Author: Ken Dropiewski

Chiesi Global Rare Diseases Announces FDA Approval of JUXTAPID® (lomitapide) Capsules for Pediatric Use in Homozygous Familial Hypercholesterolemia (HoFH)

Coronary/Structural Heart by 0 comments

Approval expands indication of JUXTAPID® to include children 2 years of age and older with HoFH This announcement was made during the week of Rare Disease Day, which aims to raise awareness about the impact of rare diseases on patients BOSTON, March 03, 2026 (GLOBE NEWSWIRE) — Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved JUXTAPID® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. JUXTAPID is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. HoFH, an ultra-rare genetic disorder, impacts an estimated 1 in 250,000 to 1 in 360,000 individuals worldwide, including children, who can be born with dangerously high low-density lipoprotein cholesterol (LDL-C) levels.1,2 Without early intervention, those living with this condition face a significantly increased risk of severe atherosclerosis.3,4 “This approval represents more than a regulatory milestone; it’s a meaningful advancement for children and families living with HoFH,” said Mitch Goldman, Senior Vice President, R&D, Chiesi Global Rare Diseases. “By expanding access to JUXTAPID for children 2 years of age and older, we’re enabling very young members of the HoFH community to benefit from the same proven treatment that has already helped adults manage their condition. This achievement reflects our unwavering commitment to bringing safe, effective therapies to those who need them most and to making a lasting difference at every stage of life.” “Children with HoFH face extraordinary challenges from the moment they’re diagnosed,” said Katherine Wilemon, Founder and CEO of Family Heart Foundation. “Their lives are shaped by frequent medical visits and the constant worry of cardiovascular risk at an age when most kids are just learning to ride a bike or play sports. The recent treatment approval for this age group marks a meaningful step forward for young children impacted by HoFH.” The FDA’s approval is grounded on evidence from a Phase 3, open-label, multicenter study (APH-19) evaluating the safety and efficacy of JUXTAPID® in 43 pediatric participants aged 5 to 17 years with HoFH who were receiving standard-of-care lipid-lowering therapy and a low-fat diet.5 Over a 24-week treatment period, JUXTAPID was titrated to each participant’s highest tolerated dose. The study demonstrated a mean 49% reduction in low-density lipoprotein cholesterol (LDL-C) from baseline, accompanied by significant decreases in non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, very low-density lipoprotein cholesterol (VLDL-C), apolipoprotein B, and triglycerides. Adverse events were primarily gastrointestinal or hepatic in nature, consistent with the known safety profile of JUXTAPID. An integrated model-based analysis confirmed that JUXTAPID is safe and efficacious for the treatment of HoFH in pediatric populations and support the dose justification in children > 2 yrs old. Overall, the results showed that JUXTAPID achieved substantial, clinically meaningful reductions in LDL-C in pediatric use for HoFH.6 USE and IMPORTANT SAFETY INFORMATIONJUXTAPID (lomitapide) is a prescription medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 2 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). It is not known if JUXTAPID is safe and effective in people with kidney problems including people with end-stage kidney disease who are not on dialysis. It is not known if JUXTAPID is safe and effective when used in children under the age of 2. IMPORTANT SAFETY INFORMATION What is the most important information I should know about JUXTAPID? JUXTAPID is available only through certified pharmacies that are enrolled in the JUXTAPID REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed JUXTAPID.There is a registry that collects information about the effects of taking JUXTAPID over time. Ask your healthcare provider for more information about this registry or visit www.JUXTAPID.com or call 1-877-902-4099. JUXTAPID may cause serious side effects, including: Liver Problems: JUXTAPID can cause liver problems such as increased liver enzymes or increased fat in the liver. For this reason, your healthcare provider should do blood tests to check your liver before you start JUXTAPID, if your dose is increased, and while you take JUXTAPID. If your tests show signs of liver problems, your doctor may lower your dose of JUXTAPID or stop it altogether.You should tell your doctor if you have had liver problems in the past, including liver problems while taking other medicines.JUXTAPID may cause nausea, vomiting and stomach pain, especially if you do not eat a low-fat diet. These side effects can also be symptoms of liver problems. Tell your healthcare provider right away if you have nausea; vomiting or stomach pain that gets worse, does not go away, or changes; fever; flu-like symptoms; yellowing of your eyes or skin; or are feeling more tired than usual while taking JUXTAPID.Do not drink more than 1 alcoholic drink per day while taking JUXTAPID. Harm to your unborn baby: Do not take JUXTAPID if you are pregnant, think you may be pregnant, or are planning to become pregnant.If you are a female who can get pregnant, you should have a negative pregnancy test result before you start on JUXTAPID. Use effective birth control while taking JUXTAPID and for 2 weeks after your last dose of JUXTAPID. If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your healthcare provider right away. Do not take JUXTAPID if you: Are taking medicines that are strong or moderate CYP34A inhibitors (for example, certain medicines used to treat bacterial, fungal, or viral infections, and medicines used to treat depression, high blood pressure or chest pain). These medicines may affect how your body breaks down JUXTAPID.Drink grapefruit juice.Have moderate to severe liver problems or active liver disease, including abnormal liver function tests. Before you take JUXTAPID, tell your healthcare provider about all of your medical conditions, including if you have liver problems; have kidney problems; have intestine or bowel problems; drink alcohol; are breastfeeding or plan to breastfeed. It is not known if JUXTAPID passes into your breastmilk. You and your healthcare provider should decide if you will take JUXTAPID or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JUXTAPID may affect the way other medicines work, and other medicines may affect how JUXTAPID works. Other possible side effects of JUXTAPID include: Problems absorbing certain nutrients. JUXTAPID makes it harder for some fat-soluble nutrients, such as vitamin E and fatty acids, to get into your body. Take supplements that contain fat-soluble vitamins each day while you take JUXTAPID.Gastrointestinal symptoms. Diarrhea, nausea, vomiting, and stomach pain or discomfort are very common when taking JUXTAPID. Strictly following a low-fat diet may help lower the chance of having these symptoms. Stop taking JUXTAPID and tell your healthcare provider if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness.Muscle pain, tenderness and weakness (myopathy). This can happen when JUXTAPID is taken with certain doses of simvastatin and lovastatin. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual while taking JUXTAPID.Increased levels of certain blood thinners. JUXTAPID can increase the level of the blood thinner, warfarin. If you take warfarin, your healthcare provider should check your blood clotting times frequently, especially after your dose of JUXTAPID changes. Liver problems caused by certain drugs. Certain medicines can cause liver problems, including isotretinoin, acetaminophen, methotrexate, tetracyclines, and tamoxifen. If you take these medicines with JUXTAPID your healthcare provider may do blood tests more often to check your liver.The most common side effects of JUXTAPID in adults and children 5 years of age and older include: diarrhea, nausea, stomach (abdominal) pain, indigestion, vomiting, and increases in liver enzymes. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of JUXTAPID. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. For additional information, please see the Medication Guide and full Prescribing Information, including BOXED WARNING. About HoFHHomozygous familial hypercholesterolemia (HoFH) is a serious, rare genetic disease that impairs the function of the receptor responsible for removing low-density lipoprotein cholesterol (LDL-C) (“bad” cholesterol) from the body. A loss of low-density lipoprotein (LDL) receptor function results in extreme elevation of blood cholesterol levels. Individuals with HoFH often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries. About JUXTAPID® (lomitapide)JUXTAPID (lomitapide) is a prescription medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 2 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). About Chiesi GroupChiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For more information visit www.chiesi.com. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system.  For more information visit www.chiesirarediseases.com.  Follow @ChiesiGlobalRareDiseases on LinkedIn, Facebook, Instagram, X and YouTube.  Chiesi Global Rare Diseases Media ContactSky StriarLifeSci CommunicationsEmail: sstriar@lifescicomms.com References Cuchel, M., Raal, F. J., Hegele, R. A., Al-Rasadi, K., Arca, M., Averna, M., Bruckert, E., Freiberger, T., Gaudet, D., Harada-Shiba, M., Hudgins, L. C., Kayikcioglu, M., Masana, L., Parhofer, K. G., Roeters van Lennep, J. E., Santos, R. D., Stroes, E. S. G., Watts, G. F., Wiegman, A., Stock, J. K., … Ray, K. K. (2023). 2023 Update on European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolaemia: new treatments and clinical guidance. European heart journal, 44(25), 2277–2291. Mainieri, F., Tagi, V. M., & Chiarelli, F. (2022). Recent Advances on Familial Hypercholesterolemia in Children and Adolescents. Biomedicines, 10(5), 1043. Graves, L. E., Horton, A., Alexander, I. E., & Srinivasan, S. (2023). Gene Therapy for Paediatric Homozygous Familial Hypercholesterolaemia. Heart, Lung and Circulation, 32(7), 769-779.Nohara, A., Tada, H., Ogura, M., Okazaki, S., Ono, K., Shimano, H., Daida, H., Dobashi, K., Hayashi, T., Hori, M., Matsuki, K., Minamino, T., Yokoyama, S., & Harada-Shiba, M. (2021). Homozygous Familial Hypercholesterolemia. Journal of Atherosclerosis and Thrombosis, 28(7), 665. Masana L, Zambon A, Schmitt CP, Taylan C, Driemeyer J, Cohen H, Buonuomo PS, Alashwal A, Al-Dubayee M, Kholaif N, Diaz-Diaz JL, Maatouk F, Martinez-Hervas S, Mangal B, Löwe S, Cunningham T. Lomitapide for the treatment of paediatric patients with homozygous familial hypercholesterolaemia (APH-19): results from the efficacy phase of an open-label, multicentre, phase 3 study. Lancet Diabetes Endocrinol. 2024 Dec;12(12):880-889. doi: 10.1016/S2213-8587(24)00233-X. Epub 2024 Oct 16. PMID: 39426393.JUXTAPID (lomitapide) Prescribing Information. Chiesi Farmaceutici S.p.A.; 2026 PP-RA-01435 V1.0

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Orchestra BioMed Announces Presentations Highlighting AVIM Therapy Potential Impact on Hypertensive Heart Disease and Heart Failure at THT and CRT

Coronary/Structural Heart by 0 comments

NEW HOPE, Pa., March 03, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced two presentations that will be given at the Technology Heart Failure and Therapeutics (“THT”) and Cardiovascular Research Technologies (“CRT”) 2026 Meetings highlighting the potential for the Company’s Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) program in hypertensive heart disease and heart failure patients. Presentation at THT 2026Atrioventricular Interval Modulation Therapy: A Device-Based Therapy for Hypertension and Diastolic Heart Failure (Tuesday, March 3, 2026, at 10:20am ET) Presenter: David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Co-Principal Investigator for the BACKBEAT global pivotal study (“BACKBEAT Study”)Dr. Kandzari will present mechanistic and clinical data highlighting the potential application of AVIM Therapy to treat diastolic dysfunction, a precursor of heart failure with preserved ejection fraction (“HFpEF”). The presentation will highlight pilot study data demonstrating sustained systolic blood pressure reductions associated with delivery of AVIM Therapy alongside improvements in cardiac hemodynamics, ventricular remodeling, and echocardiographic measures of diastolic function. Dr. Kandzari commented, “AVIM Therapy has the potential to offer a new treatment paradigm that leverages active implantable devices with a long, established clinical history. The BACKBEAT Study, which continues to accelerate and build momentum, is focused on evaluating the potentially compelling benefit of this novel, always-on therapy for hypertension in pacemaker-indicated patients. In parallel, pilot study clinical and mechanistic results demonstrate that modulation of the atrioventricular interval drives hemodynamic and autonomic nervous system function impact that could help patients with HFpEF, a population with limited therapeutic options. Together, the presentations at the THT and CRT meetings underscore that AVIM Therapy has the future potential to benefit both hypertensive heart disease and heart failure patients.” Presentation at CRT 2026Update on AVIM Therapy: A Pacemaker-Based Treatment for Hypertension (Sunday, March 8, 2026, at 9:18am ET) Presenter: Dan Burkhoff, MD, PhD, Director, Heart Failure, Hemodynamics and MCS Research, Cardiovascular Research FoundationDr. Burkhoff will summarize the robust body of pilot study clinical evidence demonstrating sustained and reproducible systolic blood pressure reductions associated with delivery of AVIM Therapy, along with improvements in hemodynamics, ventricular remodeling, and stable long-term outcomes in pacemaker-indicated patients with hypertension. Dr. Burkhoff added, “In pilot studies, AVIM Therapy demonstrated an immediate reduction in systolic blood pressure that starts upon treatment activation and persists through nearly four years of follow-up. Long-term washout pilot study data demonstrating reproducible blood pressure reduction without evidence of disease progression further highlight the unique potential clinical utility of this therapy. Sustained blood pressure control in higher risk, older, comorbid patients that does not require additional patient adherence to daily medications can have important clinical impact in a population where blood pressure management is essential to reducing the risk of stroke, myocardial infarction, and heart failure.” About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com

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Kestra Medical Technologies to Report Third Quarter Fiscal 2026 Financial Results on March 17

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KIRKLAND, Wash., March 03, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, today announced that it will report third quarter fiscal 2026 financial results on Tuesday, March 17. Management will host a corresponding conference call at 4:30 p.m. Eastern Time. A live and archived webcast of the conference call will be available in the “Events” section of the investor relations website. Participants are encouraged to register on the website 10 minutes prior to the start of the conference call. About KestraKestra Medical Technologies, Ltd. is a leading wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com

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Esperion Therapeutics and Corstasis Therapeutics Announce Esperion’s Definitive Agreement to Acquire Corstasis, Expanding Its Cardiovascular Franchise with Enbumyst™ (bumetanide nasal spray)

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ANN ARBOR, Mich. & HENDERSON, Nev.–(BUSINESS WIRE)– #CHF–Esperion (NASDAQ: ESPR) and Corstasis Therapeutics Inc., a privately-held, commercial-stage biopharmaceutical company advancing innovative outpatient therapies for the treatment of edema associated with cardiovascular, and hepatic and renal disease, today announced they have entered into a definitive agreement for Esperion to acquire Corstasis. Under the terms of the agreement, Esperion will acquire Corstasis, which developed and is commercia

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SHERPA research consortium initiates seven clinical studies to validate AI-based assistive technologies for minimally invasive brain and cancer treatments

Radiology by 0 comments

Members of the SHERPA project team

Members of the SHERPA project team

Philips Azurion interventional oncology procedure

Philips Azurion interventional oncology procedure

SHERPA project logo

SHERPA project logo

March 3, 2026 With a total budget of EUR 21.5 million, the four-year SHERPA research project is coordinated by Philips and co-funded by the EU Innovative Health Initiative (IHI) and industry partnersThe project focuses on developing automated workflows for minimally invasive neurovascular and tumor treatments – clinical procedures where staffing levels and specialized expertise are in short supplyThe clinical studies are being conducted at University Medical Center Utrecht, St Antonius Hospital, University Medical Center Hamburg-Eppendorf, Hôpital Bicêtre AP-HP, and Hospital de la Santa Creu i Sant PauOn March 4 (16:30 – 17:30 CET), SHERPA will be featured at the European Congress of Radiology 2026 in a dedicated session Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Philips-coordinated SHERPA research consortium has initiated seven clinical studies to demonstrate the benefits of AI- and robotics-assisted workflows in minimally invasive treatments for brain aneurysms* and liver tumors. Staff shortages, coupled with the complex nature of the work, place significant pressure on interventional radiologists and interventional neuroradiologists who perform these procedures. The SHERPA consortium aims to validate AI-powered technologies in imaging, data visualization, procedure planning and guidance, clinical decision support, and patient pathway orchestration. These technologies are designed to automate repetitive, time-consuming tasks, support decision-making, and accelerate learning to ease the workload of interventional (neuro)radiologists. The four-year research project is co-funded by the industry partners through in-kind contributions and additional resources, as well as by the European Union Innovative Health Initiative (IHI), and comprises 16 partners from seven European countries. “Over the past year, the SHERPA project has brought together a talented team of researchers who have developed a technology framework designed to make workflow automation a reliable companion – a ‘sherpa’ – for interventional (neuro)radiologists as they navigate some of their most complex procedures,” said Bert van Meurs, Chief Business Leader, Image Guided Therapy, at Royal Philips. “By providing a template for the future adoption of AI-enabled assistive technologies and accelerating the associated learning curve, this framework will help address the increased demand for interventional (neuro)radiologists in Europe and beyond.” “Demand for image-guided, minimally invasive procedures has outpaced the growth of the specialized workforce,” said Irene van der Schaaf, Professor Neurovascular Interventional Radiology, UMC Utrecht. “At the same time, procedures are becoming more complex and technology is advancing rapidly, making it harder for teams to keep pace. In interventional radiology, technology and human touch go hand in hand. Physicians must manage highly technical tasks – sometimes away from the patient – while continuing to provide personal care and reassurance. The SHERPA project aims to develop AI-enabled tools that simplify routine tasks, enhance patient care, and support the training of the next generation of interventional (neuro)radiologists.” On March 4, 2026, from 16:30 to 17:30 CET, SHERPA will be featured at the European Congress of Radiology (ECR) 2026 in a dedicated session titled: “Assistive Technologies for Interventional Radiologists: Enhancing Decision-Making and Streamlining Workflow with Innovations and AI-Powered Solutions.” Click here to view the agenda and register to attend the session online. Innovation through public-private partnershipThe SHERPA public-private partnership consortium comprises five medical technology industry partners, five academic partners, and five research organization and medical association partners: Industry partners: Philips, Medtronic, Sim&Cure, Interventional Systems, Barco.Academic partners: University Medical Center Utrecht (The Netherlands), University Medical Center Hamburg-Eppendorf (Germany), Hôpital Bicêtre AP-HP (France), Hospital de la Santa Creu i Sant Pau (Spain), St Antonius Hospital (The Netherlands).Research organization and medical association partners: European Institute for Biomedical Imaging Research – EIBIR, Cardiovascular and Interventional Radiological Society of Europe – CIRSE, European Society of Minimally Invasive Neurological Therapy – ESMINT, Eindhoven University of Technology – TU/e (The Netherlands), Human-Factors-Consult – HFC (Germany). Addressing staff shortages and patient access by relieving the pressure on physiciansThe World Health Organization (WHO) predicts a shortage of 600 thousand physicians in the European Union (EU) by 2030 [1]. Some of the most acute physician shortages are in interventional radiology, even in countries such as the UK that have advanced healthcare systems [2]. Among the many different procedures conducted by interventional (neuro)radiologists, treatments of brain aneurysms and liver tumors are some of the most complex and time consuming. Both rely on CT and/or MR imaging for diagnosis, real-time imaging for procedure guidance, and a high level of precision in the placement of therapeutic devices such as blood-clot inducing platinum coils to seal off a brain aneurysm or the percutaneous insertion of ablation needles to treat a liver tumor. As a result, these procedures require a very high level of operator expertise and training, which can limit patient access. The SHERPA project aims to provide interventionists with AI-powered assistive technologies that automate repetitive tasks and support decision-making across the entire workflow. By doing so, they will accelerate learning curves and improve precision and safety in complex minimally invasive interventions such as brain aneurysm repair and liver tumor ablation. During the first year of the project, the consortium successfully developed AI algorithms to help identify brain aneurysms that need treatment and algorithms to optimize patient selection and therapy planning for liver tumor ablation. They also developed robotic technology to improve procedure precision and reduce difficulty, and AI software to confirm treatment success. These have now been integrated into orchestrated end-to-end workflows for both types of procedure. SHERPA project clinical studiesOver the next three years of the four-year SHERPA project, the consortium partners will conduct a series of clinical studies to refine these assistive technologies and assess the benefits in terms of the patient experience, workload optimization, interventionist satisfaction, and performance. The five brain aneurysm studies will focus on AI-driven aneurysm detection, risk prediction, and precise treatment planning: RADAR: AI-based aneurysm detection based on CT and MR imaging.Aneurysm@risk: AI-based algorithm to predict aneurysm growth and rupture risk.ASSIST: AI-supported device selection and positioning guidance.INTERACT: Automatic collimation and projection angle suggestions to optimize imaging for procedural guidance.SAFO: Evaluation of a digital remote follow-up solution for brain aneurysm patients, enabling standardized monitoring, enhanced coordination, and seamless care across the patient pathway. The liver and lung tumor studies will leverage advanced imaging and robotic-assisted biopsy technologies, respectively, to drive greater diagnostic precision and procedural efficiency. MISTRAL: Evaluation of new Cone Beam CT workflows to optimize imaging for percutaneous liver ablations.RHODES: Evaluation of robotic-assisted versus free-hand lung biopsies with a focus on operability and device efficiency. Together, these studies will generate insights to support the acceptance and adoption of AI-based smart assistive technologies by the wider interventional radiology community. The SHERPA website can be viewed at: https://sherpa-ihi.eu. Watch videos and interviews about SHERPA here. The CORDIS project page for SHERPA can be accessed here, and the IHI factsheet for SHERPA can be found here. Notes and references*        A brain aneurysm is a weak, bulging spot in a blood vessel in the brain, which can leak or rupture.[1]     Zapata T, Muscat NA, Falkenbach M, and Wismar M. WHO Report – From Great Attrition to Great Attraction: Countering the Great Resignation of Health and Care Workers. Eurohealth, Vol.29, No.1, 2023. https://iris.who.int/server/api/core/bitstreams/488b01ab-a066-4558-a345-476570fe2802/content[2]     The Royal College of Radiologists: Clinical radiology – UK workforce census 2020 report. https://www.rcr.ac.uk/media/3gjdr23o/clinical_radiology_census_report_2020.pdf This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101194744. The JU receives support from the European Union’s Horizon Europe research and innovation program and life science industries represented by COCIR, EFPIA, Europa Bío, MedTech Europe and Vaccines Europe. SHERPA is Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or Innovative Health Initiative Joint Undertaking. Neither the European Union nor the granting authority can be held responsible for them. Media ContactSteve KlinkPhilips Medical and Scientific CommunicationsTel: +31 6 10888824E-mail: steve.klink@philips.com Joost MalthaPhilips Global External RelationsTel: +31 6 10558116E-mail: joost.maltha@philips.com About Royal PhilipsRoyal 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 2025 sales of EUR 18 billion and employs approximately 64,800 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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Members of the SHERPA project team

Philips Azurion interventional oncology procedure

SHERPA project logo

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CVRx Announces Late-Breaking Data and Scientific Presentations Highlighting Barostim Outcomes at the THT 2026 Annual Meeting

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MINNEAPOLIS, March 02, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, announced today the schedule of scientific presentations reviewing the science and outcomes of Barostim therapy at the Technology and Heart Failure Therapeutics 2026 (THT) meeting. THT, the annual conference organized by the Cardiovascular Research Foundation® (CRF®), will be held March 2-4, 2026, in Boston, Massachusetts. The presentations include late-breaking clinical data, oral sessions and posters highlighting real-world outcomes, cardiac energetics, hospitalization impact, left ventricular ejection fraction (LVEF) improvements and changes in advanced hemodynamic, respectively.  Late-Breaking REBALANCE Registry Data In a late-breaking presentation on Monday, March 2, Dr. Dmitry Yaranov will share, for the first time, data from the REBALANCE Registry, a post-market observational study designed to evaluate real-world data on the safety and benefit of Barostim therapy in the commercial setting. Dr. Yaranov will present the six-month outcomes in over 400 patients enrolled in the registry. Scientific Presentations Featuring Barostim Monday, March 2: Late-Breaking Clinical Science Session 1: Initial Six-Month Outcomes with Baroreflex Activation Therapy from the REBALANCE Registry (Dr. Dmitry Yaranov)Unmasking the Energetic Response Following Acute Titration of Baroreflex Activation Therapy Through Patient-Specific Modeling and Simulation (Dr. Rohan Goswami)Impact of Baroreflex Activation Therapy on Hospitalizations: A Single Center Retrospective Analysis (Dr. Joel Joseph) Tuesday, March 3: Electrical Therapies for Heart Failure: Barostimulation for HFrEF (Dr. Philip Adamson)Abstract Session 8: Heart Failure Reduced Ejection Fraction I Real-World Outcomes of Barostim Baroreflex Activation Therapy in Heart Failure: Analysis of a Large Multi-Institutional Database (Dr. Arvind Bhimaraj)LVEF and Functional Improvement Observed in a Post-Market Registry of Barostim Baroreflex Activation Therapy (Dr. Dmitry Yaranov) CVRx Sponsored Satellite Program CVRx will also host a satellite program on Tuesday, March 3 from 12:15-1:30 p.m. ET in Ensemble CD South, which will include the following presentations: Advances in Evidence with Baroreflex Activation Therapy (Dr. Philip Adamson)Outcomes from the REBALANCE Registry (Dr. Dmitry Yaranov)BREATHE-HF: Impact of Barostim Therapy on Cardiac Hemodynamics (Dr. Gabriel T. Sayer)BENEFIT-HF: Broadening Access to Barostim Therapy (Dr. Farooq Sheikh) During the satellite program, faculty will provide updates on the REBALANCE Registry, the BREATHE-HF trial, and the BENEFIT-HF trial. BREATHE-HF, a large physician-initiated study, is evaluating the impact of Barostim on cardiac hemodynamics. In January, CVRx announced the initiation of the BENEFIT-HF trial, a landmark randomized study supported by CMS Category B IDE coverage. The trial is designed to evaluate the impact of Barostim in a significantly expanded heart failure population, with the primary endpoint as a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. “We are excited by the new data supporting Barostim being featured at THT 2026,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are encouraged by the increasing adoption of Barostim by the heart failure community. The accelerating cadence of publications evaluating Barostim’s impact is proof of the positive patient impact and increasing acceptance of Barostim in the heart failure treatment continuum.” About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the expected enrollment of the BENEFIT-HF clinical trial and anticipated benefits of Barostim therapy. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment, the resulting impact of our addressable market and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.comMedia Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com

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Picard Medical / SynCardia Showcases Leadership in Total Artificial Heart Therapy at Technology and Heart Failure Therapeutics Conference

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New data highlight additional benefits beyond survival with the SynCardia Total Artificial Heart and preclinical progress for the next-generation Emperor system New data highlight additional benefits beyond survival with the SynCardia Total Artificial Heart and preclinical progress for the next-generation Emperor system

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Palvella Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

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WAYNE, Pa., March 02, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc. (“Palvella”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that it closed its previously announced upsized public offering on February 27, 2026. The offering consisted of 1,840,000 shares of its common stock, which included the exercise in full of the underwriters’ option to purchase 240,000 additional shares, at a price to the public of $125.00 per share. The aggregate gross proceeds to Palvella from this offering, before deducting underwriting discounts and commissions and offering expenses, were $230.0 million.

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