Experience Continues to Show CCM Therapy Addresses Clinical Need in Treating Heart Failure

MARLTON, N.J., November 16, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, announced the 100th implant in China, signifying the opportunity for its innovative Optimizer^® system delivering CCM^® therapy in markets around the world. Cardiologist Prof. Guo Tao, Executive Director of Internal Medicine, Fuwai Cardiovascular Hospital, Yunnan Province, performed the 100th procedure and emphasized the role of this therapy in providing an option and hope to patients living with the debilitating reality of heart failure.

“It is quite a coincidental milestone for us that the 10th patient implanted in our center also happened to be the 100th patient treated in China. I have paid very close attention to CCM therapy for more than 20 years now, but it wasn’t until recently we could clinically apply this technology. Under close clinical observation, our 10 CCM patients have improved even more than we anticipated. All the CCM patients in our center improved both symptomatically and on various objective indicators, which made both us and our patients very happy. Therefore, it seems from our experience that CCM is performing exactly as described in the foreign research — specifically, by modulating the exchange of calcium ions and thereby enhancing contractility of the myocardium in the acute period, then normalizing the expression of contraction-related proteins, which leads to reverse remodeling of the heart. Based on these results, we are now planning to expand the application of CCM normatively and actively while continuing to closely follow our implanted patients to obtain more clinical evidence of CCM to optimize its application so more Chinese patients can benefit from this latest innovative treatment.”

Prof. Zhang Shu, Chief Physician of Fuwai Hospital of the National Center for Cardiovascular Diseases and the Chinese Academy of Medical Sciences, Honorary Chairman of the Electrocardiology and Pacing Branch of the Chinese Medical Association, Director of the Cardiology Committee of the Chinese Medical Doctor Association, and former President of the Asia-Pacific Heart Rhythm Society further commented “Currently there are almost nine million patients with heart failure in China, and many of them have not been optimally treated. Heart failure has also become the leading cause of death among cardiovascular and other major chronic diseases in China. I believe CCM will bring good news to Chinese patients. These successful initial experiences provide our doctors with good prospects of bringing hope to the patients they care for.”

“We are proud to see the growing acceptance of this technology in markets around the world,” said Mateusz Zelewski, MD, Impulse Dynamics´ VP International. “In reaching this milestone, we have connected with physicians, patients, and their families. We are inspired by the benefits of this therapy to our patients and continue to reinforce our commitment to address the immense need for advanced heart failure options for patients around the world.”

CCM therapy was approved in China late last year, and the first implant in the country was announced on November 1, 2021. The Optimizer system delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle.

To date, CCM therapy has been used to treat heart failure in more than 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer-reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 – 60 percent.

Finding Hope Through Technology

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63 Years Old | Rancher | Pittsburgh, PA

MARLTON, N.J., JUNE 14, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a commercial-stage medical device company focused on delivering our CCMTM therapy to people with heart failure, announced that the first implants in Europe for the newly launched Optimizer® Smart Mini device were recently completed in Italy. The company announced the launch of the new technology on April 29, 2022, and the first U.S. implants on May 10, 2022.

Dr. Stefano Guarracini, Head of Cardiology at the Synergo Casa di Cura Pierangeli Hospital in Pescara, Italy, described his experience with CCM therapy and his outlook for the Optimizer Smart Mini system after the first implant. “Starting in 2019, we had the opportunity to implant Optimizer devices in several patients with heart failure. We believe in the technology and consider CCM therapy to be the only option for many patients suffering from heart failure. We are excited now to be affiliated with the first European institution to have implanted the new Optimizer Smart Mini device and look forward to the simple but more advanced patient management experiences during implants and follow-ups going forward.”

Dr. Giovani Bisignani, with the Ospedale di Castrovillari, who completed his first implant almost simultaneously in the southern Italian province of Cosenza, said, “CCM therapy is a powerful weapon against heart failure. The cutting-edge technology of the new Optimizer Smart Mini along with its smaller, physiological shape allowed us to achieve efficient implantation and initiation of CCM therapy in even less time.”

In March 2022, the company announced that its quality management system received certification under the new European Union Medical Device Regulation. We believe that the launch of the Optimizer Smart Mini system is an example of the importance of a global infrastructure to support ongoing technology innovation and access. The new components of the Optimizer Smart Mini system are equally important across international markets, including a rechargeable battery with a 20-year life and new internal technology with improved programming and potential for remote monitoring in a smaller design to make the implant procedure easier for patients and physicians.

“The pace of this international rollout is a reflection of our commitment to delivering innovation that is relevant to patients worldwide,” said Mateusz Zelewski, MD, Impulse Dynamics’ Vice President International, “It is exciting to see how quickly we can increase access to new and better technology that offers hope for more patients living with heart failure.”

The Optimizer Smart Mini delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle. CCM therapy is currently indicated in Europe to reduce hospitalizations and improve physical exercise tolerance, quality of life, and functional status for a large population of patients with systolic heart failure who remain symptomatic despite guideline-directed medical therapy.

To date, CCM therapy has already been used to treat over 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer-reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 – 60%.

Investigators Report Positive Findings From Feasibility Study of CCM in Heart FailureWith Preserved Ejection Fraction at the European Society of Cardiology Heart Failure 2022 Congress

MADRID and MARLTON, N.J., May 23, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today a late-breaking presentation of results from the CCM-HFpEF Pilot Study, which is the largest clinical trial to date studying the effects of the company’s proprietary CCM^® therapy to treat HF with preserved ejection fraction (HFpEF). The results presented — including a substantial 18 point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score — indicate that for patients with heart failure and left ventricular ejection fraction (LVEF) ≥50%, CCM therapy not only offered meaningful improvement in quality of life but also substantially decreased hospitalizations versus the patient’s experience prior to the Optimizer^® implant. The results were presented at the European Society of Cardiology’s Heart Failure 2022 Congress.

Patients with HFpEF suffer from debilitating symptoms and have very few therapeutic options. This patient population is a similar size as the one with reduced ejection fraction and has been shown to have similar struggles with quality of life, hospitalizations, and mortality.

Cecilia Linde, MD, Professor and Consultant in Cardiology at the Heart and Vascular Theme of Karolinska University Hospital and the Karolinska Institute in Stockholm, Sweden, who was the co-principal investigator for this investigation, said, “The CCM-HFpEF Pilot Study was conducted to explore the hypothesis that CCM therapy might benefit patients with HFpEF. Our hypothesis was based on evidence of greater benefits in CCM HFrEF studies in those with higher LVEF range and from case reports of HFpEF patients. In our CCM-HFpEF-Pilot Study, we found significant benefits from CCM therapy in patients with preserved LVEF, supporting prior findings. I look forward to following the progress of the recently begun pivotal AIM HIGHer trial to continue this journey further.”

Dr. Ishu Rao, Medical Director for Impulse Dynamics, welcomed these results because they confirm the potential for positive results in the company’s recently initiated AIM HIGHer trial. “We are also excited to announce that enrollment is well underway for this landmark IDE-approved, multicenter, randomized, and blinded pivotal trial designed not only to confirm Dr. Linde’s groundbreaking work presented today but to go further yet by providing the first long term morbidity and mortality results for a modern Optimizer CCM device. While Dr. Linde specifically studied patients with EFs ≥50%, in AIM HIGHer, we are examining the efficacy of CCM therapy in 1,500 patients with EFs between 40% and 60%. This represents a large cohort of patients who currently have minimal treatment options and are clamoring for help. If AIM HIGHer’s results are consistent with Dr. Linde’s findings, we may finally begin to close the significant gap in care that exists for millions of patients afflicted with HF and higher EF.”

HF affects more than 64 million people worldwide and leads to dramatic declines in a patient’s 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. CCM therapy is currently indicated in Europe for patients that have an EF below 50% and has been proven to reduce hospitalizations. However, HF patients with higher EF have had few therapeutic options thus far to alleviate their symptoms and treat their disease.

The purpose of the AIM HIGHer trial — the largest randomized, sham-controlled, device-based interventional heart failure trial — is to further assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients. CCM therapy for HFpEF has already received the FDA’s breakthrough device designation. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards consistent with the Agency’s mission to protect and promote public health.

The Optimizer Smart Mini delivers CCM therapy which consists of precisely timed electrical pulses sent to the heart. These signals are designed to improve the heart’s ability to function properly, allowing more oxygen-rich blood to be pushed out through the body.