Impulse Dynamics, a medical device company focused on therapies for heart failure, said it has raised more than $158 million in financing to expand commercialization and support development across its clinical and technology pipelines.
The Marlton, New Jersey-based company said the round was anchored by new institutional investors Sands Capital and Braidwell, and backed by returning investors Redmile, Perceptive, and Alger, along with several industry executives. Impulse Dynamics plans to use the capital to broaden access to its cardiac contractility modulation therapy, accelerate product development, and advance future commercialization efforts.
The funding comes shortly after the Centers for Medicare and Medicaid Services issued a National Coverage Determination for the company’s CCM therapy, a move that Impulse Dynamics said expands access to more than 66 million individuals. The company also noted that CCM therapy for heart failure patients was selected for the Transitional Coverage for Emerging Technologies pathway in 2025, a designation it described as an essential step in establishing the treatment as no longer experimental or investigational for coverage purposes.
Impulse Dynamics said the investment will also speed development of the investigational CCM-D HF System, a single device intended to deliver CCM therapy for heart failure symptoms alongside implantable cardioverter defibrillator therapy. The company is advancing clinical programs, including the INTEGRA-D trial, a multicenter study evaluating the CCM-D HF System, and the AIM HIGHer trial, which is evaluating CCM therapy in patients with diastolic heart failure, a population the company said represents approximately half of all heart failure patients and has limited treatment options. Impulse Dynamics added that CCM therapy is already indicated for these patients in Europe.
The company markets the Optimizer system, which delivers CCM therapy to the heart. Impulse Dynamics said CCM therapy is designed to improve heart contraction and is indicated to enhance six-minute walk, quality of life, and functional status in certain NYHA Class III heart failure 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. The company said more than 12,000 patients have been implanted to date and that it has completed numerous clinical studies, including randomized controlled trials, with results published across leading medical journals.
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“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. 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.”
Jason Spees, CEO, Impulse Dynamics
“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. 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.”
Guido Neels, Chairman of the Board of Directors, Impulse Dynamics plc
