Author: Ken Dropiewski

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

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

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 […]

Biotricity Announces Cashflow Breakeven with Biggest Quarter in History and a Revenue Increase of 11%

REDWOOD CITY, Calif., Feb. 17, 2025 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY) (“Biotricity” or the “Company”), a Technology-as-a-Service (TaaS) company operating in the remote cardiac monitor sector of consumer healthcare, today provided guidance on its financial results for the third quarter of fiscal 2025 year and (unaudited) ended December 31, 2024.

Avertix’s Guardian System Confirmed as Cost-Effective for High-Risk Acute Coronary Syndrome Patients

EATONTOWN, N.J., Feb. 14, 2025 /PRNewswire/ — Avertix Medical, Inc. (“Avertix” or the “Company”), the developer of The Guardian® system – the world’s first real-time, continuous heart attack detection and patient alerting system today announced compelling new data confirming the…

Volta Medical Artificial Intelligence-guided Cardiac Ablation Procedure Improves Treatment of Atrial Fibrillation

AI-Guided Cardiac Ablation in combination with pulmonary vein isolation was superior to the standard of care in the treatment of Persistent Atrial FibrillationVolta Medical Announces Publication of Landmark Clinical Trial in Nature Medicine. This trial marks the first large-scale demonstration of the benefits of AI in interventional cardiology. MARSEILLE, France, Feb. 14, 2025 (GLOBE NEWSWIRE) — Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced the publication of the landmark TAILORED-AF clinical trial in Nature Medicine, which demonstrated that an AI-guided procedure for persistent atrial fibrillation (AF) in combination with conventional pulmonary vein isolation (PVI) treatment, resulted in better outcomes than PVI alone. In particular, the study showed superiority in the percentage of patients that achieved freedom from atrial fibrillation (AF) with or without anti-arrhythmic drugs at 12 months after a tailored cardiac ablation guided by AI in combination with PVI when compared to PVI alone. Despite advances in catheter ablation technology, persistent AF remains one of the most challenging subtypes of atrial fibrillation to treat, affecting over 70% of all patients with atrial fibrillation globally.i The TAILORED-AF clinical trial is the first large-scale transatlantic randomized controlled trial (RCT) of ablation in a persistent atrial fibrillation (AF) population to show the benefit of going beyond conventional pulmonary vein isolation (PVI)-only extra-pulmonary vein procedure. Previous studies looking at ablation strategies for persistent AF patients have not demonstrated superior efficacy to PVI alone. The Volta AF-Xplorer™ is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs, this technology was used in the TAILORED-AF trial. “Previously, there has not been a replicable, effective treatment strategy for patients with persistent atrial fibrillation. Volta’s AI solution finally offers a solution for this large and underserved patient population,” said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. “The TAILORED-AF trial, highlights AI’s ability to help physicians treat cardiovascular disease and improve patient outcomes. In fact, this is the first large-scale international RCT in interventional cardiology demonstrating superior efficacy through the use of AI.” Summary and Results: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (TAILORED-AF) Study In the clinical trial, adults with symptomatic persistent or long-standing persistent AF who were candidates for a first-time ablation were enrolled in Europe and the United States. A total of 187 patients underwent a tailored cardiac ablation guided by Volta’s AI in addition to PVI (Tailored cohort), and 183 patients received the conventional treatment of PVI-only (Anatomical cohort) and all were followed up for 12 months. A total of 51 electrophysiologists at 26 centers in 5 countries across the US and the EU participated. For access to the full publication visit https://www.nature.com/articles/s41591-025-03517-w. The trial met the primary endpoint by demonstrating superior results in patients assigned to the Tailored cohort compared to the Anatomical cohort. 88% of patients in the Tailored cohort experienced freedom from AF 12 months after one procedure with or without anti-arrhythmic drugs compared to 70% in the Anatomical cohort (log rank p < 0.0001).In the Tailored cohort, patients experienced a higher rate of freedom from any arrhythmia after 1.2 procedures than in the Anatomical cohort (79% vs. 71%, log rank p < 0.01). Recurrences in the Tailored cohort were regarded as a “simplification” of AF which are generally easier to ablate and can be seen as a step towards stable sinus rhythm.The trial also examined several pre-specified secondary endpoints and a pre-specified subgroup analysis of patients with sustained persistent AF lasting 6 months or longer prior to enrollment. These patients represent a more advanced AF disease progression. Patients in the Tailored cohort experienced a significantly higher rate of freedom from any arrhythmia after one single procedure than in the Anatomical cohort (62% vs. 48%, log rank p = 0.04).The safety endpoint did not differ between the groups, although the procedure and ablation time were twice as long in the Tailored arm, consistent with treatment time for other PVI+ methods. “Atrial fibrillation, when left untreated, doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke. However, advancements in AI are transforming this landscape,” said Seth Goldbarg, MD, FACC, FHRS, Cardiologist, NewYork-Presbyterian, Queens. “This trial featuring AI-guided assessment of AF represents a true milestone for improvement of outcomes for this underserved and difficult to treat patient community.” About Atrial Fibrillation The American Heart Association defines AF as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure, and other heart-related complications.ii Approximately 33 million patients worldwide are living with AF.iii,iv Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition. It is estimated that only 15% of the eligible 2.5 million US patients with AF are currently being treated with catheter ablation.v About Volta Medical Volta Medical is a health technology company developing artificial intelligence software solutions with the aim of assisting cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, France, the company’s mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The Volta AF-Xplorer™ is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs during AF and atrial tachycardia procedures. The AF-Xplorer™ has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities. The solution is U.S. FDA 510(k) cleared and European CE Mark approved. For more information, visit the company’s website at www.volta-medical.com. Volta Medical has created a therapy awareness program AI for Persistent AF Care designed to educate the underserved AF patient community, for more information, visit www.aiforafib.com. U.S. Media ContactGlenn SilverFinn Partnersglenn.silver@finnpartners.comVolta ContactJeff Martin, SVP of Global MarketingVolta Medical jeffrey.martin@volta-medical.com References David DeLurgio, Jaswinder Gill, Syed Ahsan, Riyaz Kaba, Kristen M Plasseraud, Michael E Halkos, Hybrid Convergent Procedure for the Treatment of Persistent and Long-standing Persistent Atrial Fibrillation, Arrhythmia & Electrophysiology Review 2021;10(3):198–204. https://doi.org/10.15420/aer.2021.24https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/j.amjcard.2013.05.063https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]https://www.mddionline.com/cardiovascular/medtronic-makes-a-double-play-for-atrial-fibrillation

RenovoRx Highlights Promising Pre-Clinical Data Abstract: TAMP™ Therapy Platform Offers Potential to Improve Localized and Targeted Drug Delivery

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 device, highlighted its recent abstract presentation at the 2025 Society of Interventional Oncology Annual Conference (“SIO 2025”) in Las Vegas, Nevada. The abstract published promising […]