FUSION trial presented at ESC and published in Journal of the American College of Cardiology demonstrates adding non-invasive lesion-specific physiology resolves critical diagnostic uncertainty, supporting Appropriate Use Criteria for cath lab referralsSAN FRANCISCO, Aug. 28, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today announced late-breaking one-year results from an independent randomized clinical trial proving the Heartflow FFRCT Analysis safely and significantly reduced unnecessary invasive heart procedures by 44% (p < 0.001). Presented as Late-Breaking Science at the European Society of Cardiology (ESC) Congress 2026, FUSION trial, funded by the Dutch National Health Care Institute, demonstrates that standard coronary computed tomography angiography (CCTA) alone drives overutilization of invasive catheterizations.1 By adding Heartflow FFRCT Analysis to standard CCTA scans, clinicians dramatically reduced diagnostic catheter lab procedures. The FUSION study has been published simultaneously in the Journal of the American College of Cardiology (JACC). CCTA is the primary first-line test recommended by both European (ESC) and U.S. (ACC/AHA) guidelines for evaluating patients with suspected CAD. However, visual assessment of CCTAs is limited to assessing anatomy and whether plaque is present; it cannot determine lesion-specific physiology or whether a blockage significantly restricts blood flow to the heart. This diagnostic uncertainty frequently leads physicians to refer patients for invasive coronary angiography (ICA), a hospital procedure where a catheter is threaded through an artery, normally in the groin or arm, to get into the heart to assess blocked or narrowed blood vessels.1,2,3,4 These findings show Heartflow FFRCT – the only AI platform prospectively validated against invasive gold standard – bridges this critical diagnostic gap. By applying advanced AI and computational fluid dynamics to standard CT scans with documented narrowings, Heartflow creates a personalized 3D model that quantifies blood flow within the coronary arteries.5 “CCTA is established as the optimal first-line diagnostic test for coronary artery disease as it is noninvasive, but when anatomical scans show intermediate stenosis, determining whether that blockage is clinically significant remains a critical challenge,” said Alexander Hirsch, M.D., principal investigator of the FUSION trial and associate professor of cardiology at Erasmus MC in Rotterdam, Netherlands. “The FUSION trial shows that adding Heartflow lesion-specific physiology makes CCTA even more powerful and improves diagnostic efficiency. It gives clinicians the clarity to know which patients require further invasive testing, safely avoiding unnecessary invasive catheterizations while maintaining excellent patient outcomes.” One-Year FUSION Results Enrolling 528 patients with stable chest pain across twelve hospitals in the Netherlands, FUSION is an independent randomized controlled trial funded through the Dutch government’s Zorginstituut Nederland ‘Potentially Promising Care’ program. The study evaluated Heartflow FFRCT Analysis across diverse scanner vendors in both academic and community hospital settings, with blinded, independent clinical event adjudication. Key 1-year findings include: A sustained 44% relative reduction in unnecessary ICA was demonstrated at one year in the Heartflow pathway compared to the CCTA-only group (22% [57/263] Heartflow vs. 39% [103/265] CCTA alone; p < 0.001), consistent with the 90-day primary endpoint results (18% [48/263] vs. 33% [87/265] CCTA alone; p < 0.001).Overall rates of ICA were significantly lower at one year in the Heartflow pathway compared to the CCTA-only group (43% [114/263] Heartflow vs. 61% [161/265] CCTA alone; p 50% non-obstructive rate in usual care elective caths).2 Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCAI Guideline for the Evaluation and Diagnosis of Chest Pain. Circulation 2021; 144:e368–e454.3 Vrints C, et al. 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. Eur Heart J 2024; 00:1–105.4 Tonino PA, et al. Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME). N Engl J Med 2009; 360:213-224.5 Taylor CA, et al. Computational Fluid Dynamics Applied to Coronary Computed Tomography Angiography. J Am Coll Cardiol 2013; 61(22):2233-2241.6 Curzen N, et al. Fractional Flow Reserve Derived From Computed Tomography in Suspected Stable Angina: The FORECAST Trial. Eur Heart J 2021; 42(37):3807-3818.7 Douglas PS, et al. A Clinical Pathway to Optimize the Diagnostic Workup of Patients With Suspected CAD: The PRECISE Randomized Trial. JAMA Cardiol 2023; 8(7):643–652.8 15-Year Evidence Base includes DISCOVER-FLOW (JACC 2011), DeFACTO (JAMA 2012), NXT (JACC 2014), PLATFORM (Eur Heart J 2015), and ADVANCE Registry (Eur Heart J 2019).9 Narula, et al. EHJ CVI 2024.10 Danad, et al. JAMA Cardiol 2017.11 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI).12 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024. (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years).
Author: Ken Dropiewski
Florida’s First Pediatric Cardiac Robotic Surgery Performed at Nicklaus Children’s Hospital
Cardiovascular Surgeons within Nicklaus Children’s Hospital Heart Institute Have Completed the First Robotics-Assisted Atrial Septal Defect (ASD) Repair in Florida and One of Few in the Nation MIAMI, Aug. 27, 2026 /PRNewswire/ — The cardiovascular surgery team at Nicklaus Children’s…
Philips and Imricor launch cardiac interventional MR lab solution, expanding longstanding collaboration
Philips MR
Philips and Imricor’s new iMR lab solution combines 1.5T MRI with MR-compatible systems and tools to support MR-guided cardiac interventions.
August 27, 2026 The solution combines Philips’ high-performance 1.5T MRI platform and advanced interventional workflow capabilities with Imricor’s exclusive portfolio of systems and consumables for MR-guided cardiac interventions. Amsterdam, the Netherlands – August 27, 2026: Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Imricor Medical Systems (ASX: IMR), a pioneer and world-leading developer of MR-compatible products for interventional MR procedures, today announced a new Interventional MR (iMR) lab solution for Philips 1.5T MR. The first commercially available configuration [1] combines Philips’ 1.5T MRI platform and Imricor’s portfolio of iMR systems and consumables, enabling an MR-guided workflow for cardiac intervention, without compromising on MR field strength. Meeting the need for greater tissue insight during cardiac intervention Cardiac arrhythmias affect millions of people worldwide, and catheter ablation is an established and increasingly utilized treatment for many complex cardiac arrhythmias. Yet today, these procedures continue to rely primarily on X-ray fluoroscopy, which provides only indirect visualization of soft tissue while exposing patients and clinical teams to ionizing radiation. MRI has already transformed cardiac diagnosis by enabling clinicians to visualize cardiac anatomy and tissue in exceptional detail. Bringing that same level of tissue insight into intervention has the potential to help physicians guide therapy more precisely, assess treatment response during procedures and identify potential therapy gaps before a patient leaves the procedure room – all within a radiation-free work environment of an iMR. “Our ambition is not only to advance what clinicians can see with MRI, but also what they can do with it,” said Ioannis Panagiotelis, PhD, Business Leader, Magnetic Resonance at Philips. “Philips has a long history of helping clinicians perform image-guided procedures with confidence, and we believe MRI can play an even greater role in providing care. With this new iMR lab solution, enabled through our collaboration with Imricor, we’re expanding the role of cardiac MRI from diagnosis into the treatment environment.” Panagiotelis added, “Cardiac electrophysiology is just the beginning. This iMR lab solution represents an important step in Philips’ strategy to advance MRI across the care continuum, creating a platform that can expand into additional clinical areas while helping clinicians deliver the best possible care for their patients.” iMR built on Philips’ leading cardiac 1.5T MRI platform The iMR lab solution combines Philips’ high-performance 1.5T MRI platform with Imricor’s portfolio of MR-compatible systems and consumables to create a complete, connected environment for MR-guided cardiac intervention – marking the next milestone in the companies’ long-standing collaboration to bring MR-guided cardiac intervention into routine clinical practice. The first commercially available configuration includes Philips’ Cardiac MR Suite, featuring SmartHeart AI-powered cardiac planning and advanced cardiac imaging applications alongside Imricor’s NorthStar® iMR mapping and guidance system, Advantage-MR® EP Recorder/Stimulator and Vision-MR® family of electrophysiology catheters [2]. Together, these technologies enable physicians to visualize cardiac anatomy and arrhythmia substrate, actively track catheters, perform electroanatomical mapping, assess lesion formation and evaluate treatment response throughout procedures within Philips’ 1.5T MR environment. For hospitals, the iMR lab solution provides a turnkey platform for MR-guided cardiac intervention, bringing together advanced imaging, intelligent workflows and MR-compatible interventional technologies. The solution is built on Philips’ BlueSeal helium-free MRI technology[3], reducing siting complexity and enabling installation closer to cardiology departments, helping support adoption today while establishing a scalable foundation for future iMR-guided procedures. “With interventional MR, the idea is not to move procedures into diagnostic MRI suites, but rather to bring MR imaging into the procedure room, a room we call an iMR lab,” said Steve Wedan, Founder and CEO of Imricor. “Our collaboration with Philips has always been driven by this shared vision, and with our combined iMR lab solution, that vision becomes a reality today. Pairing Philips’ world-class 1.5T MR platform with Imricor’s exclusive portfolio of advanced iMR systems and interventional tools creates the world’s first state-of-the-art high-performance iMR lab solution. We believe the future is about advanced image guidance for therapies and interventions, and the future is here now.” The iMR lab solution will be showcased in Munich at ESC Congress 2026 and is commercially available immediately in CE-marked markets and, in some configurations, the U.S. Further Imricor configurations are expected to become available in the U.S. and additional markets, subject to regulatory clearances. [1] Philips issued a Third-Party Product Compatibility Declaration for Imricor’s interventional MRI (iMR) equipment and consumables. [2] NorthStar and the Vision-MR Diagnostic Catheter are commercially available in the U.S. Other Imricor products are not yet cleared/approved for sale in the U.S. [3] Helium-free operations. 7 liters of helium is permanently enclosed in the cryogenic circuit. For further information, please contact: Name Jayme ManiatisPhilips Global External RelationsTel.: +16178948368E-mail: jayme.maniatis@philips.com About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.Headquartered in the Netherlands, the company is a leader in image-guided therapy, diagnostic imaging, ultrasound, monitoring, enterprise informatics and personal health. Philips generated 2025 sales of approximately EUR 18 billion and employs approximately 63,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter. About Imricor Imricor Medical Systems, Inc. (ASX:IMR) is striving to make interventional medical procedures better, safer, and more cost effective by making it possible for these procedures to be performed under real-time magnetic resonance (MR) guidance, rather than under x-ray fluoroscopy guidance, thus taking advantage of MR’s superior imaging capabilities.
Attachment
Philips MR
Abbott’s next-generation Amulet 360™ device receives CE Mark to treat people with atrial fibrillation at risk of stroke
Amulet 360 helps seal the left atrial appendage (LAA) of a person’s heart, reducing the need for blood-thinning medication Amulet 360 builds upon Abbott’s first-generation LAA device with design updates to enhance how the implant conforms to and seals the LAA to help reduce the risk of a…
Vascular Technology, Incorporated Appoints David Pierce to Board of Directors
NASHUA, N.H.–(BUSINESS WIRE)–Vascular Technology, Incorporated (“VTI” or the “Company”), a medical device company specializing in the development, manufacturing and sale of surgical devices, today announced the appointment of David Pierce to its Board of Directors. Pierce brings more than three decades of experience leading innovation, transformation and sustainable growth across global medical device and healthcare technology markets. He currently serves on the boards of Neuraptive Therapeut
Wellness Insights in Your Hands in 60 Seconds: EYVA to Introduce Unique Touch-Based Metabolic Wellness Tracker to U.S. Market – EYVA Pro
The EYVA Pro experience brings together six key wellness indicators with personalized AI-powered insights to help consumers explore the bigger picture across their metabolic, cardiovascular, and respiratory wellness HYDERABAD, India, Aug. 27, 2026 /PRNewswire/ — What if gaining a better…
Jetstream Venture Fund Expands Healthtech Portfolio with Investments in ImageAiD and Moonrise Medical
SCOTTSDALE, Ariz., Aug. 27, 2026 /PRNewswire/ — Jetstream Venture Fund (Jetstream) announced its latest portfolio investments in healthtech pioneers ImageAiD and Moonrise Medical. Both companies are developing next-generation, AI-enabled vascular diagnostic platforms to transform the…
Conavi Medical Reports Fiscal Third Quarter 2026 Results and Operational Highlights
Net loss for Fiscal Q3 2026 was $6.3 million (Fiscal Q3 2025 – $3.6 million) reflecting continued investment in research and development activities of $4.4 million (Fiscal Q3 2025 – $3.2 million) Ended Fiscal Q3 2026 with $0.9M in cash and cash equivalents (Fiscal Q4 2025 – $5.8 million) and on August 12, 2026 closed $10 million public offering Received $1.25 Million Ontario Life Sciences Scale-Up Fund Milestone PaymentAchieved U.S. FDA 510(k) Clearance for Next-Generation Hybrid IVUS-OCT Imaging SystemAdded to Clinical Evidence Supporting Hybrid IVUS-OCT Imaging TORONTO, Aug. 27, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today reported financial results and provided an operational update for the fiscal quarter ended June 30, 2026 (“Fiscal Q3 2026”). “Fiscal Q3 was an important quarter for Conavi with FDA 510(k) clearance for our next-generation hybrid IVUS-OCT system,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “FDA clearance was a major milestone for the Company and allows us to move forward with commercialization in the U.S. We believe there is a real clinical need for a system that gives physicians the benefits of both IVUS and OCT in a single platform. The case reports published to date, with additional publications expected, add to the clinical evidence supporting hybrid imaging and demonstrate how access to both modalities can support physician decision-making in complex coronary procedures. With the subsequent completion of our $10 million financing, we are now focused on completing the transfer to production and expect our first U.S. clinical placement in H2 2026.” Fiscal Q3 2026 Financial HighlightsAll amounts are in Canadian dollars unless otherwise noted. Net loss for Fiscal Q3 2026 was $6.3 million, compared to a net loss of $3.6 million in the prior-year period. For the nine months ended June 30, 2026, net loss was $13.8 million compared to $13.7 million in the prior-year period. Licensing and R&D services revenue for Fiscal Q3 2026 was $0.1 million compared to $0.1 million in the prior-year period. For the nine months ended June 30, 2026, total revenue was $0.5 million compared to $8.8 million in the prior-year period. The prior-year period included milestone revenue under the Company’s technology transfer and licensing agreement with East Ocean Medical that did not recur in Fiscal 2026. Total operating expenses for Fiscal Q3 2026 were $6.5 million compared to $4.7 million in Fiscal Q3 2025. The increase primarily reflected higher research and development spending associated with Novasight 3.0 and transfer-to-production activities, as well as higher general and administrative expenses. Research and development expenses were $4.4 million compared to $3.2 million in the prior-year period. Cash and cash equivalents were $0.9 million as of June 30, 2026, compared to $5.8 million as of September 30, 2025. Subsequent to quarter end, the Company completed the $10 million public offering described below. For additional information regarding the Company’s financial performance, including management’s discussion and analysis, readers are encouraged to review Conavi Medical’s filings on SEDAR+ and on the Company’s website at www.conavi.com. Fiscal Q3 2026 Business and Operational HighlightsFDA 510(k) Clearance of Next-Generation Hybrid Imaging SystemOn April 20, 2026, Conavi received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its next-generation Novasight Hybrid™ intravascular imaging system. The system combines intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) to enable simultaneous and co-registered imaging of coronary arteries within a single workflow. Following clearance, Conavi has focused on completing transfer to production and preparing for a targeted market release at U.S. hospitals in calendar H2 2026. Commercial readiness activities include manufacturing readiness, reliability studies, early inventory build and finalization of production transfer documentation. $1.25 Million Ontario Life Sciences Scale-Up Fund Milestone PaymentOn June 29, 2026, Conavi received a $1.25 million milestone payment from the Province of Ontario through the Life Sciences Scale-Up Fund (“LSSUF”). The payment was triggered by the Company’s achievement of U.S. FDA 510(k) clearance. Including this payment, Conavi has received $1.75 million under the program to date and remains eligible to receive additional funding under the agreement, which provides for up to $2.5 million based on the achievement of specified milestones. Funding under the program is intended to support commercialization initiatives, manufacturing scale-up and other eligible costs associated with the launch of Conavi’s hybrid imaging system. Peer-Reviewed Publication Adds to Clinical Evidence Supporting Hybrid IVUS-OCT ImagingOn July 8, 2026, subsequent to quarter end, Conavi announced the publication of a case report in the Journal of the Society for Cardiovascular Angiography & Interventions (“JSCAI”) titled “Versatility of Hybrid OCT and IVUS Imaging Enhances Contrast-Sparing Management of Eruptive Calcified Nodules.” The case report featured Conavi’s hybrid IVUS-OCT imaging system in a complex coronary procedure involving a patient with impaired renal function and demonstrated how the complementary information provided by IVUS and OCT supported lesion assessment, treatment planning, stent optimization and management of contrast use. The authors concluded that hybrid IVUS-OCT imaging may play an important role in patients with challenging plaque morphology, particularly in the setting of chronic kidney disease. Management believes the publication adds to the growing body of clinical evidence demonstrating the potential utility of having both IVUS and OCT available through a single hybrid imaging platform. Closed $10 Million Public Offering to Support U.S. CommercializationOn August 12, 2026, subsequent to quarter end, Conavi closed its previously announced public offering for aggregate gross proceeds of $10 million. The Company intends to use the net proceeds to support a targeted market release of its Hybrid IVUS OCT system in the United States, as well as for working capital and general corporate purposes. OutlookWith FDA 510(k) clearance secured and the $10 million financing completed subsequent to quarter end, Conavi is focused on executing its U.S. commercialization strategy. Near-term priorities include completing transfer to production, building initial inventory, initiating a targeted market release at U.S. hospitals and continuing to build clinical evidence supporting adoption of hybrid IVUS-OCT imaging. About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ platform combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single system, enabling simultaneous and co-registered imaging of coronary arteries. Conavi has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid intravascular imaging system and is advancing preparations for commercialization in the United States. For more information, visit conavi.com. Notice on forward-looking statementsThis press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging, the potential utility of hybrid IVUS-OCT imaging across a range of complex coronary procedures, and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. CONTACT:Chief Financial Officer: Mark Quick, 416-483-0100Investors: Christina Cameron, 416-483-0100 ext.121, IR@conavi.com
Milestone Pharmaceuticals Announces Data Presented at ESC Congress 2026 on the Impact of Paroxysmal Supraventricular Tachycardia (PSVT) on Patients’ Daily Lives and Quality of Life Between Episodes
Research Shows that Patients with PSVT Experience a Substantial Burden Between Episodes, with Negative Impacts on Anxiety, Daily Activities, Sleep, and WorkMONTREAL and CHARLOTTE, N.C., Aug. 27, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced findings from a longitudinal study describing how paroxysmal supraventricular tachycardia (PSVT) affects patients’ daily lives and quality of life in the periods between episodes. The findings are being presented in a moderated ePoster session titled “The Impact of PSVT on Patients’ Daily Life and QoL in Between Episodes” at the European Society of Cardiology (ESC) Congress 2026 on August 30, 2026, 15:15-16:00 CET, Station 6, Research Gateway, Hall A1. “This study’s findings broaden our understanding of the patient experience with PSVT and show that its impact can extend well beyond the acute episode,” said Sean D. Pokorney, M.D., MBA, Assistant Professor of Medicine, Duke University Medical Center and the Duke Clinical Research Institute, and study presenter. “The changes patients reported in activities such as driving, travel and exercise, together with persistent anxiety between episodes, illustrate a burden that is not captured by looking at episode frequency or duration alone.” PSVT is a common heart rhythm disorder in which the heart suddenly beats very fast affecting an estimated two million people in the United States. The acute symptoms of a PSVT episode are well recognized. However, the impact of living with the condition between episodes has not been well established. This study assessed patient-reported outcomes over nearly a year, capturing how PSVT shaped participants’ activities, emotions, and quality of life outside of a healthcare setting. The results show that many people living with PSVT change their behavior, avoid everyday activities, and carry anxiety with them even when they are not having an episode. Key Findings Approximately two in three patients adjusted their lifestyle between episodes to avoid stress, and nearly 40% reduced their activity or exercise routine because of PSVT.73% of patients reported daytime activity interruption between PSVT episodes.Automobile driving (53%) and travel (43%) were the everyday activities for which avoidance between PSVT episodes was most frequently rated as bothersome or extremely bothersome (score of 6 or 7 on a 7-point scale).Anxiety persisted between PSVT episodes. Patients reported an average anxiety level of 3.1 on a 7-point scale; 26% of patients reported feeling extremely anxious at some point during the study, and 16% reported the maximum anxiety score at least once.Side effects of medications taken chronically (e.g., daily) for PSVT were frequently reported as burdens. Fatigue and weakness were each rated as bothersome or extremely bothersome (6 or 7 on a 7-point scale) by 65% of patients.Sleep (30%) and capacity for work (22%) were the most commonly reported areas of lifestyle dissatisfaction (score of 1 or 2 on a 5-point scale). Conclusions PSVT imposes a substantial quality-of-life burden between episodes, affecting anxiety, daily activities, sleep, and work. Medication side effects and activity avoidance further contribute to this burden, underscoring that the impact of PSVT extends beyond acute symptomatic episodes and highlighting an unmet treatment need.The authors call for future research to evaluate the quality-of-life impact of at-home, self-administered treatments to terminate PSVT episodes. The prospective, longitudinal, web-based survey study enrolled 247 adults in the United States and United Kingdom with a self-reported diagnosis of PSVT and no history of catheter ablation at enrollment. Participants completed a baseline survey in February 2019, weekly tracking surveys through December 2019, and a closing survey. During weeks without a PSVT episode, participants completed quality-of-life assessments, including the World Health Organization Quality of Life–Brief Version (WHOQOL-BREF), and answered questions about lifestyle changes, avoidance behaviors, emotional symptoms, and anxiety. Participants had a mean age of 52 years, 72% were female, and the population carried a substantial comorbidity burden. The study was funded by Milestone Pharmaceuticals. “Better understanding the impact of PSVT on the patients’ daily lives – including between acute events – is important as we consider the management and treatment options which can more fully address the needs of people living with this condition,” said David Bharucha, M.D., PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals. About Paroxysmal Supraventricular Tachycardia (PSVT) An estimated two million people in the United States are currently diagnosed with PSVT, which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many healthcare providers are dissatisfied with the lack of effective treatment options, with patients often electing to pursue prolonged, burdensome, and costly trips to the emergency department or even undergo invasive cardiac ablation procedures. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/ Contact:Investor RelationsKevin Gardner, kgardner@lifesciadvisors.com Media RelationsRebecca Novak, rnovak@milestonepharma.com
Cardurion Pharmaceuticals Announces Late-Breaking Presentation of Phase 2 Results for Tovinontrine (CRD-750), a PDE9 Inhibitor, in Heart Failure
Results from two Phase 2 clinical trials assessing tovinontrine in both major types of chronic heart failure will be presented at the Heart Failure Society of America annual scientific meetingBURLINGTON, Mass., Aug. 27, 2026 (GLOBE NEWSWIRE) — Cardurion Pharmaceuticals, Inc. (“Cardurion”), a clinical-stage biotechnology company discovering and developing new therapeutic approaches for the treatment of patients with cardiovascular diseases, today announced that the Company will present results from the Phase 2 CYCLE clinical trials evaluating tovinontrine (CRD-750), a novel phosphodiesterase-9 (PDE9) inhibitor, in chronic heart failure. The results will be presented in late-breaking presentations at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona taking place on October 9–12, 2026. Tovinontrine is an orally administered PDE9 inhibitor that represents a new mechanism to enhance the natriuretic peptide signaling (NPS) pathway, a clinically validated pathway for the treatment of patients with heart failure. Cardurion is the first company to bring a PDE9 inhibitor into clinical development for the treatment of chronic heart failure. “We look forward to sharing the exciting results from our CYCLE trials, which represent the first time that robust Phase 2 data have been completed for PDE9 inhibition in heart failure. Despite current standard of care, a large unmet medical need remains, and patients with chronic heart failure continue to experience high rates of morbidity and mortality,” said Howard Surks, MD, Chief Medical and Scientific Officer of Cardurion. “It is a major milestone for our company to successfully complete this large, global clinical program in both major types of heart failure, and the results of the CYCLE studies will guide the next stage of clinical development for tovinontrine as we move closer to our goal of bringing this novel PDE9 inhibitor to patients with chronic heart failure.” The presentations at HFSA in October will describe the results from Cardurion’s global, multi-center, Phase 2 clinical trials (NCT06215911 and NCT06215586) assessing the safety and efficacy of tovinontrine in the two major types of chronic heart failure: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). Details for the presentations at HFSA are as follows: CYCLE-1 REF presentation title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine (CRD-750) in Patients With Chronic Heart Failure With Reduced Ejection Fraction: The Cycle-1 REF TrialCYCLE-2 PEF presentation title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess the Safety and Effectiveness of Tovinontrine (CRD-750) in Patients With Chronic Heart Failure With Preserved Ejection Fraction: The Cycle-2 PEF Trial About PDE9 InhibitionPhosphodiesterase (PDE) 9 is an enzyme whose elevated activity in patients with heart failure reduces the beneficial effects of the natriuretic peptide signaling (NPS) pathway. The NPS pathway plays an important and protective role in cardiac function, and its activation has been shown to confer outcomes benefit for patients with heart failure. PDE9 is significantly upregulated in patients with chronic heart failure, causing disruption in the NPS pathway. Cardurion is the first company to demonstrate clinical proof-of-mechanism for PDE9 inhibition in patients with chronic heart failure with its PDE9 program. About Heart FailureHeart failure is a prevalent and growing condition that is responsible for substantial morbidity and mortality. Approximately 6.7 million adults in the United States suffer from heart failure, and approximately 50 percent of these patients die from the condition within five years of diagnosis. One in five patients with heart failure are hospitalized annually, and approximately 25 percent of these patients are re-admitted within a month of discharge. Approximately half of all patients with chronic heart failure have reduced ejection fraction (HFrEF) and half have preserved ejection fraction (HFpEF), categorized as different diseases based on the pumping ability of the heart. Significant unmet medical needs remain in heart failure, despite the reductions in morbidity and mortality from currently approved treatments for heart failure. About Cardurion PharmaceuticalsCardurion Pharmaceuticals is a clinical-stage biotechnology company discovering and developing new therapeutic approaches to address cardiovascular diseases. Cardurion has extensive expertise in cardiovascular biology, signaling pathways and drug discovery and development, and it translates that expertise into potentially groundbreaking therapeutics with the promise to address the unmet needs of patients. Cardurion’s clinical-stage pipeline consists of product candidates targeting phosphodiesterase-9 (PDE9) and calcium/calmodulin-dependent protein kinase II (CaMKII). Cardurion is the first company to advance product candidates against these novel and important targets into clinical testing for the treatment of cardiovascular disease. Cardurion is headquartered in Burlington, Massachusetts, with discovery sciences and research facilities in Shonan, Japan. For more information, please visit Cardurion’s website at https://cardurion.com and follow us on LinkedIn. CONTACT: Contacts
Investors:
Charlie Newman
Chief Business & Operating Officer
charlie.newman@cardurion.com
Media Contact:
Kathryn Morris
The Yates Network LLC
kathryn@theyatesnetwork.com



