Financial

HeartBeam Announces Pricing of $10.0 Million Underwritten Public Offering of Common Stock

HeartBeam system was recently cleared by the U.S. Food and Drug Administration (FDA) for comprehensive arrhythmia assessment 510(k) application submitted to the FDA for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software Funding is part of the Company’s strategic plan focusing on key growth milestones and preparation for U.S. commercialization […]

Jefferson Appoints Surgeon Dr. Joseph E. Bavaria as Executive Director of the Bruce and Robbi Toll Heart and Vascular Institute and Chair of the Department of Cardiac Surgery at Thomas Jefferson University

Dr. Bavaria formally joined Jefferson Health and the University’s Sidney Kimmel Medical College on January 15, 2025 PHILADELPHIA, Feb. 13, 2025 /PRNewswire/ — Jefferson kicked off American Heart Month and demonstrated the organization’s commitment to cardiovascular care with the…

IRADIMED CORPORATION Announces Fourth Quarter and Full Year of 2024 Financial Results and Increases its Regular Quarterly Cash Dividend to $0.17 Per Share from $0.15 Per Share

WINTER SPRINGS, Fla., Feb. 13, 2025 (GLOBE NEWSWIRE) — IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) announced today its financial results for the three months and year ended December 31, 2024. The Company is a leader in the development of innovative magnetic resonance imaging (“MRI”) medical devices and the Company is the only known provider of a (i) non-magnetic intravenous (“IV”) infusion pump system and (ii) a non-magnetic patient vital signs monitoring system that are each designed for use during MRI procedures.

RenovoRx Announces Closing of $12.1 Million Underwritten Public Offering of Common Stock

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, an innovative, FDA-cleared delivery platform, today announced the closing of its previously announced $12.1 million firm commitment underwritten public offering of common stock led by multiple fundamental […]

Milestone Pharmaceuticals to Host Commercial Launch Plan Investor Event in New York on February 25, 2025

MONTREAL and CHARLOTTE, N.C., Feb. 11, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced further details on its in-person and virtual Commercial Launch Plan investor event to take place in New York on Tuesday, February 25, 2025 from 10:30 AM to 12:30 PM ET. Investors planning to attend the in-person event are required to register in advance. To register, click here. Featuring presentations by Joseph Oliveto, President and Chief Executive Officer, and Lorenz Muller, Chief Commercial Officer, the event will provide an overview of Milestone’s commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). Milestone’s New Drug Application (NDA) for CARDAMYST is currently under review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. Milestone currently expects to launch in PSVT mid-2025. A live question and answer session will follow the formal presentation. About Etripamil Etripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR). It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing and outcomes of future interactions with the FDA, including the PDUFA target date; the timing of our potential commercial launch of CARDAMYST; and the ability of etripamil for PSVT to provide patients with active management and a greater sense of control over their condition. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com

Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront

Anthos Therapeutics is a clinical-stage biopharmaceutical company developing abelacimab, a potential first-in-class monoclonal antibody targeting the FXI inhibition pathwayAbelacimab is currently in Phase 3 development, with the lead indication for prevention of stroke and systemic embolism in patients with atrial fibrillationAcquisition adds a late-stage asset and is aligned with Novartis strategic focus, strength and expertise in the cardiovascular therapeutic areaTransaction expected to close in the first half of 2025, subject to customary closing conditions Basel, February 11, 2025 – Novartis today announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company with abelacimab, a late-stage medicine in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The transaction, which is subject to customary closing conditions, is fully in line with Novartis’ growth strategy and therapeutic area focus, leveraging the company’s strength and expertise in the cardiovascular area. Anthos Therapeutics, launched by Blackstone Life Sciences and Novartis in 2019, has advanced abelacimab through clinical development under a license from Novartis. Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Phase 2 data showed a significant reduction in bleeding events in patients taking abelacimab versus a standard of care direct-oral anticoagulant in patients with atrial fibrillation (AZALEA1,2). Three Phase 3 clinical trials are ongoing for patients at risk of arterial and venous clots, one in patients with atrial fibrillation (LILAC-TIMI 763) and two in cancer associated thrombosis (ASTER4) and (MAGNOLIA5). “We are excited to join forces to advance the development of abelacimab, a potential first-in-class treatment and safer approach for stroke prevention in atrial fibrillation as well as cancer-associated thrombosis,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Welcoming Anthos Therapeutics strengthens our focus in the cardiovascular space and complements our portfolio of life-changing treatments, comprehensive clinical programs, and strategic collaborations that help thousands of patients with heart disease around the world.” In July 2022 abelacimab received a Fast Track Designation from the FDA for the treatment of thrombosis associated with cancer. In September 2022 abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. “Abelacimab is a potential first-in-class medicine, which promises to be an effective and safer approach to preventing thrombosis and stroke than the current standards of care.” said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program. Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” Transaction DetailsUnder the terms of the agreement, Novartis will make an upfront payment of USD 925 million upon closing of the transaction, subject to certain customary adjustments, and potential additional payments of up to USD 2.15 billion upon achievement of specified regulatory and sales milestones. The transaction is expected to close in the first half of 2025, subject to satisfaction of customary closing conditions. About AbelacimabAbelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to Factor XI to block its activation and prevent the generation of the activated form (Factor XIa). This mimics natural Factor XI deficiency, which is associated with protection from thromboembolic disease. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for abelacimab, the acquisition of Anthos Therapeutics, Inc., or regarding potential future revenues from abelacimab. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that abelacimab will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all, nor can there be any guarantee that abelacimab will be commercially successful in the future. In particular, our expectations regarding abelacimab or the transaction described in this press release could be affected by, among other things, the satisfaction of customary closing conditions including regulatory approvals, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References1. Samer Al Said, et al. Bleeding with the FXI Inhibitor Abelacimab compared with Rivaroxaban in Patients on Antiplatelet therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Available from: https://timi.org/wp-content/uploads/2024/11/Samer-Al-Said-Bleeding-with-the-FXI-Inhibitor-Abelacimab-compared-with-Rivaroxaban-in-Patients-on-Antiplatelet-therapy-A-Prespecified-Analysis-of-the-AZALEA-TIMI-71-Trial-.pdf. Accessed February 2024. 2. Ruff C, Patel S, et al. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025; 392 (4):361-371.doi:10.1056/NEJMoa2406674 3. ClinicalTrials.gov. NCT05712200. Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) (LILAC-TIMI 76). Available from: https://clinicaltrials.gov/study/NCT05712200?term=NCT05712200&rank=1. Accessed February 2024.4. ClinicalTrials.gov. NCT05171049. A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE. Available from: https://clinicaltrials.gov/study/NCT05171049. Accessed February 2024.5. ClinicalTrials.gov. NCT05171075. A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/ Genitourinary Cancer and Associated VTE (MAGNOLIA). Available from: https://clinicaltrials.gov/study/NCT05171075. Accessed February 2024. # # # Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

Artivion Announces Release Date and Teleconference Call Details for Fourth Quarter and Full Year 2024 Financial Results

ATLANTA, Feb. 10, 2025 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, announced today that fourth quarter and full year 2024 financial results will be released on Monday, February 24, 2025 after the market closes. On…

$5 Million Gift from Lorraine and Bill Dodero Creates One-of-a-Kind Limb Preservation Center at University Hospitals Harrington Heart & Vascular Institute

$5 Million Gift from Lorraine and Bill Dodero Creates One-of-a-Kind Limb Preservation Center at University Hospitals Harrington Heart & Vascular Institute   CLEVELAND – A generous gift of $5 million from Lorraine and Bill Dodero will establish the Lorraine and Bill Dodero Limb Preservation Center at University Hospitals Harrington Heart […]

Orchestra BioMed Announces Appointment of Former Medtronic SVP of Corporate Development Christopher Cleary to Board of Directors

Medical device industry veteran brings over three decades of expertise in M&A, as well as structured research and development (“R&D”) collaborations aligned with Orchestra BioMed’s partnership-enabled business model Mr. Cleary previously served as Senior Vice President (“SVP”) of Corporate Development at Medtronic plc (NYSE: MDT) (“Medtronic”), where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for atrioventricular interval modulation (“AVIM”) therapy in hypertension with increased cardiovascular riskEric A. Rose, M.D. to transition from Board Member to Board Member Emeritus and Strategic Advisor, continuing to provide invaluable expertise and guidance to Orchestra BioMed NEW HOPE, Pa., Feb. 05, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of Christopher Cleary to its Board of Directors as an independent member, effective as of January 30, 2025. Mr. Cleary brings over three decades of experience in corporate development, mergers, acquisitions, strategic investments and structured R&D collaborations, having significantly impacted the medical technology industry through his strategic leadership and visionary approach. “We’re thrilled to welcome Chris as an independent member of the Orchestra BioMed Board of Directors, a role in which we expect he will provide invaluable guidance to help us more effectively execute our novel, partnership-enabled business model,” said David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “We got to know Chris well over the last several years as he played a key role in shaping our strategic collaboration with Medtronic. With his extensive experience in global strategy, dealmaking, investing, and partnering, Chris brings knowledge and experience that is directly relevant to our strategy, technologies, and pathways to success. He shares our vision that risk-reward sharing partnerships can be a powerful tool for advancing high-impact medical device innovations like AVIM therapy and Virtue SAB and we are excited to work closely with him on our Board.” Mr. Cleary commented, “I am excited to join the Orchestra BioMed Board of Directors and contribute to the Company’s bold mission of accelerating medical device innovation in cardiovascular disease through strategic partnerships. I believe their pioneering approach addresses key challenges limiting leading corporations’ abilities to deploy financial and operational resources to directly drive the development of promising high-impact device-based therapies. Orchestra BioMed’s collaboration with Medtronic for AVIM therapy, which I had the opportunity to help shape, is a great example of this business at work. I look forward to working with the experienced Board of Directors and entire Orchestra BioMed team to continue driving groundbreaking advancements in cardiovascular medicine like AVIM therapy, Virtue SAB and beyond.” During his time as SVP of Corporate Development at Medtronic, Mr. Cleary facilitated over 35 acquisitions and multiple structured and venture investments and orchestrated the $6 billion sale of Covidien Group S.à.r.l ‘s medical supply assets to Cardinal Health Inc. His strategic acumen and negotiation skills helped drive Medtronic’s growth and market expansion. Before joining Medtronic, Chris was the CEO of Alesia Capital Services, a management consulting firm for Fortune 500 companies, including Medtronic, Goldman Sachs, Ally, Macquarie Capital and Terex. He also led M&A teams within several businesses at GE Capital, closing acquisitions totaling more than $60 billion across 200+ transactions in the US, Canada, Europe, Asia and Latin America. Mr. Cleary also currently serves on the Board of Enterra Medical, Inc., and Pristine Surgical LLC. Mr. Cleary earned his B.A. in Biology from Colorado College. After seven years of dedicated service on Orchestra BioMed’s Board of Directors, Eric A. Rose, M.D. will transition to Board Member Emeritus and Strategic Advisor to Orchestra BioMed. This new role will allow Dr. Rose to continue contributing his wealth of industry expertise, supporting key initiatives and long-term objectives. His leadership has been instrumental in helping shape the Company’s growth and will remain a valuable asset in this advisory capacity. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, 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 Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized, pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker. 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 potential efficacy, safety and commercial value of the Company’s commercial product candidates, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs and strategic partnerships. 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 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, 2023, which was filed with the U.S. Securities and Exchange Commission on March 27, 2024, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. 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 ContactSilas NewcombOrchestra BioMed (908) 723-4489 Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMed(484) 682-4892Kkirkellis@orchestrabiomed.com