DeNovo EP Submits IPO Prospectus Following NMPA Approval of CardioPulse™ Pulsed Field Ablation Catheter
Nuomao
Cardiovascular Innovative Medical Device R&D Manufacturer
Source: Siyu MedTech
Reprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.
On March 11, 2024, the National Medical Products Administration approvedHangzhou Nuomao Medical Technology Co., Ltd.Single-Use Cardiac Pulsed Field Ablation Catheter"Innovative Product Registration Application.
As of the date of publication, the NMPA has approved a total of255 ProductsInnovative Product Registration Application (Click "Read Original" at the end of the article)
# AboutHangzhou Nuomao Medical Technology Co., Ltd.
Hangzhou Nuomao Medical Technology Co., Ltd. (formerly known as "Nuomao MedicalFounded in 2016, Nuomao is an innovative medical company incubated by Hangzhou Nuomao Medical Technology Co., Ltd., dedicated to the research, development, manufacturing, sales, and technical support of interventional medical devices for atrial fibrillation electrophysiology and stroke prevention.
# Current Status of Atrial Fibrillation Treatment
▲Radiofrequency Ablation and Cryoablation
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
It is reported that a few companies abroad have carried out research on the use of pulsed ablation catheters for the treatment of atrial fibrillation. Clinical studies with a certain sample size have preliminarily verified the safety and effectiveness of this procedure, and its therapeutic advantages have been fully demonstrated.
# UnderstandingCardioPulse™
CardioPulse™Pulse Ablation Products byNuomaoIndependently developed, with guidance from Professor Vivek Y. Reddy, a renowned cardiac electrophysiology expert in the United States, and Professor Tang Min from the Arrhythmia Center of Fuwai Hospital, Chinese Academy of Medical Sciences.This product is the first domestically produced pulsed ablation treatment for atrial fibrillation in China with full independent intellectual property rights.。
Its domestically首创的 multi-screw structure allows for easy adjustment of different diameter shapes, better adapting to variations in pulmonary vein anatomy.The pulsed electric field electrode has both ablation and mapping functions, facilitating surgical operation; itsThe adjustable bending delivery sheath has a large bending angle, allowing for easy introduction into multiple pulmonary veins.
CardioPulse™ Pulsed Field Ablation Catheter completed the first atrial fibrillation pulsed ablation surgery in Asia in December 2020. It is currently undergoing multi-center clinical trials. After completing the trials, it will apply for Class III registration approval from the National Medical Products Administration, with the hope of playing a significant role in the field of atrial fibrillation ablation as soon as possible.
In 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 Society of Arrhythmia (WSA) conference. He presented on the topic "Safety and One-Year Efficacy of the CardioPulse™ Pulsed Field Ablation System in Patients with Paroxysmal Atrial Fibrillation: The PLEASE-AF Study." This marked the first international presentation of the study's results.
Clinical studies have fully demonstrated the safety and efficacy of the CardioPulse™ pulsed ablation system in treating patients with paroxysmal atrial fibrillation.
Professor Tang Min from the Arrhythmia Center of Fuwai Hospital, Chinese Academy of Medical Sciences, stated after the surgery: "In recent years, based on the development of catheter ablation concepts and techniques, catheter ablation has become an important treatment for atrial fibrillation. In this surgery, we used Nuomao Medical's pulsed ablation system and achieved excellent surgical results. The most intuitive feeling was that it was fast and safe. I believe that with its widespread clinical application, its safety and efficacy will be further validated. The successful application of this product will usher in a new era of atrial fibrillation ablation therapy!"”
# Other Local PulsesElectric Field Ablation Company
Currently, the potential of the cardiac electrophysiology market in China is enormous, with an electrophysiology procedure penetration rate of less than 1%, indicating significant room for growth; in the domestic cardiac electrophysiology market, the market share of domestically produced brands is less than 10%, presenting vast opportunities for local substitution.
Si Yu reviewed nine other domestic pulse field ablation companies for readers' reference:
01
AccuPath was founded in November 2020 and is committed to platform-based technological innovation in the field of cardiac electrophysiology. The company has assembled a research and development team led by well-known American electrophysiology technology experts and has received strong support from returning overseas scientists, renowned clinical experts, and venture capital institutions. Its R&D centers are located in Suzhou and the United States.
AikemaEstablished nearly 10 product pipelines based on new technologies such as pulsed field ablation (PFA) and innovative three-dimensional 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 Aicompulse successfully completed the enrollment of all clinical studies.Ranked among the top tier of clinical research teams for pulsed field products both in China and internationally, with plans to launch simultaneously with Aikangmai Company's self-developed cardiac 3D mapping system in 2025.
02
Xuanyu Medical was founded in 2020 as a high-tech medical device company specializing in electrophysiology and peripheral interventions. After years of research and technological breakthroughs, the company has developed innovative medical device solutions for diseases such as atrial fibrillation and varicose veins, with the aim of becoming a leading provider of atrial fibrillation electrophysiology and peripheral vascular intervention solutions in China.
Xuanyu Medical's independently developed and produced "Multi-Channel Pulsed Electric Field Ablation Device" 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, led jointly by Apricot Capital and Industrial Securities Capital. Existing shareholders including Daotong Investment, Bangming Capital, and Haimaid Venture Capital continued to support the company, while Dingshi Capital served as the exclusive financial advisor. The funds raised will be used to further expand the R&D pipeline, clinical trials, personnel recruitment, and more.
03
Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. is a high-tech enterprise focused on the research, development, production, and sales of advanced innovative medical devices in the field of cardiac electrophysiology. Since its establishment, the company has consistently adhered to the spirit and philosophy of "nurturing life through technology," committing to provide safe and efficient comprehensive solutions for patients with tachyarrhythmia worldwide.
The company has been deeply engaged in the field of cardiac electrophysiology for two decades. Based on a profound understanding of electronic engineering and clinical science, it continuously innovates and iterates its products. It has formed a full product matrix covering equipment and consumables in the cardiac electrophysiology field and is expanding into the pain management and vascular intervention fields.
Jinjiang Electronics LEAD-PFA Pulsed Field Ablation System is a cardiac pulsed field ablation system based on magnetic positioning navigation that integrates 3D modeling, mapping, and ablation. Unlike traditional ablation technologies such as radiofrequency and cryoablation, this system uses pulsed field technology to achieve precise and rapid ablation.
The system features fast ablation speed, short operation time, and lower requirements for catheter contact, significantly improving the efficiency of the procedure. It can avoid the risks of eschar and popping associated with traditional radiofrequency ablation, while also preventing damage to adjacent tissues (nerves, coronary arteries, esophagus, etc.), greatly enhancing the safety of the surgery. This system is expected to be used for atrial fibrillation ablation, and it is foreseeable that it will bring revolutionary technological progress to atrial fibrillation ablation procedures in China.
June 10, 2022Jinjiang Electronics' self-developed "Cardiac Pulsed Field Ablation Device" has been approved by the National Medical Products Administration (NMPA) for the special review process of innovative medical devices, entering the "green channel" for special review.Jinjiang Electronics' "Cardiac Pulsed Field Ablation Device" consists of two products: the LEAD-PFA Cardiac Pulsed Field Ablation Instrument and the disposable Cardiac Pulsed Field Ablation Catheter.
04
Far-Mountain Medical is dedicated to developing China's active medical device products and has successfully established two major product directions: malignant tumor treatment and cardiovascular treatment. Among them, the Aier-Yi Steep Pulse Minimally Invasive Treatment System has obtained a Class III medical device registration certificate in China for use in the treatment of malignant liver cancer in the field of irreversible electroporation. The pulsed field ablation therapy device for cardiac electrophysiological treatment, developed by Hangzhou Nuomao Medical Technology Co., Ltd., has received approval as an innovative medical device produced in China and has been granted a national invention patent. Multi-center clinical trials have been carried out in more than ten hospitals across China.
Far Mountain Medical's pulsed field ablation system can perform surgeries under local anesthesia and achieve true non-thermal ablation, significantly enhancing the safety and effectiveness of atrial fibrillation ablation procedures.Nuomao's Pulse Field Ablation SystemIn 2019, received the National Utility Model Patent Certificate; in 2021, obtained the National Invention Patent Certificate and initiated multi-center clinical trials across China.In 2022, it passed the special approval for innovative medical devices by the national authorities, becoming the first domestically produced PFA product approved as an innovative medical device in China.
05
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 worldwide to treat critical life-threatening diseases of the nervous system, cardiocerebral system, and others.
Zhouling Medical's Self-developed LomaPulse®Pulse Field Ablation Products Utilize High-Voltage Electrical Pulses for Myocardial Selective Ablation, Avoiding Damage to Normal Tissue Surrounding the Lesion. Meanwhile, ZHOUling Medical Applies Its Unique Innovative Catheter Design Technology, Self-Learning Detection Technology, and Multi-Modal Polarization Fusion Ablation Technology in the Field of Atrial Fibrillation Treatment, Further Enhancing the Efficiency and Success Rate of Ablation Procedures.
On June 18, 2022, the LomaPulse independently developed by Zhouling Medical®Pulsed Field Ablation Product Successfully Completes China FIM Enrollment at Xiangya Third Hospital, Central South University; Patients Show Good Surgical Outcomes and Have Been Discharged After Recovery.At the end of February 2023, Zonleaf Medical's self-developed surgical pulsed field ablation system (PFSA) completed the world's first two cases of atrial fibrillation surgical pulsed field ablation surgery at Guangdong Provincial People's Hospital.
06
Shenzhen Maiwei Medical Technology Co., Ltd. was established in July 2021. It is an innovative medical device company with industry-leading multimodal energy platforms and key technologies, including pulsed electric fields, ultrasound, and radiofrequency. Currently, Maiwei Medical has developed several therapeutic innovative medical device products targeting indications such as cardiac electrophysiology (atrial fibrillation), liver tumors, and refractory hypertension. Based on the team's research accumulation of over 20 years, the company has overcome multiple bottleneck issues within the industry, achieving better clinical efficacy and safety.
In August 2023, the world's first nanosecond pulsed electric field atrial fibrillation ablation (nsPFA) system developed by Maiwei Medical successfully completed all patient enrollments for its registration clinical trial., this system is currently the 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 the 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.
07
Founded in 2002, Huitai Medical is a high-tech enterprise that integrates the research, development, production, and sales of cardiovascular and cerebrovascular interventional devices. It is the first manufacturer in China to gain market access for electrophysiological electrode catheters. The company has complete project teams covering R&D design, clinical trials, registration, and more, in both consumables and equipment fields. Over 15% of its annual turnover is invested into innovative product R&D. Huitai Medical possesses deep technical expertise and advanced manufacturing capabilities in areas such as electrophysiological electrode catheters, coronary interventional catheters, and three-dimensional equipment within the cardiovascular intervention product sector.
On February 15, 2023, it was announced that the pre-market clinical trial of Hu Tai Medical's innovative product, the cardiac pulse ablation PFA system, conducted at multiple centers in China, has successfully completed the enrollment of all patients.This cardiac pulsed field ablation (PFA) system is the world's first ablation system that integrates three key features: "contact force sensing/tissue proximity indication," "magnetic and electrical dual-position 3D mapping," and "pulsed field ablation."
The average intraoperative treatment time in clinical trials was 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 reported, further demonstrating the safety and efficacy of the PFA catheter.
08
Shanghai Xinlü 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 business focuses on the cardiovascular active interventional diagnosis and treatment field, and it has established a high-level R&D team composed of domestic and international Ph.D.s and Master's degree holders.
The company is focusing on leveraging 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.On January 7, 2023, the pulsed field ablation (PFA) system for atrial fibrillation treatment, independently developed by Shanghai Xinluitong Life Science and Technology, completed two registration clinical trials, marking the official entry of Xinluitong's PFA project into the registration clinical research enrollment phase.
9
Mind Voyage 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, providing a one-stop atrial fibrillation treatment solution centered around "3D mapping + PFA ablation."
DePolar Mapping System, independently developed by Hangzhou Nuomao Medical Technology Co., Ltd., is the world's first "four-dimensional" cardiac mapping system. The DePolar Mapping System seamlessly integrates magnetic and electrical contact mapping with non-contact mapping in both technological development and clinical application, forming a unified mapping architecture.
Relying on the DePolar mapping system, Cardionav 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 suitable for the comprehensive treatment of complex arrhythmias such as paroxysmal atrial fibrillation and atrial flutter, will also be the world's only PFA product portfolio capable of mapping persistent atrial fibrillation and achieving personalized ablation.
In August 2023, Heart Navigator 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. The funds will provide strong support for Heart Navigator Medical to advance the clinical registration and commercialization of multiple key electrophysiology products, and will also help the company further improve its R&D system, comprehensively enhancing the company's technological advantages in the global electrophysiology field.
Global MedTech TOP100: 2023 Global MedTech TOP100
2023 Global MedTech Industry Contribution Award
2023 Global Medical Technology Innovation Award
2023 Global MedTech Rising Star Award
2023 Global Innovative Medical Device Award
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
