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MOUNT LAUREL, N.J.<\/strong> \u2013 December 3, 2019 \u2013 <\/strong>Impulse Dynamics<\/a>, developer of Optimizer\u00ae<\/sup> Smart System for delivering CCM\u2122 therapy, announced the completion of an $80.25 million Series D financing with new investors.\u00a0 The proceeds will be used primarily to facilitate U.S. commercialization of the Optimizer Smart, an FDA-approved implantable device for treating chronic heart failure that has been proven to strengthen the heart and help it beat more forcibly. \u00a0Led by well-respected medical technology investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings Limited; strategic investors Zoll Medical Corporation, Abiomed and one additional corporate investor; and the company\u2019s chief executive and chief financial officers.<\/p>\n \u201cThis development brings encouraging news to the vast number of heart failure patients in the U.S. and around the world who suffer poor quality of life and have run out of viable options to treat their disease,\u201d said Simos Kedikoglou, CEO of Impulse Dynamics. \u00a0\u201cWe are extremely pleased that our new strategic and financial investors recognize the significant potential of cardiac contractility modulation, or CCM therapy, with the Optimizer Smart. \u00a0We look forward to accelerating the ramp-up of our commercial operations, particularly in the U.S. where we are just entering the market thanks to our two recent FDA approvals and CMS Transitional Pass-through payment approval, to make this potential a reality for physicians and their patients.\u201d<\/p>\n Heart failure is a chronic and progressive condition affecting an estimated 26 million people worldwide, with nearly 6 million of those in the U.S. alone.1,2<\/sup> \u00a0In people living with the disease, the heart is not able to pump forcibly enough to meet the body\u2019s needs. \u00a0Over time, this leads to symptoms including breathlessness and fatigue, making even simple, everyday activities challenging. \u00a0First-line prescription medications can ease early symptoms, but do not help with the progression of the disease and may cause side effects and have decreased effectiveness over time. \u00a0For eligible patients, CCM therapy with the Optimizer Smart may offer a new alternative to alleviate symptoms and improve quality of life. \u00a0This population represents approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.<\/p>\n In connection with the financing, Joyce Erony, managing partner at Amzak Health Investors, will join the Impulse Dynamics board of directors.\u00a0 \u201cThis is a very exciting time for a company that has achieved significant milestones in 2019 and is now launching their product in the United States.\u00a0 We are very excited about the opportunity to improve the quality of life for heart failure patients with this breakthrough therapy and we look forward to joining the Impulse team.\u201d<\/p>\n \u201cWith CCM, Impulse Dynamics has developed a very important new therapy for a large and growing patient population who until now have had no real treatment alternatives,” said Rich Gumer, managing director of Kennedy Lewis Investment Management, which has invested a combined $25 million of debt and equity in the company. \u00a0\u201cOur additional investment will help the company deliver a positive impact on a much larger scale – improving patient outcomes and generating significant savings to the healthcare system.\u201d<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.0.6″ background_color=”#005496″ custom_margin=”23px||||false|false” custom_padding=”30px|36px|30px|36px|true|true”][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ background_layout=”dark”]<\/p>\n \u00a0About the Optimizer and CCM Therapy<\/strong><\/p>\n \u00a0CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve systolic contraction of the heart.\u00a0 The Optimizer Smart System was granted Breakthrough Device designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. \u00a0CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. \u00a0In doing so, it strengthens and helps the heart contract more forcibly. \u00a0Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which have been published in over 80 articles appearing in leading medical journals.\u00a0 Studies have shown CCM therapy to sustainably improve 6-minute hall walk distance, quality of life and functional status among patients who are candidates for the device. \u00a0The Optimizer Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India and more than 40 other countries around the world.\u00a0<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ background_layout=”dark”]<\/p>\n About Impulse Dynamics<\/strong><\/p>\n \u00a0Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. \u00a0With global headquarters in Mount Laurel, N.J., the company has additional offices in Stuttgart, Germany; Orangeburg, N.Y.; and Willemstad, Curacao. \u00a0For more information please visit www.impulse-dynamics.com<\/a>.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″ background_layout=”dark”]<\/p>\n Impulse Dynamics (USA), Inc.<\/strong> [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.0.6″][et_pb_column type=”1_2″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″]<\/p>\n INVESTOR<\/strong> CONTACT<\/strong>:<\/p>\n Gerry Haines, CFO [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.0.6″][et_pb_text _builder_version=”4.0.6″]<\/p>\n
523 Fellowship Road, Suite 203
Mt. Laurel, NJ 08054<\/p>\n
Impulse Dynamics
g.haines@impulse-dynamics-multisite.flywheelsites.com<\/a><\/p>\n