Breakthrough Therapy Now Commercially Available in South America’s Most Populous Country
MARLTON, N.J. – January 05, 2021 – Impulse Dynamics, a company dedicated to helping healthcare providers improve the lives of people with heart failure, today announced the first patient in Brazil was treated with its innovative CCM® therapy delivered by the Optimizer® system. The patient was treated by Dr. Edvaldo Xavier, cardiologist at Santa Casa de Maceió in Maceió, Alagoas.
“It was with enormous satisfaction that we were able to perform the first Optimizer Smart CCM implant in Brazil, a new therapy for eligible patients with heart failure,” said Dr. Xavier. “The implantation of the CCM device was relatively simple, without any major difficulties and the patient reported an improvement in symptoms the next morning. It’s our hope that this procedure opens the doors for other centers in Brazil and elsewhere in Latin America to begin implanting the Optimizer Smart, bringing hope to heart failure patients for a better quality of life and fewer cardiovascular events. We are extremely satisfied with the support provided by i2Medi Comercial Medica, and we’re hopeful we can perform more implants, making our patients happy and enabling our medical team to provide positive results with this therapy.”
The Optimizer delivers cardiac contractility modulation 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, allowing more oxygen-rich blood to reach the body.1 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 has the potential to improve the quality of life for patients who are no longer adequately responding to medications to manage their symptoms or slow the progression of their condition.1
“We are delighted to offer CCM therapy to the healthcare community in Brazil,” said Dr. Mateusz Zelewski, VP International Sales at Impulse Dynamics. “Heart failure is a global health issue impacting millions of patients with symptoms that massively disrupt their daily lives. Our breakthrough technology enables physicians to make a positive impact on the lives of their patients. For many patients, it’s a desperately needed reason for them to feel hopeful again. The excitement for the first patient in Brazil adds to the continued enthusiasm we’ve seen from patients and providers all over the world as CCM therapy becomes available to them.” The Optimizer device is similar in size to a pacemaker and is implanted during a minimally invasive procedure while the patient is under light sedation. It has been used to treat over 5,000 patients and is currently available in the United States, Europe, China, Brazil, India and more than 40 other countries around the world.
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
1 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).