EnChannel Medical completes the acquisition of core assets of Acutus Medical's AcQMap™ high-resolution imaging and mapping platform

This transaction not only covers intellectual property, technical documents, clinical data, and equipment, but also signifies that the development of non-contact mapping technology has entered a new stage of integration.

Against the global backdrop of unclear treatment pathways for persistent atrial fibrillation, this transaction could reshape the competitive landscape of complex arrhythmia mapping technologies and provide more precise visualization tools for electrophysiology interventions.

Feng Jun, CEO of EnChannel MedicalDisplay："This strategic acquisition will accelerate our mission to achieve efficient and precise visualization treatment for atrial fibrillation. Building on existing achievements and integrating our proprietary technology, we are reshaping the future of diagnosis and treatment for persistent atrial fibrillation."

# Transaction Overview: Asset Acquisition Rather Than Business Combination"Light Integration"

This acquisition is not a business combination in the traditional sense, but rather a specific technological asset acquisition by EnChannel Medical.Point-to-point acquisition.

According to EnChannel Medical,The transaction involves the following content:AcQMap™ Key intellectual property, quality and regulatory documents related to the platform, certain system equipment, and catheter products for R&D purposes, but excludingAcutus MedicalThe integration of the overall business or employee team.

This type of"Light integration" deals are increasingly becoming a common method for innovative companies in the medical device industry to optimize asset structures and enhance technology market share. Unlike capital-intensive full acquisitions, technology asset acquisitions are more targeted, facilitating strategic focus and rapid implementation of technology transfer.

As forAcutus MedicalIn this regard, it also aligns with its own2023the strategic restructuring path since the year——Gradually exit the development of high-cost, high-investment mapping systems with long payback periods, and focus on left atrial puncture products with higher profit margins and cooperation agreements with major medical companies (such as Medtronic).。

# From Contact to Non-contact: The Evolutionary Logic of Mapping Technology

The development of cardiac mapping technology is afromFrom "point" to "surface", from "slow" to "fast", from "phenomenon" to "mechanism analysis"of a spiral evolution process.

Traditional contact mapping systemBy making point-by-point contact via a catheter with multiple small endocardial myocardial regions, local electrical signals are collected over multiple cardiac cycles and gradually integrated into a comprehensive map of electrical activity on the heart chamber surface. Although effective for regular rhythms, this method is slow and unable to reconstruct the complete dynamic patterns of irregular activations such as atrial fibrillation, often resulting in reduced accuracy and specificity due to signal averaging.

In contrast,Non-contact mapping technologyBy collecting electrical signals through a multi-electrode array distributed within the cardiac chambers, real-time three-dimensional activation mapping of the entire atrium during a single heartbeat is reconstructed.This method not only significantly improves mapping efficiency but also preserves the true dynamic changes of rhythm, enabling accurate tracking of both regular and highly complex arrhythmias, such as atrial fibrillation.

Acutus MedicalTheAcQMap™ is the second-generation non-contact mapping platform, with technology advanced compared to the first generationEnSite Arrayof "voltage-to-voltage" mapping (byEndocardial Solutions EnChannel Medical (originally founded, later acquired by Abbott) achieved a significant leap forward.Through "voltage-"Charge density" mapping achieves higher spatial resolution and signal reconstruction accuracy。

EnChannel Medical's self-developed "Action Potential Mapping" represents a significant leap forward in third-generation non-contact mapping technology,First realizationPrecise tracking of the dynamic processes of depolarization and repolarization in cardiac action potentials.This innovation addresses the limitation of traditional mapping systems in covering repolarization electrophysiological processes, providing a more comprehensive electrophysiological mapping foundation for deciphering the triggering and sustaining mechanisms of atrial fibrillation, thereby supporting individualized and precise treatment for persistent atrial fibrillation.

▲EnChannel Medical Cardiac ElectrophysiologyThe Evolution of "Source"

Chief Scientific Officer of EnChannel MedicalGraydon BeattySay："Many of our team members have participated in the development of three generations of non-contact mapping technology. The first generation achieved reconstruction of cardiac electrical signals, the second generation resolved the electrophysiological physical sources of the signals, and the third generation realized physiological restoration of action potentials, truly revealing the essential dynamics of cardiac conduction. This acquisition integrates the core methodologies and resources we have accumulated over the years, further advancing the integrated workflow combining navigation, mapping, and imaging. We will continue building a world-leading electrophysiology ecosystem, deeply analyzing atrial fibrillation mechanisms, optimizing personalized therapies, and enhancing clinical outcomes."

He divided the three generations of technology into:The first generation reconstructed electrical signals, the second generation understood the source of the signals, and the third generation revealed the meaning of the signals.

This definition clearly outlines the direction and value of technological evolution.

# AcQMap™ System: The Industrial Life Cycle from Breakthrough to Transfer

As the core of this transaction,AcQMapThe ™ system was once regarded as a significant achievement leading the second-generation non-contact mapping platform.

Acutus Medical was first launched in the United States in 2018.AcQMap High-Resolution Imaging and Mapping System and 3D Mapping Catheter。

The AcQMap™ high-resolution imaging and mapping platform is an advanced cardiac electrophysiology imaging and mapping system primarily used to guide catheter ablation therapy for arrhythmias, especially atrial fibrillation and atrial tachycardia. Its core advantage lies inCombining ultrasound imaging with charge density mapping technology, EnChannel Medical has achieved high-resolution, three-dimensional cardiac chamber reconstruction and dynamic visualization of electrical activity.。

Main Features and Technical Advantages

• 3D Ultrasound Imaging and Charge Density Mapping:The AcQMap system utilizes a 3D imaging and mapping catheter inserted into the cardiac chamber, which consists of six arms equipped with 48 ultrasound sensors and 48 electrodes. It rapidly acquires ultrasound point cloud data of the cardiac chamber to construct an accurate three-dimensional anatomical model. Meanwhile, the system employs charge density mapping technology (more precise than traditional voltage mapping) to display the propagation waveforms of cardiac electrical activation, enabling global, non-contact, real-time monitoring of cardiac electrical activity.

• SuperMap AlgorithmThe algorithm can distinguish various arrhythmia morphologies and cycle lengths within a single non-contact recording, enabling rapid mapping of both stable and transient rhythms, significantly enhancing the efficiency and precision of diagnosis and ablation.

• Real-time dynamic mapping:After constructing the 3D anatomical map, the AcQMap system can continuously generate beat-by-beat activation maps, helping physicians evaluate ablation effectiveness in real time and adjust treatment strategies based on changes in electrical activity.

• Personalized Treatment Support:System ConfigurationThe two analytical tools, AcQTrack and SlowZone, automatically identify abnormal conduction patterns and slow conduction zones, assisting physicians in developing personalized ablation strategies, minimizing unnecessary ablation, and preserving cardiac tissue.

• Clinical Applications and Scope of Use:AcQMap is primarily intended for patients with complex arrhythmias requiring endocardial catheter ablation, and is suitable for use by cardiac specialists with expertise in electrophysiology and ablation at tertiary medical institutions. It is not suitable for certain patients, such as those with prosthetic heart valves, permanent pacemakers, severe coagulation disorders, or active infections.

• System Composition:includingThe AcQMap Console (signal processing and transmission), AcQMap Workstation (display and analysis platform), AcQMap 3D Imaging and Mapping Catheter, and patient surface electrode kit constitute a complete electrophysiology mapping solution.

However, despite the technological leadership,AcQMapEnChannel Medical has not achieved the expected growth inflection point on its commercialization path. Data shows,2020after its annual listing,Acutus MedicalThe contradiction between sustained high R&D investment and weak market expansion continues to exist;2024Year, company downsizing70%, and gradually sell non-core businesses,AcQMapThe "transfer" of the assets is almost a foregone conclusion.

This evolution also indirectly confirms that in the field of electrophysiology, technological breakthroughs alone are insufficient to create a moat; strong product ecosystem integration capabilities and long-term capital support are also required.

# AboutAcutus Medical

Acutus MedicalEstablished in2011year, located in Carlsbad, California, USA, byRandy WernethEstablishment,EnChannel Medical is a medical technology company dedicated to developing innovative treatment solutions for arrhythmias. For many years, the company has been committed to developing and manufacturing innovative technologies and products for the diagnosis and treatment of cardiac rhythm disorders, with a particular focus on imaging, navigation, and electrophysiological mapping systems used in catheter ablation procedures.

EnChannel Medical2020year8Moon6EnChannel Medical, listed on Nasdaq, has built a global sales network through product development, acquisitions, and international collaborations, offering a broad range of highly differentiated electrophysiology products that provide customers with catheter-based solutions for arrhythmia treatment.

Core Business and Products

Acutus MedicalDeveloped includingAcQMap™Multiple products including the high-resolution imaging and mapping platform. This system combines 3D ultrasound imaging and charge density mapping technology to help physicians more accurately diagnose and treat complex arrhythmias.

The company also produces catheters and accessories for left atrial puncture, which are widely used in electrophysiology and structural heart procedures, helping physicians perform critical operations safely and efficiently.

Its product line includesAcQMap 3DImaging and mapping catheters,AcQGuideControllable sheath and others have been obtainedFDAandCECertification。

Strategic Adjustment and Market Performance

In recent years,Acutus MedicalConducted a strategic reorganization, focusing on the manufacturing and distribution of left atrial puncture products, especially in conjunction with EnChannel MedicalMedtronicEnChannel Medical is gradually exiting the electrophysiology mapping and ablation business through company collaborations to improve financial performance and cash flow.

2024In the year, the company's ongoing operational revenue reached2020ten thousand US dollars, a year-on-year increase181%, with a significant reduction in operating loss to10million USD, indicating significant financial improvement.

EnChannel Medical2024The company conducted large-scale layoffs, reducing approximately70%Employees focused on supporting Medtronicproduct manufacturing and distribution agreement.

# About EnChannel Medical

EnChannel MedicalEstablished in2020year5EnChannel Medical, established by senior electrophysiology experts from China and the United States, is headquartered in Guangzhou, China, and has a wholly-owned subsidiary in California, USA.

EnChannel Medical's self-developedDePolarThe mapping system is the world's first cardiac solution by EnChannel Medical.“Four-dimensional”Mapping system.DePolarThe mapping system has seamlessly integrated magnetic-electric positioning contact mapping and magnetic-electric positioning non-contact mapping in both technical development and clinical application, establishing a unified mapping architecture.

Relying onDePolarEnChannel Medical has built the mapping system“Magnetic-electric 3D+MagnetoelectricPFA”integrated three-dimensionalPFAProduct portfolio, proactively establishing a diverse range of global innovationsPFAAblation catheter, suitable for comprehensive treatment of complex arrhythmias such as paroxysmal atrial fibrillation and atrial flutter, and will also be the only product globally capable of mapping and enabling personalized ablation for persistent atrial fibrillation.PFAProduct portfolio.

EnChannel Medical's pioneering“5DCardiac Electrophysiological Mapping Technology”3D spatial positioning and“Depolarization-Repolarization”Time-axis coupling enables real-time dynamic visualization of atrial fibrillation mechanisms, significantly improving the accuracy and success rate of catheter ablation.