First phase of enrollment of single device for CCM® and ICD therapy complete

Marlton, NJ, April 28, 2025 (GLOBE NEWSWIRE) -- Impulse Dynamics® plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it reached an important milestone in the INTEGRA-D™ clinical trial, successfully completing the efficacy phase of the study. Results were presented by Dr. Niraj Varma as a late-breaking clinical trial at the 2025 Heart Rhythm conference in San Diego, CA. The completion of this milestone represents an important step toward bringing to market a single device, the CCM-D® HF System, which combines Impulse Dynamics®' proprietary CCM® therapy for the treatment of HF symptoms with implantable cardioverter defibrillator (ICD) therapy.

 The CCM-D® device successfully converted induced ventricular fibrillation (VF) in patients in the trial, meeting the primary efficacy endpoint – conversion of induced VF to a normal rhythm at the time of device implantation – in 100 percent of patients enrolled consecutively in the INTEGRA-D™ trial.

 “Most of these patients experience severe heart failure symptoms and a reduced quality of life,” said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at NewYork-Presbyterian, Professor of Cardiology at Columbia University Vagelos College of Physicians and Surgeons, Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine, and Co-Principal Investigator for the INTEGRA-D™ trial. “These patients often receive a standard ICD that does not relieve heart failure symptoms. The INTEGRA-D™ trial aims to evaluate a new type of device – CCM-D® HF System – designed to address this treatment gap by offering symptom relief for patients with heart failure.”

 “We are pleased with the progress of our INTEGRA-D™ clinical trial, which continues to deliver on our commitment to advance therapy for HF patients,” said Jason Spees, CEO, Impulse Dynamics®. “In the United States, around 800,000 people have ICDs, with about 150,000 new ICDs implanted each year[1]. The CCM-D® HF System is a significant innovation that will give those patients an option for life-saving technology that also helps restore their quality of life.”

 "These result of defibrillator efficacy testing with CCM-D® opens a potential new pathway to manage HF patients in the future”, said Niraj Varma, M.D., Ph.D., Professor of Medicine and Director of Cardiac Pacing and Tachyarrhythmia at the Cleveland Clinic, and National Principal Investigator of the INTEGRA-D™ clinical trial. "We are looking forward to continuing to study this new therapy and understanding its potential role in cardiac care for HF patients.”

 The INTEGRA-D™ trial is a multicenter, prospective, single-arm study evaluating the safety and efficacy of CCM-D® HF System in 300 patients.  The trial is nearing enrollment completion, and a Premarket Approval (PMA) will be filed with the full safety and efficacy outcomes after completing six-month follow-up.

 About Impulse Dynamics®

Impulse Dynamics® is dedicated to advancing the treatment of heart failure (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, which includes an implantable pulse generator (IPG) implanted in a minimally invasive procedure and approved for commercial use in the United States and countries worldwide. More than 10,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for HF patients with debilitating symptoms who otherwise have few effective options available to them. The company is currently engaged in another significant clinical trial called AIM HIGHer. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM® therapy in patients with symptomatic HF with an ejection fraction (EF) of 40 to 70 percent (inclusive). The trial is currently in its initial enrollment phase. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, X (formerly Twitter), and Facebook.

 About the Optimizer® and CCM® Therapy 

The Optimizer® system delivers CCM® therapy — the company’s proprietary technology — to the heart, providing an important treatment option for the millions of patients suffering from heart failure. CCM® therapy is designed to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body.[2] 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.

  CCM® is the brand name for cardiac contractility modulation — the non-excitatory electrical pulses delivered by the implantable Optimizer® device to improve heart contraction. CCM® therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM® helps the heart contract more forcibly. 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.

  Forward-looking Statements

 This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM® therapy. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; commercial success and market acceptance of CCM® therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer® systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM® therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM® therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.

1. 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.
2. European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202

Contact:

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