Recently, Impulse Dynamics, a developer of heart failure products including cardiac pacemakers, announced that it has secured $136 million (equivalent to 980 million yuan) in financing. The investors include well-established investment firms Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare. The company previously raised $101 million in May 2022 and also received $45 million in funding in May 2017.

Chief Executive Officer Jason Spees said in a statement"We continue to make commercial progress worldwide, with more than 9,000 heart failure patients having received CCM (Cardiac Contractility Modulation) therapy implants, benefiting millions of people."

CCM includes an implantable pulse generator connected to the myocardium, known as the Optimizer System. The electrical signals it generates do not synchronize the timing of heartbeats but rather help enhance the contraction of the left ventricle by triggering the expression of genes in myocardial fibers that control calcium flow and contraction.

From basic animal experiments to clinical studies, it has been confirmed that CCM can enhance the contractility of ventricular muscle, improve cardiac function and clinical symptoms in heart failure patients, and increase exercise tolerance.

Although devices like the Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) are used to address arrhythmias or synchronization issues, compared to the former two, Cardiac Contractility Modulation (CCM) is the only device that trains the heart and improves the contractility of the cardiac muscle.

Spees added, "By successfully registering our INTEGRA-D clinical trial on the Optimizer Integra CCM-D system, we are getting closer to significantly impacting the implantable cardioverter defibrillator (ICD) market." Spees made the statement after assuming the role of president.Last SeptemberAppointed as Chief Executive Officer and Chief Commercial Officer.

Although the company's current Optimizer Smart Mini system has received FDA approval and CE marking, this device uses CCM technology to send unique electrical impulses to the heart, aiming to improve cardiac function and quality of life for patients with heart failure.

Optimizer Smart Mini is a specific product launched by the company that utilizes CCM technology to assist in managing heart failure. The product is suitable for symptomatic heart failure patients with a reduced ejection fraction between 25% and 45%. However, Impulse Dynamics is also recruiting participants for a clinical study to examine the use of CCM in these patients. The ejection fraction is preserved between 40% and 60%.

The company previously in May 2022Raised $101 million in financing, including equity and debt. Alger and Squarepoint Capital joined as new investors, while Abiomed and Kennedy Lewis Investment Management returned as previous supporters.

Impulse Dynamics is the "pioneer" in the development of Cardiac Contractility Modulation (CCM) technology.According to the company's official website, its core product, the Optimizer Smart System, includes an implantable stimulation device about the size of a pacemaker and an external charging station. Doctors will implant the stimulation device along with leads into the right ventricular septum of the patient’s heart while the patient is under mild anesthesia. After implantation, doctors will customize the programming for the patient and activate the device. The Optimizer Smart delivers electrical pulses to stimulate the heart muscle for a total of 5 hours each day, and patients need to charge the device once a week using the external charger.The service life of Optimizer SmartSystem can reach up to 15 years.

According to reports,The product was awarded the title of "Breakthrough Device" by the U.S. Food and Drug Administration (FDA) in 2015, and it is the only FDA-approved CCM device available in the United States.

Optimizer Smart System Granted "Breakthrough Device" Designation by FDA, the First and Only FDA-Approved Device to Deliver CCM Therapy in the U.S. or Other Regions.Optimizer has been used to treat more than 9,000 patients.Currently available in the United States and Europe(Obtained CE Mark in October 2016), China, Brazil, India, and over 40 other countries worldwide.

In 2023, a heart failure patient in the United States was implanted with a new dual-function heart failure device, CCM-D, developed by Impulse Dynamics——Optimizer IntegraCCM-D, which is also the world's first implant of this product.

November 2022,Impulse Dynamics Announces the 100th Implant in ChinaThis marks the continuous adoption of its innovative Optimizer® system providing CCM® therapy in markets around the world. Professor Guo Tao, Executive Director of Internal Medicine at Fuwai Yunnan Cardiovascular Hospital and a cardiologist, performed the 100th procedure and highlighted the role of this therapy in offering options and hope for patients with heart failure.

"For us, this is a very coincidental milestone, as the 10th patient to receive an implant at our center also happens to be the 100th patient treated in China. I have been closely following CCM therapy for over 20 years, but it is only recently that we have been able to apply this technology clinically. After close clinical observation, the improvement in our 10 CCM patients has even exceeded our expectations. All of our center's CCM patients have shown improvements in both symptoms and various objective indicators, which has made both us and our patients extremely pleased."Therefore, from our experience, the role of CCM is exactly as described in foreign studies — specifically, by regulating calcium ion exchange, thereby enhancing the contractility of the myocardium during the acute phase, and then normalizing the expression of contraction-related proteins, which leads to reverse remodeling of the heart. Based on these results, we now plan to standardize and actively expand the application of CCM, while continuing to closely monitor implanted patients, gather more clinical evidence for CCM, optimize its application, and allow more Chinese patients to benefit from this latest innovative therapy."

Professor Shu Zhang, Chief Physician at the National Center for Cardiovascular Diseases and Fuwai Hospital of the Chinese Academy of Medical Sciences, Honorary Chairman of the Cardiac Pacing and Electrophysiology Branch of the Chinese Medical Association, Chairman of the Cardiology Committee of the Chinese Medical Doctor Association, and former President of the Asia Pacific Heart Rhythm Society, further commented: "Currently, China has nearly 9 million patients with heart failure, many of whom are not receiving optimal treatment. Heart failure has also become the leading cause of death from cardiovascular and other major chronic diseases in China."Believe that CCM will bring good news to Chinese patients. These successful preliminary experiences provide a good prospect for our doctors and bring hope to the patients they care for."

As the clinical value of CCM technology is proven, Chinese medical device companies are also beginning to enter this field.In February 2024, LePu Medical (300003.SH) officially announced that its self-developed, China's first cardiac contractility modulator (CCM) completed the first clinical trial enrollment at Hefei High-tech Cardiovascular Hospital in Anhui Province.

It is estimated that heart failure affects 6.5 million Americans and nearly 64 million people worldwide, and by 2030, more than 8 million people in the United States (one in every 33 individuals) will have heart failure. Heart failure is a condition in which the heart gradually weakens and is unable to pump blood with enough force to supply oxygen-rich blood to meet the body's needs. Patients with heart failure experience debilitating symptoms including shortness of breath, fatigue, confusion, and leg swelling, which make daily activities challenging and significantly reduce their quality of life.

Traditional heart failure treatments have limited effectiveness in improving the heart's pumping strength.，Even without improvement, nearly 50% of heart failure patients die within five years of diagnosis.Today, most patients with heart failure take medications to slow the progression of the disease and control symptoms.

As the disease progresses, these treatments will lose efficacy, and the quality of life for heart failure patients will continue to decline. By 2030, the total annual cost of heart failure is expected to reach $70 billion.

▲ Source of the article:Medical Device Innovation Network Reference: The Paper

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