Coronary/Structural Heart

Cadrenal Therapeutics Enhances Anticoagulation Pipeline Through Acquisition of eXIthera’s Portfolio of Factor XIa Inhibitors

Acquisition significantly enhances the Company’s pipeline by adding novel assets in acute and chronic anticoagulation settingsCompany is strategically poised to deliver differentiated therapeutics across the spectrum of cardiovascular thrombotic risk PONTE VEDRA, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy, today announced the acquisition of the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors. The acquisition significantly enhances Cadrenal’s pipeline, adding drug candidates that address large and underserved segments of the current $38 billion global anticoagulation market. eXIthera’s lead asset, frunexian, is a first-in-class, Phase 2-ready intravenous (IV) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions. “With this acquisition, Cadrenal is the only company in the world developing a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors, a promising new class of anticoagulants,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “These newly acquired assets will expand Cadrenal’s capabilities in an effort to address even more critical gaps in current antithrombotic treatment, especially for patients for whom current therapies are unreliable or carry excessive bleeding risk.” Unlike current anticoagulants on the market, which increase the risk of bleeding by broadly impairing coagulation, eXIthera’s compounds are mechanism-based inhibitors of Factor XIa, offering high potency, selectivity, and tunable pharmacokinetics. Factor XIa inhibition is one of the most active and exciting areas of current thrombosis research. “This acquisition reinforces Cadrenal’s long-term vision of becoming a category leader in anticoagulation,” added Pham. “With tecarfarin planning a trial in patients with end-stage kidney disease transitioning to dialysis, our plans for LVAD patients, and the current addition of frunexian and EP-7327, we believe that Cadrenal is strategically positioned to deliver differentiated therapeutics across the entire spectrum of patients with cardiovascular thrombotic risk.” Assets Acquired: Frunexian: Phase 2-ready IV Factor XIa agent for acute anticoagulationEP-7327: IND-ready oral small molecule candidate for chronic indicationsExtensive portfolio of additional novel FXIa small molecules Under a pre-existing license agreement, Sichuan Haisco Pharmaceuticals retains rights to frunexian in China, having completed a successful Phase 1 trial there. Under the terms of the license, Cadrenal will be entitled to receive royalties on future sales of frunexian in China. Deal Terms Overview: Under the terms of the acquisition agreement, eXIthera will receive milestone payments from Cadrenal totaling up to $15 million, contingent upon the realization of certain future clinical and regulatory milestones. Additionally, eXIthera will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets. About Cadrenal Therapeutics, Inc.Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal aims to reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven. Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs). For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the acquisition significantly enhancing Cadrenal’s pipeline and addressing large and underserved segments of the global anticoagulation market; the size of the global anticoagulation market; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment with the acquisition; Cadrenal becoming a leader in anticoagulation; commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; Cadrenal’s receipt of royalties on future sales of frunexian in China; the payment to eXIthera of milestone payments by the Company totaling up to $15 million contingent upon the realization of certain future clinical and regulatory milestones as well as global sales of the acquired assets upon future commercialization; Cadrenal’s ability to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets; and tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment; the payment of milestone payments and royalties; Cadrenal successfully advancing tecarfarin and the acquired assets into clinical practice; the commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. For more information, please contact: Cadrenal Therapeutics:Matthew Szot, CFOpress@cadrenal.com Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700CVKD@lythampartners.com

European Society of Cardiology (ESC) Congress 2025 Late Breaking Results Confirm Caristo FAI-Score™ Technology’s Superior and Complementary Predictive Value for Cardiac Death Beyond hsCRP

FAI-Score has stronger predictive value than hsCRP for 10-year cardiac death, even among those with zero calcium score and no visible coronary plaque In patients with low hsCRP, high FAI-Score predicts 7-fold higher risk of cardiac death OXFORD, England, Sept. 11, 2025 /PRNewswire/ –…

JenaValve Announced ESC Guidelines Recognize TAVI as Class IIb Recommendation for Aortic Regurgitation

IRVINE, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that the newly published guidelines from the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) include transcatheter aortic valve implantation (TAVI) as a treatment option for patients with severe, symptomatic aortic regurgitation (AR) when ineligible for surgery. This decision marks the first formal recommendation for TAVI in AR guidelines.

Catheter Precision Announces Tender Win and First Purchase Order in Croatia

FORT MILL, S.C., Sept. 10, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market today announced that it has received the first purchase order from a hospital in Croatia after winning a competitive tender bid.

Orchestra BioMed Presents New AVIM Therapy Clinical Data at HRX Demonstrating Substantial and Sustained Blood Pressure Reductions that are Reproducible Upon Reactivation Following Washout

Results from long-term follow up of patients treated with atrioventricular interval modulation (“AVIM”) therapy show blood pressure-lowering effects are sustained for years after activation, reversible with no observed rebound hypertension upon deactivation of treatment, and reproducible upon reactivation following a washout periodSimultaneous peer-reviewed publication of AVIM therapy mechanistic and clinical results Orchestra BioMed and Medtronic (NYSE: MDT) have a strategic collaboration to develop and commercialize AVIM therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, an estimated global population of over 750,000 patients annuallyAVIM therapy has FDA Breakthrough Device Designation for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk, an estimated U.S. population of over 7.7 million patients NEW HOPE, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced new data from its AVIM therapy program, presented at the HRX Live 2025 Meeting, in Atlanta, GA, demonstrating that the blood pressure-lowering effects of AVIM therapy may be sustained for years after activation, are reversible with no evidence of rebound hypertension or blood pressure exceeding initial baseline values, and can be restored upon reactivation. These data further support AVIM therapy’s potential role as a controllable, programmable, and durable device-based therapy for uncontrolled hypertension. Avi Fischer, MD, Senior Vice President of Medical Affairs and Innovation at Orchestra BioMed presented an overview of mechanistic and clinical data supporting the potential role of AVIM therapy for the treatment of uncontrolled hypertension during the Innovation Summit at HRX Live 2025, as part of the session titled “Pacing and Implanted Device Therapy.” His presentation coincided with the simultaneous peer-reviewed publication of these results in Heart Rhythm O₂, titled, “Atrioventricular Interval Modulation (AVIM) for Management of Hypertension.” Dr. Fischer stated, “These results add to the growing body of promising data supporting AVIM therapy’s potential role as a novel and programmable treatment option for patients whose hypertension remains uncontrolled despite existing medical regimens. The sustainability, reversibility and reproducibility of effect demonstrated in these results provides additional confidence in the efficacy and safety profile of AVIM therapy currently under investigation in the BACKBEAT global pivotal study. Importantly, these data highlight the potential for AVIM therapy to halt the progression of hypertensive heart disease, which could have significant clinical benefit to millions of patients globally.” Key Findings: Sustainable blood pressure reduction during chronic treatment with AVIM therapy: A group of patients (n=16) who originally participated in the MODERATO II trial and underwent long-term follow-up for an average of 3.6 years had sustained 24-hour ambulatory systolic blood pressure (“aSBP”) reductions of 8.9 mmHg (p

Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 26-29

WASHINGTON, Sept. 4, 2025 /PRNewswire/ — The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 26-29, at the at the Minneapolis Convention Center in Minneapolis, MN….

Idorsia to collaborate with two leading academic medical centers to launch IMPACT-HTN – a US initiative to transform care for patients with difficult-to-control hypertension

Multi-phase program to standardize treatment, generate real-world evidence and explore AI-powered tools to improve outcomes for hypertension patients Allschwil, Switzerland & Radnor, Philadelphia – September 5, 2025Idorsia Ltd (SIX: IDIA) announces a first-of-its-kind initiative with the Stanford Hypertension Center and Duke Heart Center to launch IMPACT-HTN, a new three-phase program to transform and modernize the management of difficult-to-control hypertension. Patients requiring multiple medications for difficult-to-control hypertension face increasing challenges with care coordination, evaluation of underlying causes, and worsening outcomes. The initiative, led by Dr. Vivek Bhalla of the Stanford University School of Medicine and Dr. Sreekanth Vemulapalli of Duke University School of Medicine, is expected to generate real-world evidence, standardize clinical decision-making and deliver scalable tools that leverage AI technology to help identify patients with difficult-to-control hypertension who may benefit from innovative therapies that utilize new pathways, including Idorsia’s once-daily TRYVIO™ (aprocitentan), the first systemic hypertension treatment to target a new pathway in over 30 years. Sreekanth Vemulapalli, MD, Associate Professor of Medicine, Duke Heart Center, commented:“With novel therapies emerging to improve hypertension control, we are thrilled to work with our esteemed colleagues at Stanford and other hypertension centers to standardize the evaluation, management and access to innovative therapies for our patients with difficult-to-control hypertension. We’ll be collaborating with companies to develop high-touch AI tools aimed at supporting the care of our patients to meet people where they are. This is a cross-institutional collaboration which we hope to expand to improve the outcomes of our patients.” Despite progress in improving patient outcomes, hypertension remains a major global health issue, affecting an estimated 50% of adults in the U.S. Patients whose blood pressure that remains above target despite the use of appropriate therapy face significantly higher risks of cardiovascular events, including heart attack, stroke and kidney failure, and are nearly twice as likely to experience premature mortality compared to those with controlled blood pressure. Difficult-to-control hypertension is defined as above-goal elevated blood pressure in a patient despite the concurrent use of multiple antihypertensive drug classes. Vivek Bhalla, MD, Associate Professor of Medicine/Nephrology, Founding Director of the Stanford Hypertension Center, commented: “The IMPACT-HTN program challenges the boundaries of the standard care model for hypertension treatment by building a platform to fundamentally shift how we approach difficult-to-control hypertension. I’m proud to collaborate with Idorsia and Dr. Vemulapalli as well as Dr. Kenneth Mahaffey, the Founding Director of the Stanford Center for Clinical Research for this initiative. By developing and publishing best practices, analyzing real-world data and harnessing emerging technologies, we’re working to deliver impactful solutions that can transform hypertension care and improve lives.”The multi-phased IMPACT-HTN program is expected to deliver actionable tools, data and insights to improve care for those with difficult-to-control hypertension, including: A digital care algorithm to standardize how difficult-to-control hypertension is assessed and managed. Through interactive tools such as patient-facing algorithms, AI chatbots and a program portal, this initiative aims to transform protocols to improve patient care.A personalized hypertension risk score that will build on existing risk scores for prevention to better identify difficult-to-control hypertension patients at risk for negative cardiovascular outcomes so appropriate treatment protocols can be implemented sooner. A prospective early patient experience initiative that will enroll patients from hypertension specialty centers to better understand the treatment obstacles for patients with difficult-to-control hypertension and how newer treatments, like Idorsia’s TRYVIO, are impacting the treatment paradigm. Srishti Gupta, MD, CEO of Idorsia, commented: “We are proud to have pioneered the first treatment tackling a new pathway in hypertension in over three decades and as a leader in this area, we understand that our commitment to improving patient outcomes goes beyond the medicine. We are proud to collaborate with two of the world’s leading research institutions, on this exciting new program and believe IMPACT-HTN will help reimagine the pathways of care for hypertension patients who need additional options.” TRYVIO, a dual endothelin receptor antagonist (ERA) is now available to prescribe. It is indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. TRYVIO is now included in the American College of Cardiology’s (ACC) and the American Heart Association’s (AHA) new comprehensive clinical practice guidelines for the management of high blood pressure, but many patients remain undiagnosed and undertreated. Important Safety InformationTRYVIO may cause serious side effects, including:TRYVIO can cause major birth defects if used by pregnant patients and has a BOXED Warning for embryo-fetal toxicity. People who can become pregnant must not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO.People who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO, each month during treatment with TRYVIO, and 1 month after stopping TRYVIO.People who can become pregnant should use acceptable birth control before starting treatment with TRYVIO, during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body. If you are a person who can become pregnant, your healthcare provider will talk to you about pregnancy testing recommendations and the need to use acceptable birth control, the benefits and risks of TRYVIO, and the need to report suspected pregnancy right away to your healthcare provider. What is TRYVIO?TRYVIO is a prescription medicine used to treat high blood pressure (hypertension) in adults who are taking other high blood pressure medicines and whose blood pressure is not well controlled.Do not take TRYVIO if you are pregnant or currently trying to become pregnant.allergic to aprocitentan or any of the ingredients in TRYVIO. Before taking TRYVIO, tell your healthcare provider about all of your medical conditions, including if you: have liver problemshave heart failurehave anemiahave kidney problems or get dialysisare pregnant or plan to become pregnant during treatment with TRYVIO. TRYVIO can cause serious birth defects.are breastfeeding or plan to breastfeed. It is not known if TRYVIO passes into your breastmilk. Do not breastfeed if you take TRYVIO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.TRYVIO may cause other serious side effects, including: Liver problems. TRYVIO may cause liver problems. Your healthcare provider should do blood tests to check your liver before starting treatment and as needed during treatment with TRYVIO. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with TRYVIO: nausea or vomiting yellowing of your skin or whites of your eyes pain in the upper right stomach dark urine tiredness fever loss of appetite itching Fluid retention. Fluid retention and swelling are common during treatment with TRYVIO and can be serious. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider may treat you with other medicines (diuretics) if you develop fluid retention or swelling.Low red blood cell levels (anemia). Anemia is common during treatment with TRYVIO and can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with TRYVIO.Decreased sperm count. TRYVIO may cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you. Your healthcare provider may stop treatment with TRYVIO if you develop certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of TRYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO® in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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