Impulse Dynamics Receives Approval to Sell Optimizer CCM Devices in China

NEWS

NMPA Clears the Way for Impulse Dynamics to Deliver Hope for Heart Failure Population

MARLTON, N.J., February 22, 2021 — Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced that the National Medical Products Administration (NMPA) approved the application for market authorization of the Optimizer^® CCM^® device for patients with heart failure in the People’s Republic of China. HF impacts several million citizens in China, and approximately 500,000 new cases are diagnosed each year. For many of these patients who remain symptomatic after optimal pharmaceutical treatment, CCM therapy can now help them improve their symptoms and quality of life, including such basic activities as the ability to walk and exercise.

“Heart Failure has become a serious disease that severely affects the life span and quality of life of Chinese people, and it is also becoming a greater burden on our society due to growing population, complications in treatment, and challenges in dealing with relapses,” asserted Professor Zhang Shu from Fuwai Hospital. “The NMPA newly approved implantable CCM device from Impulse Dynamics, which is designed to improve the contractility of the myocardium, shines hope upon many heart failure patients of our country because this could become the treatment of choice by physicians.”

The Optimizer delivers CCM therapy, the company’s proprietary technology, to the heart. CCM therapy is the first approach of its kind designed to improve contraction of the heart, potentially allowing more oxygen-rich blood to reach the body. CCM therapy delivers precisely timed electrical pulses to the heart during the absolute refractory period of the beating cycle, just after the heart contracts. This breakthrough technology can improve the quality of life for patients who are no longer adequately responding to medications to manage their symptoms.

With an enduring presence in the Asia-Pacific region and an office in Beijing, Impulse Dynamics has undertaken scientific and clinical work for over ten years in China. “We are honored to receive approval from the NMPA after a rigorous evaluation process,” said Simos Kedikoglou, CEO of Impulse Dynamics. “Reaching this important milestone is another example of our long-term commitment to the clinical and commercial development of CCM therapy globally to help heart failure patients tackle this debilitating disease. We look forward to working closely with our long-term investors and partners, Henderson, CITIC, the Minth Group, and the recently added CR-CCT to launch this breakthrough, life-changing technology in China in the very near future.” Kedikoglou affirmed.

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 improve 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 that is proven 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 effective options available to them.¹ To learn more visit www.impulse-dynamics.com, or follow the company on LinkedIn and Twitter.

Impulse Dynamics (USA), Inc.
50 Lake Center Executive Parkway, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933
www.impulse‐dynamics.com

INVESTOR CONTACT:

Gerry Haines, CFO
Impulse Dynamics
g.haines@impulse-dynamics.com

MEDIA CONTACT:

Rex Richmond
rex.richmond@impulse-dynamics.com
612-201-1540

References

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/aa

2 Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and
Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart
Association. Circulation. 2016; 133:e38-e360.

3 Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of
cardiac contractility modulation. JACC Heart Failure. 6(10), 874-883 (2018).