Impulse Dynamics Secures $80.25 Million Financing

Funding to Accelerate Commercialization of the Optimizer Smart System for Heart Failure

MOUNT LAUREL, N.J.–(BUSINESS WIRE)–#BreakThroughDevice—Impulse Dynamics, developer of Optimizer^® Smart System for delivering CCM™ therapy, announced the completion of an $80.25 million Series D financing with new investors. 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. Led 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’s chief executive and chief financial officers.

“This 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,” said Simos Kedikoglou, CEO of Impulse Dynamics. “We 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. We 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.”

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 In people living with the disease, the heart is not able to pump forcibly enough to meet the body’s needs. Over time, this leads to symptoms including breathlessness and fatigue, making even simple, everyday activities challenging. First-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. For eligible patients, CCM therapy with the Optimizer Smart may offer a new alternative to alleviate symptoms and improve quality of life. This population represents approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.

In connection with the financing, Joyce Erony, managing partner at Amzak Health Investors, will join the Impulse Dynamics board of directors. “This 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. 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.”

“With 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. “Our 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.”

About the Optimizer and CCM Therapy

CCM 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. 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. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. In doing so, it strengthens and helps the heart contract more forcibly. Impulse 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. 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. The 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.

About Impulse Dynamics

Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. With global headquarters in Mount Laurel, N.J., the company has additional offices in Stuttgart, Germany; Orangeburg, N.Y.; and Willemstad, Curacao. For more information please visit www.impulse-dynamics.com.

References

¹https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/
² Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133:e38-e360.

Contacts

INVESTOR CONTACT:

Gerry Haines, CFO

Impulse Dynamics

g.haines@impulse-dynamics.com

MEDIA CONTACT:

Diana Soltesz

Nobles Global Communications

diana@noblesgc.com
818-618-5634