Marlton, NJ, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Impulse Dynamics®, 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.

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.

This news comes on the heels of the recent Centers for Medicare and Medicaid Services (CMS) announcement issuing a National Coverage Determination (NCD) for CCM® therapy, expanding access to the therapy for more than 66 million individuals(1).  CCM® 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® therapy is no longer experimental or investigational.  (Link)

“This support recognizes the evidence-based outcomes of CCM® therapy, with over 12,000 patients implanted to date, and opens the pathway to greater care for HF patients.” said Jason Spees, CEO, Impulse Dynamics®. “As 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® therapy to more HF patients in need.  Furthermore, it will accelerate the ongoing development and future commercialization of the CCM-D® HF System, a single device designed to deliver CCM® therapy for the treatment of HF symptoms along with life-saving, implantable cardioverter defibrillator (ICD) therapy.” 

“Impulse Dynamics is uniquely positioned to fill a critical gap in HF care: providing symptom relief for patients who have limited treatment options beyond medications,” 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® HF System.'

The funding will fuel commercialization efforts, facilitate the progress of future product pipelines, and support groundbreaking clinical trials, such as the INTEGRA-D and AIM HIGHer trials. The INTEGRA-D trial is a multicenter study evaluating the CCM-D® 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).  However, most of these patients are struggling with HF symptoms, since traditional ICD therapy does not treat HF symptoms.  The investigational CCM-D® HF System represents a potential advancement, offering patients an option that may relieve HF symptoms while also providing the life-saving therapy of an ICD. The AIM HIGHer trial is evaluating CCM® therapy in patients with Diastolic HF.  These patients represent approximately half of all HF patients, and there are currently minimal treatment options.   CCM therapy is already indicated for these patients in Europe.

About the Optimizer® System and CCM® Therapy 

The Optimizer® system delivers CCM® therapy — the company’s proprietary technology — to the heart, providing clinically meaningful improvement to quality of life for appropriate HF patients. CCM® therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body^[4]. CCM® 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® has completed numerous clinical studies, including several randomized controlled trials, the results of which appeared in more than 100 publications in leading medical journals.

About Impulse Dynamics®

Impulse Dynamics® is dedicated to advancing the treatment of HF for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM® therapy, which uses the Optimizer® technology platform, to improve quality of life in HF patients. CCM® therapy is delivered through the Optimizer® 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.

   

https://www.medicare.gov/about-usRobert G. Hauser, The Growing Mismatch Between Patient Longevity and the Service Life of Implantable Cardioverter-Defibrillators, Journal of the American College of Cardiology, Volume 45, Issue 12, 2005,Khanra D, Manivannan S, Mukherjee A, et al. Incidence and Predictors of Implantable Cardioverter-defibrillator Therapies After Generator Replacement-A Pooled Analysis of 31,640 Patients’ Data. J Innov Card Rhythm Manag. 2022 Dec 15;13(12):5278-5293.European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202

Rohan More, VP of Global Marketing Impulse Dynamics 856-642-9933 rmore@impulsedynamics.com