The Latest Cardiac and Vascular News
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 […]
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
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 […]
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
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
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
ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is the first hospital in Italy to adopt the cutting-edge Genesis Robotic Magnetic Navigation (RMN) system. “As electrophysiologists, our primary goal is to improve the lives of our patients,” said Dr. Mario Volpicelli, Head of the Electrophysiology Unit of the hospital. “With the Genesis RMN system, we now have an unprecedented level of precision and control during cardiac ablation procedures, allowing us to target arrhythmias with unmatched accuracy while minimizing risk to our patients.” 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. “The adoption of the Genesis Robotic Magnetic Navigation system marks a significant milestone in our commitment to providing the highest standard of care to our patients.” added Giuseppe Russo, General Manager of the Hospital Santa Maria della Pietà. “We are proud to lead the way in Italy, revolutionizing cardiac treatment through innovative robotic technology.” added Luigi Caliendo, Chief of the Cardiology Department of the Hospital. “We are honored to partner with Hospital Santa Maria della Pietà in bringing the benefits of robotics to patients in Italy,” said David Fischel, Stereotaxis Chairman and CEO. “The adoption of the Genesis system reflects our shared commitment to advancing standard of care, innovation, and patient-focused solutions in electrophysiology.” 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
MONTREAL and CHARLOTTE, N.C., May 22, 2024 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced it will partner with Arrhythmia Alliance to raise awareness of supraventricular tachycardia (SVT). SVT Awareness Day will be held on Wednesday June 5, 2024, during World Heart Rhythm Week (June 4-10), to raise awareness of SVT, a type of arrhythmia or rapid heart rhythm that leaves people with palpitations (“racing heart rate”), breathlessness, and anxiety. SVT can cause the heart to beat much faster than normal, up to as high as 250 beats per minute (a normal heart rate for the average adult is 60 to 100 beats per minute). “We are honored to partner with the Arrhythmia Alliance on educational initiatives for SVT Awareness Day. These efforts align perfectly with our mission to develop and commercialize innovative cardiovascular solutions that can improve the lives of people living with complex and life-altering heart conditions,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We are immensely thankful for the work of the Arrhythmia Alliance in filling the gap in SVT education in support of patients.” To address some of the challenges facing people who are affected by SVT, Arrhythmia Alliance and its partners have developed certain resources for patients with SVT; these resources include virtual coffee mornings for people living with SVT, Live X Chat, and Facebook Live, all aimed at raising awareness of the condition and helping people seek medical advice and treatments. Additionally, there will be a release of educational videos from patients and healthcare providers to accompany the above resources. Activities will include: An estimated two million people in the United States are currently diagnosed with SVT, also referred to as PSVT or paroxysmal supraventricular tachycardia. SVT 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, often forcing patients to limit their daily activities. The uncertainty of when an episode of SVT will occur 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 current lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. SVT episodes can be short-lived for just a few minutes or last several hours. Diagnosis can be challenging as the timing of irregular heart rhythm is unpredictable, and, therefore, is difficult to identify unless an electrocardiogram can record an episode at the time it occurs. Another challenge is that despite treatment some people with SVT continue to have symptoms. In addition, some may stop taking medication because they cannot tolerate the side effects. For additional information on SVT, visit SVT Heart to Heart provided by Milestone Pharmaceuticals. About Arrhythmia Alliance Arrhythmia Alliance is a coalition of patients, caregivers, healthcare professionals, policy makers and all those involved in or affected by cardiac arrhythmias (heart rhythm disorders). For more information, visit https://heartrhythmalliance.org/aa/us/. World Heart Rhythm Week Arrhythmia Alliance World Heart Rhythm Week is an annual Awareness Week that focuses on raising awareness of all arrhythmias (irregular heart rhythms) including Sudden Cardiac Arrest, Atrial Fibrillation, SVT, and Syncope (unexplained loss of consciousness). For more information, visit: https://heartrhythmalliance.org/aa/us/get-involved/world-heart-rhythm-week. 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: Milestone’s ability to develop and commercialize innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. 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; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, 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 (SEC), including in its annual report on Form 10-K for the year ended March 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 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: Kim Fox, Vice President, Communications kfox@milestonepharma.com
May 22, 2024 Philips wearable ePatch and AI analytics platform help detect potentially life-threatening irregular heartbeatsThe solution helps University Hospital Vall d’Hebron achieve reduced average length of stay, relieve emergency room pressure, and reduce costs Amsterdam, the Netherlands, and Madrid, Spain – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the successful nationwide rollout of its ambulatory cardiac monitoring service in Spain using its unique wearable ePatch paired with its AI-driven Cardiologs analytics platform. 14 Spanish healthcare providers across the country are now using the company’s ePatch extended wear Holter monitors to detect life-threatening heart arrhythmias such as atrial fibrillation (AF). The solution has been proven to detect heart arrhythmias missed by traditional Holter monitors, enhance patient comfort, improve care access, and potentially better clinical outcomes, in addition to reducing overall costs. Philips’ ePatch provides reliable data for up to 14 days of continuous monitoring. When paired with Philips’ AI-driven Cardiologs analytics platform, the solution empowers the hospitals’ cardiology and neurology teams with an end-to-end solution that enhances their ability to detect and diagnose AF – a potentially life-threatening [1] cardiac arrhythmia and also the world’s most common. AF significantly increases the risk of stroke, dementia, and heart failure, yet often goes undetected due to its lack of noticeable symptoms and infrequent occurrence intervals. “The key advantage for healthcare professionals lies in its user-friendly interface and high-quality 14-day continuous recording capabilities,” said Dr. Jorge Pagola, Neurologist Postdoctoral Researcher at University Hospital Vall d’Hebron, Barcelona, Spain. “Applied as a chest patch in just a few minutes, it seamlessly integrates an analysis program, facilitating swift examination of recordings. Thanks to its AI-based analysis assistant, AF events can be classified for rapid review by our team. Patients experience enhanced comfort as they are free from cumbersome cables of the conventional Holter, allowing them to dress, shower, and carry out their daily activities without any hindrance.” Dr. Jorge Pagola further explains, “Using the ePatch program, we expedited hospital discharge for 80 patients in 2023. This initiative led to a reduced average length of stay, relieved emergency room pressure, and an estimated total cost reduction of € 28.800 in 2023 [2].” Pilot programs in major hospitals across SpainIn addition to Hospital Vall d’Hebron, where Philips’ ePatch is being used to detect post-discharge AF in patients, pilot projects demonstrating the device’s effectiveness in cardiology and neurology are being conducted at other major hospitals in Madrid, Barcelona, Bilbao, Alicante, Madrid, Cadiz, and Navarra [3]. Applications include monitoring patients for AF after cardiac ablation therapy or heart valve replacement procedures, and studies of the link between magnesium insufficiency and AF. In some Spanish hospitals, the ease-of-use and cost benefits of Philips ePatch are helping reduce waiting lists that built up during the COVID-19 pandemic, making a tangible difference to people’s access to care. In total, more than 1500 patients are currently being monitored with Philips ePatch devices in Spain. “This innovative new service allows clinical teams to conveniently monitor patients as they go about their everyday activities for extended periods of time, collecting the real-life data that helps reveal the patient’s true condition,” said Miquel Barras, Ambulatory Monitoring & Diagnostics Lead for Philips in Spain. In a recent US study comparing the diagnostic abilities of 7-day and 14-day monitoring with Philips’ extended wear ePatch compared to conventional 24-hour Holter monitoring, the ePatch detected 2x more clinically significant heart arrhythmias during 7 days of monitoring and more than 2.5x as many over 14 days [4]. [1] Heart.org[2] Data on file in hospital Vall d’Hebron[3] Madrid: Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Infanta Elena, Hospital de La Princesa, University Hospital Quironsalud Madrid, Hospital Universitario Rey Juan Carlos. Barcelona: Vall d’Hebron University Hospital, Hospital Clínic de Barcelona, Hospital de Sant Joan Despí Moisès Broggi, Hospital Sant Joan de Déu Barcelona, Hospital Universitari de Bellvitge, Hospital de Sant Pau. Bilbao: Hospital Universitario Cruces. Alicante: Hospital General Universitario de Elche. Cadiz: Hospital Universitario De Jerez. Navarra: Hospital General de Navarra.[4] Parikh, P, Grigoriadis, C, Dunn, A. et al. Diagnostic Yield of 24-hour Holter vs 7-day and 14-day ePatch Extended Wear Holter. J Am Coll Cardiol. 2023 Mar, 81 (8_Supplement) 149. Research conducted by Philips ECG Solutions.https://doi.org/10.1016/S0735-1097(23)00593-4 For further information, please contact: César García RequenaPhilips IbéricaTel: +34 670 264 471Email: cesar.garcia.requena@philips.com Joost Maltha External RelationsTel: +31 6 10 55 8116 Email: joost.maltha@philips.com About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, today announced new study data demonstrating that HeartBeam AI combined with vectorcardiography (VCG) outperformed an expert panel of heart rhythm cardiologists in detecting atrial flutter. HeartBeam AI is the […]
