The Latest Cardiac and Vascular News
Adults with type 2 diabetes on semaglutide injection 1 mg, whose dose was increased to 2 mg, were associated with a statistically significant 6% lower risk of major adverse cardiovascular events (MACE), compared to switching to tirzepatide (up to 15 mg)1 Retrospective real-world analysis…
As population most at risk for vascular disease surges, shortages leave people in 2,400+ U.S. counties without a vascular surgeon ROSEMONT, Ill., Sept. 28, 2026 /PRNewswire/ — More than 75 million people in the United States live in a county without a vascular surgeon, according to new…
FAYETTEVILLE, Ark., Sept. 28, 2026 /PRNewswire/ — HeartX, powered by HTA and MedAxiom — along with leading cardiovascular programs across the country — has selected five startup healthcare companies to participate in the 2026 accelerator program. HeartX is a cardiovascular-focused…
Expands Company’s Portfolio of Advanced Neurovascular Catheters to Support Treatment in Smaller and More Distal Anatomies WEST JORDAN, Utah, Sept. 28, 2026 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced U.S. Food and Drug Administration 510(k) clearance for the FreeClimb® 46 catheter with Tenzing® 4. The two components are engineered as an integrated system to provide neurovascular access. FreeClimb® 46 and Tenzing® 4 are the newest offerings in Route 92’s portfolio of advanced neurovascular catheters. The FreeClimb 46 system joins FreeClimb 54, 70 and 88, and complements the HiPoint® 70 and HiPoint 88 systems, which also feature the company’s proprietary Monopoint® single-operator system. All Route 92 access and aspiration catheters are powered by custom-sized Tenzing delivery catheters. The navigational capabilities of Tenzing enable atraumatic, precise, and controlled access through neurovascular anatomy, establishing stable access for the treatment of complex neurovascular diseases. “In neurovascular intervention, access is critical,” said Matthew D. Alexander, M.D., Medical Director of Neurointerventional Radiology at Sutter Medical Center in Sacramento, California. “Tenzing supports consistent navigation through even the most challenging cases, allowing us to reach the anatomy we need to treat. The FreeClimb 46 with Tenzing 4 expands Route 92’s catheter technologies to smaller and more distal vessels, where the clinical need is large and accurate delivery is critical to achieving the best outcomes for my patients. I look forward to bringing this next level of neurovascular access into my practice.” The FreeClimb 46 catheter system, including Tenzing 4, and all Route 92 catheters and systems are covered by a portfolio of more than 200 issued patents in the U.S. and international jurisdictions.About Route 92 Medical, Inc.Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering, innovative product design and revolutionary procedural change. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn. CONTACT: Contacts:
For media:
Gwen Gordon
Gwen@gwengordonpr.com
DURHAM, N.C., Sept. 28, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the addition of life science industry veterans Scott Coward and Paul Kuznik to the Company’s Board of Directors, both of whom bring substantial experience in the areas of commercialization, enterprise leadership, and global operations. “We are delighted to welcome two distinguished commercialization and life science leaders to the Humacyte Board as we continue to expand our ongoing Symvess® launch and prepare for our planned commercial launch of the ATEV in the dialysis access indication,” said Dr. Laura Niklason, Founder, President, and Chief Executive Officer of Humacyte. “Scott Coward brings a track record of success through his leadership at Exact Sciences and has significant experience in board service and executive leadership within publicly traded life sciences companies. Paul Kuznik has extensive experience in vascular healthcare and cardiovascular devices, including extensive leadership roles in commercialization, enterprise leadership, manufacturing, strategic planning, and physician engagement. We look forward to their contributions as we work toward our anticipated U.S. market launch in dialysis.” Scott Coward served as Executive Vice President, Chief Legal Officer, Chief Administrative Officer and Secretary of Exact Sciences Corporation from January 2015 to December 2022. Mr. Coward led the integration of Genomic Health Corp. following its acquisition by Exact Sciences. He also served on the Exact Sciences board of directors from December 2022 to March 2026. Mr. Coward has been an attorney at K&L Gates since July 2026 and was previously a partner in the firm from 2008 through 2014. During that tenure, he served in different leadership roles, including as the managing partner of the Raleigh office. Mr. Coward brings significant experience in public company board service and corporate governance, executive leadership within publicly traded life sciences companies, mergers and acquisitions and post-acquisition integration, executive compensation, compliance and legal affairs, organizational leadership during periods of substantial growth and change, and has partnered with executive management teams and boards through transformational corporate events. Mr. Coward received his J.D. from Columbia Law School and his B.S. from the University of North Carolina at Chapel Hill. He has been appointed to the Company’s Audit Committee. “I am honored to join the Humacyte Board of Directors at such an exciting time for the Company,” said Mr. Coward. “Humacyte’s pioneering work in regenerative medicine has the potential to transform patient care, and I look forward to working with the Board and management team to support the Company’s continued growth and long-term success.” Paul Kuznik is a medical technology executive whose career spans more than three decades in vascular healthcare, cardiovascular devices, and medical diagnostics. Mr. Kuznik served as the Chief Executive Officer and a member of the Board of Directors from 2015 to 2018 at Bolton Medical, a developer of endovascular technologies for complex aortic disease, which was acquired by Terumo Corporation. Following the acquisition, Mr. Kuznik remained with Terumo Corporation, one of Japan’s leading global medical technology companies. He helped lead the integration of Bolton Medical with Vascutek to create Terumo Aortic and subsequently served as President of Terumo Aortic United States from 2019 to 2020 and as President of Terumo Aortic North America from 2020 to 2023. Mr. Kuznik brings extensive experience in commercialization, enterprise leadership, organizational integration, strategic planning, manufacturing, clinical affairs, regulatory oversight, quality systems, physician engagement and board governance. Mr. Kuznik is a graduate of the United States Military Academy at West Point and served as an officer in the United States Army. He has been appointed to the Company’s Commercial Committee. “I’m thrilled to join the Board of Directors at Humacyte as the Company’s regenerative medicine technologies have the potential to make a significant impact across numerous markets while benefiting patients throughout the world,” said Mr. Kuznik. “I’m excited to work with the Board of Directors and Humacyte in our efforts to expand both physician and patient access to the innovative regenerative vascular solutions offered by the Company.” About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com Photos accompanying this announcement are available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/debe51f6-5e18-4813-9829-d8e85bd71f10https://www.globenewswire.com/NewsRoom/AttachmentNg/4e6163ac-4843-48ad-b0bb-76203e9bda00
CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR). MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as no
Company holds exclusive access to imaging data from 2,100+ U.S. hospitals through its ongoing data partnership with vRad, the largest teleradiology provider in the United StatesBOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) — GuideAI Health Corp. (Cboe CA: GDAI) (FSE: ZN0) (“GuideAI” or the “Company”) is pleased to announce the renewal of its data exclusivity agreement with vRad (Virtual Radiologic), which aims to develop artificial intelligence models for the detection and characterization of multiple vascular diseases. The renewed collaboration provides GuideAI with exclusive access to imaging data from more than 2,100 hospitals across the United States, which the Company believes to be one of the largest and most diverse real-world imaging datasets of its kind. Under the renewed partnership, GuideAI retains exclusive rights to develop AI models using de-identified imaging data generated across vRad’s national network of more than 2,100 hospitals and healthcare facilities. GuideAI’s technology is currently deployed within the workflow of vRad’s approximately 500 radiologists, where it supports the identification of vascular disease at the point of care. The scale and diversity of vRad’s dataset provide GuideAI with a durable foundation on which to train and validate its algorithms. Building on its work in peripheral arterial disease, the Company intends to expand its platform to the detection and characterization of multiple vascular diseases, with the goal of surfacing disease earlier and supporting more precise, more comprehensive treatment decisions for patients nationwide. GuideAI Health CEO, Raj Shah, commented, “Renewing our exclusive data collaboration with vRad is a defining moment for GuideAI. Access to imaging data from more than 2,100 hospitals, combined with the trust of the 500 radiologists who already have access to our technology in their daily workflow, gives us an exceptional foundation to build clinically meaningful AI, furthering our aim of helping clinicians catch disease earlier and improve outcomes for patients.” About GuideAI Health Corp. GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease. By surfacing disease earlier, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care. For more information, please visit www.guideaihealth.com. On Behalf of the Board of Directors: Raj Shah CEO Contact: Phone: (416) 309-3583Email: info@guideaihealth.com Cautionary Note Regarding Forward-Looking Statements This news release contains certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities laws (collectively, “forward-looking information”). Forward-looking information in this news release includes, but is not limited to, statements regarding: the continuation and anticipated benefits of the Company’s renewed data exclusivity agreement and collaboration with vRad; the Company’s continued exclusive access to, and ability to use, de-identified imaging data generated across vRad’s network; the scope, scale, diversity and anticipated value of that dataset; the continued deployment and use of GuideAI’s technology within vRad’s radiology workflow; the Company’s ability to train, develop, validate and commercialize artificial intelligence models for the detection and characterization of vascular diseases; the expansion of the Company’s platform beyond peripheral arterial disease; the potential for the Company’s technology to identify disease earlier, support more precise and comprehensive treatment decisions and improve patient outcomes; and the Company’s business plans, objectives and future activities. Forward-looking information is often, but not always, identified by words or phrases such as “anticipates”, “believes”, “expects”, “intends”, “plans”, “aims”, “goal”, “may”, “will”, “would”, “could”, “should”, “potential”, “continue” and similar expressions. Forward-looking information is based on management’s estimates, assumptions and expectations as of the date of this news release, including assumptions regarding: the continued validity and enforceability of, and performance by the parties under, the renewed agreement; the Company’s continued ability to access and lawfully use sufficient quantities of de-identified imaging data; the quality, completeness, diversity and representativeness of the available data; the continued availability, performance and integration of the Company’s technology within vRad’s workflow; the Company’s ability to retain qualified personnel, secure required financing and other resources, protect its intellectual property and data rights, and complete development, testing and validation activities; and the receipt of any required regulatory, clinical, commercial or third-party approvals. Although the Company considers these assumptions reasonable, they may prove to be incorrect. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied, including risks relating to: the termination, non-renewal, amendment, breach or unenforceability of the renewed agreement; interruptions, restrictions or loss of access to imaging data or the vRad network; limitations in the quantity, quality, completeness, diversity or representativeness of available data; privacy, data protection, cybersecurity, data de-identification, consent and regulatory compliance; the accuracy, reliability, generalizability, validation and clinical utility of artificial intelligence models; development delays, technical failures, integration challenges and the inability to achieve expected performance or commercial objectives; changes in laws, regulations, standards of care or regulatory requirements applicable to artificial intelligence, medical devices, healthcare or data use; failure to obtain or maintain required approvals; intellectual property disputes and the inability to protect proprietary rights; competition and technological change; dependence on key personnel, collaborators, service providers and third parties; the availability of capital and other resources; and the possibility that the anticipated clinical, operational or commercial benefits of the collaboration and the Company’s technology will not be realized. Additional risks are described in the Company’s public disclosure documents available under its profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking information. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law.
Enrollment completed in the double-blind, placebo-controlled Phase 4 study (NCT05955326) of sovateltide (Tycamzzi®), with final study data expected in Q1 2027Five sovateltide abstracts accepted at World Stroke Congress, October 21-23, 2026, Seoul, South Korea, including an interim analysis of the Phase 4 trialGlobal Phase 3 RESPECT-ETB trial (NCT05691244) actively enrolling and remains on track for topline data in early 2028 WILLOWBROOK, Ill., Sept. 28, 2026 (GLOBE NEWSWIRE) — Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company developing novel therapeutics for critical care and neurovascular conditions, today announced that enrollment is complete in its 160-patient Phase 4 clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke in India. The Phase 4 study (NCT05955326) is a post-approval commitment required by Indian regulators. The double-blind, placebo-controlled trial utilizes the same sovateltide dosing regimen, randomization, and 24-hour treatment window as the global Phase 3 RESPECT-ETB trial, and the same protocol and eligibility criteria as the Phase 3 study that supported approval in India. The primary endpoint is the proportion of patients with adverse events and serious adverse events. Key secondary endpoints measure Day 90 neurological recovery, functional independence, and disability using the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and the Barthel Index. Final data are expected in Q1 2027. Pharmazz conducted a prespecified interim analysis in September 2025, when the first 80 patients reached the Day 90 endpoint, and presented those results at the International Stroke Conference 2026 in New Orleans. In that analysis, 92% of sovateltide-treated patients achieved an mRS score of 0 to 2 at Day 90, compared with 58% in the control arm (p=0.0004889). No drug-related adverse events were observed. “Dosing the final patient in our Phase 4 study marks an important milestone in our mission to address severe neurovascular conditions with high unmet medical needs,” said Dr. Anil Gulati, M.D., Ph.D., Chairman and Chief Executive Officer of Pharmazz, Inc. “Acute ischemic stroke remains a leading cause of long-term disability worldwide, and treatment options are limited. The fact that Sovateltide has been used to treat more than 140,000 patients in India since launch provides empirical real-world evidence that the selective endothelin B receptor agonist is able to promote neurogenesis, angiogenesis, and neuronal survival. We are actively enrolling in our global Phase 3 RESPECT-ETB trial and look forward to reporting final data in early 2028.” Upcoming Presentations at the 18th World Stroke Congress Five presentations will be made on-site at the upcoming 18th World Stroke Congress, taking place October 21-23, 2026, at the Convention & Exhibition Center, Seoul, South Korea. A meta-analysis assessing the effectiveness and safety of sovateltide in patients with acute ischemic strokeA global Phase III trial (RESPECT-ETB) to evaluate safety and effectiveness of sovateltide (Tycamzzi®) in ACIS patients Effect of sovateltide (Tycamzzi®) on the thrombolytic activity of alteplase and tenecteplaseAn interim analysis of multicentric, randomized Phase 4 clinical trial of sovateltide (Tycamzzi®) in AIS patients The development of sovateltide for cerebral ischemic stroke patients. About Sovateltide Sovateltide (IRL-1620) is a first-in-class endothelin-B receptor agonist that promotes neurogenesis, angiogenesis, and neuronal survival following acute hypoxic and ischemic insults. The drug is currently being evaluated in clinical programs for acute ischemic conditions. The Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial is being conducted at 57 sites in the US, Germany, Spain, and the UK, and is designed to enroll 514 stroke patients. In September 2026, the U.S. FDA granted Orphan Drug Designation to sovateltide for the treatment of neonatal hypoxic-ischemic encephalopathy. About Orphan Drug Designation The FDA’s Orphan Drug Designation program provides orphan status to investigational drugs and biological products intended to safely and effectively treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, which may include tax credits for qualified clinical testing, exemptions from prescription drug user fees (PDUFA), and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval for the designated indication. About Pharmazz, Inc. Pharmazz, Inc. is a biopharmaceutical company focused on developing and commercializing first-in-class therapies for critical care medicine. For more information, please visit www.pharmazz.com. Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be “forward-looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors David Costello MediaShruti Gulati Tel+1 630 780 6087 Tel+1 630 780 6087E maildavid.costello@pharmazz.com E mailshruti.gulati@pharmazz.com
Montreal Heart Institute Joins Multinational Study Evaluating a Self-Administered 70 mg Repeat-Dose Regimen of EtripamilMONTREAL and CHARLOTTE, N.C., Sept. 24, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the Montreal Heart Institute, recently activated as the first Canadian clinical trial site for the ReVeRA-301 Phase 3 pivotal trial evaluating etripamil nasal spray for the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR), has enrolled their first patient. The expansion into Canada advances the multinational study toward its target of 150 patients with treated AFib-RVR events. ReVeRA-301 is evaluating the same 70 mg repeat-dose regimen that is U.S. Food and Drug Administration (FDA)-approved for paroxysmal supraventricular tachycardia (PSVT) as CARDAMYST® (etripamil) nasal spray. “Activating clinical trial sites and enrolling study participants in Canada are important steps toward advancing ReVeRA-301 and reflect the momentum behind our global enrollment efforts following the recent first enrolled patient in the United States,” said David Bharucha, M.D., PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals. “We are honored to continue our work with the strong Canadian community of cardiovascular investigators and centers with deep experience in atrial fibrillation research.” “Following the promising Phase 2 data, we are pleased to advance etripamil into this pivotal Phase 3 trial in AFib-RVR,” said Adrian Petzl, M.D., Cardiologist-Electrophysiologist, Montreal Heart Institute, and investigator on ReVeRA-301. “The ability to intervene promptly with a self-administered therapy outside of the emergency department could represent a meaningful change for patients living with this condition. We are excited that the Montreal Heart Institute is at the forefront of this global research initiative.” About ReVeRA-301 ReVeRA-301 is a Phase 3 multinational, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil nasal spray in approximately 150 patient events with AFib-RVR. Prompted by symptoms, patients will self administer, in a medically unsupervised setting (e.g., at home), the same 70 mg dose of etripamil and repeat-dose regimen that supports the current FDA indication for the treatment of PSVT. Based on safety data demonstrated to date, Milestone is currently pursuing a single-study supplemental new drug application (sNDA) registration pathway for the treatment of AFib-RVR. The primary endpoint for ReVeRA-301 is reduction in ventricular rate (VR) within 30 minutes. The study will also evaluate a key secondary endpoint of symptom improvement via patient-reported outcomes. Clinical trial sites and enrollment information can be found at https://clinicaltrials.gov. The trial advances research from ReVeRA-201, a multi-center Phase 2, randomized controlled study of the efficacy and safety of etripamil nasal spray for the acute reduction of symptomatic AFib-RVR in an emergency room setting. The clinical trial showed that a single dose of etripamil nasal spray at 70 mg reduced VR and improved both relief of symptoms and treatment satisfaction. About Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) Atrial fibrillation (AFib) is the most common sustained arrhythmia, affecting over 6 million people in the United States. The prevalence of AFib in Canada is similarly problematic to that in the United States. The Canadian Cardiovascular Society estimates that AFib affects approximately 1-2% of the population, up to approximately 800,000 people in Canada, and represents a substantial and growing public health burden. AFib presents with an irregular heart rate and is classified as paroxysmal, persistent, or permanent. When there is a rapid heart rate during AFib, it is referred to as “atrial fibrillation with rapid ventricular rate (AFib-RVR).” Market research indicates that 30-40% of patients with AFib experience at least one episode of RVR per year requiring urgent medical attention. These episodes commonly cause palpitations, shortness of breath, and weakness. While AFib is rarely life-threatening, it is a serious condition that often requires treatment and increases the risk of serious complications if not properly managed. Current options for acute AFib-RVR management are limited and often involve an emergency department visit for IV beta blockers, IV calcium channel blockers, or electrical cardioversion. About CARDAMYST in the United States CARDAMYST® (etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com. U.S. FDA IndicationCARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil) What is CARDAMYST? CARDAMYST is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT). It is not known if CARDAMYST is safe and effective in children. Do not use CARDAMYST if you: are allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete list of ingredients in CARDAMYST.have limitations in activities due to heart failure (moderate to severe heart failure).have Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).have sick sinus syndrome without a permanent pacemaker.have second degree or higher atrioventricular (AV) block. Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you: have a history of fainting.have low blood pressure.are pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this time, pump and throw away your breast milk. Talk to your healthcare provider about the best way to feed your baby after using CARDAMYST. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of CARDAMYST? CARDAMYST may cause serious side effects, including: Fainting due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST may cause dizziness and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back and seek medical help. The most common side effects of CARDAMYST include: nasal discomfortnasal congestionrunny nose throat irritationnosebleed These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see the full Prescribing Information https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/ Cautionary Note on Forward-Looking StatementsThis 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: Milestone’s business strategy and plans; the design, timing, and enrollment of the ReVeRA-301 Phase 3 clinical trial for AFib-RVR, including the anticipated number of patients and sites; the potential for etripamil to serve as a treatment option for patients with AFib-RVR, including as a self-administered therapy; the commercialization and market adoption of CARDAMYST; the development of etripamil for additional indications, including Phase 2 development in pediatric PSVT patients; expectations regarding the efficacy and safety of etripamil for AFib-RVR based on Phase 2 findings; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; 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, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone’s 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 and conflicts, and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related to 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, 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. Contact:Investor RelationsKevin Gardner, kgardner@lifesciadvisors.com Media RelationsRebecca Novak, rnovak@milestonepharma.com
