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BioSig Announces Closing of $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Westport, CT, May 30, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of an aggregate of 1,570,683 shares of its common stock at a purchase price of $1.91 per share and concurrent private placement unregistered warrants to purchase up to 1,570,683 shares of common stock at an exercise price of $1.78 per share. The unregistered warrants are immediately exercisable and will expire five years from the date of issuance. H.C. Wainwright & Co. acted as exclusive placement agent for the offering. The gross proceeds to the Company from the offering were approximately $3 million, before deducting placement agent fees and other offering expenses payable by the Company. BioSig intends to use the net proceeds of this offering for working capital and general corporate purposes. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants or the shares of common stock underlying such unregistered warrants) described were offered and sold by BioSig pursuant to a shelf registration statement on Form S-3 (File No. 333-251859) that was previously filed with the Securities and Exchange Commission (“SEC”) on December 31, 2020, and subsequently declared effective on January 12, 2021. The offering of the shares of common stock were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at placements@hcwco.com. The offer and sale of the unregistered warrants issued in the concurrent private placement were made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioSig Technologies, Inc. BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements include, but are not limited to, statements related to the intended use of proceeds from the offering. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates; and (ix) market and other conditions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see BioSig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Annual Report on Form 10-K, filed with the SEC on April 16, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

InnovHeart Announces First-In-Human Trans-Septal Implantation of Saturn Mitral Valve Replacement

NEWTON, Mass. and MILAN, May 30, 2024 /PRNewswire/ — InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral regurgitation (MR), announced today the first trans-septal clinical trial implant with the proprietary Saturn Transcatheter Mitral Valve. Excellent hemodynamic results are reported for the patient, a 79 year old female suffering from severe mixed (degenerative and functional) mitral regurgitation. The Trans-Septal TMVR procedure was performed as part of the on-going European clinical trial, the CASSINI-EU study, on May 8th, 2024 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD1; Giedrius Davidavičius, MD1; Agnė Drąsutienė, MD1; Vilhelmas Bajoras, MD1; supported by Torsten Vahl, MD2; Lauren Ranard, MD2; Paolo Denti, MD3; and Stefano Stella, MD3.
“We were honored to work with this outstanding international team providing life-changing novel TMVR therapy for this high surgical-risk patient. It is particularly rewarding to support the InnovHeart progression from trans-apical to trans-septal delivery of the Saturn Valve at our Institute,” said Dr. Giedrius Davidavičius. “This first case is a critical step to validate that the Saturn valve can be successfully delivered via a fully percutaneous, transfemoral transseptal approach. The Saturn prosthesis has a unique modular design comprising an annular ring and low-profile valve that can reverse remodel the native annulus, avoid LVOT obstruction and eliminate MR” said Dr. Torsten Vahl.  
“Overall, this important case demonstrates that the Saturn valve can be successfully implanted with either retrograde or antegrade approaches. It is exciting to add trans-septal delivery and begin to expand the clinical experience for the Saturn valve beyond the initial trans-apical study, now in long-term follow-up. I continue to believe that Saturn will become a valuable new therapy with fewer anatomical exclusions than other technologies, with the potential to treat a wider range of patients,” said Dr. Paolo Denti who is the Principal Investigator for the CASSINI-EU study. “We are very grateful for the skilled physicians who successfully completed our first trans-septal CASSINI study case and for our Founder and CTO, Giovanni Righini, for realizing this very important milestone for patients and the company,” said David Wilson, InnovHeart CEO. The CASSINI-EU study will expand to multiple countries and enroll up to 30 patients with moderate to severe or severe MR.
1 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania2 Structural Heart and Valve Center, New York-Presbyterian Hospital, Columbia University Irving Medical Center, New York, USA 3 San Raffaele University Hospital, Milano, Italy
About InnovHeart
InnovHeart is a medical device company dedicated to providing new treatment options for people suffering from moderate to severe or severe mitral regurgitation (MR) and who need a mitral valve replacement. The InnovHeart proprietary Saturn Transcatheter Mitral Valve Replacement (TMVR) System is designed to eliminate mitral regurgitation and restore normal valve function. InnovHeart is a privately held company located in Colleretto Giacosa, Italy and Newton, Mass, USA. For more information, please visit www.InnovHeart.com and follow us on LinkedIn and X (@InnovHeart).
Caution: The SATURN Transcatheter Mitral Valve Replacement (TMVR) System is limited to investigational use and is not commercially available in any country.

SOURCE InnovHeart

Revolutionizing Oncology Care: AI-Powered Ultrasound Device Enhances Cardiac Monitoring for Chemotherapy Patients

REDMOND, Wash., May 30, 2024 (GLOBE NEWSWIRE) — A recent study published in the European Heart Journal highlights the significant enhancements that the Kosmos ultrasound system, developed by EchoNous, brings to cardiac evaluations for chemotherapy patients. This AI-powered device enables even non-expert ultrasound users, such as junior oncologists and nurses, to accurately and swiftly assess left ventricular ejection fraction (LVEF), a crucial indicator of heart health and a critical measure to monitor in patients undergoing chemotherapy treatment. Dr. Dimitri Dionysopolous, one of the study’s authors, highlighted the Komsos’s significant impact: “With very little training, oncology staff can accurately measure a patient’s heart function in real-time. Our study revealed that the measurement process is very fast, taking less than 10 minutes from start to finish, which could dramatically change how we implement care in practice.” Kosmos, equipped with AI algorithms Trio and Kosmos Auto EF, guides users through the scanning process, making it easier to learn and enabling precise cardiac and abdominal imaging, along with more efficient LVEF calculations. This system, which produces high-quality echocardiographic images at the point of care, is a testament to the potential of AI in healthcare. “This is a tremendous result that fits into many conversations happening around healthcare right now,” said Graham Cox, CEO at EchoNous. “Healthcare organizations desperately need to enable less trained medical staff to perform ultrasound exams, and this study shows that it’s feasible with Kosmos and its AI capabilities.” In the study involving 115 patients, cardiologists performed traditional echocardiography and compared it with scans that oncology staff, including senior oncologists, residents, and nurses, performed using the Kosmos ultrasound system. The findings demonstrate that non-ultrasound experts can effectively use Kosmos, achieving diagnostic accuracy between 89 to 94 percent among different operators. These promising results suggest a future where Kosmos could be widely used by oncology staff, leading to faster clinical workflows and enhanced care for cancer patients. EchoNous will be showcasing the potential of Kosmos at the 2024 ASCO Annual Meeting from May 31 to June 4. Attendees are invited to visit our booth to learn more and chat with us. About EchoNous Headquartered in Redmond, Washington, EchoNous is a leader in creating innovative point-of-care ultrasound solutions. By combining premium ultrasound performance with cutting-edge AI educational tools, EchoNous expands the accessibility of advanced diagnostic capabilities, enabling more clinicians to obtain crucial patient information more swiftly. For further details, visit www.echonous.com. For further information, please contact: Luke BaldwinVP Global Marketing & Product ManagementLuke.Baldwin@EchoNous.com

The Lancet Publishes Results from World’s Largest Coronary CT Registry Showing New AI Technology Can Predict Cardiac Events Due to Coronary Inflammation At Least 10 Years in Advance

OXFORD, England, May 30, 2024 /PRNewswire/ — Caristo Diagnostics Limited, a global leader in cardiovascular disease diagnostics and risk prediction, announced the results of a landmark clinical study published in The Lancet that support the ability of Caristo’s CaRi-Heart® AI technology to quantify coronary artery inflammation and accurately predict cardiac events.
This landmark study, titled “Inflammatory risk and cardiovascular events in patients without obstructive coronary artery disease: the ORFAN multicentre, longitudinal cohort study,” analysed results from the first 40,000 patients enrolled in the “ORFAN” registry, the world’s largest study that evaluates coronary computed tomography angiography (CCTA) imaging biomarkers in predicting long-term cardiovascular outcomes.
Key study findings include:

Among patients undergoing CCTA, more than 80% did not have obstructive coronary artery disease (CAD) at the time of imaging, but twice as many fatal and non-fatal cardiac events occurred in that group
Coronary inflammation, as measured by Caristo’s CaRi-Heart FAI-ScoreTM, predicted fatal and non-fatal cardiac events (including heart attack and new heart failure), independently from traditional risk factors, routine clinical CCTA interpretation, calcium scoring and plaque quantification, at least 10 years in advance
Even among the 50% of patients who had no or minimal coronary plaque at the time of the initial CCTA, those with the most abnormal FAI-Score results experienced a 9.5-fold higher risk for cardiac mortality and 5.5-fold higher risk for major adverse cardiac events (MACE)
Caristo’s AI-Risk model, CaRi-Heart Risk Score, outperformed other scores in routine clinical use for prediction of cardiac mortality, and when presented to clinicians, resulted in changes of management decision in 45% of the patients. Most changes were due to clinicians’ decision to target the previously undetected coronary inflammation.

“The ORFAN study is an expanding global registry which will include long-term clinical and outcome data for 250,000 patients from around the world, and we are very pleased to publish these initial results,” said Keith Channon, MD, Professor of Cardiovascular Medicine at the University of Oxford, Caristo’s Chief Medical Officer, and co-author of The Lancet publication. “Coronary inflammation is a crucial piece of the puzzle in predicting heart attack risk. We are excited to discover that CaRi-Heart results performed exceptionally well in predicting patient cardiac events. This tool is well positioned to help clinicians identify high-risk patients with seemingly ‘normal’ CCTA scans.”
Ron Blankstein, MD, Professor of Medicine and Radiology at Harvard Medical School, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and co-author of the publication, commented: “This study, which represents one of the largest studies in the field of CCTA, has important implications for the field of preventive cardiology. I am excited about the potential of the FAI-Score biomarker, which has promising prognostic value beyond existing CT-based methods such as plaque, calcium scoring, and CAD-RADS based interpretation.”  
The study underlines the need for a robust risk prediction tool that can identify vulnerable patients with inflamed coronary arteries, particularly in those without obstructive CAD. This approach would transform CCTA from a test used to triage a minority of patients for further intervention into a prevention tool that guides management for all patients undergoing CCTA.
SCCT Webinar to Feature Study Co-Authors on June 27:
On June 27 at 11am EDT, the Society of Cardiovascular Computed Tomography (SCCT) will host a webinar on The Lancet publication findings to be presented by the lead author, Prof. Charalambos Antoniades, and joined by several co-authors (Prof. Channon, Prof. Stefan Neubauer, Prof. Ed Nicol, Prof. Blankstein and Prof. Milind Desai). The webinar will present the key results from The Lancet publication along with a panel discussion on the implications of this landmark study. Check www.caristo.com in early June for the webinar registration link.
Caristo’s patented CaRi-Heart technology marks a scientific breakthrough that is radically transforming the traditional approach to heart disease prediction, prevention and management. The technology applies advanced AI algorithms to routine coronary computed tomography angiography (CCTA) scans to visualize and quantify coronary inflammation, the otherwise invisible disease mechanism responsible for many fatal heart attacks and strokes. Prior to this publication by The Lancet, earlier validation results showing CaRi-Heart technology’s ability to aid the prediction of heart attacks were published in leading medical journals including the Lancet, JACC, European Heart Journal, and Cardiovascular Research.
The CaRi-Heart® technology is in clinical use in the UK, European Union, and Australia.
About Caristo Diagnostics Limited
Caristo Diagnostics is a global leader in cardiac and vascular disease diagnostics and risk prediction. Founded in 2018 as a spin-out company from the University of Oxford, the world’s #1 research university, Caristo has developed a portfolio of imaging-based and AI-assisted platforms that can be applied to aid the prediction and diagnosis of heart attack, stroke, and diabetes. Caristo has been recognized by Newsweek as one of the best digital health companies, and highlighted by Nature as one of the most exciting science-based companies to have emerged from academic labs. Find Caristo online on its website, LinkedIn and X.
Logo: https://mma.prnewswire.com/media/2054669/4734272/Caristo_Logo.jpg
ContactFrank Cheng, Caristo Diagnostics CEO[email protected]
SOURCE Caristo Diagnostics

BioSig Announces $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Westport, CT, May 30, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,570,683 shares of its common stock at a purchase price of $1.91 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, BioSig has also agreed to issue and sell to the same purchasers unregistered warrants to purchase up to 1,570,683 shares of common stock at an exercise price of $1.78 per share. The unregistered warrants will become immediately exercisable upon issuance and will expire five years from the date of issuance. The closing of the offering is expected to occur on or about May 30, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be approximately $3 million, before deducting placement agent fees and other offering expenses payable by the Company. BioSig intends to use the net proceeds of this offering for working capital and general corporate purposes. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants or the shares of common stock underlying such unregistered warrants) described above are being offered by BioSig pursuant to a shelf registration statement on Form S-3 (File No. 333-251859) that was previously filed with the Securities and Exchange Commission (“SEC”) on December 31, 2020, and subsequently declared effective on January 12, 2021. The shares of common stock to be issued in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at placements@hcwco.com. The offer and sale of the unregistered warrants are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioSig Technologies, Inc. BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements include, but are not limited to, statements related to the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates; and (ix) market and other conditions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see BioSig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Annual Report on Form 10-K, filed with the SEC on April 16, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

Medtronic announces pricing of €3.0 billion of senior notes

DUBLIN, May 29, 2024 /PRNewswire/ — Medtronic plc (the “Company”) (NYSE: MDT) announced today that its wholly-owned indirect subsidiary, Medtronic, Inc., has priced an offering (the “Offering”) of €850,000,000 principal amount of 3.650% senior notes due 2029, €850,000,000 principal amount of 3.875% senior notes due 2036, €600,000,000 principal amount of 4.150% senior notes due 2043, and €700,000,000 principal amount of 4.150% senior notes due 2053 (collectively, the “Notes”). All of Medtronic, Inc.’s obligations under the Notes will be fully and unconditionally guaranteed by the Company and Medtronic Global Holdings S.C.A., a wholly-owned subsidiary of the Company and the indirect parent of Medtronic, Inc., on a senior unsecured basis. 
The net proceeds of the Offering are expected to be used for general corporate purposes, which may include repayment of outstanding commercial paper and other indebtedness. The Offering is expected to close on June 3, 2024, subject to customary closing conditions. The joint book-running managers for the Offering are Citigroup Global Markets Limited, J.P. Morgan Securities plc, Merrill Lynch International and Mizuho International plc.
The Offering is being made only by means of a prospectus dated March 3, 2023, and prospectus supplement (together, the “Prospectus”). You may get these documents for free by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus may be obtained by contacting Citigroup Global Markets Limited, toll-free at +1 800 831 9146, J.P. Morgan Securities plc at +44 20 7134 2468 (non-U.S. investors), or J.P. Morgan Securities LLC collect at +1 212 834 4533 (U.S. investors), Merrill Lynch International, toll free at +1 800 294 1322 and Mizuho International plc, at +44 20 7248 3920.
About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.  
Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the Offering and the expected use of proceeds therefrom, and the expected closing date of the Offering.
You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectus related to the offering referenced above, as well as the risk factors and cautionary statements described in Medtronic plc’s filings with the SEC, including the risk factors contained in Medtronic plc’s most recent Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.

Contacts:

Erika Winkels
Ryan Weispfenning

Public Relations
Investor Relations

+1-763-526-8478
+1-763-505-4626

SOURCE Medtronic plc

Kardium announces positive 1-year outcomes for PULSE-EU trial with the Globe® System, showing promise for improving the treatment of atrial fibrillation

VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial. These findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting […]

Remedy Pharmaceuticals Gets Rights To Acute Stroke Drug Back From Biogen; Announces Clinically Meaningful and Statistically Significant Results From Pre-specified Subgroup and Post Hoc Analyses of Phase 3 Study

NEW YORK, May 29, 2024 /PRNewswire/ — Remedy Pharmaceuticals, a pioneer in stroke drug development, announced that prespecified subgroup analyses from the Phase 3 CHARM clinical trial of CIRARA (IV glibenclamide) showed meaningful improvements in functional outcomes on the modified Rankin Scale (mRS), which were further validated in post hoc analyses.
The findings follow the early termination of the pivotal Phase 3 trial by Cambridge-based Biogen after a strategic realignment of resources, and the return of the program to Remedy.
The CHARM clinical trial was a multicenter, multinational, double-blind, randomized, placebo-controlled Phase 3 study involving patients aged 18-85 with a large hemispheric infarction (LHI), as indicated by an Alberta Stroke Program Early Computed Tomographic (CT) Score (ASPECTS) value of 1-5 (on a scale of 0-10) or an ischemic core volume of 80-300 ml by CT perfusion (CTP) or magnetic resonance imaging (MRI) diffusion weighted imaging. Patients were eligible if study drug was expected to start within 10 hours after they were last known well and were randomly assigned in a 1:1 ratio of CIRARA or placebo. A total of 535 patients were enrolled, including 431 patients aged 18-70 (the efficacy analysis population) and 81 patients aged 71-85.
Despite neutral top-line results, in pre-specified analyses, patients who received rtPA, underwent endovascular thrombectomy (EVT), were enrolled using CTP/MRI, had wake-up strokes, or were enrolled in the U.S., all had directionally improved functional outcomes in favor of CIRARA. A pre-specified analysis in patients with an NIH Stroke Scale (NIHSS) ≤20 (n=274) yielded statistically significant improvements in functional outcomes (Odds Ratio 1.66, p=0.03). With EVT therapy increasingly used in LHI, the Odds Ratio of 1.75 in the EVT subset, while not statistically significant, was particularly encouraging.
Building on these findings, post hoc analyses examining the impact of stroke severity on outcomes were performed and revealed significant findings:

In the mITT population with CTP/MRI lesion volume

Beckman Coulter Secures FDA Clearance for Heart Failure Assay on DxI 9000 Immunoassay Analyzer

New Access NT-proBNP Assay Detects Heart Failure Biomarker in Less than 11 Minutes Patient Results Evaluated Within Context of Clinically RelevantAge-Based Cutoffs, Disease Comorbidity Data and Gender ParametersBREA, Calif., May 29, 2024 /PRNewswire/ — Beckman Coulter, a global leader in clinical diagnostics, today announced U.S. Food and Drug Administration clearance of its Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay for the assessment of heart failure in less than 11 minutes on the Beckman Coulter DxI 9000 Immunoassay Analyzer*. The Access NT-proBNP assay aids in diagnosing patients suspected of having acute heart failure in emergency departments as well as assessing the severity and risk stratification of patients with heart failure and acute coronary syndrome.

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The award-winning DxI 9000 Immunoassay Analyzer sets a new standard for today’s busy labs addressing today’s speed, reliability, reproducibility, quality, and menu expansion demands.

According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 have heart failure, accounting for approximately 8.5% of all heart disease deaths in the United States. Beckman Coulter’s Access NT-proBNP assay measures concentrations of N-terminal pro B-type natriuretic peptide in serum or plasma that originates in a person’s heart. High levels of natriuretic peptides can indicate heart failure.  

As recommended in the latest heart failure guidelines from the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay provides age-based cutoffs for diagnosis of heart failure to ensure results are evaluated in the appropriate clinical context for each patient. In addition to age, other patient factors such as gender, obesity and kidney failure can affect natriuretic peptide levels. The Access NT-proBNP assay provides clinical performance information for these subsets of patients to assist clinicians’ sample data interpretation and diagnoses.
“We continue to be excited by the quality, sensitivity and specificity of the assays being developed for DxI 9000 Analyzer,” Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay for Beckman Coulter.  “FDA clearance of the Access NT-proBNP assay is just the latest confirmation of the platform’s capability to develop ever increasingly more sensitive and clinically relevant diagnostics. The combination of DxI 9000 Analyzer’s expanding menu of assays and its operational excellence, highlighted by ZeroDaily Maintenance, PrecisionVision Technology, and IntelliServe is driving laboratory demand around the globe.”  About Beckman Coulter. Inc. A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what’s now to what’s next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, Calif., with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher.  Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow’s science and technology to improve human health.Follow and connect with Beckman Coulter Diagnostics via LinkedIn, X, and Facebook.*Full name DxI 9000 Access Immunoassay Analyzer© 2024 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2024-12984.SOURCE Beckman Coulter Diagnostics

Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment

ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the first in the Northeast United States to offer the Genesis System. Genesis is the latest advancement in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmias may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “Our adoption of advanced robotic technology significant enhances our ability to precisely diagnose and treat patients suffering from complex cardiac arrhythmias,” said Dr. Benjamin D’Souza, Cardiac Electrophysiologist at Penn Presbyterian Medical Center. “We are committed to leveraging cutting-edge innovations to provide patients with the best care. Our team has leveraged the precision and safety of robotics to treat patients that often have few other options for care. With unmatched accuracy, we can tailor treatments to each patient’s unique anatomy, enhancing safety and efficacy.” “We are excited to partner with Penn Presbyterian to pioneer the Genesis Robotic System in the Northeast,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to supporting Penn Presbyterian in growing a highly successful and impactful robotic heart care program that advances patient care, clinical research and technology advancement.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com