Author: Ken Dropiewski

Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure

NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) — Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.

Elutia to Debut EluPro™ at HRS 2025 — Experience the Difference Biology Makes

Introduction of EluPro at Heart Rhythm 2025 in San Diego, April 25-27, 2025 SILVER SPRING, Md., April 02, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, is proud to announce the debut of its EluPro™ Antibiotic-Eluting BioEnvelope designed for cardiac implantable electronic devices (CIEDs) and neurostimulators at the Heart Rhythm Society’s annual meeting (HRS 2025). Attendees will have the opportunity to experience firsthand the soft, conforming feel of EluPro and discover how its natural biomatrix supports healing while delivering trusted antibiotics to reduce bacterial colonization. Engineered for both performance and handling, EluPro features a proprietary biomatrix that drapes naturally around CIEDs, avoiding the rough, stiff feel often associated with synthetic alternatives. Combined with a trusted dual-antibiotic combination, EluPro offers physicians a solution designed for both efficacy and ease of use without compromise. “We are thrilled to introduce EluPro at HRS 2025 and give clinicians the opportunity to feel the difference biology makes,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “With its soft, conforming biomatrix and proven antibiotics, EluPro represents a meaningful step forward in CIED antibiotic envelope technology.” Elutia invites physicians and medical professionals to experience EluPro firsthand at booth #2418 at the San Diego Convention Center from April 25-27, 2025. Attendees interested in scheduling a meeting with Elutia during the conference may register through the HRS 2025 meeting portal here or contact ir@elutia.com. Those unable to attend can contact Elutia to speak with a representative and learn more about how EluPro is redefining CIED protection. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the potential for EluPro to represent a meaningful step forward in CIED antibiotic envelope technology. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.

Kestra Medical Technologies, Ltd. to Report Third Quarter Fiscal 2025 Financial Results on April 14

KIRKLAND, Wash., April 02, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced that it will report financial results for the third quarter fiscal 2025 on Monday, April 14. Management will host a corresponding conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. A live and archived webcast of the conference call will be available in the “Events” section of the investor relations website. Participants are encouraged to register on the website at least 10 minutes prior to the start of the conference call. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com

Breakthrough AI Indicator for HFpEF and Cardiotoxicity Added to Exo Iris®

Exo unveils its 10th FDA-cleared AI, delivering instant, on-device Global Longitudinal Strain (GLS) analysis — no cloud, no lag, no guesswork Identify signs of heart failure and cardiotoxicity SANTA CLARA, Calif.–(BUSINESS WIRE)–Exo (pronounced “echo”), the leader in AI-powered, accessible medical imaging, announced its latest FDA 510(k) clearance for Global Longitudinal Strain […]

AngioDynamics Reports Fiscal Year 2025 Third Quarter Financial Results

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, today announced financial results for the third quarter of fiscal year 2025, which ended February […]

Seven New Data Sets Demonstrate Penumbra’s Computer Assisted Vacuum Thrombectomy (CAVT) Technology Is Safe, Fast and Effective, Improves Patient Outcomes, and Delivers Healthcare Resource Benefits

ALAMEDA, Calif., April 2, 2025 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced seven significant computer assisted vacuum thrombectomy (CAVT™) data presentations during the 2025 Society of Interventional Radiology (SIR) Annual Scientific…

Daxor Corporation Announces New Data from Duke University and Highlights Key BVA Insights at American College of Cardiology’s 74th Annual Scientific Session and Expo

BVA and Pressure Session Attracted 400+ Clinicians; Duke University Showcased Valuable New BVA Findings in Dedicated Poster Presentation Oak Ridge, TN, April 02, 2025 (GLOBE NEWSWIRE) — Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, announces excellent visibility of Daxor’s technology at the premier global cardiology conference, the American College of Cardiology (ACC) 74th Annual Scientific Session and Expo held in Chicago from March 29-31st. New data presented from Duke University Medical Center confirmed blood volume analysis (BVA) as a more precise measure of congestion in heart failure patients along with a focus session on the value of BVA compared to less reliable pressure measurement in heart failure care. At a standing-room-only session attended by over 400 participants, titled, “When Pressure ≠ Volume: Understanding Complex Hemodynamic Situations and Pitfalls,” Dr. Marat Fudim of Duke University Health emphasized that pressure-based assessments frequently misrepresent true volume status. The research reinforces that volume management, rather than pressure management, should be the cornerstone of heart failure treatment. “The intense interest in the session highlights how much the awareness of BVA is growing and the need for direct volume measurement is being increasingly recognized in the cardiology community,” said Michael Feldschuh, Daxor’s President and CEO. New research findings were also showcased from the Duke study, “Correlation Between Changes in Total Blood Volume and Measures of Congestion During Heart Failure Hospitalization,” which revealed that the following commonly used proxy markers believed to be useful for volume care did not, in fact, correlate with intravascular volume: Urine outputWeight changeBiomarkers CA-125, NT–proBNP “This research from Duke adds to the substantial body of evidence of the unique value of BVA and reinforces the urgent need for precision in managing congestion in heart failure,” said John L. Jefferies, MD, MBA, MPH, Chief Medical Officer, Daxor Corporation. “Traditional methods often mislead, relying on indirect markers that do not accurately reflect true blood volume status. BVA provides the clarity clinicians need to make informed decisions, optimize treatment, and ultimately improve patient outcomes.” About ACC The American College of Cardiology (ACC) envisions a world where science, knowledge and innovation optimize cardiovascular care and outcomes. We believe in the power of community. With more than 56,000 members worldwide spanning the entire cardiovascular team, we serve as the professional home for clinicians and researchers seeking the latest science, research, and education. United with our members, chapters, and global cardiovascular partners, we are focused on transforming cardiovascular care and improving heart health for all. For more information visit https://www.acc.org/. About Daxor Corporation Daxor Corporation (Nasdaq: DXR), is the global leader in blood volume measurement technology focused on blood volume testing innovation. We developed and market the BVA-100® (Blood Volume Analyzer), the only diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. Over 65,000+ tests have been performed at leading hospital centers across the U.S., enhancing hospital performance metrics in a broad range of surgical and medical conditions, including significantly reducing mortality and readmissions in heart failure and critical care. Daxor has several ongoing trials in the areas of heart failure treatment with support from the NIH and is under contract developing analyzers to improve combat casualty care with the U.S. Department of Defense. Daxor’s mission is to advance healthcare by enabling optimal fluid management with blood volume analysis. Daxor’s vision is optimal blood volume for all. For more information, please visit our website at Daxor.com. Sign up to receive news on Daxor’s innovative technology HERE. Forward-Looking Statements Certain statements in this release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the impact of hiring sales staff and expansion of our distribution channels. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, FDA regulatory actions, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and additional other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Daxor does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact:Bret ShapiroSr. Managing Partner, CORE IR1-516-222-2560brets@coreir.com

Edgewise Therapeutics Announces Positive Top-Line Results from Phase 2 CIRRUS-HCM Four-Week Trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM)

– Phase 2 trial of EDG-7500 demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM – – Four-week treatment with EDG-7500 demonstrated substantial improvements in measures of feel and function, reductions in key cardiac biomarkers and…