Coronary/Structural Heart

Madrigal to Present New Data from the Company’s MASH Program at EASL 2026 Demonstrating the Effects of Rezdiffra on Markers of Cardiovascular and Portal Hypertension Risk

Secondary analysis from the Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 trials examines improvements in lipid profiles for Lp(a), LDL-C and ApoB with Rezdiffra® (resmetirom)Analysis of two-year data in patients with compensated MASH cirrhosis (F4c) examines improvement in ANTICIPATE-NASH risk scores, a marker for clinically significant portal hypertensionAdditional abstracts focus on early real-world evidence with Rezdiffra and the ability of noninvasive biomarkers to predict fibrosis improvement in patients treated with Rezdiffra CONSHOHOCKEN, Pa., May 20, 2026 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that multiple abstracts from its Rezdiffra development and real-world evidence programs will be presented at the European Association for the Study of the Liver (EASL) Congress 2026, taking place May 27–30 in Barcelona, Spain. The presentations highlight the breadth of evidence supporting Rezdiffra, including a secondary analysis on cardiometabolic risk in patients with MASH, non-invasive risk stratification in patients with compensated cirrhosis and early real-world evidence from routine clinical practice. “The body of data presented at EASL 2026 reinforces Madrigal’s leadership in MASH and clearly supports the continued integration of Rezdiffra into clinical practice as a foundational therapy,” said David Soergel, M.D., Chief Medical Officer of Madrigal. “These analyses extend beyond liver-focused assessments to explore Rezdiffra’s effects on markers of cardiovascular risk and provide important new insights about noninvasive measures of treatment response in patients with moderate to advanced fibrosis (F2-F3) and well-compensated MASH cirrhosis (F4c).” Madrigal Poster Presentations at the EASL Congress 2026: TitlePresenterReducing CV risk in patients with MASH independent of baseline based on Lp(a) and LDL lowering by resmetiromMeena BansalBaseline ANTICIPATE score and response predicts liver outcome events in a 180 patient MASH cirrhosis cohort treated with resmetiromNaim AlkhouriIn F0-F1 and F2-F3 MASH, ≥5% weight loss significantly lowers VCTE and ELF independent of biopsy fibrosis improvement; resmetirom and not placebo reduction of ELF and VCTE are associated with biopsy improvement of fibrosis, independent of weight lossRohit LoombaEarly real-world effectiveness of resmetirom in adults with metabolic dysfunction associated steatohepatitis and moderate-to-advanced fibrosisNaim AlkhouriTwelve-month changes in liver function enzymes and lipids in patients receiving resmetiromChristina ParrinelloNon-invasive test-driven modeling of patient eligibility for resmetirom therapy in MASLD: Data from the German SLD-RegistryMaurice MichelEarly and Week 52 biomarker (MRI-PDFF, ALT, MRE and PRO-C3) responses to resmetirom predict improvements in MASH and liver fibrosisRohit LoombaMachine learning models of non-invasive tests to predict MASH and fibrosis stage based on MAESTRO-NAFLD-1 and MAESTRO-NASH liver biopsiesRohit Loomba Rezdiffra (resmetirom) is a once-daily, oral, liver-directed thyroid hormone receptor (THR)-β agonist designed to address key underlying causes of MASH. It was the first medication approved for the treatment of MASH in the U.S. and Europe. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and MASH resolution primary endpoints. Rezdiffra also reduced liver stiffness, liver fat, liver enzymes and atherogenic lipids in the MAESTRO-NASH trial and improved health-related quality of life. At one year, 91% of patients treated with Rezdiffra 100mg achieved improvement or stabilization of liver stiffness as measured by vibrational-controlled transient elastography (VCTE), a test that is frequently used to monitor treatment response in clinical practice. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Rezdiffra is not approved in any geography for the treatment of patients with cirrhosis. About MASHMetabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, the need for liver transplantation and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S., and the fastest-growing indication for liver transplantation in Europe. Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10 to 17 times higher risk of liver-related mortality as compared to patients without fibrosis. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients. As disease awareness improves and disease prevalence increases, the number of diagnosed patients F2 to F4c MASH is growing. About Rezdiffra What is Rezdiffra? Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.This indication is approved based on improvement of MASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than MASH.have gallbladder problems or have been told you have gallbladder problems, including gallstones.are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby. A pregnancy safety study for women who take Rezdiffra during pregnancy collects information about the health of you and your baby. You or your healthcare provider can report your pregnancy by visiting https://pregnancyregistry.madrigalpharma.com/ or calling 1-800-905-0324. are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, because Rezdiffra is not recommended in patients taking these medicines.Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra? Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice) or stomach pain/tenderness.gallbladder problems. Gallbladder problems such as gallstones, or inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with MASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting.The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach pain, vomiting, dizziness and constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324. Please see the full Prescribing Information, including Patient Information, for Rezdiffra. About Madrigal Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com and follow us on LinkedIn. Forward-Looking Statements This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to Rezdiffra’s effects on markers of cardiovascular risk and the potential benefit of Rezdiffra in patients with compensated MASH cirrhosis. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; our ability to successfully commercialize Rezdiffra in the U.S. and Europe; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of our clinical trials, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for our trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action or of any other product candidate; market demand for and acceptance of Rezdiffra; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; our ability to protect our intellectual property rights; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission (SEC) for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part 1A of its Annual Report on Form 10-K for the year ended December 31, 2025, and as updated from time to time by Madrigal’s other filings with the SEC.Madrigal may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Madrigal’s website in addition to following its press releases, filings with the SEC, public conference calls, and webcasts. Madrigal Pharmaceuticals, Rezdiffra® and associated logos are trademarks of Madrigal Pharmaceuticals, Inc. Investor ContactTina Ventura, IR@madrigalpharma.com Media ContactChristopher Frates, media@madrigalpharma.com

EuroPCR 2026: Elixir Medical’s DynamX® Bioadaptor Demonstrates Significantly Lower Event Rates Than Drug-Eluting Stent

EuroPCR 2026: Elixir Medical’s DynamX® Bioadaptor Demonstrates Significantly Lower Event Rates Than Drug-Eluting Stent in Long-Term Follow-Up, Including Reduction in Cardiovascular DeathParis, France, May 19, 2026 (GLOBE NEWSWIRE) — Significantly lower TLF rates (2.8% versus 7.8%, p=0.020) with DynamX® compared to Resolute Onyx DES with no new events in bioadaptor arm between 3 and 4 years 88% reduction in Cardiovascular Death (0.5% versus 3.7%, p=0.020) with DynamX® compared to DES PARIS – May 19, 2026 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced four-year results from the large 445-patient BIOADAPTOR Randomized Controlled Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute Onyx™ Drug-Eluting Stent (DES) at 34 centers in Japan, Europe, and New Zealand. The data were presented at a late-breaking clinical trial session during the EuroPCR 2026 conference in Paris. “Interventional cardiologists typically use a drug-eluting stent (DES) during percutaneous coronary intervention (PCI) to open the heart blockage and keep the artery open. These interlocked mesh-like tubes, however, permanently cage the artery, limiting its function and contributing to an annual 2-3% increase in adverse clinical events over time,” – said Professor Stefan Verheye, M.D., Ph.D., interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium and leading DynamX® investigator. “The bioadaptor is a new type of unlocking, adaptive implant designed to keep the artery open while restoring normal vessel function, its compliance and pulsatility.” Late-breaking four-year results presented at EuroPCR highlight durable clinical outcomes with the DynamX® bioadaptor, with no new target lesion failure (TLF) or cardiovascular death (CVD) events observed between years three and four, maintaining a very low plateauing rate of adverse events compared to the continued annual increase seen with DES. DynamX® demonstrated a 66% lower TLF rate (2.8% versus 7.8%; p=0.020) compared to DES, reflecting significant clinical benefit and long-term durability of PCI treatment with bioadaptor. The TLF reduction was driven by improvement across all components of the device-related combined endpoint, including: 88% lower cardiovascular death (0.5% versus 3.7%, p=0.020), a statistically significant reductionNumerically lower target vessel myocardial infarction (0.9% versus 1.8%)Numerically lower clinically driven target lesion revascularization (1.4% versus 2.8%) These findings highlight a key differentiation of the bioadaptor implant from drug-eluting stents: while DES outcomes continue to accrue adverse events over time, DynamX® demonstrates stabilization of event rates following restoration of vessel function at 6 months post-procedure. Substantial clinical improvement was also observed in the left anterior descending (LAD) artery, with TLF rates dramatically lower with DynamX® compared to DES (2.7% versus 10.6%; p=0.021), potentially reflecting an amplified impact of restoring vessel function in this hemodynamically critical coronary vessel responsible for about 50% of heart blood supply. “The DynamX® bioadaptor represents a significant advancement in PCI by providing functional restoration of the artery,” – remarked Shigeru Saito, M.D., trial principal investigator and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.” PCI procedures have been successful at improving the conductance of blood through diseased, blocked coronary arteries. Stents establish luminal diameter and improve the acute mechanical result of PCI compared to balloon angioplasty. However, DES do not restore the physiology of the vessel wall because they create rigid scaffolding. This constrains vessel elasticity and prevents return to a more normal, pulsatile function. The DynamX® bioadaptor first achieves the initial objective of opening the artery in establishing luminal diameter to improve blood flow. Unlike DES, it transitions to a different structure following an initial period of healing where it unlocks and provides the essential radial dynamic support to the diseased artery, allowing the treated segment to recover pulsatility and compliance. “The four-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT have shown consistently across multiple randomized clinical trials significantly lower, plateauing clinical events with DynamX® bioadaptor compared to DES treatment, demonstrating the clear benefit of restoring a key function of arteries, hemodynamic modulation, with this breakthrough technology.” – said Motasim Sirhan, CEO of Elixir Medical. About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is part of Elixir Medical’s robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients. About DynamX® Sirolimus Eluting Coronary Bioadaptor SystemThe DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through four-year clinical follow-up.  The DynamX® Sirolimus Eluting Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device, limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn. ### Media Contact:Richard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216

AVS, Now Part of Stryker, Enrolls First Patient in First-in-Human Coronary Intravascular Lithotripsy Study

BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company recently acquired by Stryker and focused on treating severely calcified arterial disease, today announced the enrollment of the first patient in its first-in-human (FIH) study for Pulsatile Intravascular Lithotripsy (PIVL) therapy in a coronary indication. The POWER CAD I study will evaluate the feasibility of the Pulse IVL™ System for the treatment of patients with moderate to severely calcified coronary arteri

Mineralys Therapeutics Announces Presentation of New Data from the Phase 3 Launch-HTN Trial of Lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)

– Oral presentation highlights efficacy and safety profile of lorundrostat in patients with uncontrolled hypertension and chronic kidney disease – RADNOR, Pa., May 18, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that new data from its Phase 3 Launch-HTN trial in participants with hypertension and CKD will be featured in an oral presentation at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026), taking place May 28–31, 2026 in Gdańsk, Poland. Details for the Oral Presentation: Abstract Title:Lorundrostat for Hypertension in CKD: Results from the LAUNCH-HTN TrialPresenter:Liffert Vogt, MD, PhD, professor, Nephology and Renal Transplantation, Amsterdam UMC and University of Amsterdam, Amsterdam, the NetherlandsSession Date/Time:Saturday, May 30th at 17:15 – 17:30 CESTSession Title:Clinical Trials. Hot line Session 2Session Location:Blue Room About Launch-HTN Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring. About Chronic Kidney Disease (CKD)CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 1 in 10 of adults aged 18 or older (37 million people) are estimated to have CKD. Approximately 21% of adults with high blood pressure are estimated to have CKD. The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening BP control. When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly. Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation. About HypertensionHaving sustained, elevated blood pressure (BP) (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed six late-stage clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About MineralysMineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward-Looking StatementsMineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the anticipated timing of the U.S. Food and Drug Administration’s (FDA) review of our accepted New Drug Application (NDA) and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of our NDA submission; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com

Tulyp Medical Appoints Industry Veteran Steve Motes as CEO to Lead Next Phase of Growth in the US

Steve Motes brings deep expertise in Mechanical Circulatory Support(MCS) and early-stage company leadership Company backed by Sofinnova Partners and leading medtech entrepreneurs and cardiologists PARIS, France and Dallas, Texas – May 18th, 2026 – Tulyp Medical, a Paris-based medical device company developing an intelligent pressure-driven perfusion system, today announced the appointment […]

Philips introduces SmartIQ to address the trade-off between image quality and radiation dose in coronary procedures

Philips Azurion with SmartIQ technology

Physicians are using Philips Azurion with SmartIQ technology during an medical procedure.

May 18, 2026      Greater differentiation of clinical details through contrast-rich images with reduced background noise​For coronary procedures, a new ultra-low dose protocol employs over 50% less X-ray radiation dose [1]First SmartIQ clinical pilot study published in JSCAI, further building on Philips’ strong track record in evidence generation [2] Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced Philips SmartIQ, a breakthrough coronary imaging technology for its Azurion image-guided therapy. Developed in collaboration with leading cardiovascular centers, SmartIQ is designed to address one of the field’s most fundamental challenges: the trade-off between image quality and radiation exposure for patients and clinical staff. It aims to empower clinicians with exceptional image quality, enabling them to see exactly what they need, while it aims to provide reassurance that X-ray dose and contrast levels are optimized. “With this new imaging technology, we can go really low in dose and achieve even better image quality. It’s a win-win,” said Dr. Mark Winkens, Interventional Cardiologist at Elisabeth-TweeSteden Hospital (ETZ) in Tilburg, the Netherlands.Philips will showcase SmartIQ at EuroPCR 2026 (May 19–22, Paris, France), where attendees can experience the technology firsthand and hear directly from early clinical adopters. During dedicated clinical sessions, clinicians will share initial case experiences and present real-world multicenter results. Leveraging Philips’ strong track record in evidence generation, the first blinded clinical pilot study evaluating SmartIQ was recently published in Journal of the Society for Cardiovascular Angiography & Interventions. The study suggests that the algorithm scored higher on image quality and was preferred in the vast majority of blinded comparisons, while maintaining or lowering radiation and contrast dose. The technology builds on Philips’ industry-leading ClarityIQ platform, which has previously been associated with radiation exposure reductions between 23% and 83%, depending on the clinical area [3]. In parallel, further strengthening Philips’ evidence-generation efforts, the ongoing RADIQAL trial is designed to assess the impact of SmartIQ on radiation dose compared to ClarityIQ while maintaining procedural performance. The study has recently reached 60% of total enrollment and completed enrollment at European sites, marking an important milestone. Final study completion and results are expected in due course. SmartIQ represents the next step forward in image quality and dose management for coronary imaging. It includes an ultra-low dose protocol for coronary procedures that employs over 50% less X-ray radiation dose compared with the lowest dose settings available with Philips ClarityIQ [1]. This setting aims to enable acquisition of coronary cine runs at fluoroscopy dose levels, depending on system and clinical conditions [4]. “For too long, clinicians have had to choose between image quality and radiation dose during coronary procedures,” said Mark Stoffels, Business Leader Image-Guided Therapy Systems at Philips. “With our breakthrough SmartIQ technology, we believe that trade-off no longer has to define coronary imaging. This is not an incremental step forward – it represents one of Philips’ boldest advances yet in helping clinicians see what they need while aiming to further reduce exposure for patients and clinical teams.” “Image quality is the foundation of every decision we make in the cath lab. SmartIQ has genuinely surprised us. It delivers the clarity we need at very low radiation dose levels,” said Dr. Nicolaj Brejnholt Støttrup, Interventional Cardiologist at Aarhus University Hospital in Aarhus, Denmark. SmartIQ is the latest example of Philips’ long-term commitment to reducing radiation exposure across image-guided therapy. Together with innovations such as DoseAware, LumiGuide and EchoNavigator, it reflects a system-wide approach designed to help clinicians achieve the image quality they need while continuing the aim to reduce radiation exposure for patients and staff. SmartIQ is CE-marked and available in Europe and selected markets on both new and existing Azurion systems. The technology is not yet cleared for use in the United States. [1] Compared with the low ClarityIQ setting on Azurion systems, SmartIQ ultra-low left coronary 15 fps cine runs specify average reference air kerma reductions of 58% on Azurion M12 and 62% on Azurion M20 across all field sizes as stated in the IFU.[2] Assar et al., Exploring a Novel Processing Algorithm to Improve Image Quality and Reduce X-Ray and Contrast Dose for Coronary Angiography: A Blinded Pilot Study. Journal of the Society for Cardiovascular Angiography & Interventions, 2026, 105343[3] In 37 individual comparative studies, Philips ClarityIQ was associated with reductions in patient radiation exposure. The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional radiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task. See website: https://www.philips.com/clinicallyproven [4] The radiation dose reduction potential of SmartIQ is currently investigated in the RADIQAL trial. The RADIQAL trial is a multi-center randomized clinical trial to assess the impact of SmartIQ on radiation dose compared to the current ClarityIQ while maintaining procedural performance. This includes a comparison to the limitation of the reference air kerma rate in fluoroscopy of