The Latest Cardiac and Vascular News
TORONTO, Sept. 16, 2025 (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, announced that it has submitted its next generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration (“FDA”) for 510(k) clearance for coronary applications.
Designation supports accelerated development of AI-driven platform to improve outcomes and reduce clinical burden. DETROIT and OR YEHUDA, Israel, Sept. 16, 2025 /PRNewswire/ — PatenSee, a clinical-stage medical device company, announced that the U.S. Food and Drug Administration (FDA)…
Sean Shoffstall Will Lead Transformation of One of the Most Robust Cardiovascular Dataset on the Planet Into AI Use Cases That Drive Precision Patient Outcomes TAMPA, FL, UNITED STATES, September 16, 2025 /EINPresswire.com/ — PaceMate, the remote cardiac monitoring platform that leading healthcare providers trust, today announced the appointment of Sean […]
Data strongly supports the technology for effective, efficient and safe probe placement versus blind intubation Sept. 8, 2025 – MINNEAPOLIS – Visura Technologies, Inc., announced today positive data from the TEECAD product registry, demonstrating the product’s ability for physicians to successfully visualize and safely and effectively navigate the esophageal […]
SANTA CLARA, Calif. – September 15, 2025 – Today, Johnson & Johnson announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium in extremely narrowed vessels to expand treatments in patients suffering from peripheral artery disease (PAD). The first-of-its-kind Forward IVL […]
SCOTTSDALE, Ariz., Sept 14, 2025 – SimonMed Imaging (“SimonMed”), one of the nation’s leading outpatient medical imaging providers and radiology practice, is proud to announce the appointment of Dr. Sean Raj, MD, MBA, to Chief Medical Officer, in addition to his ongoing role as Chief Innovation Officer. A nationally recognized […]
Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1In addition, new results from SOUL will be presented at one of the largest diabetes conferences (EASD) later this week, showing that oral semaglutide significantly reduced hospitalisations compared with placebo2 Bagsværd, Denmark, 15 September 2025 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial. SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus® on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD)1. Rybelsus® is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit1. “Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.” New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo2. Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants3. In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus®. Novo Nordisk has also submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide (Wegovy® in a pill) in adults living with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy® would become the first oral GLP-1 RA indicated for chronic weight management. Rybelsus® is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019. It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes4-8. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial, with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide versus placebo, when added to standard of care, on cardiovascular outcomes in people with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease (CKD). The SOUL trial was initiated in 2019. The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE; a composite objective consisting of cardiovascular death, heart attack and stroke) 1. The SOUL trial demonstrated a superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo in people with type 2 diabetes and cardiovascular disease and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with a proven cardiovascular benefit1. About Rybelsus® Rybelsus® (oral semaglutide) is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise7, 9. Rybelsus® is administered once daily and is approved for use in the following therapeutic dosages: 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, 14 mg, 25 mg and 50 mg4, 5. Rybelsus® offers superior blood glucose lowering versus multiple comparators4, 5, together with consistent weight reduction4, 5, 10, reduction in cardiometabolic risk factors10 and reduction in major adverse cardiovascular events (MACE) 1. Rybelsus® is now the first and only oral GLP-1 RA available in the EU for type 2 diabetes with a proven cardiovascular benefit1. It is currently available in 48 countries11, and more than 2.4 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide12. About Wegovy®Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in heart failure with preserved ejection fraction (HFpEF)-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis13. In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition, as well as for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in combination with a reduced calorie diet and increased physical activity14. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289globalmedia@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comMax Ung+45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin+45 3079 1471cftu@novonordisk.comAlex Bruce +45 34 44 26 13axeu@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com _______________________References1. McGuire DK, et al. N Engl J Med. 2025;392(20):2001-2012.2. Buse JB, et al. Oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; 15-19 Sep 2025; Vienna, Austria.3. Inzucchi SE, et al. Oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; 15–19 Sep 2025; Vienna, Austria. 4. Rosenstock J, et al. JAMA. 2019;321(15):1466-1480.5. Rodbard HW, et al. Diabetes Care. 2019;42(12):2272-2281.6. Pratley R, et al. Lancet. 2019;394(10192):39-50.7. Rybelsus® (oral semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf. Last accessed: September 2025.8. Aroda VR, et al. Lancet. 2023;402(10403):693-704.9. Rybelsus® (oral semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus. Last accessed: September 2025.10. Husain M, et al. N Engl J Med. 2019;381(9):841-851.11. Novo Nordisk Data on File. LEA portal Product Planning, 25th Aug 2025.12. Novo Nordisk Data on File. IQVIA Jun’25 Patients R3M Vol. data. 2025.13. Wegovy® (semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information_en.pdf. Last accessed: September 2025.14. Wegovy® (semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s015lbl.pdf. Last accessed: September 2025.
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PR250915-Rybelsus-label-update-SOUL
GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced the appointment of Linda M. Richardson to the role of Chief Commercial Officer, effective September 16, 2025. Ms. Richardson joins the Company with more than 30 years of experience in sales and marketing, commercial, corporate and business development across a range of therapeutic areas, including metabolic disease, hepatology, cardiovascular and addiction medicine. During her career, she has led multiple product launches, built successful commercial franchises and contributed to a variety of business development transactions. “Linda joining Altimmune marks a key strategic addition to our executive team as we approach the initiation of Phase 3 development of pemvidutide in MASH. To add a leader with her pedigree positions Altimmune, and pemvidutide, for future commercial success,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “Her deep expertise and strong track record will be instrumental to our strategic business execution and growth.” Ms. Richardson added, “I believe that pemvidutide represents a rare opportunity in the area of hepato-metabolic disease and is differentiated from other marketed and development-stage therapies with significant potential to improve the lives of patients with MASH. Additionally, there are sizeable opportunities in Alcohol Use Disorder and Alcohol-associated Liver Disease where we continue to investigate the potential utility of pemvidutide in these highly prevalent and underserved indications. I am pleased to bring my experience to Altimmune and thrilled to begin leading Altimmune’s commercial-readiness efforts.” Ms. Richardson served as Chief Commercial Officer and Executive Vice President at Intercept Pharmaceuticals, a liver disease company, departing in early 2024 following the Company’s acquisition by Alfasigma. Prior to joining Intercept, she was Chief Strategy and Commercial Officer at Chimerix. Earlier in her career, she held a variety of senior-level marketing and commercial positions, including at Sanofi, where she was Global Commercial Head of Lixisenatide, the Company’s GLP-1 program and Marketing Lead for MULTAQ and AUVI-Q, Reliant Pharmaceuticals, where she launched Lovaza for hypertriglyceridemia, and at GSK. She holds a bachelor’s degree in English from the University of Pennsylvania. Inducement GrantIn connection with being named as Chief Commercial Officer, Ms. Richardson will receive, in the aggregate, options to purchase 278,000 shares of Altimmune’s common stock, and 96,000 restricted stock units (“RSUs”). The options will have an exercise price equal to the closing price of Altimmune’s common stock on September 16, 2025 (the “Grant Date”). Based on the closing price of Altimmune’s common stock on September 12, 2025, Altimmune would issue approximately 168,112 options as inducement awards under its 2018 Inducement Grant Plan, and the balance as incentive stock options under its 2017 Omnibus Incentive Plan. The final allocation of options between the 2018 Inducement Grant Plan and 2017 Omnibus Plan are subject to adjustment based on the closing price of Altimmune’s common stock on the Grant Date. One-fourth of the shares underlying the options will vest on the one-year anniversary of the Grant Date and thereafter 1/36th of the shares underlying the options will vest monthly, such that the shares underlying the options will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to Ms. Richardson’s continued employment with Altimmune on such vesting dates. One-fourth of the RSUs will vest on the one-year anniversary of the Grant Date and thereafter the RSUs will vest in three substantially equal annual installments, such that the RSUs will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to Ms. Richardson’s continued employment with Altimmune on such vesting dates. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). About AltimmuneAltimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead product candidate is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-associated Liver Disease (ALD) and obesity. For more information, please visit www.altimmune.com. Forward-Looking StatementsAny statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD, ALD and obesity, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements, or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Jake RobisonInizio Evoke CommsPhone: 619-849-5383jake.robison@inizioevoke.com This press release was published by a CLEAR® Verified individual.
– Results were published in the Journal of Vascular Surgery –
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
