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
The Optimizer Smart system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 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.
CCM is the brand name for cardiac contractility modulation — the 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, 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 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. CCM therapy has proven 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.
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, the continued momentum for the adoption of CCM therapy and use of the Optimizer Smart system globally; the ability for CCM therapy and our products and technology to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer 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; company’s ability to expand and grow its business into new geographic markets; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for its 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
Global Vice President, Marketing
Manager, Public Relations
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
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3 Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of
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