Impulse Dynamics Surpasses 10,000 Patients Benefiting From CCM® Therapy for Heart Failure

AGÊNCIA DE COMUNICAÇÃO Conteúdo de responsabilidade da empresa 13 de maio de 2024

Impulse Dynamics

Marlton, NJ, May 13, 2024 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today that it has reached a worldwide milestone by surpassing 10,000 patients having received the Optimizer^® system for the treatment of moderate HF. This milestone highlights the benefit and importance of this therapy in helping patients live a full life with HF.

“I noticed positive changes since the procedure, such as not feeling cold or numb, I could walk every day and everywhere, did my regular chores and shopping, and shared activities like swimming with my daughter,” said Tracey, who received her CCM^® device in 2023. “I’m no longer huffing, puffing, or gasping for air,” said Joe, another HF patient who received his CCM device in 2022. “I’m reborn a whole new person no longer incapacitated. My life has changed so much that we’re considering taking a trip. And my wife is ecstatic because I have my life back, and we have ours again.”

“We are deeply motivated by the patients who benefit from CCM therapy. Their progress inspires us to continuously enhance our technology, aiming to improve the lives of those suffering from heart failure,” said David Prutchi, Chief Technology Officer for Impulse Dynamics, who has worked on the development of CCM therapy since its inception.

David had the opportunity to meet one of these patients, Raynita, who was implanted with an Optimizer device this year. Raynita saw immediate improvement after starting CCM therapy and gave the following remarks on the experience: I feel like a different person. I can do things I havent done in years. I am attending my granddaughters college graduation!

CCM is available in 44 countries, and the technology has continued to advance, based on the needs of patients and physicians. The latest generation of the proprietary CCM technology is the Optimizer Smart Mini, which offers a rechargeable battery with 20-year battery life and a smaller size designed to make the implant procedure faster and easier for patients and physicians.

We are committed to ongoing innovation in this important therapy that has such a clear clinical need around the world, said Jason Spees, CEO of Impulse Dynamics. We are also getting closer to significantly impacting the implantable cardioverter defibrillator (ICD) market with successful enrollment in our INTEGRA-D clinical trial on the CCM-D^® HF System, which is the first-of-its-kind technology, combining the lifesaving benefits of an ICD with HF symptom relief through CCM therapy in one device.

The patients statements in this Press Release represent the testimonials of their individual outcomes and may not be typical for all patients.

About the Optimizer and CCM Therapy 

The Optimizer Smart Mini system delivers CCM therapy the companys 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.[1] CCM therapy is indicated to improve 6-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 indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

CCM is the brand name for cardiac contractility modulationthe 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 articles from leading medical journals.

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 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 44 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 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, X (formerly 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. These forward-looking statements are based on managements 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 companys future research and development costs, capital requirements and the companys needs for additional financing; commercial success and market acceptance of CCM therapy; the companys 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 companys ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the companys business model and strategic plans for its products, technologies and business, including its implementation thereof; the companys ability to expand, manage and maintain its direct sales and marketing organization; the companys 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 companys 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 companys views as of any date subsequent to the date of this press release.

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

Attachment

• David and Raynita

Scott Way, Executive Vice President, General Counsel
Impulse Dynamics
856-434-7906
sway@impulsedynamics.com

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

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