Author: Ken Dropiewski

Bracco and the European Society of Radiology build on long-standing partnership at ECR 2025 through new campaign to advance innovative and sustainable approaches in radiology

Bracco will present an immersive experience at its booth to educate congress attendees on the importance of corporate commitment to sustainability and how its MR imaging portfolio contributes to the progress of sustainable radiology. Bracco will reinforce its commitment to deepening…

Shape Memory Medical Announces European Enrollment in the AAA-SHAPE Randomized Controlled Pivotal Trial

SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first enrollment in Europe in the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) […]

National Board of Echocardiography and Inteleos Form Cardiovascular Imaging Coalition to Launch Innovative Multimodality Certification Program

ROCKVILLE, Md., Feb. 20, 2025 (GLOBE NEWSWIRE) — The National Board of Echocardiography (NBE) and Inteleos have established the Cardiovascular Imaging Coalition (CVIC) to streamline the maintenance of certification (MOC) process for physicians specializing in multiple cardiac imaging modalities. This groundbreaking initiative addresses the challenges of time and expense physicians face in maintaining multiple certifications across cardiovascular computed tomography (CT), nuclear cardiology (NC), cardiovascular magnetic resonance imaging (CMR), and echocardiography. The CVIC is developing an integrated, case-based MOC process that will provide immediate feedback and learning opportunities to enhance patient care. While this new program is under early development, NBE will continue to offer its annual longitudinal assessment process for Maintenance of Certification in Echocardiography (MOCE), ensuring flexibility for physicians who specialize in single imaging modalities. Additionally, Inteleos will enhance its MOC experience for physicians certified in individual cardiovascular imaging specialties. “We are thrilled to help physicians who use multiple cardiovascular imaging modalities streamline their certification maintenance process,” says NBE President Roberto Lang, MD. Luciana Young, MD, Chair of the Inteleos Board of Directors, adds, “Inteleos is committed to modernizing cardiovascular imaging certification maintenance through the CVIC, implementing meaningful evaluations that reflect the daily practice of multimodality imagers.” The CVIC plans to have an initial MOC for multi-modality cardiovascular imagers assessment in the near future, but will keep the community fully informed on development progress. CVIC will also establish a centralized hub for efficient management of multiple imaging specialty certifications, benefiting both testamurs and certified physicians. About the National Board of Echocardiography Founded in 1996, the NBE is a non-profit organization advancing excellence in clinical echocardiography through certification examinations. The organization has administered over 42,000 exams across its programs, including ASCeXAM®, Advanced PTEeXAM®, Basic PTEeXAM®, and CCEeXAM®, with more than 17,000 physicians worldwide achieving NBE Diplomate status. About Inteleos Inteleos™ is a non-profit organization dedicated to ensuring equitable access to quality healthcare globally. It oversees the American Registry for Diagnostic Medical Sonography® (ARDMS®), the Alliance for Physician Certification & Advancement™ (APCA™), and the Point-of-Care Ultrasound Certification Academy™ (PCA), collectively representing 150,000 certified medical professionals worldwide. The APCA Council’s Cardiovascular Imaging certification examinations include the Certification Board of Cardiac Computed Tomography (CBCCT), the Certification Board of Cardiac Magnetic Resonance (CBCMR), and the Certification Board of Nuclear Cardiology (CBNC). The Inteleos Foundation manages the organization’s philanthropic initiatives. CONTACT: Contact Information:

Lisa Jordan (240) 386-1579

Taryn Reed (240) 386-1627

Customer Care (240) 386-1710

Serenity Medical Announces Clinical Publication of First Prospective Multicenter Trial of the River™ Stent, a Novel Venous Sinus Stent for Treating Idiopathic Intracranial Hypertension (IIH)

Publication in the Journal of NeuroInterventional Surgery Reports Outcomes for Treatment of IIH Patients Who Are Refractory or Intolerant to Medications Publication in the Journal of NeuroInterventional Surgery Reports Outcomes for Treatment of IIH Patients Who Are Refractory or Intolerant to Medications

Autonomix Medical, Inc. Selected for Podium Presentation at the 2025 CRT Annual Meeting

Presentation to highlight Autonomix’s catheter-based technology and key findings from lead-in patients in ongoing human clinical trial in pancreatic cancer pain patients THE WOODLANDS, TX, Feb. 20, 2025 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today announced it will present its technology and lead-in subject findings in a podium presentation at the 2025 Cardiovascular Research Technologies (CRT) Annual Meeting being held March 8-11, 2025 in Washington, DC.The podium presentation will be part of the Innovation HUB session which features companies with innovative products/services that have not yet been fully market-released and with technology status that may include early stage/prototype, pre-clinical, first-in-human and CE Mark. Details of the presentation are as follows: Title: Catheter-Based Transvascular RF Neural Ablation For Severe Pancreatic Cancer Pain: First Results From The Elpis StudyPresenter: Dr. Robert Schwartz, Chief Medical Officer of AutonomixSession Date and Time: Monday, March 10, 2025 from 2:00 PM – 2:40 PM ET CRT is a leading educational forum on new cardiovascular technology and procedures for physicians and health-care professionals. CRT provides a forum for exemplary education for interventional cardiologists, general cardiologists, cardiothoracic and vascular surgeons, catheterization laboratory managers, nurses and technologists, scientists and those with an interest in cardiovascular medicine. The annual CRT meeting features focused educational and training sessions that discuss new trial data, explore evidence-based research and demonstrate the most up-to-date techniques that can be directly applied to clinical and academic practices For more information about the CRT25, please visit the event website here. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024 and the Offering Prospectus filed with the SEC on November 25, 2024, and in other filings made by us from time to time with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLC Jenene Thomas 908.824.0775 autonomix@jtcir.com

BridgeBio Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Commercial Update

– As of February 17, 2025, 1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval – Attruby (acoramidis), the first and only near-complete TTR stabilizer (≥90%) was approved by the FDA to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients on November 22, 2024 – Acoramidis was approved as BEYONTTRA™ in the EU on February 10, 2025, achieving a $75 million milestone payment and ongoing royalties in a tiered structure beginning in the low-thirties percent on sales in the EU – Acoramidis demonstrated a 59% hazard reduction on the composite endpoint of all-cause mortality and first cardiovascular-related hospitalization in the variant ATTR-CM population by month 30; to the Company’s knowledge, this benefit is the largest and the only statistically significant result in this patient population, which has an aggressive phenotype and poor prognosis – Fully enrolled three global registrational studies – FORTIFY (BBP-418 for LGMD2I/R9), CALIBRATE (encaleret for ADH1), and PROPEL 3 (infigratinib for achondroplasia) – with last participant – last visit expected for each study before the end of 2025 – The Company ended the fourth quarter with $681 million in cash, cash equivalents, and short-term restricted cash. Further, the Company expects to receive $105 million in regulatory milestones in 1H 2025 from acoramidis Europe and Japan approvals PALO ALTO, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases announced today its financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on Attruby’s commercial progress. Commercial Progress: As of February 17, 2025, 1,028 unique patient prescriptions for Attruby have been written by 516 unique healthcare providers since FDA approval. ”I am very encouraged by the strength of the Attruby launch, with prescriptions being successfully filled across all patient types,” said Matt Outten, Chief Commercial Officer of BridgeBio. “In conversations with healthcare providers and patients, we have repeatedly heard that Attruby’s category-leading results – time to separation of just three months, along with a 42% reduction in all-cause mortality and recurrent hospitalizations and a 50% reduction in cardiovascular hospitalizations at 30 months – set it apart as a clinically meaningful advancement for ATTR-CM. Combined with our industry-leading patient support programs, we believe Attruby is delivering a much-needed change in the treatment landscape.” Pipeline Overview: ProgramStatusNext expected milestone Acoramidis for ATTR-CMApproved in U.S. and EUJapan approval in 1H 2025BBP-418 for LGMD2I/R9 FORTIFY, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Encaleret for ADH1CALIBRATE, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Infigratinib for achondroplasiaPROPEL 3, Phase 3 study enrollment completed Last Participant – Last Visit in 2H 2025Infigratinib for hypochondroplasiaACCEL, run-in for Phase 2 study ongoingEnrollment completion date to be announcedBBP-812 for Canavan diseaseCANaspire Phase 1/2 study ongoingEnrollment completion date to be announced Key Program Updates: “It is exciting to see patients, physicians, and payers resonate with our message that the greater levels of TTR stabilization that Attruby delivers can be of benefit to the patients we serve and that the TTR protein is clinically important, not toxic.” said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. “We look forward to continuing to partner with the community to ensure that we find all patients that can be helped and ease their path to getting on therapy, when appropriate, as much as possible.” Attruby (acoramidis) – the first approved, near-complete (≥90%) TTR stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (≥90%), to reduce cardiovascular death and cardiovascular-related hospitalization (CVH) in adult patients with ATTR-CM.On February 10, 2025, the European Commission approved BEYONTTRA (acoramidis) for use in adult patients with ATTR-CM in the EU.Preliminary results from the ongoing ATTRibute-CM open-label extension (OLE) study of Attruby in ATTR-CM were simultaneously published in Circulation and presented at the American Heart Association Scientific Sessions, showing that Attruby demonstrated statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at month 36 within the OLE, and 46% (p

VitalConnect, Inc. Secures $100 Million in Financing

SAN JOSE, Calif.–(BUSINESS WIRE)–VitalConnect®, Inc., a leader in biosensor technology, specializing in ambulatory cardiac monitoring, today announced the closing of $100 million in financing through a combination of equity and debt capital. The equity financing was led by new investor Ally Bridge Group, with significant participation from the Company’s existing […]