Stuttgart, Germany – August 23rd, 2015 – Impulse Dynamics announced today (23 August, 2015) the first implantation of its Optimizer IVs device in the Kingdom of Saudi Arabia, at the King Faisal Specialist Hospital & Research Centre (KFSH&RC) in Riyadh. The implantation was performed by Dr. Bandar Al Ghamdi. The CCM team at KFSH&RC includes Dr. Jehad Al Buraiki, Heart Centre Director, Dr. Majid Al Fayyadh, Heart Centre Deputy Director, Dr. Azam Shafquat, Consultant cardiologist/ electrophysiologist and Dr. Bandar Al Ghamdi, Consultant cardiologist/ electrophysiologist.
The Optimizer IVs is a minimally invasive implantable device designed to treat Chronic Heart Failure (CHF), a growing public health problem in Saudi Arabia. “We are happy to have the Optimizer system which gives a new therapeutic option and hope to our heart failure patients in Saudi Arabia” commented Dr. Al Ghamdi. The Optimizer system is based on the novel Cardiac Contractility Modulation (CCM) technology, and delivers non-excitatory electric pulses to the heart. “This therapy will address those patients with symptomatic heart failure and narrow QRS complex despite pharmacological therapy for whom there is no other device based option” Dr. Al Ghamdi continued.
“These implants are a significant milestone in our continued commercial expansion” said Dr. Simos Kedikoglou, CEO of Impulse Dynamics. “CCM is a well-established technology that meets a major need globally, and we plan to further expand its introduction in Saudi Arabia and other Middle Eastern countries to benefit more patients with heart failure.“
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.
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
Global Vice President, Marketing