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FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials

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With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.

Clario’s SpiroSphere® integration with the wireless COR-12 is now FDA 510(k) cleared, allowing for consecutive collection of spirometry and ECG data during a single site visit.
The flexibility of the wireless COR-12 ECG enables integrated respiratory and cardiac safety trials for on-site, hybrid or remote trial design considerations.
The wireless feature of the SpiroSphere® ECG improves patient experience by removing the need for lead wires while maintaining high-quality data collection and accelerating trial timelines.

PHILADELPHIA, June 13, 2024 /PRNewswire/ — Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This technological advancement allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario’s SpiroSphere® platform, consolidating all data into a single, unified database. This streamlines the clinical trial process and eliminates the need for separate ECG devices or multiple databases for a study.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, initially did not include ECG functionality. Now, the introduction of the SpiroSphere® ECG features the wireless COR-12 ECG device. This advancement enables customers to run integrated respiratory and cardiac safety trials on a single device and single database, simplifying the clinical trial process.
“The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology,” said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario. “This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”
Ellen Street, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario added, “Our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model. With this wireless technology, site clinicians can now comfortably record both ECG and spirometry data in a single session on a single device, which can reduce the necessity for multiple devices, reduce burden, and accelerate trial timelines.”
This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.
About ClarioClario is a leading healthcare research and technology company that generates high clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.
Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.
For more information, go to Clario.com or follow us on LinkedIn.
Media Contact:Alexis NavratilCommunications Manager[email protected] 
SOURCE Clario

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Anthos Therapeutics Announces ~84% of Eligible Patients Have Transitioned to Abelacimab in the AZALEA-TIMI 71 Extension Study of Atrial Fibrillation Patients at a Moderate-to-High Risk of Stroke

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75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study. When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment. “The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr. Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women’s Hospital, Senior Investigator of the TIMI Study Group, an Associate Member of the Broad Institute of MIT and Harvard, and an Associate Professor of Medicine at Harvard Medical School. The initial results of the AZALEA-TIMI 71 study1 of patients with atrial fibrillation at moderate-to-high risk of stroke were presented at the American Heart Association 2023 scientific congress during a late-breaking session. For the primary endpoint, abelacimab 150 mg dosed once-monthly, demonstrated a highly significant 67% reduction in major or clinically relevant non-major bleeding.1 In addition, there was a substantial 74% reduction in major bleeding alone and a 93% reduction in gastrointestinal (GI) bleeding, all favoring abelacimab over rivaroxaban, a standard-of-care anticoagulant.1 “We are very pleased that the open-label extension of the AZALEA-TIMI 71 study has completed its transition phase and that the vast majority of eligible patients voluntarily opted to receive abelacimab 150 mg once-monthly moving forward,” said Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. “Too many patients with diagnosed atrial fibrillation are not receiving an anticoagulant today or are taking an inappropriate dose, due to the risk or fear of bleeding, the possibility for drug-drug interactions, dosing complications due to age or renal status or just because they forget to take their daily medication. If approved, it is our hope that abelacimab will provide patients with the protection they need against blood clots, but with a placebo-like bleeding profile.” Atrial fibrillation, or AF, is the most common type of irregular heart rhythm. The most severe complication of AF is stroke,2 which can be prevented by taking an anticoagulant, or “blood thinner.” The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 However, data from multiple patient registries and claims-based data analyses highlight that approximately 40% to 60% of patients with atrial fibrillation are either not on an anticoagulant or are receiving a sub-therapeutic dose and are thereby not benefiting from the protection that anticoagulants provide. This underuse of anticoagulants has been cited as one of the greatest public health issues facing cardiovascular patients.4 About Abelacimab Abelacimab is a highly selective, fully human monoclonal antibody that binds to FXI and locks it in the inactive state, preventing the formation of activated FXI (FXIa). As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status. Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.5 Abelacimab is the only Factor XI inhibitor being studied for both conditions. In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.1 In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the AZALEA-TIMI 71 Phase 2 Study The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily. With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:1 Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P

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ACSD Granted Significant Telemedicine Patent

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IRVINE, Calif., June 5, 2024 /PRNewswire/ — ACS Diagnostics, Inc. of Irvine CA, with executive offices in Chattanooga TN, has been granted U.S Patent No. 11,980,452. The patent relates to ACSD’s Cardiac Monitoring CORE technology, specifically ambulatory ECG. The patented CORE device provides for multiple telemedicine related tests , including ECG/EKG, Holter, Event, and Mobile Cardiac Telemetry. The Core monitor integrates a cell phone module to alleviate the necessity for a companion phone for patient transmissions.
This is the fifth CORE technology patent, and relates to a single cardiac monitoring device offering to perform more than one of the above mentioned test modalities. The Core monitor is the only telemedicine device that is patented to offer the worldwide cardiology community all these tests within a one device. With this patent, the days of a provider needing to purchase a different monitor for each test are over.
This technology, and all related test modalities, are being successfully used by thousands of US customers, transmitting ECG patient data 24/7 to our California based IDTF laboratory. The ACSD IDTF laboratory is completely staffed with cardiac technicians to monitor patients and alert physicians to significant cardiac events.
A number of companies provide products for this market, including GE Healthcare, Medtronic, BioTelemetry / Philips, Boston Scientific, Samsung, Hill-Rom, IRhythm Technologies, Johnson & Johnson, OSI/Spacelabs, and a host of smaller players.
ACSD respects intellectual property rights and has a growing portfolio of patents, which are listed at www.ACSD4u.com/patents. ACSD firmly believes in innovation through research and development, and it will vigorously enforce its intellectual property rights.
SOURCE ACS Diagnsotics

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AliveCor’s AI-backed ECG Offerings Featured in New Film Series on Innovative Technologies Presented by the Consumer Technology Association

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The Human Component series, produced by BBC StoryWorks Commercial Productions, is now available to stream 
MOUNTAIN VIEW, Calif., June 5, 2024 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced its participation in The Human Component, a new online branded series developed for the Consumer Technology Association (CTA) and produced by BBC StoryWorks Commercial Productions, the commercial content division of BBC Studios.
The series showcases innovative technologies that are supporting healthier communities, stronger societies and a more resilient planet. Through compelling, human-led films, The Human Component celebrates global efforts to maximize the full potential of technology.
“We are incredibly proud to take part in The Human Component alongside innovators who are just as committed to introducing game-changing ideas to improve lives as we are,” said Priya Abani, CEO of AliveCor. “The series beautifully depicts the real-life impacts of technologies like our AI-backed ECG solutions and services, and how they are helping transform society for the better.”
AliveCor’s film shares the story of Dr. Cleveland Francis, a cardiologist and musician who was diagnosed with a heart condition after collapsing at home. After his episode, Dr. Francis used one of AliveCor’s FDA-cleared Kardia™ devices to take a real-time, clinical-grade ECG that he shared with his doctor, leading to a definitive diagnosis. Capable of remotely identifying six of the most common arrhythmias in just 30 seconds, Kardia personal ECGs place the power of advanced AI technology directly into users’ hands. They also offer healthcare providers a way to capture patients’ elusive arrhythmias, contributing to earlier diagnoses and improving clinical decision-making.
This is the second series that BBC StoryWorks has created for CTA, a trade association that brings together companies that improve lives through technology. By highlighting how innovators across industries are advancing groundbreaking new technologies, The Human Component explores how we can solve some of the most pressing challenges facing the world today.
To learn more, watch AliveCor’s full film at alivecor.com/cleveland-cardiology-ai.
About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.
SOURCE AliveCor, Inc.

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First Irish patient implanted with innovative heart failure management system from Irish Company FIRE1

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DUBLIN–(BUSINESS WIRE)–Dublin-based FIRE1 today announced that the first Irish patient has been successfully implanted with its FIRE1™ System for remote heart failure monitoring. The innovative system has the potential to positively impact thousands of people living with heart failure in Ireland every year and alleviate the burden on hospital emergency rooms. The […]

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Revolutionizing Oncology Care: AI-Powered Ultrasound Device Enhances Cardiac Monitoring for Chemotherapy Patients

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REDMOND, Wash., May 30, 2024 (GLOBE NEWSWIRE) — A recent study published in the European Heart Journal highlights the significant enhancements that the Kosmos ultrasound system, developed by EchoNous, brings to cardiac evaluations for chemotherapy patients. This AI-powered device enables even non-expert ultrasound users, such as junior oncologists and nurses, to accurately and swiftly assess left ventricular ejection fraction (LVEF), a crucial indicator of heart health and a critical measure to monitor in patients undergoing chemotherapy treatment. Dr. Dimitri Dionysopolous, one of the study’s authors, highlighted the Komsos’s significant impact: “With very little training, oncology staff can accurately measure a patient’s heart function in real-time. Our study revealed that the measurement process is very fast, taking less than 10 minutes from start to finish, which could dramatically change how we implement care in practice.” Kosmos, equipped with AI algorithms Trio and Kosmos Auto EF, guides users through the scanning process, making it easier to learn and enabling precise cardiac and abdominal imaging, along with more efficient LVEF calculations. This system, which produces high-quality echocardiographic images at the point of care, is a testament to the potential of AI in healthcare. “This is a tremendous result that fits into many conversations happening around healthcare right now,” said Graham Cox, CEO at EchoNous. “Healthcare organizations desperately need to enable less trained medical staff to perform ultrasound exams, and this study shows that it’s feasible with Kosmos and its AI capabilities.” In the study involving 115 patients, cardiologists performed traditional echocardiography and compared it with scans that oncology staff, including senior oncologists, residents, and nurses, performed using the Kosmos ultrasound system. The findings demonstrate that non-ultrasound experts can effectively use Kosmos, achieving diagnostic accuracy between 89 to 94 percent among different operators. These promising results suggest a future where Kosmos could be widely used by oncology staff, leading to faster clinical workflows and enhanced care for cancer patients. EchoNous will be showcasing the potential of Kosmos at the 2024 ASCO Annual Meeting from May 31 to June 4. Attendees are invited to visit our booth to learn more and chat with us. About EchoNous Headquartered in Redmond, Washington, EchoNous is a leader in creating innovative point-of-care ultrasound solutions. By combining premium ultrasound performance with cutting-edge AI educational tools, EchoNous expands the accessibility of advanced diagnostic capabilities, enabling more clinicians to obtain crucial patient information more swiftly. For further details, visit www.echonous.com. For further information, please contact: Luke BaldwinVP Global Marketing & Product ManagementLuke.Baldwin@EchoNous.com

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Kardium announces positive 1-year outcomes for PULSE-EU trial with the Globe® System, showing promise for improving the treatment of atrial fibrillation

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VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial. These findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting […]

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Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment

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ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the first in the Northeast United States to offer the Genesis System. Genesis is the latest advancement in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmias may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “Our adoption of advanced robotic technology significant enhances our ability to precisely diagnose and treat patients suffering from complex cardiac arrhythmias,” said Dr. Benjamin D’Souza, Cardiac Electrophysiologist at Penn Presbyterian Medical Center. “We are committed to leveraging cutting-edge innovations to provide patients with the best care. Our team has leveraged the precision and safety of robotics to treat patients that often have few other options for care. With unmatched accuracy, we can tailor treatments to each patient’s unique anatomy, enhancing safety and efficacy.” “We are excited to partner with Penn Presbyterian to pioneer the Genesis Robotic System in the Northeast,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to supporting Penn Presbyterian in growing a highly successful and impactful robotic heart care program that advances patient care, clinical research and technology advancement.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com

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Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™

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MONTREAL and CHARLOTTE, N.C., May 29, 2024 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the United States Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024. “The FDA’s acceptance of our NDA for CARDAMYST brings Milestone one step closer in our mission in providing a new, convenient and effective treatment option for patients with PSVT,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “We understand the frequent impact that PSVT has on patients, as well as the underappreciated burden it places on their families and caregivers. Our progress toward providing a sense of security for patients is a result of the dedicated Milestone team, patients, and investigators to whom we are thankful.” The CARDAMYST clinical trial program represents the largest data package ever studied for an acute drug treatment intended for patient self-management of PSVT events. Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST. The brand name is conditionally approved by the FDA. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About CARDAMYST (etripamil) nasal spray CARDAMYST 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. The clinical trial program for CARDAMYST 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 CARDAMYST (etripamil) nasal spray, a novel calcium channel blocker 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 our ability to bring a new PSVT therapeutic option to market; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; the timing of the launch of etripamil; and our ability to advance commercial preparations to support the anticipated launch of etripamil. 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; 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 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

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Stereotaxis Receives CE Mark Recertification Under EU’s MDR Regulatory Framework

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ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certificate shows that the Stereotaxis Quality System is in accordance with MDR and that Stereotaxis’ products now have a valid CE Mark under MDR. This MDR certification will support regulatory clearances of upcoming innovations. “This final step in the certification of our products and quality systems under MDR is the culmination of several years of diligent work by the Stereotaxis team,” said Matthew Stepanek, Sr. Director of Regulatory Affairs, Quality & Technical Writing. “We appreciate the collaboration with our Notified Body in this entire process.” “This is a reflection of Stereotaxis’ commitment to high-quality devices, systems, and processes to ensure the best possible experience for the patients and physicians that rely on our technology,” said David Fischel, Chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Company Contacts:                                                        David L. FischelChairman and Chief Executive Officer Kimberly R. Peery                                                        Chief Financial Officer 314-678-6100Investors@Stereotaxis.com

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