Impulse Dynamics Announces FDA Approval of Optimizer Smart System for Heart Failure Treatment and Files IPO Prospectus

VCBeat (WeChat Official Account: vcbeat) has learned that on March 21, 2019, medical device company Impulse Dynamics announced that its leading implantable Optimizer Smart System had received FDA approval for the treatment of heart failure.

In 2015, Impulse Dynamics received FDA clearance for the Optimizer Smart Device, designed to effectively treat patients with heart failure. On December 4, 2018, the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee voted unanimously in favor of the Optimizer Smart Device, marking its first major breakthrough.

“The FDA’s approval of the Optimizer Smart Device means that we finally have a system in the United States capable of effectively treating heart failure patients, particularly those with ineligible left ventricular ejection fraction (LVEF) who are often not candidates for cardiac resynchronization therapy (CRT),” said William T. Abraham, MD, Distinguished Professor at The Ohio State University Wexner Medical Center. “The Optimizer Smart System, combined with guided medical management, can transform the lives of many heart failure patients in the U.S. Therefore, for these patients, this is a truly ‘game-changing’ system.”

The Optimizer smart device is the first and only FDA-approved system specifically designed for patients with Stage III heart failure. Patients with Stage III heart failure (NYHA Class III) are in normal sinus rhythm and are not candidates for cardiac resynchronization therapy (CRT). Their left ventricular ejection fraction (LVEF) typically ranges from 25% to 45%. CRT treatment is generally indicated only for patients with moderate to severe chronic heart failure and an LVEF of ≤30%, leaving approximately 70% of heart failure patients with few therapeutic options to manage their condition.

Dr. Daniel Burkhoff, Medical Advisor at Impulse Dynamics, commented, “FDA approval marks the culmination of years of development of this disruptive clinical technology, addressing a critical unmet need in the current heart failure treatment paradigm. We will continue to advance this technology and conduct clinical trials to evaluate the efficacy of our CCM therapy for patients with heart failure.” Cardiac Contractility Modulation (CCM) delivers unique electrical pulses during the refractory period following cardiac contraction. Unlike pacemakers or defibrillators, CCM therapy works by modulating the strength of myocardial contraction rather than its frequency.

CCM is the brand name for Cardiac Contractility Modulation therapy, which delivers non-excitatory electrical pulses during the refractory period of the cardiac cycle via an implantable Optimizer Smart Device to improve cardiac contractility. To date, more than 3,500 heart failure patients have received implants of the Optimizer Smart Device, which is used in Europe, China, Brazil, India, and over 40 countries worldwide.

Dr. Simos Kedikoglou, CEO of Impulse Dynamics, announced that the company will launch this device in the United States later this year. “We are thrilled to make the Optimizer Smart Device, associated with CCM therapy, available in the U.S., and we look forward to expanding Impulse Dynamics’ commercial activities both in the United States and globally,” he said.

To date, Impulse Dynamics has completed two rounds of financing totaling $75 million. Its investors are Beijing Jinshi Investment Co., Ltd. and Lee Shau Kee, Chairman and Vice President of Hong Kong’s Henderson Land Development.

Impulse Dynamics, founded in 1996 and headquartered in Stuttgart, Germany, is led by a team of professionals including scientists, physicians, and engineers, dedicated to researching and developing electronic therapies for chronic heart failure. The company has completed numerous clinical studies, including randomized controlled trials, with results published in more than 80 prestigious medical journals worldwide. As a global leader in cardiac medicine innovation, Impulse Dynamics operates in the United States, Europe, and Asia.

(Compiled by Wang Shuijing)