Statement issued by the company (Announcement)<\/p>\n
Impulse Dynamics<\/strong>\u00ae, a global medical device company committed to improving the lives of people with heart failure (HF), announced today that it raised more than $158 million in financing to enhance commercialization and fuel both the clinical and technology pipelines.<\/p>\n This significant investment demonstrates the unwavering trust and commitment of investors towards the company’s vision and expansion. The substantial investment was anchored by new institutional investors including Sands Capital and Braidwell and supported by returning investors Redmile, Perceptive, and Alger, and several prominent industry executives.<\/p>\n This news comes on the heels of the recent Centers for Medicare and Medicaid Services (CMS)<\/strong> announcement issuing a National Coverage Determination (NCD) for CCM\u00ae therapy, expanding access to the therapy for more than 66 million individuals(1).\u00a0 CCM\u00ae therapy for HF patients is one of only five therapies selected for the Transitional Coverage for Emerging Technologies (TCET) pathway in 2025. This determination marks a transformative milestone for HF patients and their providers, validating that CCM\u00ae therapy is no longer experimental or investigational.\u00a0 (Link<\/a>)<\/p>\n \u201cThis support recognizes the evidence-based outcomes of CCM\u00ae therapy, with over 12,000 patients implanted to date, and opens the pathway to greater care for HF patients.\u201d said Jason Spees<\/strong>, CEO, Impulse Dynamics\u00ae.\u00a0\u201cAs the NCD removes a significant barrier to access by providing coverage and reimbursement for a substantial patient population, this investment will help expand access to CCM\u00ae therapy to more HF patients in need.\u00a0 Furthermore, it will accelerate the ongoing development and future commercialization of the CCM-D\u00ae HF System, a single device designed to deliver CCM\u00ae therapy for the treatment of HF symptoms along with life-saving, implantable cardioverter defibrillator (ICD) therapy.\u201d<\/p>\n \u201cImpulse Dynamics is uniquely positioned to fill a critical gap in HF care: providing symptom relief for patients who have limited treatment options beyond medications,\u201d said Guido Neels, Chairman of the Board of Directors, Impulse Dynamics plc. “The organization has successfully built a strong foundation of clinical evidence and is advancing a promising pipeline of next-generation technologies, including the investigational CCM-D\u00ae HF System.”<\/p>\n The funding will fuel commercialization efforts, facilitate the progress of future product pipelines, and support groundbreaking clinical trials, such as the INTEGRA-D<\/strong> and AIM HIGHer trials<\/strong>. The INTEGRA-D trial is a multicenter study evaluating the CCM-D\u00ae HF System. In the United States, more than 100,000 new ICDs are implanted each year, contributing to the approximately 800,000 individuals already living with these devices(2,3). \u00a0However, most of these patients are struggling with HF symptoms, since traditional ICD therapy does not treat HF symptoms. \u00a0The investigational CCM-D\u00ae HF System represents a potential advancement, offering patients an option that may relieve\u00a0HF symptoms while also providing the life-saving therapy of an ICD. The AIM HIGHer trial is evaluating CCM\u00ae therapy in patients with Diastolic HF. \u00a0These patients represent approximately half of all HF patients, and there are currently minimal treatment options. \u00a0 CCM therapy is already indicated for these patients in Europe.<\/p>\n The Optimizer\u00ae system delivers CCM\u00ae therapy \u2014 the company\u2019s proprietary technology \u2014 to the heart, providing clinically meaningful improvement to quality of life for appropriate HF patients. CCM\u00ae therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body[4]<\/sup>. CCM\u00ae therapy is indicated to improve six-minute hall walk, quality of life, and functional status of NYHA Class III HF patients who remain symptomatic despite guideline directed medical therapy, are not receiving CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent. Impulse Dynamics\u00ae has completed numerous clinical studies, including several randomized controlled trials, the results of which appeared in more than 100 publications in leading medical journals.<\/p>\n Impulse Dynamics\u00ae is dedicated to advancing the treatment of HF for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM\u00ae therapy, which uses the Optimizer\u00ae technology platform, to improve quality of life in HF patients. CCM\u00ae therapy is delivered through the Optimizer\u00ae system and approved for commercial use in the United States and countries worldwide. More than 12,000 patients have received the therapy as part of clinical trials and real-world use, where it is shown to be safe and effective for HF patients with debilitating symptoms who otherwise have few effective options available to them.<\/p>\nAbout the Optimizer\u00ae System and CCM\u00ae Therapy<\/h2>\n
About Impulse Dynamics\u00ae<\/h2>\n