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
Other News
Stryker completes acquisition of Inari Medical, Inc., providing entry into the high-growth peripheral vascular segment
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.
Milestone® Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil
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
Berlin Heals Holding AG Successfully Raises Over 7Million CHF Round for Initiating First Studies of New Less Invasive Approaches
ZUG, Switzerland, Feb. 18, 2025 /PRNewswire/ — Berlin Heals Holding AG, a late stage MedTech start up, has developed a breakthrough method and a product for the therapy of heart failure. The product – an electronic device called C-MIC – has already successfully been tested in patients in…
Endovascular Engineering Raises $42 Million in Series B Financing to Advance the Treatment of Pulmonary Embolism
MENLO PARK, Calif., Feb. 18, 2025 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”) has secured $42 million in an oversubscribed Series B financing to advance its next generation clot removal technology platform for venous thromboembolism (VTE). The round was co-led by 415 Capital and…
International Stroke Conference 2025: Remedy Pharmaceuticals Unveils Landmark CIRARA® Data Demonstrating Significant Improvements in Stroke Outcomes
NEW YORK, Feb. 18, 2025 /PRNewswire/ — Remedy Pharmaceuticals, a leader in stroke drug development today announced efficacy data from the Phase 2 GAMES-RP and Phase 3 CHARM studies of CIRARA (intravenous glyburide) for the treatment of Large Hemispheric Infarction (LHI) presented at the…
Kestra Medical Technologies, Ltd. Appoints Al Ford as Chief Commercial Officer
KIRKLAND, Wash., Feb. 18, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies Ltd. (“Kestra”), a wearable medical device and digital healthcare company, announced today that Al Ford is joining the company as Chief Commercial Officer (CCO). Mr. Ford will be responsible for advancing sales strategies and leading the Kestra commercial team. “We are pleased to welcome Al to the team,” said Brian Webster, President and Chief Executive Officer at Kestra. “With significant experience managing strategic sales and commercial operations, he brings valuable knowledge, perspective, and leadership to our organization. Al also has deep experience in the underlying defibrillation technologies that are central to the ASSURE® system. We are confident that he will be an impactful addition as we continue to drive adoption of our lifesaving system.” Mr. Ford brings 20 years of experience in MedTech organizations to his new role at Kestra. Most recently, he served as Chief Commercial Officer at Axonics where he led the development and execution of their commercialization strategy. Prior to that, he was Chief Commercial Officer at Cardiac Science Corporation. “I am honored to join Kestra in a commercial leadership role that aligns seamlessly with my experience,” said Mr. Ford. “The innovative Cardiac Recovery System® portfolio, and its ability to positively impact the lives of a meaningfully underserved patient population, were significant factors in my decision to join Kestra. I look forward to working with the team to execute on our commitment to patients and their prescribers.” 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 diagnostic monitoring and therapeutic technologies that are intuitive, intelligent, and connected. Kestra was founded in 2014 by leaders from the external (AED) and implantable (ICD) defibrillation industries. For more information, visit www.kestramedical.com. INVESTOR CONTACTMarissa Bych or Webb CampbellGilmartin Groupinvestor.relations@kestramedical.com MEDIA CONTACTRhiannon PickusKestra Medical Technologies, Inc.Rhiannon.Pickus@kestramedical.com
Orchestra BioMed Appoints Vivek Reddy, M.D. as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of Bioelectronic Therapies Scientific Advisory Board
The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy for patients who have uncontrolled hypertension and a pacemaker indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai NEW HOPE, Pa., Feb. 18, 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 Vivek Reddy, M.D., as Executive Chairman of the Company’s BACKBEAT Study Steering Committee and Chairman of its Bioelectronic Therapies Scientific Advisory Board. In these roles, Dr. Reddy will provide critical leadership in continuing to execute the BACKBEAT global pivotal study and further develop scientific evidence and clinical value for the Company’s bioelectronic therapies portfolio. Dr. Reddy commented, “I believe strongly in the transformative potential of AVIM therapy to help address uncontrolled hypertension in populations with increased cardiovascular risk such as the pacemaker-indicated patients we are focusing on in the BACKBEAT study. Hypertension is a critical global health challenge affecting hundreds of millions of patients worldwide. For patients with increased cardiovascular risk, the prospect of integrating an always-on, adjustable hypertension treatment that doesn’t rely on patient adherence is truly exciting. I am dedicated to driving the successful completion of the BACKBEAT study and synchronizing efforts among Orchestra BioMed’s clinical advisors to fully realize the potential of AVIM therapy for hypertension populations with increased cardiovascular risk. I’m also excited about exploring other therapeutic applications for which we believe there is potential utility for this novel technology.” “We are thrilled to have Dr. Vivek Reddy assume these key leadership roles to help drive successful completion of the BACKBEAT global pivotal study and maximize the clinical value AVIM therapy can potentially offer to patients with uncontrolled hypertension worldwide,” said David Hochman, Chairman, Chief Executive Officer, and Founder of Orchestra BioMed. “While Dr. Reddy has been a long-standing advisor to this exciting program, his expanded role will allow him to further engage in establishing awareness of AVIM therapy in the clinical community and drive effective communication across our distinguished team of clinical advisors. We believe his leadership will be instrumental in educating the clinical community about the BACKBEAT study and AVIM therapy, ultimately helping us and our colleagues at Medtronic deliver this exciting device-based treatment option to patients worldwide. We also look forward to collaborating closely with Dr. Reddy as we continue research and development of our proprietary bioelectronic therapies for additional indications such as heart failure.” Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai. Dr. Reddy has led groundbreaking work in catheter ablation for atrial fibrillation and ventricular tachycardia, as well as leadless pacing and has been at the forefront of device therapies for stroke prevention, positioning him as one of the most respected experts in electrophysiology. Under his leadership, Mount Sinai has served as the lead investigational site for many pioneering clinical trials, and in 2014 implanted the world’s first leadless pacemaker. Dr. Reddy’s commitment to advancing medical innovation and his track record in clinical study leadership will play a pivotal role in the continued success of Orchestra BioMed’s efforts to revolutionize device-based cardiovascular solutions. About Orchestra BioMedOrchestra 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 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. 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 and safety of the Company’s commercial product candidates, additional indications of the Company’s proprietary bioelectronic therapies, implementation of the Company’s ongoing BACKBEAT global pivotal study, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs, strategic partnerships and plans to expand its product pipeline. 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
Michel Lussier Joins Caristo Diagnostics Board of Directors
Seasoned MedTech, Biotech and Digital Health leader and entrepreneur brings business and operational insights to fast-growing digital diagnostics company OXFORD, England, Feb. 18, 2025 /PRNewswire/ — Caristo Diagnostics, a global leader in cardiovascular disease diagnostics and risk…
CARMAT: Aeson® total artificial heart highlighted as a very promising solution for heart failure patients with pulmonary hypertension in The Journal of Heart and Lung Transplantation
Up to 25% of advanced heart failure patients suffer from pulmonary hypertension Aeson® could potentially become a standard treatment for these thousands of patients, both as a bridge-to-transplant and destination therapy February 17, 2025 01:00 AM Eastern Standard Time PARIS–(BUSINESS WIRE)–Regulatory News: “In our experience with patients suffering from pulmonary […]



