Trial Evaluates FDA-Designated Breakthrough Therapy for Patients Who Lack Treatment Options
MARLTON, N.J., March 14, 2022 — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the first patient has been enrolled in the quadruple-blinded sham-controlled AIM HIGHer IDE clinical study (Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction, NCT: 05064709) evaluating CCM® therapy for patients who have left ventricular ejection fraction ranging between 40% and 60% inclusive. The study will be conducted across approximately 150 centers worldwide.
Simos Kedikoglou, MD, CEO of Impulse Dynamics, said, “AIM HIGHer is another example of our continuous investment in CCM therapy for the benefit of HF patients. Impulse Dynamics is undertaking extensive product and clinical development to bring hope to HF patients worldwide and help them lead more comfortable and productive lives.”
“AIM HIGHer is a remarkable study in several respects,” said Ishu Rao, MD, Medical Director for Impulse Dynamics. “Not only is this the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted, but it’s studying a label expansion for a new, large, and quite different patient population. These patients have few effective options for treating their condition, and this study is an important step towards offering a solution to this significant unmet medical need.”
HF affects more than 64 million people worldwide and leads to dramatic declines in the quality of life. Patients are often classified by a measure of cardiac function known as the ejection fraction (EF), which describes the percentage of blood pumped out of the left ventricle with each heartbeat. Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.
Nareg Minaskeian, PhD, MD, a cardiac electrophysiologist with Southwest Cardiovascular Associates in Mesa, AZ who conducted the first AIM HIGHer implant procedure remarked, “We’re already using CCM therapy for HF patients who have reduced ejection fraction with excellent results, and we have a great deal of hope that CCM will also prove to be effective in patients with a higher EF.”
Javed Butler, MD, MPH, MBA, President of Baylor Scott & White Research Institute, SVP of Baylor Scott & White Health System in Dallas, TX, Distinguished Professor of Medicine at the University of Mississippi and Primary Investigator for the AIM HIGHer trial commented, “It is exciting to have this important trial move from planning to execution phase. This is a high-risk group of patients without many good therapeutic options. CCM therapy is a promising approach to treat these patients, and the AIM HIGHer trial will provide much-needed evidence in this area.”
Dr. Oussama Wazni, Section Chief of Electrophysiology at the Cleveland Clinic and Co-Primary Investigator of AIM HIGHer, was similarly enthused: “We are pleased to begin the AIM HIGHer trial and commend Dr. Nareg Minaskeian on implanting the first device as part of the study. This trial will evaluateCCM therapy in heart failure patients with an EF over 40% — a group that currently has few treatment options.”
The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body.[1] This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms.[1] CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
[1] European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202
About the Optimizer® Integra CCM-D™ System and CCM® Therapy
The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. This device is being used in an FDA-approved Investigational Device Exemption (IDE) study and is not available for sale in the United States.
Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.
CCM therapy delivers non-excitatory electrical pulses from the implantable Optimizer device in a manner designed to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during their absolute refractory period. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure 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 heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, Twitter, and Facebook.
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, and CCM therapy combined with an ICD delivered via a single device (CCM-D), and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Integra CCM-D System and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. 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.
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933
www.impulse‐dynamics.com
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Impulse Dynamics
isegal@impulsedynamics.com
856-642-9933
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Impulse Dynamics
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