DeNovo Electrophysiology's CardioPulse™ Pulsed Field Ablation Catheter, China's First Basket-Shaped Cardiac PFA System, Receives NMPA Approval and Files IPO Prospectus

Mar 12, 2024 12:22 CST Updated 12:22

Nuomao

Cardiovascular Innovative Medical Device R&D Manufacturer

Source of the article:Heart Future；Editor: Bai Xiaofei

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

Heart Future

Recently, the National Medical Products Administration approvedHangzhou Nuomao Medical Technology Co., Ltd."Single-Use Cardiac Pulsed Field Ablation Catheter”Innovative Product Registration Application。This isFirst Domestic LaunchPetal/Basket-shaped Catheter, can easily complete pulmonary vein isolation without relying on 3D, which might open a new era in atrial fibrillation treatment.

The product consists of a catheter and connecting cable.Used in conjunction with the cardiac pulse electric field ablation instrument produced by the company., by controlling and releasing pulsed electric field energy of appropriate intensity, selectively induces irreversible electroporation damage only to the myocardial cells in the lesion area that requires treatment, thereby achievingTreatment of Atrial FibrillationThe purpose.

This product provides more options for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.。

As of the date of publication, the NMPA has approved a total of255 ModelsInnovative Product Registration Application.

# CardioPulse™ Pulsed Field Ablation Product

CardioPulse™ Pulsed Field Ablation Product byNuomao's Self-Developed, renowned American cardiac electrophysiology expert Professor Vivek Y. Reddy and Professor Tang Min from the Arrhythmia Center of Fuwai Hospital, Chinese Academy of Medical Sciences, provided guidance for the project development. The product is one with complete independent intellectual property rights.The Second Product in ChinaPulse Ablation Products for Atrial Fibrillation Treatment。

▲Image SourceOfficial CompanyNet

ItsFirst of its kind in ChinaThe multi-screw structureEasy to adjust for different diameter shapes, can better adapt to varying pulmonary vein anatomical differences; pulse electrodeWith both ablation and mapping functions, facilitating surgical operation; its adjustable bending delivery sheath has a large bending angle, easily achievingIntroduction of Multiple Pulmonary Veins。

CardioPulse™ Pulsed Field Ablation Catheter Completed the First Atrial Fibrillation Pulsed Ablation Surgery in Asia in December 2020.2In November 2023, Professor Tang Min from Fuwai Hospital, Chinese Academy of Medical Sciences, representing the PLEASE-AF research group, was invited to attend the 17th World Arrhythmia Congress (WSA) and delivered a presentation titled "Safety and One-Year Efficacy of the CardioPulse™ Pulsed Field Ablation System in Patients with Paroxysmal Atrial Fibrillation:The sharing of the PLEASE-AF study marks the first international presentation of its results.

Clinical studies have fully demonstrated,CardioPulse™ Pulsed Field Ablation System for the Treatment of Patients with Paroxysmal Atrial FibrillationGood safety and effectiveness。

Professor Tang Min from the Arrhythmia Center of Fuwai Hospital, Chinese Academy of Medical Sciences, stated after the surgery: "In recent years, with the development of catheter ablation concepts and technology,Catheter ablation has become an important treatment method for atrial fibrillation.In this surgery, we achieved good surgical results by using the pulsed ablation system from Nuomao Medical.The most intuitive feeling is fast and safe., it is believed that with its widespread clinical application, the safety and efficacy will be further validated. The successful application of this product will usher in a new era of atrial fibrillation ablation treatment!"

# AboutNuomao

Hangzhou Nuomao Medical Technology Co., Ltd. (formerly "Nuomao Medical") was established in 2016 as a company incubated by Nuomao, and is committed to...Interventional medical devices for atrial fibrillation electrophysiology and stroke preventionAn innovative medical enterprise engaged in the research and development, manufacturing, sales, and technical support.

The company's main products areAtrial Fibrillation Pulse Field Ablation and Other Electrophysiological DevicesAndLeft Atrial Appendage Occluders and Other Stroke Prevention Devices。

The company currently has 144 patents. As of the date of this report, the company's financing history is as follows:

# Current Status of Atrial Fibrillation Treatment

Atrial fibrillation is a heart disease that poses a serious threat to human health. Compared with non-atrial fibrillation patients,Patients with atrial fibrillation have higher mortality rates, readmission rates, and stroke incidence, along with a general decline in quality of life.According to the epidemiological survey data from the Atrial Fibrillation Center,The prevalence of atrial fibrillation among adults in China has reached 1.6%., which means that currently in China there areApproximately 20 million patients with atrial fibrillation。

With the continuous advancement of medical technology, patients with atrial fibrillation have more treatment options. Among them,Catheter ablation has become the main treatment for maintaining sinus rhythm in patients with atrial fibrillation., and pulmonary vein isolation (PVI) is the cornerstone of catheter ablation therapy.

However, despite years of clinical exploration of various ablation energy sources, including radiofrequency and cryoablation, the development of these energy sources seems to have hit a bottleneck. High ablation recurrence rates, significant impact of surgical outcomes by the operator's experience, and high incidence of ablation-related complications have remained insurmountable obstacles for these modalities.

Therefore, there is an urgent need for a new type of catheter ablation technology that is safer, easier to operate, and more efficient to address these issues.

Relevant data shows that in 2022, radiofrequency ablation accounted for 88% and cryoablation accounted for 12% of atrial fibrillation ablation procedures in China. It is expected that pulsed field ablation will be commercialized in China within two years.By 2028, the number of atrial fibrillation ablation procedures in China will reach 590,000 cases, among whichThe proportion of pulsed electric field ablation procedures will reach about 9%.。

Application of Pulse Ablation TechnologyHigh Voltage Pulsed Electric FieldProducing specific effects within the heart chambers. When an electric field acts on tissue cells, the phospholipid bilayer in the cell membrane will shift and rearrange according to the direction of the electric field, a process that will causeIrreversible Electroporation of Cell MembraneThis electroporation will trigger the apoptosis mechanism, effectively eliminating and blocking the transmission of abnormal potentials.

Pulse ablation has the following advantages：

Selective, without damaging surrounding tissues
Non-thermal ablation method, basically no thermal damage
Will not cause pulmonary vein stenosis
Low contact requirement, short discharge time

▲Comparison of Pulsed Field Ablation and Radiofrequency Ablation

# Overview of the Pulsed Electric Field Ablation Market

In the U.S. market,MedtronicAnnounced in December 2023: Its Key PFA ProductPulseSelect Pulsed Field Ablation (PFA) System Receives FDA Approval, which can be used to treat paroxysmal and persistent atrial fibrillation, becomingThe World's First PFA System to Receive FDA Approval。

Following closely,Boston ScientificAlso announced in January 2024, itsFarapulse Pulse Field Ablation (PFA) System Receives FDA Approval, used to isolate pulmonary veins when treating drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF).The Second FDA-Approved PFA Product in the World。

In the European market, Boston Scientific'sFarapulse Pulsed Field Ablation SystemAs early as January 2021, it received EU CE approval, becomingThe World's First PFA Product to Receive CE ApprovalIn November 2023, Medtronic'sPulseSelect Pulsed Electric Field AblationSystem approved by CE, becomingThe Second PFA System in the World to Obtain CE Certification。

February 2024,Johnson & JohnsonTheVaripulse Pulsed Electric Field Ablation SystemReceived CE approval, becoming globalThe Third CE-Certified PFA Product。

It is reported that the Varipulse pulsed field ablation system is used to treat symptomatic drug-refractory recurrent paroxysmal atrial fibrillation.Previously, the product received approval from Japan's MHLW in January 2024, becomingThe first PFA product launched in Japan。Based on the progress of the Varipulse pulsed field ablation system, industry insiders expect that Johnson & Johnson's Varipulse is likely to become the third PFA product to receive FDA approval.

In addition, another global device giantAbbottAlso developed a strong interest in PFA technology. In January 2024, Abbott announced that its subsidiaryNovel Volt Pulsed Electric Field Ablation System Initiates Clinical Trials, to obtain EU CE certification. Abbott also expects the FDA to approve the IDE clinical trial application for the Volt pulsed field ablation system in the first half of this year.

As Medtronic, Johnson & Johnson, Boston Scientific, Abbott and other multinational giants have received approval or expedited registration for their PFA products in major device markets such as the United States and Europe, the four major device giants are expected to engage in fierce competition in the global electrophysiology market to capture market share.

It should be noted that PFA is considered a disruptive innovation technology, and its scaled application may lead to the contraction of markets and reduction in revenue for traditional products such as radiofrequency ablation, cryoablation, and 3D mapping systems. Currently, major electrophysiology companies like Medtronic and Johnson & Johnson generate most of their revenue in the electrophysiology field from traditional products like radiofrequency ablation and 3D mapping systems. Therefore,How to balance corporate revenue, business competition, and PFA promotion will become an issue the giants need to consider.。

Outside the U.S. and European markets,As the world's second-largest medical device market, China is also a key focus for major PFA companies.. As of now,Medtronic, Johnson & Johnson, and Boston Scientific's PFA products have all entered the NMPA Innovative Medical Device Special Review Process.. However, Chinese companiesThe cardiac pulse electric field ablation system of Jinjiang Electronics isThe World's First PFA Product Approved by the National Medical Products Administration (NMPA)。

In December 2023, the pulsed field ablation system independently developed by Jinjiang Electronics received approval from the National Medical Products Administration for marketing in China, intended for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.It is reported that its pulsed field ablation system consists of two parts: the LEAD-PFA cardiac pulsed field ablation generator and a single-use cardiac pulsed field ablation catheter.

NuomaoCardiPulse, a self-developed cardiac pulsed field ablation catheter, was approved for marketing by the NMPA on March 11, 2024.Becomes the second cardiac pulsed field ablation system approved by NMPA。

In addition to Jinjiang Electronics and Nuomao, other PFA products made in China have also made varying degrees of progress.For example, the PFSA system developed by ZHOU LING Medical completed the world's first two cases of surgical pulsed field ablation for atrial fibrillation in February 2023.Xinluitong's pulsed electric field ablation system completed two registration clinical trial surgeries in January 2023.

ThisIn addition, the PFA products of domestic innovative companies such as Northcore Life, Ruidi Bio, AccuPulse, XuanYu Medical, Maiwei Medical, Nuomao, Hongtong Industry, Epflex (a subsidiary of Huitai Medical), and Shangyang Medical (a subsidiary of MicroPort EP) have all entered the NMPA special review process. Approximately 50 other companies are also developing PFA cardiac ablation systems.

# PulseElectric Field Ablation Players in China

Currently, the potential of China's cardiac electrophysiology market is enormous, with an electrophysiology procedure penetration rate of less than 1%, offering vast room for development; in China's cardiac electrophysiology market, the market share of domestically produced brands is less than 10%, presenting significant opportunities for domestic substitution.

Jinjiang Electronics

Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. is a company focused onHigh-end Innovative Medical Devices in the Field of Cardiac ElectrophysiologyA high-tech enterprise engaged in R&D, production, and sales. The company has been deeply involved in the field of cardiac electrophysiology for twenty years. Based on a profound understanding of electronic engineering and clinical science, it continuously innovates and iterates its products, gradually formingA full product matrix covering devices and consumables in the cardiac electrophysiology field, with extensions into pain management and vascular intervention.Expand.

In December 2023, the National Medical Products Administration approved the innovative product registration applications for "Disposable Cardiac Pulsed Field Ablation Catheter" and "Pulsed Field Ablation Generator" submitted by Jinjiang Electronic Medical Technology Co., Ltd. This isThe First Approved Cardiac Pulsed Field Ablation Product in China(NMPA Registration No. 20233012051).

Jinjiang Electronics LEAD-PFA Pulsed Field Ablation System is a magnetic navigation-based system andIntegrated with 3D modeling, mapping, and ablationNuomao's cardiac pulsed field ablation system. Unlike traditional ablation technologies such as radiofrequency and cryoablation, this system uses pulsed field technology to achieve precise and rapid ablation.

The system has a fast ablation speed, short procedure time, and lower requirements for catheter contact.Significantly improved the efficiency of the surgeryIt can avoid the risks of eschar and popping in traditional radiofrequency ablation surgery, while also preventing damage to adjacent tissues (nerves, coronary arteries, esophagus, etc.),Significantly improved the safety of the surgery. This system is expected to be used in atrial fibrillation ablation procedures and will foreseeably bring revolutionary technological progress to atrial fibrillation ablation in China.

Aikema

AccuPath was founded in November 2020 and is committed to深耕于Cardiac Electrophysiology FieldThe platform-based technological innovation has enabled the company to build a research and development team led by a well-known electrophysiology technology expert from the United States. The team has received strong support from returning overseas scientists, renowned clinical experts, and venture capital institutions. Its research and development centers are located in Suzhou and the United States.

AccuPath has established nearly 10 product pipelines based on new technologies such as pulsed field ablation (PFA) and innovative 3D mapping, covering the complete process of diagnosis and treatment for atrial fibrillation, premature ventricular contractions, and other arrhythmia ablations. In April 2023,AccuPulse Pulsed Field Ablation System, independently developed by Accuro Medical, has successfully completed the enrollment for all clinical studies.`, ranking among the top tier of clinical research teams for pulsed electric field products both in China and internationally,`Planned to be launched simultaneously with Aikema's self-developed cardiac 3D mapping system in 2025.。

Xuanyu Medical

Xuanyu Medical was founded in 2020 and is a company focused onElectrophysiology and Peripheral Intervention FieldsHigh-tech medical device company. Through years of research and development and technological breakthroughs, it has already made its strategic layout.Disease areas such as atrial fibrillation and varicose veinsInnovative Medical Device Solutions Aim to Become a Leading Provider of Atrial Fibrillation Electrophysiology and Peripheral Vascular Intervention Solutions in China.

Xuanyu Medical Company's independently developed and produced"Multi-channel Pulsed Electric Field Ablation System" completed its first clinical trial in March 2022, showing significant efficacy.In June 2022, Xuanyu Medical announced the completion of its Series A financing round worth hundreds of millions of yuan. This round of investment was jointly led by Apricot Capital and Xingzhen Capital, with continued support from existing shareholders such as Daotong Investment, Bangming Capital, and Haimaidi Ventures. Dingshi Capital served as the exclusive financial advisor. The funds raised will be used to further expand the R&D pipeline, clinical trials, and personnel recruitment.

Far Mountain Medical

Far Mountain Medical was founded in 2014, focusing onIrreversible Electroporation Technology, LayoutTwo major product directions: malignant tumor treatment and cardiovascular treatment, with Tianjin Yingtai Li An Kang Medical Technology Co., Ltd. and Shanghai Yuan Shan Medical Technology Co., Ltd. under its umbrella.

Under its umbrellaAieryi Steep Pulse Minimally Invasive Treatment System, has obtained the Class III medical device registration certificate for the treatment of malignant solid liver tumors in the field of irreversible electroporation. Used forPulse Field Ablation Device for Cardiac Electrophysiology Treatment, has obtained authorization for its own patented technology in China,And multi-center clinical trials have been carried out in more than ten hospitals across China.。

Nuomao's pulsed field ablation system can perform surgeries under local anesthesia, achieving true non-thermal ablation, and significantly improving the safety and effectiveness of atrial fibrillation ablation procedures.Nuomao's pulsed field ablation systemIn 2019, received the National Utility Model Patent Certificate; in 2021, received the National Invention Patent Certificate, and launched multi-center clinical trials in China.In 2022, it passed the special approval for innovative medical devices by the state and became the first domestically produced PFA product approved as an innovative medical device in China.

Zhouling Medical

Zhouling (Shanghai) Medical Device Co., Ltd. is an innovation-driven medical device company focused on R&D, dedicated to providing high-quality medical devices for patients in China and around the world.Treatment of Nervous System, Cardio-Cerebral SystemAnd other life-threatening major diseases.

Zhouling MedicalThe self-developed LomaPulse® pulsed electric field ablation product uses high-voltage electric pulse energy that enables myocardial selective ablation, avoiding damage to normal tissues surrounding the lesion.At the same time, Zhouling Medical applies its uniquely innovative catheter design technology, self-learning detection technology, and multi-modal polarization fusion ablation technology to the field of atrial fibrillation treatment, which will further improve the efficiency and success rate of ablation surgeries.

On June 18, 2022, the LomaPulse® pulsed field ablation product independently developed by Zhouling Medical successfully completed the first-in-China (FIM) enrollment at the Third Xiangya Hospital of Central South University. The patients had good surgical outcomes and have since been discharged after recovery. By the end of February 2023, the surgical pulsed field ablation system (PFSA), also independently developed by Zhouling Medical, was used to perform the world's first two cases of surgical pulsed field ablation for atrial fibrillation at Guangdong Provincial People's Hospital.

Maiv Micro Medical

Shenzhen Maiwei Medical Technology Co., Ltd. was established in July 2021 and is a company with industry-leadingMultimodal energy platforms and key technologies such as pulsed electric fields, ultrasound, and radiofrequencyInnovative medical device companies. Currently, Maiwei Medical has targetedIndications such as cardiac electrophysiology (atrial fibrillation), liver tumors, and refractory hypertensionLayout of multiple innovative medical device products for treatment, breaking through several bottleneck problems in the industry, and achieving better clinical efficacy and safety.

In August 2023, the product developed by Maiwei MedicalWorld's First Nanosecond Pulsed Electric Field Atrial Fibrillation Ablation (nsPFA) System Completes Enrollment for All Registrational Clinical Trials, the system is currently nationwideThe World's Only nsPFA Product to Enter Registered Clinical Trials。

The product has received high praise from clinical experts for its excellent performance and the technical advantages of the third-generation nanosecond pulsed electric field ablation (nsPFA). nsPFA, with its high efficiency and low stimulation of nanosecond pulses, effectively addresses issues associated with existing PFA technologies, such as high anesthesia requirements, muscle contractions, and patient pain, making PFA atrial fibrillation ablation procedures more efficient and safer.

Huitai Medical

Founded in 2002, Huitai Medical is a company that integratesCardiovascular and Cerebrovascular Interventional DevicesA high-tech enterprise integrating R&D, production, and sales.The First Manufacturer in China to Obtain Market Access for Electrophysiology Electrode CathetersThe company has complete project teams in product R&D design, clinical, and registration for both consumables and equipment fields, investing over 15% of its annual turnover into innovative product development. It has deep technical reserves and high-end manufacturing capabilities in the cardiovascular interventional products field, including electrophysiology electrode catheters, coronary intervention catheters, and 3D equipment.

It is reported that the pre-market clinical trial of HuTai Medical's innovative product, the cardiac pulse ablation PFA system, conducted at multiple centers in China, has successfully completed the enrollment of all patients.The cardiac pulse ablation PFA system is the world's first ablation system that integrates three key features: "pressure sensing/contact indication," "magnetic and electrical dual-position 3D mapping," and "pulse ablation."。

In clinical trialsThe average intraoperative treatment time is only about 50 minutes, with an immediate pulmonary vein isolation rate of 100%.。The follow-up results of the completed surgeries have been good, with no serious device-related adverse events occurring, further proving the safety and effectiveness of the PFA catheter.

Xinlv Tong

Shanghai Xin Lü Tong Life Technology Co., Ltd. is a modern comprehensive high-tech enterprise dedicated to the high-end medical device field, integrating scientific research, development, production, and sales. The company's main businesses are concentrated inCardiovascular Active Interventional Diagnosis and TreatmentField, a high-level R&D team composed of doctoral and master's degree holders from China and abroad has been established.

The company is focusing on utilizing the latest international cardiac electrophysiology technology to independently develop a highly innovative, world-class quality, yet domestically priced high-tech product, benefiting patients both in China and internationally. In January 2023, Shanghai Xinlü Tong Life Technology's self-developedPulse Field Ablation (PFA) System for Atrial Fibrillation Completes Two Registration Clinical Trials, marking that Xin Lü Tong Technology's PFA project has officially entered the registration clinical research enrollment phase.

Xin Hang Lu Medicine

Heartvoyage Medical was founded in 2020 by senior electrophysiology experts from China and the United States. Headquartered in Guangzhou, China, the company has established a wholly-owned subsidiary in California, USA. The company's mission is to develop next-generation atrial fibrillation treatment products.Provide a one-stop atrial fibrillation treatment solution centered around "3D mapping + PFA ablation"。

Self-developed by Xinhang Road MedicineThe DePolar mapping system is the world's first cardiac "4D" mapping system.The DePolar mapping system is the first to seamlessly integrate magnetic and electrical contact mapping with non-contact magnetic and electrical mapping in both technological development and clinical application, forming a unified mapping architecture.

Relying on the DePolar mapping system, Cardioviz Medical has built an integrated 3D PFA product portfolio of "magnetic and electric 3D + magnetic and electric PFA," proactively deploying a variety of globally innovative PFA ablation catheters. It is suitable for the comprehensive treatment of complex arrhythmias such as paroxysmal atrial fibrillation and atrial flutter, and will also be...The world's only PFA product portfolio capable of mapping persistent atrial fibrillation and achieving personalized ablation。

In August 2023, Heartvoyage Medical announced the completion of its Series A financing. This round of financing was jointly led by Lapam Investment and Lilly Asia Ventures (LAV), with a total financing amount of 200 million RMB.This round of financing will provide strong support for Heartvoyage Medicine to advance the clinical registration and commercialization of multiple重磅 electrophysiology products., and help the company further improve its R&D system, comprehensively enhancing its technological advantage in the global electrophysiology field.

# Global Leading Cardiovascular Device Company

Medtronic｜J&J MedTech|Boston ScientificBoston Scientific|

Edwards Lifesciences | Abbott Abbott｜

# Chinese Cardiovascular Device Companies Listed in China

# Innovative Devices Approved in China in 2023

China Cardiovascular Innovation Device List [2023 Review]

#2023 Medical Devices Entering the Innovation Channel in China

XinQing Medical (NyokAssist Interventional Ventricular Assist System)

Beixins Life (Cardiac Pulsed Field Ablation)

Hanling Medical (Transcatheter Aortic Valve)

# Other Unlisted/Start-up Cardiovascular Companies