environment, cosmetics), Infotech (telecoms, internet of things, big data, AI), Enertech (green energies, chemistry, materials), and so on. Our mission is to accelerate and simplify the links between research and industry, in the interests of societal progress. To do this, we fund and support the next generation of French researcher-entrepreneurs, helping them to achieve success and international recognition. As a member of the SATT network, Erganeo is laying the foundations for a desirable future in the Paris Region ecosystem, a breeding ground for innovation with 20,000 researchers in over 350 cutting-edge research laboratories. Since its creation, Erganeo has invested nearly €44m, helping to sign 120 licenses with companies of all sizes and to create 34 start-ups. Press contact: Caroline Pontifice - caroline.pontifice@erganeo.com Attachment PR in English

Company’s AI-enabled technology for future heart attack risk assessment accepted into FDA’s TAP Pilot and to be validated in landmark TRANSFORM trial DENVER--(BUSINESS WIRE)-- Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia. Its purpose is to support physicians with a more accurate and personalized risk assessment for patients at risk of major adverse cardiovascular events (MACE), including heart attacks, before they happen. The FDA’s Breakthrough Device Designation is granted for technologies that have the possibility to encourage more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The FDA supports these novel technologies to ensure timely availability when no approved alternatives exist and/or because these technologies hold potential for considerable improvement over existing approved alternatives for patients. The Cleerly CAD Staging System was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot. Only devices that have gained Breakthrough Device Designation are accepted into the TAP Pilot, with the purpose to help companies make these devices accessible to patients and physicians as quickly as possible. “As Cleerly continues to develop cardiovascular innovations to support patients and healthcare professionals, we are honored to have received Breakthrough Device Designation and join the TAP Pilot,” said James K. Min, MD, Founder and CEO of Cleerly. “This designation from the FDA highlights the critical need for better heart disease risk assessment methods. Our approach to heart disease, inspired by the most successful preventive care paradigms in medicine – including mammograms, colonoscopies, and lung CTs – enables personalized diagnosis and risk assessment and exemplifies our commitment to enhancing CAD evaluation, aiming to prevent heart attacks before they occur.” The Cleerly CAD Staging System will be further validated in the landmark TRANSFORM randomized controlled trial that will enroll individuals who are asymptomatic for heart disease with diabetes, pre-diabetes or metabolic syndrome. Current assessment for future MACE in asymptomatic patients is still based on risk factors rather than the diagnosis and staging of actual CAD, the cause for the vast majority of heart attacks. While risk factors show reasonable prognostic value across a large population, they are indirect markers of CAD, and their relationship with CAD severity and CAD risk on an individual level is unpredictable and unreliable. “As our Cleerly CAD Staging System becomes available to physicians and patients, it will provide the rationale for preventive tailored treatment of CAD with risk-based therapy goals,” said Udo Hoffmann, MD, MPH, Chief Scientific Officer of Cleerly. “We are thrilled that we’re able to work closely with the FDA and our TRANSFORM partners to demonstrate the effectiveness of the CAD Staging System in a scientifically rigorous way and eventually offer it to all patients who may benefit.” Cleerly is committed to accelerating the availability of its technology to healthcare providers and patients alike. Cleerly’s mission extends beyond innovation; it is a commitment to saving lives by revolutionizing the prevention and treatment of heart disease. About Cleerly® Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced non-invasive CT imaging. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: .