Marlton, NJ, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced new leadership appointments:
- Noel Colón, Chief Operating Officer (COO)
- Peter Donato, Chief Financial Officer (CFO)
- Paul Bae, Chief Administrative Officer (CAO)
- Anthony Hong, Chief Science and Strategy Officer (CSSO)
“We are pleased to add these proven leaders to the Impulse Dynamics executive team – which now has more than 175 collective years of experience and success building commercial stage medical companies,” said Jason Spees, Chief Executive Officer, Impulse Dynamics. “This team further strengthens the foundation for the next stage of the company, including strong future growth potential with the success of our proprietary CCM-D® HF System – combining our proprietary CCM® system (which improves the quality of life of heart failure patients) with an implantable defibrillator in a single device and procedure.”
“We have chosen to invest in these leadership roles to drive innovation and evidence generation, elevate performance, and achieve key milestones as we strive to revolutionize the treatment of heart failure.” said Shlomi Nachman, Chairman of the Board.
Noel Colón, COO, brings 33 years of medical device industry experience and a long history in the cardiac implantable business. He spent 15 years at Medtronic in various roles, including Senior Vice President, Research and Development, and Chief Quality Officer. Colón also spent 17 years at Boston Scientific (Guidant) CRM in leadership roles across manufacturing, development, and quality.
Peter Donato, CFO, was executive vice president and CFO of Zomedica prior to joining Impulse Dynamics. He brings 32 years of experience, including 20 years in public and private executive leadership roles, primarily in the life sciences industry. Donato was CFO of Standard Bariatrics, a start-up surgical device company purchased by Teleflex in late 2022. Donato also held CFO roles at Neuronetics, Assurex Health, Bovie Medical (now APYX), Iris International (formerly IRIS), and was the corporate controller at Cyberonics (now LIVN).
Paul Bae, CAO, brings decades of medical device leadership experience, including Abbott’s acquisition of St. Jude Medical, focused on legal, compliance and human resources (HR). Most recently, Bae served as Chief Legal Officer at Canon Medical Systems USA, Inc. He also spent 14 years at St. Jude Medical, serving as Chief Human Resource Officer, Chief Compliance Officer, and legal leadership roles through the acquisition by Abbott Labs.
Anthony Hong, CSSO, brings a successful 32-year track record in strategic planning and executing complex early- to late-stage programs in the pharmaceutical, biotech, and medical device industries. He has extensive experience utilizing clinical evidence to support coverage, payment, and inclusion in the guidelines. Most recently, Hong spent 13 years at Biosense Webster and Cardiovascular & Specialty Solutions Group of J&J MedTech as VP of Global Strategic Marketing, VP of WW Preclinical & Clinical Research, Medical Affairs, and Biostats/Programming/Data Management, as well as global leadership roles in Health Economics and Regulatory Affairs.
About the CCM-D® HF System and CCM® Therapy
The CCM-D® HF System is an investigational device that combines CCM® (cardiac contractility modulation) therapy and ICD (implantable cardioverter defibrillator) therapy into one device. “Investigational” means that the study device is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA).
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 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 receiving CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.
CCM is the brand name for cardiac contractility modulation — a therapy that delivers non-excitatory electrical pulses from 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® 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 10,000 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.
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 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.
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Attachment
Rohan More Impulse Dynamics 856-642-9933 rmore@impulsedynamics.com
source: Impulse Dynamics
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