Impulse Dynamics Secures $136 Million in New Funding to Advance Dual-Function CCM-D Heart Failure Therapy

Feb 14, 2024 00:00 CST Updated Feb 18, 11:53

Impulse Dynamics

Chronic Heart Failure Medical Device Developer

Perceptive Advisors

Private Hedge Fund Sponsor

Redmile Group

Healthcare Venture Capital Firms

Alger

Growth Investment Management Company

Hobart Healthcare

Medical Device Developer

Source of the article:Heart NotCome;Editor: Yang Liurong

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,Focus on Heart Failure TreatmentTheImpulse DynamicsAnnouncement Completed$136 million (RMB 978 million) in financing，This round of financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare. The funds willDrive commercialization efforts, develop future product pipelines, and support groundbreaking clinical trials., such as the INTEGRA-D and AIM HIGHer clinical trials.

One of the company's main products isOptimizer Integra CCM-D System, which is aDual Heart Device, combining two established therapies—Cardiac Contractility Modulation (CCM) and Implantable Cardioverter Defibrillator (ICD) are combined into one treatment method.Aimed at minimizing symptoms associated with heart failure and arrhythmias, its extended battery life helps limit the need for additional procedures. As part of the INTEGRA-D clinical trial, patients are currently being treated with this device.

Impulse Dynamics is the pioneer in the development of Cardiac Contractility Modulation (CCM) technology., whose first product, Optimizer I, completed the first CCM device implantation in 2001. Currently, Impulse Dynamics'CCM Product (Optimizer) Has Been Launched in 44 Countries/Regions, including the United States, the European Union, China, Brazil, and India.In 2021, the new generation of cardiac contractility modulatorCCM OPTIMIZER Smart Receives NMPA Approval for Marketing in China, marking the beginning of CCM heart failure treatment in China.

As the clinical value of Cardiac Contractility Modulation (CCM) technology has been proven, medical device companies in China have also started to enter this field. In November 2023,Lepu MedicalIndependently DevelopedImplantable Cardiac Contractility ModulatorApproved by the National Medical Products Administration (NMPA) for the special review of innovative medical devices, entering a special review procedure, will accelerate the registration and market launch of implantable cardiac contractility modulators,And completed the first clinical implantation, becomingThe First Chinese-produced Myocardial Contraction Modulator to Complete Clinical Application。

# Optimizer Integra CCM-D System

Optimizer Integra CCM-D system, developed by Impulse Dynamics, is aNovel Dual-Function Heart Failure Device. It is a small device that can be implanted in the body, connected to the heart by wires, and canProvided simultaneouslyCardiac Contractility Modulation (CCM) Therapy and Implantable Cardioverter Defibrillator (ICD) Therapy。The Optimizer Integra CCM-D system is rechargeable and has a long lifespan.Its battery life could potentially reach 20 years., which means patients can reduce the frequency and risks associated with changing devices.

CCM TherapyIs throughSend precisely timed electrical impulses to the myocardiumTo enhance myocardial contractility and improve pumping function, which can improve the quality of life for patients with heart failure and alleviate symptoms such as shortness of breath and fatigue.ICD TherapyIt is throughSend an electric shock to the heartTo correct rapid or irregular arrhythmias, which can prevent sudden death in patients with heart failure.

Impulse DynamicsCurrently ProvidedOptimizerThe system has been acquired.FDAAnd the EUCECertification。CCMTreatment is applicable toSymptomatic despite guided medical therapyNYHA IIIPatients with advanced heart failure, they are not suitable for receiving cardiac resynchronization therapy (CRT), and the left ventricular ejection fraction is25%To45%Between.CCMTreatment can improve the patient's66-minute walk distance, quality of life, and functional status。

# Financing Details

Impulse DynamicsPlanPlanUtilize resourcesGoldSupport INTEGRA-D and AIM HIGHer Trialsetc.The INTEGRA-D trial is a multicenter study evaluating the combination of CCM and ICD therapies in a single device (Optimizer Integra CCM-D).AIM HIGHer Clinical Trial is a multicenter study designed to evaluate the safety and efficacy of CCM therapy in symptomatic heart failure patients with an ejection fraction (EF) of 40% to 60% (inclusive).

Impulse Dynamics CEO Jason Spees said: "This round of financing will accelerate our business growth, both commercially and in terms of advanced technological innovation."Currently, there isMore than 9,000 heart failure patients have received CCM therapy, benefiting millions.. WeWill continue to promote the commercialization of CCM therapy worldwide.By successfully registering the INTEGRA-D clinical trial on the Optimizer Integra CCM-D system, we are getting closer to significantly impacting the implantable cardioverter defibrillator (ICD) market.”

"Most patients who currently receive standard ICDs benefit life-savingly from defibrillators but still struggle with heart failure symptoms. With CCM-D, these patients will be able to gain the life-saving benefits of a defibrillator and relief from heart failure symptoms, all in one device."

# About CCM Therapy

Cardiac Contractility Modulation (CCM) is a novel implantable electronic device for the treatment of heart failure.CCM TherapyTransmitting non-excitable electrical signals to the right side of the ventricular septum during the absolute refractory period of ventricular contraction., and will not trigger a new action potential.It has been confirmed by both basic animal experiments and clinical studies,CCM can enhance the contractility of ventricular muscle, improve cardiac function and clinical symptoms in heart failure patients, and increase exercise tolerance.。

The Principle of CCMIs throughStandard Pacing ElectrodeDuring the absolute refractory period of the myocardial cell action potential (i.e., within 30ms after sensing myocardial excitation), non-excitatory high-voltage biphasic pulses (voltage 7.5V, pulse width 5.0ms) are delivered to stimulate the subendocardial myocardium of the interventricular septum. Through mechanisms such as normalizing the activity of key calcium ion regulatory proteins and balancing cardiac autonomic nerve tension, the aim is to improve the patient's cardiac function.Long-term effects can reverse myocardial remodeling. Although devices such as implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy (CRT) are used to address rhythm or synchronization issues, compared to the former two,CCM is the only therapeutic device that can train the heart and improve myocardial contractility.。

The CCM signals are delivered by Impulse Dynamics' Optimizer system (Optimizer IV), which is an implantable pulse generator. The device is implanted through minimally invasive surgery under local anesthesia, typically in the right chest area.CCM therapy has been evaluated in patients with heart failure with reduced ejection fraction (HFrEF).Compared with pacemakers or defibrillators,OptimizerThe system is designed to modulate the intensity of myocardial contraction rather than the rhythm.CCM therapy is performed regularly throughout the day.

# AboutImpulse Dynamics

Impulse Dynamics was founded in 1998.Headquartered in Stuttgart, Germany,Dedicated to the R&D of Cardiac Contractility Modulation (CCM). The company pioneered its patented technologyCCM, throughOptimizerTechnical platform to improve the quality of life for patients with heart failure.ItsThe Core Optimizer received the FDA Breakthrough Device Designation in 2015 and was approved for FDA marketing in 2019.Currently, more than 9,000 patients have been implanted worldwide.

The company is a pioneer in CCM therapy., the therapy delivered by the Optimizer system has been proven to significantly improve the quality of life for patients with heart failure. For the many heart failure patients who currently lack effective treatment options,CCM is a safe and effective minimally invasive treatment option.。

In February 2012, Impulse Dynamics and Australian company Vitality Devices entered into a strategic Asia-Pacific distribution agreement. Under the agreement, Vitality will distribute Impulse Dynamics' Optimizer® device for the treatment of chronic heart failure (CHF). The device will be sold in multiple countries and regions, including Australia, Singapore, Malaysia, and South Korea.

From 2016 to 2017, Impulse Dynamics completed two rounds of financing totaling 75 million US dollars, which were used to continuously expand the scope of product commercialization and promote the progress of clinical and product development.

Overseas Cardiovascular Devices:

Products from Chinese cardiovascular companies: