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

MOUNT LAUREL, N.J. – December 3, 2019 – 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.”

References

¹ https://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.