The Latest Cardiac and Vascular News
BILLERICA, Mass.–(BUSINESS WIRE)–Access Vascular, Inc. (AVI), a leader in tackling critical vascular access challenges with its advanced hydrophilic biomaterial technology, today announced that its portfolio of vascular access catheters made with MIMIX® technology has been added to Recon Supply’s Federal Supply Schedule (FSS) contract, as well as their Distribution and […]
New real-world evidence presented at THT 2025 and published simultaneously in the Journal of Cardiac Failure (JCF) demonstrates large and statistically significant reductions in hospital visits and length of stay in patients with heart failure and reduced ejection fractionMINNEAPOLIS, Feb. 12, 2025 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the presentation of new real-world evidence at the Technology and Heart Failure Therapeutics (THT) conference in Boston. The study demonstrated large and statistically significant reductions in hospital visits (hospitalizations and emergency department visits) and length of stay after Barostim implantation, compared to before. The research was published simultaneously and is available now in the Journal of Cardiac Failure. “Despite contemporary medications, the clinical and economic burden of heart failure remains unacceptably high. This new study showing significant reductions in real-world healthcare utilization associated with the Barostim implant is critically important for clinicians and payers when considering this device for their patients,” said Jacob Abraham, MD, Section Head of Advanced Heart Failure at Providence Heart Institute in Portland, Ore. “While we know Barostim plus medications demonstrates long-term improvements in symptoms and quality of life, we now have compelling real-world evidence supporting a significant reduction in healthcare utilization as well.” This analysis was performed using data from the Premier Healthcare Database, a large all-payer database including data from more than 1,300 institutions. Three hundred and six (306) Barostim patients were identified in the data set. Comparisons were performed for the 12 months prior to Barostim implant and for an average of almost two years post-implant (1.92±1.87 years). Length of stay was found to be significantly reduced. Hospital visits (hospitalizations and emergency department visits) were categorized as all-cause, cardiovascular, and heart failure related. The analysis found: 86% reduction in all-cause hospital visits (p
Late-breaking oral presentation features echocardiographic data analysis showing favorable impact of AVIM therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failureHypertension is the leading cause of diastolic dysfunction; both conditions are common in older patients and contribute to the development of heart failure NEW HOPE, Pa., Feb. 12, 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 a late-breaking oral presentation of data on the benefits of atrioventricular interval modulation (“AVIM”) therapy on patients with diastolic dysfunction at the Technology and Heart Failure Therapeutics (“THT”) 2025 Conference in Boston, Massachusetts. The retrospective analysis of data from the MODERATO II study demonstrated that AVIM therapy significantly improved echocardiographic (“Echo”) markers of diastolic dysfunction, an important component in the development of heart failure, in hypertensive patients. The presentation titled “Effects of Atrioventricular Interval Modulation (AVIM) Therapy in Subjects with Hypertension and Diastolic Dysfunction” is being delivered in a late-breaking clinical science session at THT by Marat Fudim, M.D., M.H.S. Advanced Heart Failure Cardiologist, Duke Health on Wednesday, February 12, 2025, at 10:43am ET. Dr. Fudim commented, “For many patients with long-standing hypertension, the heart can undergo structural and functional changes that result in diastolic dysfunction, the progression of which is directly linked to the development of heart failure. By reducing systolic blood pressure and favorably impacting intra-cardiac pressures and volumes, AVIM therapy directly affects diastolic filling and myocardial relaxation. This analysis of MODERATO II data provides exciting insights that suggest that, beyond lowering systolic blood pressure, AVIM therapy improves diastolic function and leads to favorable ventricular remodeling. Given the strong link between uncontrolled hypertension, diastolic dysfunction, and heart failure, these findings highlight the opportunity to intervene earlier and leverage AVIM therapy for the prevention of heart failure.” Key Findings: A retrospective, treatment-blinded analysis of MODERATO II assessed the impact of 6 months of AVIM therapy on systolic blood pressure (“SBP”) and Echo markers of diastolic dysfunction (“DD”) using core lab Echos with independent blinded adjudication. Patients were classified as with DD (“DD+”) or without DD (“DD-”) using the American Society of Echocardiography Guidelines. From the MODERATO II study cohort (n=47), 36 patients had technically sufficient Echo data, and 61% of this group (22/36) had Echo evidence of DD. Using key measures of diastolic function, AVIM therapy: Significantly reduced office and ambulatory SBP in patients with DD through 6 months Ambulatory SBP (“aSBP”) was reduced in AVIM-treated DD+ patients (N=12) by 8.3±9.7 mmHg (p
Adrian Lam appointed President and CEO of CorVista HealthDon Crawford to retire following a distinguished 42-year career in MedTechTim Attebery to serve as Chairman of the Board of Directors BETHESDA, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced that Don Crawford will retire from his role as President and Chief Executive Officer (CEO) after a successful ten-year tenure. The Board of Directors has appointed Adrian Lam to the role of President and Chief Executive Officer. Tim Attebery, CEO of Cardiovascular Associates of America, former CEO of the American College of Cardiology (ACC) and current Board Director, will become Board Chairman. “It has been a privilege working with an exceptionally talented and dedicated team, united by a shared passion for improving cardiovascular care,” Don Crawford said. “Adrian is a dynamic, resourceful, and decisive leader who is perfectly suited to advance CorVista’s mission. He brings a proven track record of developing innovative products, building high-performing teams, and translating advanced technology into impactful medical products that improve patient outcomes.” “I am incredibly honored to lead such an innovative and mission-driven organization. The team is at the forefront of AI-enabled cardiovascular diagnostics and it’s amazing to see real patient impact even from its early days of launch. The system is able to achieve, in the doctor’s office, levels of diagnostic accuracy normally reserved for radiology. This opens up CorVista to rural and remote populations, where there is trouble with access to radiology or specialist cardiology care,” said Adrian Lam. Under Crawford’s leadership, CorVista Health has launched two pivotal U.S. Food and Drug Administration (FDA) cleared products, including the first major advancement in Pulmonary Hypertension (PH) diagnostics in more than 40 years, which secured an FDA Breakthrough Designation. He will remain on as Special Advisor to the CEO to ensure a smooth leadership transition. “As Don transitions out of his role, we want to thank him for his many years of dedicated service. We are proud of the foundation he built and look forward to partnering with Adrian to deliver on our promise to transform cardiovascular care,” said Tim Attebery. “Adrian’s diverse background as an investor-operator and a seasoned business executive uniquely positions him to navigate the future of our business and deliver meaningful value to our patients, providers, and stakeholders.” Adrian brings over 20 years of expertise in global MedTech, BioTech, and Life Science Tools. At Stryker, he led the Advanced Biomaterials R&D Group, spearheading development of multiple FDA-cleared products. As an early executive at Genesis Medtech, he helped scale the company from startup to unicorn in just over a year, driving innovation, business development, and operational integration. Previously, he managed an equity portfolio at the healthcare fund Sectoral Asset Management, building a global network of investors and industry leaders. He is also the founder of Bioworld Ventures, an investment and company-building platform run by healthcare executives and entrepreneurs. Adrian holds degrees in Biomedical Engineering and Economics from Duke University. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvistahealth.com Contacts CorVista Health Media RelationsEmail: media@corvistahealth.com
WARRINGTON, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, announced that an istaroxime presentation featuring the positive Phase 2b SEISMiC study was given on February 11, 2025 at the Technology and Heart Failure Therapeutics Conference in Boston, MA.
Bioxodes raises €2.7 million from existing investors in Series A extensionInterim data from BIRCH intracerebral hemorrhage (ICH) Phase 2a trial in Q1 2025Recruitment of up to 16 additional patients continues in BIRCH BIOX-101 Phase IIb ICH study preparations ongoing, to start upon close of Series B Gosselies (Belgium), 12 February 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has raised €2.7 million from existing investors in an extension of its Series A funding round, now totaling about €15 million. The proceeds will allow the company to deliver full results from BIRCH, its Phase 2a trial of BIOX-101 to treat intracerebral hemorrhage (ICH), an orphan disease with no currently approved therapeutic intervention, and prepare for the launch of a potentially registrational Phase 2b trial of BIOX-101 for ICH. “The Series A extension is an important financial commitment from our existing investors, and an invaluable sign of confidence in the future of Bioxodes,” said Marc Dechamps, Chief Executive Officer at Bioxodes. “We are at a crucial moment in the development of BIOX-101, a first-in-class therapeutic to treat the devastating effects of intracerebral hemorrhagic stroke, a high unmet medical need. In the first half of this year, we will update investors about a number of crucial milestones, including the strengthening of our top management, interim results from the BIRCH Phase 2a study, a decision about the Orphan Drug Designation of BIOX-101, and our Series B funding round.” Recruitment for the randomized, open-label BIRCH trial is continuing after Bioxodes enrolled the first 16 patients in December. Bioxodes is planning to present an interim analysis of these patients when the data become available. Bioxodes is also expecting an imminent response from U.S. and EU regulators about its Orphan Drug Designation for BIOX-101, which it applied for in the fourth quarter of 2024. ICH is classified as an orphan disease in U.S. and Europe; drugs developed for orphan indications can have relatively rapid and cost-effective paths to market compared to other drugs. For example, the Phase 2b trial of BIOX-101 could be sufficient to register the product for marketing authorization before the end of this decade. At the same time, Bioxodes is working to ramp up production of BIOX-101 for a potential registrational international Phase 2b trial, which it plans to launch early next year, with recruitment expected to start in the first quarter of 2027. The Chemistry, Manufacturing and Controls (CMC) required to generate BIOX-101 for Phase 2b will take approximately a year to complete. Bioxodes is launching a series B funding round of about 50 million in Q2 2025, to support CMC and clinical development for BIOX-101, as well as to develop the drug candidate for additional indications including ischemic stroke and undisclosed thrombo-inflammatory diseases. In addition, Bioxodes will research other novel options to treat thrombotic and inflammatory diseases. BIOX-101 is synthesized based on a small protein found in the saliva of the tick1. It is designed to reduce the harmful secondary brain injuries that occur after a hemorrhagic stroke. BIOX-101 has demonstrated striking benefits in preclinical proof-of-concept studies, including the prevention of blood clot formation, as well as a reduction in detrimental neuroinflammation after an ICH. Unlike anticoagulants currently marketed to prevent blood clot formation, BIOX-101 reduces clotting without increasing the risk of bleeding. BIOX-101 also inhibits the activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier About Bioxodes Bioxodes is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. Since its founding in 2013, Bioxodes has developed its lead asset BIOX-101, a first-in-class drug candidate aimed at patients with thrombo-inflammatory disease. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for the prevention of (thrombo-)inflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region, and the company is registered in Belgium under number 825.151.779. For more information please visit www.bioxodes.com or contact: HEAD OFFICES BioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 1 6041 Gosselies, Belgium+32 496 590354investment@bioxodes.com MEDIA RELATIONSAlexandra Schiettekatte communication@bioxodes.com +32 476 65 04 38 COHESION BUREAU EU MEDIA RELATIONSSophie Baumont sophie.baumont@cohesionbureau.com INVESTOR RELATIONS Giovanni Ca’ Zorzi giovanni.cazorzi@cohesionbureau.com 1 Ixodes ricinus
Attachment
20250211 – Bioxodes PR Series A extension – final
MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, an innovative, FDA-cleared delivery platform, today announced the closing of its previously announced $12.1 million firm commitment underwritten public offering of common stock led by multiple fundamental […]
— Late-Breaking Clinical Data Presented at the Technology and Heart Failure Therapeutics (THT) Annual Meeting Demonstrates Safety and Efficacy of the Reprieve System Compared to Optimal Diuretic Therapy to Manage Fluid Volume Overload — — Company Plans Initiation of Randomized Pivotal Trial in the First Half of 2025 to Support Premarket […]
The approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalization (CVH)) durably separated relative to placeboA 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30 Acoramidis is the first and only approved ATTR-CM treatment in the U.S. and EU with a label specifying near-complete stabilization(≥90%)Relative increases in serum TTR concentrations resulting from greater TTR stability have been associated with reduced risk of all-cause and cardiovascular mortality in the general population in recent literature1BridgeBio will receive a $75 million milestone payment from Bayer and will also receive royalties in a tiered structure beginning in the low-thirties percent on sales of BEYONTTRA in the EU PALO ALTO, Calif., Feb. 11, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced the European Commission has granted marketing authorization in the European Union (EU) for acoramidis, under the brand name BEYONTTRA™, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. Bayer will be responsible for all commercial activity for acoramidis in the EU. “ATTR-CM is a rapidly progressing disease with a poor prognosis when left untreated, making the approval of acoramidis, which has demonstrated improved benefit on all-cause mortality and cardiovascular-related hospitalizations in as few as three months, a very important accomplishment for patients. We are pleased that people living with ATTR-CM will have access to another treatment option in the EU,” said Marianna Fontana, M.D., Ph.D., Professor of Cardiology and Honorary Consultant Cardiologist at the National Amyloidosis Centre, Division of Medicine, University College London. The approval in the EU is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients in need. “The EU approval of acoramidis is a significant advancement for patients living with ATTR-CM in need of new disease-modifying treatments for their condition,” said Dr Jonathan Fox, BridgeBio Cardiorenal Chief Medical Officer. “This approval would not have been possible without the commitment of the clinical trial participants and their families, and the dedicated support of the physicians and scientists involved in the clinical program. Alongside our able partners at Bayer we look forward to this new opportunity to serve ATTR-CM patients across the European Union.” Following EU approval, Bayer will launch acoramidis in the first half of 2025. Acoramidis was approved as Attruby™ by the U.S. FDA in November 2024 with a label specifying near-complete stabilization of TTR. As reported on January 13, BridgeBio has seen strong commercial momentum, with 430 patient prescriptions written by 248 physicians since the U.S. approval. In March 2024, BridgeBio and Bayer initiated a collaboration for acoramidis, which granted Bayer exclusive commercialization rights in the EU. Based on terms of the licensing agreement, BridgeBio will receive a $75 million milestone payment upon European Commission approval. BridgeBio will also receive royalties in a tiered structure beginning in the low-thirties percent on sales of acoramidis in the EU following initiation of commercialization efforts. Acoramidis is currently under review for approval by the Japanese Pharmaceuticals and Medical Devices Agency and the Brazilian Health Regulatory Agency . 1Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA Cardiol. 2024 Dec 4:e244102. About BEYONTTRABEYONTTRA is an orally administered near-complete (≥90%) stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). BEYONTTRA was generally well-tolerated. The most common side effects were mild and included diarrhea and abdominal pain that were resolved without drug discontinuation. For full prescribing information, please refer to the Summary of Product Characteristics (SmPC) which will be available on the European Medicines Agency (EMA) website once published. About BridgeBio Pharma, Inc.BridgeBio Pharma, Inc. (BridgeBio) 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, Twitter and Facebook. BridgeBio Pharma, Inc. Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the impact of BEYONTTRA on clinical outcomes; the potential benefits of BEYONTTRA, including its efficacy and potential to reduce cardiovascular-related hospitalizations, improve survival, and preserve functional capacity and quality of life for patients; and the potential outcomes and expected timing of regulatory reviews and approvals in Japan and Brazil, reflect BridgeBio’s current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions BridgeBio has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies, as reflected in or suggested by these forward-looking statements, are reasonable, BridgeBio can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to, the risks associated with BridgeBio’s dependence on third parties for development, manufacture, and commercialization activities related to BEYONTTRA; government and third-party payor actions; risks and uncertainties relating to competitive products and other changes that may limit demand for BEYONTTRA; the risk that regulatory authorities may require additional studies or data to support the continued commercialization of BEYONTTRA; the risk that drug-related adverse events may be observed during commercialization or clinical development; the risk that data and results may not meet regulatory requirements or otherwise be sufficient for further development, regulatory review, or approval; the risk of other regulatory agencies not agreeing with BridgeBio’s regulatory approval strategies, components of BridgeBio’s filings (such as clinical trial designs, conduct, and methodologies), or the sufficiency of data submitted; the continuing success of its collaborations, including compliance with applicable regulations for the purchase, distribution, storage, export, and sale of active pharmaceutical ingredients and medicinal products; uncertainty regarding any impacts due to global health emergencies, including delays in regulatory review, manufacturing, and supply chain interruptions; adverse effects on healthcare systems and disruption of the global economy; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip; and increasing rates of inflation and changing interest rates on BridgeBio’s business operations and expectations. These risks, as well as those set forth in the Risk Factors section of BridgeBio’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and its other filings with the U.S. Securities and Exchange Commission, should be carefully considered. Moreover, BridgeBio operates in a highly competitive and rapidly changing environment, in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. BridgeBio Media Contact:Bubba Murarka, EVP Communicationscontact@bridgebio.com (650)-789-8220
MONTREAL and CHARLOTTE, N.C., Feb. 11, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced further details on its in-person and virtual Commercial Launch Plan investor event to take place in New York on Tuesday, February 25, 2025 from 10:30 AM to 12:30 PM ET. Investors planning to attend the in-person event are required to register in advance. To register, click here. Featuring presentations by Joseph Oliveto, President and Chief Executive Officer, and Lorenz Muller, Chief Commercial Officer, the event will provide an overview of Milestone’s commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). Milestone’s New Drug Application (NDA) for CARDAMYST is currently under review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. Milestone currently expects to launch in PSVT mid-2025. A live question and answer session will follow the formal presentation. 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 atrial fibrillation with rapid ventricular rate (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 solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. 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 the timing and outcomes of future interactions with the FDA, including the PDUFA target date; the timing of our potential commercial launch of CARDAMYST; and the ability of etripamil for PSVT to provide patients with active management and a greater sense of control over their condition. 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, 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, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. 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. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com
