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CCM Therapy Addresses an Unmet Clinical Need and Offers Hope to Millions With Heart Failure

MARLTON, N.J., April 26, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce a worldwide milestone achievement as the 7,000th patient has received the Optimizer® Smart for the treatment of moderate HF. Dr. Raul Weiss, Professor of Clinical Medicine and Director of the Electrophysiology Fellowship Program at the Ohio State University Wexner Medical Center in Columbus, Ohio, conducted the implant procedure in less than 45 minutes, underscoring the significant clinical experience that exists for the therapy.

“It’s great to see the breakthrough technology of Optimizer Smart improving the lives of so many patients,” said Dr. Weiss. “I was an early adopter of this technology and was involved in early clinical trials. It is gratifying to see the patients treated and reported in more than 100 publications. Our experiences with CCM have been positive, and as more of my colleagues are now seeing those same positive results, I expect the number of CCM patients to grow even more significantly.”

“We are pleased to have reached yet another milestone in our relentless quest to change the way HF is treated,” said Simos Kedikoglou, MD, CEO of Impulse Dynamics. “While this is certainly an achievement that can be expressed in numbers, what’s most important is what we know to be the impacts CCM has on patients, their families, and their extended communities.”

This milestone is significant because it showcases clinical experience that continues to define and support the utility of this technology in providing hope for patients living with heart failure. In the time since this technology was imagined, it is now available in 44 countries, and the technology has continued to advance based on the needs of patients and physicians. Impulse Dynamics is steeped in a culture that celebrates making patients our top priority. From its very inception, the company has held fast to an important tenet — put patients first, and business will follow.

Dr. Marc Silver, a cardiologist in Chandler, Arizona, and a founding member of the Heart Failure Society of America, expressed the following regarding the critical role of referring providers. “It’s well-known that the large majority of patients with moderate heart failure here in the US, and the millions internationally who may benefit most from CCM therapy, are being cared for by cardiology practitioners in their local communities. Knowing about this treatment option, being able to identify appropriate candidates, and considering it for ones who are indicated adds an important tool to the armamentarium of front-line providers in the fight against heart failure.”

The Optimizer Smart delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve heart 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 indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

About the Optimizer and CCM® Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve systolic contraction of the heart. The Optimizer Smart System was granted “Breakthrough Device” designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. In doing so, it strengthens and helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which have been published in over 80 articles appearing in leading medical journals. Studies have shown CCM therapy to sustainably improve 6-minute hall walk distance, quality of life, and functional status among patients who are candidates for the device. The Optimizer Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India, and more than 40 other countries around the world.

About Impulse Dynamics
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM® therapy, which is delivered by the company’s Optimizer system, a breakthrough, FDA-approved treatment verified to improve the quality of life for heart failure patients.[1] CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few alternatives available to them.1  To learn more, visit www.ImpulseDynamics.com, or follow the company on social media at LinkedIn, Twitter, and Facebook. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/

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

INVESTOR CONTACT:

Harriss Currie
CFO
Impulse Dynamics
hcurrie@impulsedynamics.com
856-642-9933

MEDIA CONTACT:  

Rex Richmond
Director of Media Relations
Impulse Dynamics
rrichmond@impulsedynamics.com
856-642-9933

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