Author: Ken Dropiewski

Milestone Pharmaceuticals to Present New Analysis from Investigational Etripamil Nasal Spray Clinical Trials for PSVT at the American Heart Association Scientific Sessions 2025

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Data show consistent efficacy, safety, and tolerability findings across multiple clinical trials that evaluated self-administered etripamilMONTREAL and CHARLOTTE, N.C., Nov. 03, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that new data analyses surrounding its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT), etripamil nasal spray, consistently showed efficacy and a favorable safety profile across multiple studies comprising the global development program. The poster, “Combined Efficacy, Safety, and Test Dose Tolerability of Etripamil for Acute Paroxysmal Supraventricular Tachycardia (PSVT) Across Multiple Clinical Trials,” will be presented on Monday, November 10 (10:30–11:30 AM CST) at the American Heart Association Scientific Sessions 2025, in New Orleans, La. The data will be presented by James Ip, M.D., Professor of Medicine and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Department of Medicine, New York Weill Cornell-Presbyterian Hospital. Key Findings: Analysis of data from 622 unique enrolled patients across multiple trials showed consistent efficacy of etripamil across multiple study phases, types of trial design, and geographic regions, with etripamil treatment showing similarly greater conversion rates for symptomatic PSVT episodes compared with placebo arms.Across studies, the median time to conversion in patients self-administering etripamil was 18.5 minutes (95% CI: 15.7 to 21.0 minutes).The Kaplan-Meier estimate, from the pooled data for conversion of PSVT to sinus rhythm (SR) by 30 minutes of drug administration, was 59.6% (range: 53.6% to 64.3%). By 60 minutes post-administration, etripamil conversion rates rose to 63.2% to 75.1% across studies.Safety data from over 1,050 etripamil-treated patients were favorable, consistently shown, and characterized by predominantly mild, transient, and nasal-site localized adverse events.The low rate of test-dose failures (1.4%) among over 1,100 patients administered etripamil in SR further indicates the consistent tolerability of etripamil. “These results show the consistent efficacy, with onset soon after self-administration, and safety of etripamil nasal spray across a wide range of studies and patient populations,” said David Bharucha, M.D., PhD, FACC, Chief Medical Officer of Milestone. “The potential for patients to self-administer etripamil and achieve rapid termination of symptomatic PSVT episodes would represent a meaningful advance in the management of PSVT, a condition that frequently leads to emergency room visits and causes significant burden for patients.” Study Methods This analysis involved a systematic review of randomized-controlled and open-label trials evaluating etripamil in adult patients with documented PSVT. Studies were selected based on their focus on self-administered etripamil for acute termination of symptomatic PSVT episodes, with inclusion criteria encompassing patients aged 18 years or older with a history of PSVT confirmed by electrocardiogram (ECG). These studies included: Phase 2: NODE-1; Phase 3: NODE-301 (Parts 1 and 2 [RAPID] and its extensions); and NODE-302 and NODE-303 (open-label extensions). A New Drug Application (NDA) for CARDAMYST is currently being evaluated by the U.S. Food & Drug Administration (FDA) which has set a new Prescription Drug User Fee Act (PDFUA) target date of December 13, 2025.  About Etripamil Etripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil for the treatment of an abnormal heart rhythm, paroxysmal supraventricular tachycardia or PSVT. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: expectations in regards to etripamil’s efficacy; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; the timing of the PDUFA date; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com

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InspireMD Names Peter A. Soukas, M.D., as Chief Medical Officer

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MIAMI, Nov. 03, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Peter A. Soukas, M.D., as Chief Medical Officer to advance its mission to deliver best-in-class tools for carotid intervention.

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BridgeBio to Present Data from the Overall ATTR-CM Variant and V142I (V122I) Populations from ATTRibute-CM at the AHA Scientific Sessions 2025

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PALO ALTO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced today that ten moderated digital posters will be shared at the American Heart Association (AHA) Scientific Sessions 2025, taking place in New Orleans, LA from November 7 – 10, 2025. Moderated Digital Posters: Acoramidis Effect on All-Cause Mortality in Patients with p.V142I (V122I) Variant ATTR-CM: Findings from the ATTRibute-CM StudyPresenter: Marianna Fontana, M.D., University College London, UKDate/time: Saturday, November 8 at 3:15 pm CT Acoramidis Reduces All-Cause Mortality and First Cardiovascular Hospitalization in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from the ATTRibute-CM StudyPresenter: Prem Soman, M.D., Ph.D., University of Pittsburgh School of Medicine, U.S.Date/time: Saturday, November 8 at 9:15 am CT Acoramidis Reduces All-Cause Mortality and Cardiovascular-Related Hospitalizations Through Month 42 in Transthyretin Amyloid Cardiomyopathy Across All Pre-specified Patient SubgroupsPresenter: Lily Stern, M.D., Cedars-Sinai Heart Institute, U.S.Date/time: Saturday, November 8 at 3:15 pm CT Acoramidis Lowers NT-proBNP in a Larger Proportion of ATTRibute-CM Study Participants with Transthyretin Amyloid Cardiomyopathy Compared with Placebo, Independent of Atrial Fibrillation StatusPresenter: Mathew Maurer, M.D., Columbia University Irving Medical Center, U.S.Date/time: Saturday, November 8 at 9:15 am CT Demographic Disparities in Tafamidis Treatment and Clinical Outcomes Across the United StatesPresenter: Nicole Cyrille-Superville, M.D., Atrium Health Sanger Heart & Vascular Institute Kenilworth, Charlotte, NC, U.S.Date/time: Saturday, November 8 at 12:15 pm CT Geographic Disparities in Transthyretin Amyloid Cardiomyopathy Prevalence in United States VeteransPresenter: Sandesh Dev, M.D., Southern Arizona VA Health Care System, U.S.Date/time: Saturday, November 8 at 3:15 pm CT Serum Transthyretin Levels at Day 28 are Associated with Cardiovascular Outcomes: Insights from the ATTRibute-CM StudyPresenter: Nitasha Sarswat, M.D., UChicago Medicine, U.S.Date/time: Sunday, November 9 at 3:15 pm CT Acoramidis Improved Clinical Outcomes, Function, Quality of Life and NT-proBNP in Patients with Transthyretin Amyloid Cardiomyopathy Regardless of Atrial Fibrillation Status at BaselinePresenter: Richard Cheng, M.D., University of Washington, Seattle, WA, U.S.Date/time: Sunday, November 9 at 3:15 pm CT Acoramidis Reduces the Risk of All-Cause Mortality and Cardiovascular-Related Hospitalization Compared with Placebo in Participants with Transthyretin Amyloid Cardiomyopathy and Early-Stage Heart Failure Regardless of Atrial Fibrillation History: Insights from ATTRibute-CM Presenter: Ronald Witteles, M.D., Stanford University School of Medicine, U.S.Date/time: Saturday, November 8 at 3:15 pm CT Vutrisiran Healthcare Resource Utilization, Costs, Discontinuation, and Mortality: A Retrospective Database Analysis Presenter: Nicole Bart, M.D., Ph.D., St Vincent’s Hospital Sydney, AUDate/time: Monday, November 10 at 10:45 am CT About Attruby™ (acoramidis) INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATION Adverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BridgeBioBridgeBio Pharma (BridgeBio; Nasdaq: BBIO) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, and YouTube. BridgeBio Media Contact:Bubba Murarka, Executive Vice President, Corporate Developmentcontact@bridgebio.com   (650)-789-8220 BridgeBio Investor Contact:Chinmay Shukla, Senior Vice President, Strategic Financeir@bridgebio.com

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FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

Coronary/Structural Heart Regulatory by 0 comments

PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) — Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR® Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA* submission. “We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition,” commented Vice Chairman and CEO, Wayne Paterson. The PARADIGM Trial is co-chaired by Dr. Michael J. Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital, Texas and Professor Stephan Windecker, Chairman of the Department of Cardiology at Bern University Hospital, Switzerland. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1000 patients across the Unites States, Europe and Canada in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265). *A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs minimize bias and allow a clear comparison between treatment groups. **Subject to Institutional Review Board (IRB) approval About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements including statements regarding the intent for the PARADIGM Trial. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Investor Relationsinvestor@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200 Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D.Blueprint Life Science Group+1 917 330 4269                                                                                                        Website  www.anteristech.comX  @AnterisTechLinkedIn  https://www.linkedin.com/company/anteristech

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Conavi Expands Leadership Team to Support Next Phase of U.S. Commercialization

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– Mark Quick Appointed Chief Financial Officer, Bringing Extensive Public Company Capital Markets Expertise — Current CFO, Stefano Picone, will take on a Transitional Strategic Role to Support Leadership Continuity During Growth Phase — Leadership additions follow submission of next-generation Novasight™ to the FDA for 510(k) clearance -TORONTO, Nov. 03, 2025 (GLOBE NEWSWIRE) — Conavi Medical  (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 announced strategic leadership changes aligned to the Company’s planned commercial launch and expansion in the United States.Conavi 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, and is actively building the infrastructure required to support a successful U.S. launch in the largest market for intravascular imaging globally.As part of these preparations, Conavi has appointed Mark Quick as Chief Financial Officer, bringing strong capital-markets expertise from senior roles at publicly traded life sciences and medtech companies. He will oversee financial strategy and investor engagement as Conavi prepares for launch in the United States.Stefano Picone will take on a transitional strategic role with the Company as the Chief Strategy Officer. Having successfully guided Conavi through its go-public transaction, first public equity financing, and organizational scale-up, Mr. Picone now shifts focus to strategic execution and ensuring continuity as the Company advances through this commercial scale-up period.“We are entering a very exciting chapter for Conavi as we prepare for broader U.S. adoption of our hybrid imaging platform,” said Thomas Looby, Chief Executive Officer of Conavi Medical. “Mark brings the ideal financial and strategic mindset to help guide our U.S. launch and expand our presence in the capital markets. Stefano’s leadership over the past decade has been instrumental in establishing the corporate foundation we stand on today, and we are grateful for his significant financial stewardship and continued support as we execute on Conavi’s long-term growth and value-creation strategy. With these leadership enhancements and U.S. expansion activities advancing, we are confident we have the right team, capabilities, and focus in place to deliver success in the United States and create long-term value for shareholders.”“Conavi has a differentiated and highly compelling technology platform,” said Mark Quick, Chief Financial Officer of Conavi Medical. “I’m excited to join at this stage of growth and look forward to working with the team to advance a strong financial, operational, and capital markets strategy as the Company prepares for commercialization.”Mark Quick — Chief Financial OfficerMr. Quick is a seasoned finance executive with more than 20 years of experience in the medical technology and life sciences sectors. Prior to joining Conavi, he held senior financial leadership roles with publicly traded companies on Nasdaq, where he led capital markets strategy, budgeting and forecasting, financial reporting, and corporate development initiatives. Earlier in his career, Mr. Quick served as a sell-side equity research analyst at Canaccord Genuity, where he covered the medical device industry. Mr. Quick holds a Bachelor of Science in Mechanical Engineering from the University of Massachusetts, Amherst, and an International Master of Business Administration from the University of South Carolina.About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System has regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com.Cautionary Statement Regarding Forward-Looking InformationThis news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to transitions in the Company’s strategic leadership, Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S. and other U.S. expansion activities.These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.Neither the TSX Venture Exchange nor its Regulation 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:Investors: Christina Cameron, IR@conavi.com

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InterVene Receives FDA 510(k) Clearance for Recana®, the First Fully Integrated Thrombectomy System for Venous In-Stent Restenosis and Native Vessel Obstructions

Peripheral/Endo by 0 comments

REDWOOD CITY, Calif.–(BUSINESS WIRE)–InterVene, Inc., a privately held medical device company pioneering interventional devices for venous occlusions, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Recana® Thrombectomy Catheter System for treating venous in-stent restenosis and native vessel obstructions. Recana is a fully […]

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