Author: Ken Dropiewski

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

Coronary/Structural Heart by Comments are Disabled

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

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

Financial by Comments are Disabled

– 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

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VitalConnect, Inc. Secures $100 Million in Financing

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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 […]

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BIOTRONIK and Egg Medical Form Strategic Alliance to Improve Radiation Protection for Interventional Healthcare Workers

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BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, today announced it is partnering with Egg Medical, Inc., a global leader in radiation protection technology, to co-sell Egg Medical’s EggNest™ Radiation Protection Systems for healthcare workers in the United States. The EggNest Systems (EggNest XR, EggNest Protect & EggNest Complete) are […]

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CathVision Receives CE Mark for ECGenius System, Advancing Cardiac Monitoring and Analytics Technology in Europe

Coronary/Structural Heart by Comments are Disabled

COPENHAGEN, Denmark, Feb. 19, 2025 /PRNewswire/ — CathVision, a medical technology company developing advanced electrophysiology solutions, is proud to announce that it has received CE Mark for its breakthrough product, ECGenius System. This regulatory milestone allows CathVision to…

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OrphAI Therapeutics Announces Appointment of Dr. Aaron Waxman to Board of Directors

Financial by Comments are Disabled

Leading clinician and researcher in Pulmonary Disease TherapeuticsNEW HAVEN, Conn., Feb. 19, 2025 (GLOBE NEWSWIRE) — OrphAI Therapeutics Inc. (“OrphAI”), a clinical-stage biopharmaceutical company developing novel therapeutics for diseases with unmet needs, announced today the appointment of Aaron B. Waxman, M.D., Ph.D. to its Board of Directors. Waxman is a distinguished clinician and researcher specializing in pulmonary disease, with a particular focus on pulmonary hypertension (PH). He has authored over 150 peer-reviewed publications, including more than 70 in the field of PH. Dr. Waxman has served as a principal investigator for numerous clinical trials evaluating investigational treatments for PH, including Sotatercept and Treprostinil. His research contributions span key areas including inflammatory mediators driving vascular remodeling, early disease phenotyping, and the application of invasive cardiopulmonary exercise testing for diagnosis and disease monitoring. In addition to his research, Dr. Waxman is the Executive Director of the Center for Pulmonary Heart Disease, and the Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital and an Associate Professor of Medicine at Harvard Medical School. He has a dual appointment at Mass General Brigham in Cardiovascular Medicine and Pulmonary and Critical Care. His work has significantly advanced understanding of the pathophysiology of pulmonary vascular diseases and has led to innovative approaches in both clinical care and therapeutic development. Dr. Aaron Waxman holds a Ph.D. in Anatomy and Neuroscience from Albany Medical College and an M.D. from Yale University School of Medicine. He completed his residency in internal medicine at Yale New Haven Hospital, followed by two fellowships: one at the Howard Hughes Medical Institute and another in pulmonary and critical care medicine at Yale University school of Medicine and Yale New Haven Hospital. Dr. Waxman is board certified in internal medicine, pulmonary disease, and critical care medicine. “Dr. Aaron Waxman provides a wealth of expertise and leadership in the study and development of new and approved agents in the pulmonary vascular disease armamentarium. His guidance and insights will be invaluable as we progress LAM-001 in pulmonary hypertension and other indications. After working with Aaron on our clinical trial of LAM-001 in pulmonary hypertension, it is an honor to now have him join our Board of Directors,” said Dr. Brigette Roberts, CEO and Director of OrphAI. “I am delighted to join the OrphAI Therapeutics’ Board of Directors,” said Dr. Waxman. “I look forward to working with their team to develop new, innovative therapies for pulmonary vascular diseases.” ”We are excited to welcome Dr. Aaron Waxman to our Board of Directors,” said David Scheer, Chairman of the Board of Directors at OrphAI. “His clinical leadership will be an important contribution to the company as we advance our programs through clinical development towards commercialization.” About OrphAI Therapeutics OrphAI Therapeutics’ mission is to transform the lives of patients in need of safe and effective disease modifying therapeutics. The company is currently developing two investigational therapies across multiple indications: LAM-001, a proprietary inhaled form of rapamycin, currently in Phase 2 for Groups 1 and 3 pulmonary hypertension and bronchiolitis obliterans syndrome (BOS); and AIT-102, a proprietary analogue of mithramycin, in preclinical development, for the treatment of transcriptionally dysregulated tumors. To learn more, please visit: OrphAI-Therapeutics.com CONTACT: MEDIA CONTACT:
info@orphai-therapeutics.com

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Stryker completes acquisition of Inari Medical, Inc., providing entry into the high-growth peripheral vascular segment

Peripheral/Endo by Comments are Disabled

Portage, Michigan, Feb. 19, 2025 (GLOBE NEWSWIRE) — Stryker (NYSE: SYK), a global leader in medical technologies, announced today that it has completed the acquisition of Inari Medical, Inc. (NASDAQ: NARI), a company that provides innovative solutions for venous thromboembolism (VTE) clot removal without the use of thrombolytic drugs. The addition of Inari brings an established peripheral vascular position to Stryker in the fast-growing VTE segment.

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Milestone® Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil

Coronary/Structural Heart by Comments are Disabled

Extends US patent protection until 2042MONTREAL and CHARLOTTE, N.C., Feb. 19, 2025 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). The patent, once issued on U.S. Patent Application No.: 17/865,697, covers the repeat dose regimen used in the RAPID Phase 3 study that evaluated CARDAMYST in PSVT and proposed for the package insert as part of the CARDAMYST New Drug Application (NDA) currently under review by the U.S. Food and Drug Administration (FDA). The issuance of the Notice of Allowance potentially extends our intellectual property protection for CARDAMYST in the United States until July 2042, which is an additional 6 years of potential protection for our intellectual property portfolio. “This added protection will position us to optimize the commercial value of CARDAMYST,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “The new patent underscores Milestone’s continued development of our patent portfolio and our commitment to innovation in cardiology.” The repeat dose regimen, proposed in the NDA for CARDAMYST, directs the patient to administer a second 70 mg dose of CARDAMYST should the patient continue to experience symptoms from their PSVT episode ten minutes after their initial dose. Milestone’s NDA for CARDAMYST is currently under review at the FDA with a Prescription Drug User Fee Act (PDUFA) target date of March 27, 2025. The Company continues to advance commercial preparations to support the anticipated launch in mid-2025. The CARDAMYST brand name is conditionally approved by the FDA. About EtripamilEtripamil 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 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 PharmaceuticalsMilestone 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 potential extension of protection under our intellectual property portfolio; the potential of etripamil to provide health care providers with a new treatment option to enable on-demand care and patient self-management and 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.comKevin Gardner, kgardner@lifesciadvisors.com

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