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Solaris Endovascular Receives FDA Breakthrough Device Designation for Solaris DE™, a new Drug-Eluting Covered Stent

DALLAS, TX, UNITED STATES, May 5, 2026 /EINPresswire.com/ — Solaris Endovascular, Inc, a medical device company focused on next-generation endovascular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its first-in-class Solaris DE™ drug-eluting covered stent indicated for use in hemodialysis patients for […]

Bioxodes presents positive final Phase 2a intracerebral hemorrhage results at ESOC affirming breakthrough potential of BIOX-101

Final results confirm and build on interim BIRCH results in 23 ICH patients Primary safety endpoint met with no mortality observedEncouraging efficacy signals on all clinical and biomarker endpoints New adaptive pivotal Phase 2b/3 trial design meets EMA and FDA registration requirements – potentially upon positive Phase 2b dataPoster presentation at European Stroke Organisation Conference (ESOC) 2026 Gosselies, Belgium, 6 May 2026 (14:30 CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announced positive final results from its Phase 2a clinical trial of its investigational therapy, BIOX-101, in 23 patients with intracerebral hemorrhage (ICH). The data and regulatory discussions support progression into a single pivotal adaptive Phase 2b/3 trial. The open-label randomized 3:1 Phase 2a proof-of-concept study showed favorable safety and tolerability, no mortality and no microhemorrhages at Day 7. Furthermore, encouraging signals were observed across multiple measures, including hemorrhage volume, edema growth, several key inflammation biomarkers, and a trend towards functional improvement in patients treated with BIOX-101 compared to standard of care (SoC). “These final BIRCH data are highly encouraging in a disease where there are no approved therapeutic options. The directional findings on hemorrhage volume, edema growth and functional recovery, together with a clean safety profile in patients who typically face very poor outcomes, provide a strong basis for advancing BIOX-101 into the planned pivotal adaptive Phase 2b/3 trial,” said Prof. Robin Lemmens, MD, PhD, Principal Investigator of the BIRCH trial and head of the stroke unit at University Hospitals Leuven. “These final clinical proof of concept results provide strong evidence supporting our biological therapeutic candidate’s mechanism of action as the first disease modifying breakthrough therapy for ICH patients. Recent discussions and feedback from regulators and our regulatory consultants in the U.S. and Europe have validated our new adaptive Phase 2b/3 pivotal trial design, which we will initiate upon accessing sufficient funding,” said Marc Dechamps, Chief Executive Officer at Bioxodes. “We believe that positive Phase 2b data could enable us to register BIOX-101 for accelerated approval around the end of 2029 and launch this breakthrough therapy towards the end of 2030 in the U.S. and in 2031 in Europe. We are in advanced discussions with both potential partners and investors and expect to have the resources required to advance this urgently needed candidate to patients without delay.” Among the findings disclosed at ESOC 2026: Reduced hemorrhage volume. At Day 3, hemorrhage volume in the BIOX-101 arm had decreased by 2.19 mL vs a 3.85 mL increase in the SoC arm. Limited edema growth. At Day 3, perihematomal edema (PHE) growth in the BIOX-101 arm was 6.44 mL, versus 10.46 mL in the SoC arm. This finding is critical, as growth in perihematomal edema (PHE) is a biomarker that has been shown to be associated with poor functional outcomes in patients with ICH1; PHE will serve as a key secondary endpoint in the planned pivotal trial.Fewer secondary lesions with BIOX-101. In patients treated with BIOX-101, 5.9% (1/17) showed secondary ischemic lesions on day 7, vs 16.7% (1/6) in the SoC arm.More stable inflammatory profile. BIOX-101 was associated with a more stable neutrophil-to-lymphocyte ratio over time compared with SoC, suggesting diminishing of the acute systemic inflammatory response following ICH.Trend towards functional improvement. At Day 90, 7 of 16 BIOX-101 patients achieved a modified Rankin Scale (mRS) score of 0–2, indicating functional independence, compared to 0 of 5 patients in the SoC arm.Clear target engagement. BIOX-101 demonstrated controlled exposure during 48-hour infusion (mean t½β: 31.45 h) with a fast and reversible antithrombotic effect lasting up to 72 hours, confirming inhibition of FXIa and FXIIa coagulation factors.Favorable safety. No mortality and no microhemorrhages at Day 7 were observed in either arm. Three SAEs in two BIOX-101 patients (11.8%) were considered unlikely drug-related or unrelated; three SAEs were observed in two SoC patients (33.3%)Poster presentation detailsAbstract title: BIRCH: A Phase IIa proof-of-concept study of BIOX-101 in spontaneous intracerebral haemorrhage Abstract number: ESOC2026LB16 Poster number: P143 Date and time: Wednesday, 6 May 2026, 13:00–14:00 CEST Location: Poster area, MECC Maastricht, the Netherlands.  About the BIRCH trial – BIRCH (NCT05970224) is a multicenter, open-label, randomized 3:1 Phase 2a proof-of-concept trial conducted at 8 stroke units in Belgium. The trial evaluated BIOX-101 administered as a 48-hour intravenous infusion within 24 hours of symptom onset in 23 patients with first-ever spontaneous ICH (5–60 mL hemorrhage volume) compared to standard of care. Bioxodes is currently planning a pivotal adaptive Phase 2b/3 trial with up to 500 patients with functional outcomes as primary endpoint 2. PHE volume will serve as a key secondary efficacy endpoint, following the results from the Phase 2a trial. The company is of the view that compelling Phase 2b interim efficacy data would be sufficient to support an accelerated approval pathway, and that BIOX-101 could be granted U.S. approval in late 2030, and 2031 in the EU. The company is actively engaged in a €70 million Series B fundraising to finance the trial, manufacturing, and registration of BIOX-101. Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat intracerebral hemorrhage (ICH), the deadliest and most disabling form of stroke, for which no approved therapy exists. BIOX-101’s unique dual mechanism of action has the potential to address a broad range of thromboinflammatory diseases beyond ICH. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region (SPW Recherche), and the company is registered in Belgium under number 825.151.779. For further information, please contact: HEAD OFFICESBioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 16041 Gosselies, Belgium+32 496 59 03 54investment@bioxodes.comMEDIA RELATIONS, BELGIUMAlexandra Schiettekatte communication@bioxodes.com+32 476 65 04 38  INVESTOR RELATIONSGiovanni Ca’ ZorziCohesion Bureaugiovanni.cazorzi@cohesionbureau.comMEDIA RELATIONS, INTERNATIONALDouwe MiedemaCohesion Bureaudouwe.miedema@cohesionbureau.com 1 Peer-reviewed analysis in press, authors include members of Bioxodes’ Clinical Advisory Board2 Measured by the modified Ranking Scale (mRS), which gives a single score ranging from 1 to 6 reflecting a patient’s level of functional independence.
Attachment

20260506 Bioxodes PR ESOC data (final)

Orchestra BioMed Receives $15 Million Investment from Ligand Under Previously Announced Strategic Financing Agreement

$15 million payment fulfills previously scheduled tranche under royalty-based financing agreement, bringing total capital received from Ligand to $40 million to date in exchange for tiered royalty interest in Orchestra BioMed’s future revenue as well as equityFunding supports continued execution of Orchestra BioMed’s pivotal trials for Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) This payment, together with a $20 million investment from Medtronic (NYSE: MDT) announced separately, represents a total of $35 million in fresh strategic capital received on May 1, 2026 under previously disclosed agreements NEW HOPE, Pa., May 06, 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 the receipt of a $15 million payment from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) pursuant to the previously disclosed Revenue Participation Right Purchase and Sale Agreement (the “Royalty Purchase Agreement”). The payment completes a scheduled tranche under the agreement and reflects Ligand’s continued strategic capital support of Orchestra BioMed’s late-stage cardiovascular programs, AVIM Therapy and Virtue SAB, which are both being evaluated in ongoing randomized, controlled pivotal trials. Todd Davis, Chief Executive Officer of Ligand, commented: “We are pleased to complete this second tranche investment to Orchestra BioMed as the Company continues to advance pivotal trials for its two compelling, proprietary cardiovascular therapies, AVIM Therapy and Virtue SAB. Both device-based therapies have the potential to meaningfully improve outcomes for patients with significant unmet medical needs. Since our initial tranche investment, Orchestra has made strong progress, including continued acceleration of the BACKBEAT Trial enrollment, partnership realignment with Terumo, and the initiation of patient enrollment in the Virtue Trial. This progress reinforces our confidence in Orchestra BioMed’s ability to execute across both programs, and we look forward to key upcoming clinical and corporate milestones.” “We and Ligand designed our strategic capital partnership to align funding with execution, and the receipt of this additional tranche from Ligand reflects continued and timely progress against that plan,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “We congratulate Ligand on an outstanding run of recent successes in its portfolio and its continued strategic growth. We believe Orchestra BioMed’s programs can contribute meaningfully to Ligand’s continued royalty growth in the next few years. As we advance both of our pivotal-stage programs, this type of partnership-driven capital enables us to remain focused on delivering results that enhance the long-term value potential of both AVIM Therapy and the Virtue platform.” The $15 million investment follows an initial $20 million investment received at closing of the initial tranche under the Royalty Purchase Agreement on August 4, 2025 and completes Ligand’s $35 million royalty financing commitment under the Royalty Purchase Agreement. As previously announced, Ligand also purchased an additional $5 million of Orchestra BioMed common stock in an equity private placement in August 2025. This payment, together with a $20 million investment from Medtronic announced separately, represents a total of $35 million in fresh strategic capital received by Orchestra BioMed on May 1, 2026 under previously disclosed agreements. 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 by 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 and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations 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 LigandLigand is a leading royalty aggregator, partnering with biopharmaceutical companies to finance and advance late-stage clinical development programs. Ligand owns and manages one of the largest and most diversified portfolios of biopharmaceutical royalties in the industry, with economic interests in more than 100 development and commercial-stage assets. Ligand funds high-value programs in exchange for long-term economic interests, aligning capital with clinical and commercial success. Ligand’s royalty portfolio is designed to deliver consistent and predictable revenue streams across a broad range of therapeutic assets. Ligand also licenses its proprietary technologies, Captisol® and NITRICIL™, to support drug development and formulation across its global partner network. For more information, visit www.ligand.com or follow Ligand on X and LinkedIn. References to information included on, or accessible through, Ligand’s websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM TherapyAVIM 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 is evaluating 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 two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SABVirtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. 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, the potential benefits of Breakthrough Device Designation, 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, 2025, which was filed with the SEC on March 12, 2026. 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 KirkOrchestra BioMedkkirkellis@orchestrabiomed.com

Milestone Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 13, 2026

MONTREAL and CHARLOTTE, May 06, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will report financial results for the first quarter ended March 31, 2026, and provide a business update before the market open. The announcement will be followed by a conference call and webcast for investors at 8:30am ET. Conference Details: Conference Date:Wednesday, May 13, 2026Conference Time:8:30am ETConference Dial-in:1-877-407-0792International Dial-in:1-201-689-8263Conference ID:13760062Webcast link:Click here. Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start time. A replay of the audio webcast of the call will be available under the News & Events section of Milestone’s website, www.milestonepharma.com. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the control of symptomatic episodic attacks associated with AFib-RVR. Contact: Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Media Relations  Rebecca Novak, rnovak@milestonepharma.com

Philips delivers strong order intake, comparable sales growth and margin expansion in Q1; 2026 outlook reiterated

May 6, 2026Q1 2026 Group performance Comparable order intake growth 6% Group sales of EUR 3.9 billion, reflecting 4% increase in comparable salesIncome from operations increased to EUR 241 millionAdjusted EBITA margin increased 40 basis points to 9.0%Operating cash flow of EUR 188 million, with free cash flow of EUR 28 million2026 outlook reiterated Roy Jakobs, CEO of Royal Philips:“We delivered a good start to 2026, with strong order intake growth at 6%, comparable sales growth of 4% and margin expansion of 40 basis points, reflecting disciplined execution against our plan in an uncertain macro-environment. Sales grew across segments and was led by North America and Europe. We are moving forward with full energy on our new plan to accelerate profitable growth, built on three strategic pillars: focused segment-specific strategies, differentiated platform-based innovations, and disciplined execution. We are proud to remain the number one MedTech patent applicant in Europe and to have secured regulatory approval for key AI-powered innovations such as SmartHeart, which automates cardiac MR imaging planning in one click. Our unique, differentiated platforms drove strong demand by combining hardware, software and AI. DeviceGuide gained regulatory approval, adding AI-powered real-time guidance to complex cardiac procedures on the Azurion image-guided therapy platform. Our OneBlade grooming platform resonated with customers by providing superior experience and versatility in use. Disciplined execution underpins our progress as we navigate an increasingly dynamic macro-environment. In response to external pressures, we are focused on what we can control: stepping up productivity actions to offset the impact of tariffs and higher cost inflation, keeping our savings plans on track, and further strengthening our supply chain. At the same time, we are intensifying commercial and service excellence to reach more customers and consumers through our innovations. With quality at the heart of our operations, our entire team is dedicated to delivering better care for more people.” Group and segment performanceComparable order intake increased 6%, driven by growth in both Diagnosis & Treatment and Connected Care and continued strong performance in North America and International Region. Group comparable sales increased 4%, with growth across all segments led by Personal Health. Adjusted EBITA margin increased 40 basis points to 9.0%, mainly driven by higher sales and underlying gross margin, supported by recently launched innovations and productivity, despite the impact from higher tariffs and cost inflation. Income from operations increased to EUR 241 million. Free cash flow totaled EUR 28 million. Diagnosis & Treatment comparable sales increased 2%. Adjusted EBITA margin was 9.8%, up 30 basis points, mainly driven by higher sales and productivity, partly offset by higher tariffs and cost inflation. Connected Care comparable sales increased 3%. Adjusted EBITA margin declined 60 basis points to 2.9%, mainly due to the impact of higher tariffs and cost inflation, partly offset by productivity and higher sales. Personal Health comparable sales increased 9%. Adjusted EBITA margin increased 60 basis points to 15.8%, driven by higher sales and productivity, and partly offset by higher tariffs, advertising and promotions spend, and cost inflation.Innovation highlights Philips remains No. 1 in MedTech at the European Patent Office and the largest Dutch patent applicant, reflecting its leadership in health technology through AI-enabled, platform-based innovations that integrate hardware, software and data to improve care from hospital to home.Philips received FDA 510(k) clearance for two AI-powered cardiology solutions, reinforcing its platform-based innovation strategy. DeviceGuide integrates seamlessly with the Azurion platform to enable real-time guidance during mitral valve procedures and improve outcomes and workflow, while SmartHeart automates 14 standard and advanced cardiac MR views in one click under 30 seconds, reducing breath holds by up to 75%, enhancing efficiency and patient comfort.Philips strengthened its CT portfolio with FDA 510(k) clearance for two AI-enabled systems: Verida Spectral CT delivers anatomical and functional insights from a single low-dose scan, while Rembra CT combines industry-leading speed with an 85 cm wide bore, enabling near real-time imaging and efficient workflows for complex cases.Philips launched its Sonicare 1000-4000 Series, bringing its No. 1 dentist recommended sonic toothbrush brand technology to its most accessible price point. New ranges with Next-Generation Sonicare technology were also launched, including the 5700-7300 Series in the US, delivering a gentle yet effective clean with up to 10x more plaque removal, as well as the Sonicare 7000 in China, to continue to demonstrate leadership in the premium oral care segment.Philips signed a long-term strategic partnership with WellSpan Health, expanding its role as a preferred provider across all imaging modalities and advancing a systemwide approach to imaging and diagnostic technologies. The partnership will enable standardized platforms, life cycle management and integrated service delivery across WellSpan’s 12 hospitals and its diagnostic imaging centers and ambulatory surgery centers.Philips signed a five-year Enterprise Monitoring as a Service partnership with University Health San Antonio to enable system-wide patient monitoring. The scalable model supports standardized monitoring, centralized surveillance and advanced analytics, helping create a future-ready, integrated care environment.Philips expanded its partnership with AdventHealth through a five-year enterprise service agreement for imaging services across its network. The collaboration reintroduces Philips’ full-service model across modalities, while supporting long-term imaging infrastructure focused on quality and performance. Productivity Disciplined cost management and productivity initiatives delivered EUR 126 million in savings in the quarter. Philips is on track to deliver EUR 1.5 billion in savings under its 2026-2028 productivity program. OutlookPhilips reiterates its full-year 2026 outlook: Comparable sales growth: 3%-4.5%Adjusted EBITA margin: 12.5%-13.0%Free cash flow: EUR 1.3-1.5 billion Philips 2026 outlook includes currently known information, including tariffs, within an uncertain macro environment. It excludes any potential International Emergency Economic Powers Act (IEEPA) tariff refunds. It excludes ongoing Philips Respironics-related proceedings, including the investigation by the US Department of Justice. Capital allocationTo cover certain of its obligations arising from its long-term incentive plans, Philips will repurchase up to 4 million shares. At the current share price, the shares represent an amount of up to approximately EUR 91 million. The repurchases will be executed through one or more individual forward transactions, expected to be entered into in the second and/or the third quarter of 2026, in accordance with the Market Abuse Regulation and within the limits of the authorization granted by the company’s General Meeting of Shareholders. Philips expects to take delivery of the shares in Q4 2028. Further details will be available via this link. Further information: conference call, video webcast and websiteRoy Jakobs, CEO, and Charlotte Hanneman, CFO, will host a conference call for investors and analysts at 10:00 am CET today to discuss the first quarter results. A live webcast of the conference call will be available on the Philips Investor Relations webpage and can be accessed here. A replay and related materials, which include additional information, including forward-looking statements and further information on our outlook, will be available on the Philips Investor Relations webpage. Click here to view the release online For further information, please contact:Michael FuchsPhilips Global External RelationsTel.: +31 6 1486 9261E-mail: michael.fuchs@philips.comDorin DanuPhilips Investor RelationsTel.: +31 20 59 77055E-mail: dorin.danu@philips.comAbout 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 64,300 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter. Forward-looking statements and other important informationForward-looking statementsThis document and the related oral presentation, including responses to questions following the presentation, contain certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about our strategy, estimates of sales growth, future Adjusted EBITA*, future restructuring and acquisition-related charges and other costs, future developments in Philips’ organic business and the completion of acquisitions and divestments. Forward-looking statements can be identified generally as those containing words such as “anticipates”, “assumes”, “believes”, “estimates”, “expects”, “should”, “will”, “will likely result”, “forecast”, “outlook”, “projects”, “may” or similar expressions. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.These factors include, but are not limited to, macro-economic and geopolitical changes – including the war in Ukraine and ongoing tensions in the Middle East – as well as measures such as enacted and proposed tariffs and trade actions introduced in response to rising global tensions; Philips’ ability to keep pace with the changing health technology environment; Philips’ ability to gain leadership in artificial intelligence and health informatics in response to developments in the health technology industry; integration of acquisitions and their delivery on business plans and value creation expectations; ability to meet expectations with respect to ESG-related matters; securing and maintaining Philips’ intellectual property rights, and unauthorized use of third-party intellectual property rights; failure of products and services to meet quality or security standards, adversely affecting patient safety and customer operations; the resilience of our supply chain; challenges in simplifying our organization and our ways of working; attracting and retaining personnel; breach of cybersecurity; challenges in driving operational excellence and speed in bringing innovations to market; treasury and financing risks; tax risks; reliability of internal controls; compliance with regulations and standards involving quality, product safety, (cyber) security and artificial intelligence; and compliance with business conduct rules and regulations including privacy, existing and upcoming ESG disclosure and due diligence requirements. As a result, Philips’ actual future results may differ materially from the plans, goals and expectations set forth in such forward-looking statements. For a discussion of factors that could cause future results to differ from such forward-looking statements, see also the Further information chapter included in the Annual Report 2025.Third-party market share dataStatements regarding market share contained in this document, including those regarding Philips’ competitive position, are based on outside sources such as specialized research institutes, as well as industry and dealer panels, in combination with management estimates. Where information is not yet available to Philips, market share statements may also be based on estimates and projections prepared by management and/or based on outside sources of information. Management’s estimates of rankings are based on order intake or sales, depending on the business.Market Abuse RegulationThis press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.Use of non-IFRS informationIn presenting and discussing the Philips Group’s financial position, operating results and cash flows, management uses certain non-IFRS financial measures. These non-IFRS financial measures should not be viewed in isolation as alternatives to the equivalent IFRS measure and should be used in conjunction with the most directly comparable IFRS measures. Non-IFRS financial measures do not have standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other issuers. A reconciliation of these non-IFRS measures to the most directly comparable IFRS measures is contained in this document. Further information on non-IFRS measures can be found in the Annual Report 2025.PresentationAll amounts are in millions of euros unless otherwise stated. Due to rounding, amounts may not add up precisely to totals provided. All reported data is unaudited. Financial reporting is in accordance with the accounting policies as stated in the Annual Report 2025. Certain prior-year balances have been reclassified to conform to the current period presentation. Per share calculations for all periods presented have been retrospectively adjusted to reflect the issuance of shares in 2025 with respect to the share dividend for 2024. *) Non-IFRS financial measure. Refer to Reconciliation of non-IFRS information.

AtriCure Reports First Quarter 2026 Financial Results

MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced first quarter 2026 financial results. “Our first quarter results reflect the durability of AtriCure’s growth model, fueled by disciplined execution and increased adoption of our innovative products,” said Michael Carrel, President and Chief Executive Officer

HeartSciences Signs First SaaS Revenues Agreement following full launch of MyoVista Insights™

Agreement with St. Vincent Health marks HeartSciences’ transition from early adopter installations to commercial SaaS deployments following the full launch of MyoVista Insights at the American College of Cardiology Annual Scientific SessionSouthlake, TX, May 05, 2026 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today announced that it has signed a commercial agreement with St. Vincent Health, a Critical Access Hospital serving Lake County, Colorado, to deploy the MyoVista Insights™ platform. The agreement marks an important commercial milestone for HeartSciences, representing the Company’s first mainstream revenue-generating deployment of MyoVista Insights, building on previously announced reference and early adopter installations. MyoVista Insights is offered under a SaaS-based recurring revenue model, and HeartSciences is in active discussions with additional healthcare organizations and expects further commercial agreements over the coming quarters. MyoVista Insights is a cloud-native, SaaS-based ECG management platform purpose-built to improve workflow efficiency, provide enterprise-grade EHR interoperability, and enable the deployment of cleared AI-ECG algorithms directly into routine clinical workflows. It is device-agnostic and designed to scale across healthcare facilities of all sizes. Andrew Simpson, Chief Executive Officer of HeartSciences, said, “This agreement represents an important commercial milestone for HeartSciences as we transition from early adopter installations to revenue-generating deployments of MyoVista Insights. Following our full launch at ACC, we are seeing strong market interest in a scalable, device-agnostic ECG management platform designed to bring AI-enabled cardiac insights into everyday clinical workflows. We believe this agreement is the first of multiple commercial opportunities across healthcare organizations of varying sizes.” Justin “Bubba” Bartlett, Chief Executive Officer of St. Vincent Health, added, “At St. Vincent Health, we are focused on bringing modern, high-quality care to our community. MyoVista Insights gives our clinicians a cost-effective, SaaS ECG platform that is easy to deploy, integrates the latest AI directly into existing workflows, and supports our mission to elevate cardiac care for the patients we serve.” For more information about MyoVista Insights™, please visit www.heartsciences.com or follow the Company on X (@HeartSciences). Healthcare providers interested in opportunities may contact info@heartsciences.com. About HeartSciences HeartSciences is a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”). The Company’s MyoVista Insights platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making. Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions. For more information, please visit: https://www.heartsciences.com. X: @HeartSciences About St. Vincent Health St. Vincent Health, located in Leadville, Colorado, is an independent community hospital that has served Lake County since 1879. Operated by the St. Vincent General Hospital District, the hospital provides 24/7 emergency, primary care, surgical, and rehabilitation services to its community. For more information, please visit www.stvincent.health. Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 24, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2025 filed with the SEC on September 11, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2025 filed with the SEC on December 15, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2026 filed with the SEC on March 16, 2026, and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Investor Relations: Integrous CommunicationsMark Komonoski, PartnerPhone: 877 255 8483Email: mkomonoski@integcom.us Media Contact: HeartSciencesGene GephartPhone: +1 682 244 2578 Ext. 2024Email: info@heartsciences.com