Cardiac Complexes, Premature

CARDIFF-BY-THE-SEA, Calif., April 22, 2025 /PRNewswire/ -- Field Medical Inc., a pioneer in cardiac pulsed field ablation (PFA) technology, today announced the successful closing of $40 million in Series A financing. The round includes $20 million in new capital and the conversion of $20 million in seed-round debt. Participants include several leading strategics, venture capital firms and family offices, with multiple seed investors reinvesting – underscoring strong confidence in the company's initial focus on ventricular tachycardia (VT) and the broader versatility of its technology. The funding will support the completion of two pilot studies – VCAS for VT and Field PULSE for atrial fibrillation (AF) – as well as continued development of Field's commercial PFA system and operational scale-up in preparation for VERITAS, the company's pivotal trial focused on VT. "This financing is a pivotal milestone as we advance in redefining how electrophysiologists approach ablation therapy," said Steven Mickelsen, M.D., founder and chief executive officer of Field Medical. "With the support of our investors, we are accelerating the development of the FieldForce™ Ablation System, building on early clinical evidence, and moving closer to our commercial goal of expanding access to next-generation PFA solutions for cardiac ablation." "We are encouraged by the strong support and confidence from both new investors and our reinvesting seed-round investor base," said Oskar Dadason, chief financial officer. "This funding enables us to execute our strategic plan with speed and focus as we transition from early-stage innovation into commercial readiness." Field Medical is developing transformative technology for the treatment of all cardiac arrhythmias, including VT and AF. The FieldForce Ablation System, featuring the first built-for-purpose, contact force focal PFA catheter, enables an instantaneous ablation workflow, with therapy delivered in a fraction of a second. Recent results from the VCAS (VT) and PULSE (AF) pilot studies demonstrate the system's versatility. Powered by FieldBending™, the company's proprietary technology that delivers brief, high-intensity electric fields, the System is positioned as the single, advanced solution for treating a full spectrum of cardiac arrhythmias. About Field Medical® Inc. Founded in 2022, Field Medical is advancing next-generation pulsed field ablation (PFA) technologies to address the complex needs of modern cardiac ablation. The company is led by Dr. Steven Mickelsen, a pioneer in pulsed electric field technology and a leading innovator in the field. His foundational work in PFA established the basis for modern advancements in the technology, which Field Medical continues to refine with its groundbreaking solutions. In 2024, Field Medical's technology was recognized by the FDA with Breakthrough Device Designation and inclusion in the TAP Pilot Program. For more information, visit and follow us on LinkedIn and X . The FieldForce™ Ablation System is an investigational device and is limited by federal (or United States) law to investigational use. The Growing Prevalence of VT and AF Ventricular tachycardia (VT) and atrial fibrillation (AF) are two of the most common and serious arrhythmias, contributing to stroke, heart failure, sudden cardiac death and escalating health care costs. VT and premature ventricular contractions (PVCs) affect more than 6 million people in the United States and Europe, while AF impacts an estimated 2% to 6% of the global population. The AF catheter ablation market is currently valued at $5 billion and is projected to grow at a compound annual growth rate of 13% to 16%, surpassing $11 billion by 2034. In comparison, the global VT market— which includes devices and catheter ablation—was valued at approximately $12.5 billion in 2021 and is expected to grow at a compound annual growth rate of 5.26%, reaching $17 billion by 2027. Notably, the catheter ablation segment within the VT treatment market is projected to grow at a higher rate of 13% annually during this period, reflecting increased adoption of catheter-based interventions for VT management. Media Contact Holly Windler 619.929.1275 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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First and only contact force pulsed field ablation (PFA) system designed to transform treatment for millions with life-threatening ventricular arrhythmias.Preliminary data of VCAS study will be presented at HRS 2024 in Boston, Mass.CARDIFF-BY-THE-SEA, Calif., May 9, 2024 /PRNewswire/ -- Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic. The Ventricular Catheter Ablation Study, VCAS, will enroll up to 60 patients at up to 5 sites world-wide. The VCAS investigational study is a critical step towards demonstrating safety and performance of the FieldForce™ Ablation System, developed specifically to address the limitations of existing pulsed field ablation (PFA) and radiofrequency (RF) ablation systems, including a more time efficient treatment protocol for the treatment of ventricular arrhythmias. Preliminary results will be presented on May 16, 2024, at the Heart Rhythm Scientific Sessions in Boston, Mass. Continue Reading Field Medical’s FieldForce™ Catheter tip (A). The FieldBending™ technology utilizes an innovative internalized electrode within a fluid lumen seen in the cutaway (B). Voltage is delivered between the external and internal electrodes resulting in desirable electric field characteristics. The FieldForce™ Catheter is the first and only contact force PFA catheter optimized for the ventricles. "The FieldForce Ablation System, as the first contact force PFA system for ventricular ablation, is demonstrating significant promise early in our trials," said Vivek Reddy, MD, Director of Electrophysiology for the Mount Sinai Health System. "This is my first experience with a technology capable of achieving rapid complete transmural left ventricular (LV) ablation, offering highly targeted treatment options and an efficient workflow. Although these results are quite preliminary, the potential of this system to revolutionize catheter ablation of complex ventricular arrhythmias is profound, potentially surpassing the current standard of care. The scientific community will benefit from the comprehensive results from the completed study." PFA Adoption and Transition from Atrial to Ventricular Arrhythmias PFA has revolutionized the treatment of atrial fibrillation (AF) over the past decade, thanks to pioneering work by Field Medical CEO Steven Mickelsen, MD, founder of Farapulse which was subsequently acquired by Boston Scientific. His development of PFA technology marked a significant shift in cardiac electrophysiology, enhancing safety and reducing procedure times. This innovation set a new standard in the industry, leading to widespread adoption and the transformation of ablation practices. With PFA's proven success in atrial settings, Field Medical is now poised to extend these benefits to ventricular arrhythmias, signaling a pivotal evolution in the management of complex ventricular cardiac conditions. Ventricular Arrhythmia Burden It is estimated that ventricular arrhythmia impact over 6 million patients in the US and Europe. Ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular contractions (PVCs), and pose a substantial risk, often leading to sudden cardiac death if not adequately managed. Current ventricular catheter ablation methods involve lengthy procedures and significant risks associated with thermal ablation, like conventional RF ablation. Field Medical's PFA technology aims to address these challenges by providing the first and only contact force PFA catheter optimized to work in the ventricle. This novel technology may enable predictable, time efficient, and safe treatment option. FieldBending™ takes advantage of non-intuitive physics to deliver intense, yet brief, electric fields designed to safely reduce procedure times dramatically."Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes," said Steven Mickelsen MD, CEO of Field Medical. "With the promising early data for our VCAS study, in much the same way that PFA transformed AF, the FieldForce Ablation System is optimized to transform how ventricular arrhythmias are treated, offering hope to millions of patients worldwide. With the strong investor support, renown physician engagement and the groundbreaking potential of our technology, we are set to redefine the standards of cardiac ablation once again." About VCAS Study Field Medical's VCAS Study is a pivotal segment of a prospective safety and feasibility study, assessing the innovative FieldForce Ablation System in patients with ventricular arrhythmias. The VCAS-I group focuses on individuals suffering from ventricular tachycardia (VT), while the VCAS-II group targets those experiencing frequent premature ventricular complexes (PVCs). This study is instrumental in evaluating the performance of Pulsed Field Ablation (PFA), thereby potentially reducing procedural time compared to traditional Radiofrequency (RF) ablation. The trial aims to demonstrate that PFA can safely treat and improve overall outcomes for patients with challenging ventricular arrhythmias. For study information, visit clinicaltrials.gov NCT: NCT06203262. About Field Medical,™ Inc . Founded in 2022, Field Medical is at the forefront of developing second-generation pulsed field ablation (PFA) technologies, designed to meet the technical and safety challenges of modern cardiac ablation procedures. Under the leadership of Dr. Steven Mickelsen, CEO, a globally recognized expert in pulsed electric field technology, the company has pioneered the proprietary FieldBending™ technology. This innovation was developed to concentrate therapeutic effects and reduce unwanted far-field effects, with the potential to improve patient outcomes while simplifying the clinical experience for physicians. Field Medical focuses on expanding the applications of PFA beyond atrial fibrillation (AF) to address complex ventricular arrhythmias—a condition affecting over 6 million people in North America and Europe alone, often leading to sudden cardiac death, heart failure and significant clinical symptoms if not managed effectively. The company's comprehensive product portfolio, including the FieldForce™ Catheter, FieldForce™ Ablation System, and the FieldFlex™ Sheath, is specifically optimized to work in complex ventricular environments. For more information, visit and follow us on LinkedIn and X.The FieldForce™ PFA Ablation System is an investigational device and is limited by Federal (or United States) Law to investigational use. SOURCE Field Medical, Inc.