Momentum Continues as Depth of Clinical Experience Expands Worldwide
MARLTON, N.J., May 15, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today a worldwide milestone achievement with the 9,000th patient receiving the Optimizer® system for the treatment of moderate HF. The Optimizer system is the only device approved by the U.S. Food and Drug Administration (FDA) in the United States to deliver CCM therapy. Dr. Steven Gubin, a cardiologist and the President of Stern Cardiovascular, is part of the care team that completed the procedure at Baptist Memorial Hospital-Memphis, offering CCM therapy to a patient living with the debilitating effects of HF. This milestone highlights the momentum building globally for CCM therapy, using the Optimizer platform to improve quality of life in HF patients.
“I am excited to have a new therapy option for heart failure patients,” said Dr. Gubin, who has been practicing for 30 years. “One of my heart failure patients, Aubretta Bean, who is a cancer survivor, continued to have symptoms despite her compliance with guideline-directed medical therapy for heart failure. She let me know that she felt better almost immediately after receiving the implant and continues to improve daily. It has been extremely rewarding to see such improvement in her quality of life. Her lab work four weeks later showed her BNP (a common test to diagnose heart failure) decreased by 81%, which is consistent with improvement in her heart failure symptoms.”
“Before my CCM implant, I could not walk from one room to the other without gasping for air. It was like being underwater and trying to breathe through a straw,” said Aubretta Bean. “Heart failure changed my life so quickly. You might think housework is a chore, but when you can’t make your bed or do the dishes, you realize how quickly you would love to do that again. Now after my Optimizer implant, I can do all these things! I look forward to planning my days again and not just trying to get through them. I have eight grandkids and two great-grandkids that I can travel to see!”
Drs. Eric Johnson, David Lan, and Chris Ingelmo are all electrophysiologists at Stern Cardiovascular that have treated ten patients at Baptist Memorial Hospital-Memphis with CCM therapy since March 2023. Dr. Chris Ingelmo completed the milestone procedure for the 9,000th patient treated with CCM therapy. The results have been encouraging, with significant improvement in patient symptoms.
“We are inspired by such stories highlighting the potential for clinicians to use CCM therapy to make a positive impact on HF patients’ lives,” said Simos Kedikoglou, MD, CEO of Impulse Dynamics. “The growing cadence of implants and the emergence of such inspiring stories reinforces our commitment to delivering meaningful advances in CCM technology and clinical data.”
CCM therapy is now available in 44 countries, and the technology has continued to advance based on the needs of patients and physicians. The latest generation of Impulse Dynamic’s proprietary Optimizer platform is the Optimizer Smart Mini, which offers a rechargeable battery with 20-year battery life and a smaller size designed to make the implant procedure faster and easier for patients and physicians.
About the Optimizer® Integra CCM-D™ System and CCM® Therapy
The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. This device is being used in an FDA-approved Investigational Device Exemption (IDE) study and is not available for sale in the United States.
Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to 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 therapy delivers non-excitatory electrical pulses from the implantable Optimizer device in a manner designed to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during their absolute refractory period. 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 technology 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. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be 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, and CCM therapy combined with an ICD delivered via a single device (CCM-D), 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 Integra CCM-D 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; 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