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Cardiac System Medical Device Developer

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Chronic Heart Failure Medical Device Developer
VCBeat (WeChat ID: vcbeat) learned from foreign media reports that on December 3, 2019, GermanyDeveloper of Medical Devices for Chronic Heart FailureImpulse Dynamics Announces Completion of $80.25 Million Series D Financing Round, Led by Healthcare Technology Investor Amzak Health Investors, with Participation from Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences, Minth Holdings Limited, ZOLL Medical Corporation, Abiomed, and the CEO and CFO of Another Company
Impulse Dynamics, a medical device company founded in 1996 and led by CEO Simos Kedikoglou, is dedicated to improving the treatment of chronic heart failure through the FDA-approved Optimizer Smart, an implantable device. This round of financing will be used to accelerate the commercialization of Optimizer Smart in the United States.
Heart failure is a chronic, progressive disease affecting approximately 26 million people worldwide, including nearly 6 million in the United States alone. In patients with heart failure, the heart is unable to pump blood forcefully enough to meet the body’s needs. Over time, this leads to symptoms such as shortness of breath and fatigue, making daily activities difficult for patients. First-line prescription medications can alleviate early symptoms but do not help control disease progression and may even cause side effects. For eligible patients, CCM therapy using Optimizer Smart may offer a new alternative to alleviate heart failure symptoms and improve quality of life; this population accounts for approximately 70% of patients with NYHA Class III heart failure.
CCM is the trademarked name for “Cardiac Contractility Modulation,” a therapy delivered by the implantable Optimizer device that uses non-excitatory electrical impulses to improve systolic contraction. The Optimizer Smart has been granted Breakthrough Device designation by the U.S. Food and Drug Administration. CCM therapy delivers unique electrical impulses to cardiac cells during the absolute refractory period (which occurs immediately after the heart begins to contract), thereby enhancing and assisting the heart in achieving stronger contractions.
Impulse Dynamics has completed multiple clinical studies, including several randomized controlled trials, with results published in 80 leading medical journals. The Optimizer Smart has been implanted in more than 4,000 patients and is currently available in the United States, Europe, China, Brazil, India, and over 40 other countries and regions worldwide.
Alongside this financing round, Joyce Erony, Managing Partner at Amzak Health Investors, will join the Board of Directors of Impulse Dynamics. “This is a very exciting time for a company that achieved significant milestone accomplishments in 2019 and is now launching its own product in the United States,” said Joyce Erony. “We are delighted to have the opportunity to improve the quality of life for heart failure patients through Impulse Dynamics’ breakthrough therapy, and we look forward to joining the Impulse team.”
Regarding this financing round, Simos Kedikoglou, CEO of Impulse Dynamics, stated: “We are delighted that our new strategic investors recognize the significant potential of Cardiac Contractility Modulation (CCM) therapy using the Optimizer Smart system. We look forward to accelerating our commercial operations, particularly in the United States, thanks to our recent FDA approval and CMS transitional pass-through payment status, as well as the physicians and patients who are helping to realize this potential.”
Rich Gumer, Managing Director at Kennedy Lewis Investment Management, stated, “With CCM, Impulse Dynamics has developed a critically important new therapy for a large and growing patient population that, until now, has lacked viable alternative treatments. Our additional investment will help the company expand its positive impact—improving patient outcomes and generating significant cost savings for the healthcare system.”
About Amzak Health Investors
Amzak Health Investors (Amzak Health) manages its investment activities in the healthcare sector through Majalin LLC, an independent firm led by Joyce Erony and Anders Hove. Headquartered in New York City, Majalin operates under the name Amzak Health. Since 2005, Amzak Health’s principals have invested in more than 50 healthcare companies. Amzak Health invests across the healthcare landscape, including therapeutics, medical devices, diagnostics, and services.
(Compiled by Wang Fang)