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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



