Orangeburg, New York & Stuttgart, Germany. December 18, 2017 – The China Food and Drug Administration (CFDA) has approved Impulse Dynamics’ Optimizer® system for treatment of chronic heart failure.  The announcement was made on December 12, 2017 by Impulse Dynamics’ CEO, Dr. Simos Kedikoglou.  “This is a major milestone for Impulse Dynamics, as it will help us offer Cardiac Contractility Modulation therapy to many patients in China who are in need of heart failure symptom relief.  It is also indicative of the efforts and investments the company has made in China, as we are one of the very few private companies that have reached such an achievement in-house, reflecting the dedication and commitment of the company’s employees globally,” said Dr. Kedikoglou.

The implantable Optimizer device delivers non-excitatory Cardiac Contractility Modulation signals to the heart muscle, and initiates multiple biochemical and neurohormonal changes to the myocardium.  As a result, the contractility of the myocardium increases with no concomitant increase in oxygen consumption, enabling the heart to operate more efficiently.  The Optimizer® has been successfully implanted in over 3,500 patients worldwide to date, and Cardiac Contractility Modulation technology is approved for sale in Europe, Australia, Brazil, India, New Zealand and Hong Kong.  The device is also referenced in the 2016 European Heart Failure Association guidelines as a potential treatment for heart failure patients.

Dr. Kedikoglou said that Impulse Dynamics is committed to developing its operations in China and making Cardiac Contractility Modulation and the Optimizer® available to Chinese heart failure patients with the approved indication.  The company plans to start commercial sales in China in due course.

About Impulse Dynamics

Impulse Dynamics is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company is focused on delivering its proprietary CCM therapy, which is delivered by the company’s Optimizer device, the CE-marked, and FDA-approved treatment verified to improve the quality of life for heart failure patients. CCM therapy is a safe, effective, and minimally invasive treatment option for many heart failure patients who otherwise have few effective options available to them.1 To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, 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, and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer 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; commercial success and market acceptance of CCM therapy; the company’s 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 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
www.impulse‐dynamics.com

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

INVESTOR RELATIONS:

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

MARKETING OPERATIONS: 

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

PUBLIC RELATIONS:  

Ian Segal
Manager, Public Relations
Impulse Dynamics
isegal@impulsedynamics.com
856-642-9933