Company Profile

Guangdong Pulse Medical Technology Co., Ltd.

Focusing on the research and development and production of cardiovascular medical devices

Guangdong Pulse Medical Technology Co., Ltd. (hereinafter referred to as "Pulse Medical") is a high-tech enterprise dedicated to the research, development, production, and sales of cardiovascular medical devices. The company headquarters and pilot production base are located in Zhuhai National High-tech Industrial Development Zone, including a Class 10,000 cleanroom, a Class 10,000 sterile testing room, a microbial limit testing room, and a positive control testing room, possessing advanced research conditions such as independent physical and chemical testing laboratories. The company's product research personnel have a global presence, distributed in countries such as China, the United States, and Germany, with domestic locations including Zhuhai, Shanghai, Beijing, Tianjin, Hangzhou, Chengdu, Xiamen, Xi'an, Hong Kong, and Macau.

The company's strategic focus is on the original research and development of high-end cardiovascular implantable and interventional medical devices. It possesses complete independent intellectual property rights for its products and adopts a "substitution of imports" business development approach. Since the reform and opening up, many industries in China have evolved from "import substitution" to "industrial leapfrogging," achieving large-scale exports of Chinese products and making China the most modern world factory, surpassing Europe and the United States. Currently, in the field of high-end cardiovascular implantable and interventional medical devices, China is still in the early stages of industrial development. Overall, China's "import substitution" in the field of high-end cardiovascular medical devices has only just begun.

China has a massive population base, presenting a huge growth potential for the cardiovascular medical device market. With 1.4 billion people and an urbanization rate exceeding 60%, China has over 840 million urban residents. In contrast, the combined population of the 50 European countries is only 740 million, Japan only 125 million, and the United States only 328 million. Currently, the overall cost of minimally invasive cardiovascular interventional surgery remains high, suppressing consumer demand. The release of high-end consumer demand in China will be a gradual process. However, with China's economic development and increased health awareness among residents, the market demand for high-end cardiovascular medical devices in China will continue to grow in the long term.

Minimally invasive interventional therapy (also known as interventional radiology) is an emerging, cutting-edge interdisciplinary field. Minimally invasive interventional therapy represents a milestone in the leap forward of clinical medicine and a groundbreaking advancement. The research and development of cardiovascular implantable and interventional medical devices is extremely challenging and involves high barriers to entry, requiring the comprehensive application of multiple disciplines such as pathology, anatomy, physiology, imaging, internal medicine, surgery, materials science, engineering, and technology. Currently, interventional treatment methods and implantable medical devices worldwide are still immature and undergoing development and improvement, possessing enormous potential for growth. Pulse Medical is determined to participate in this era of medical innovation.

Our company has pioneered a successful "medical-engineering integration" new product development model. Senior cardiovascular minimally invasive interventional surgeons possess extensive clinical experience and a deep understanding of the advantages, disadvantages, and individual patient needs of existing clinical medical devices. The collaboration and mutual inspiration between clinical medical experts and corporate engineering technicians yield excellent results in product optimization and technological innovation. Since 2016, the State Council has strongly supported and encouraged researchers in public institutions to engage in part-time innovation and start businesses while employed. Our company has taken the lead in utilizing this national policy to actively explore the "medical-engineering integration" R&D model.

Our R&D system brings together academicians from the Chinese Academy of Sciences and the Chinese Academy of Engineering in the field of cardiovascular medicine, directors of cardiology centers in top-tier hospitals, and clinical experts in minimally invasive interventional cardiovascular treatment. This has injected strong innovative power into our product development, placing our research capabilities at a leading level in the industry. Our "medical-engineering integration" new product development model allows Pulse Medical to achieve rapid development by standing on the shoulders of domestic and international medical giants. Years of practice have shown that this "medical-engineering integration" R&D model has achieved excellent results—low risk, high efficiency, and low investment—something that is difficult to achieve solely through a company's own engineering and technical capabilities.

Our Leftear left atrial appendage occlusion system is one of the achievements of our "medical-engineering integration" R&D model. Based on the clinical experience of our R&D system's physicians, our Leftear left atrial appendage occlusion device features a completely new structural design. It incorporates the advantages of similar foreign products while overcoming their shortcomings, possessing unique advantages. The long-term clinical use cases of foreign left atrial appendage occlusion devices are equivalent to a large-scale clinical trial. The structural design of our Leftear left atrial appendage occlusion device overcomes the structural defects of similar products from the United States and Germany, significantly improving the performance and therapeutic effect of our product, demonstrating a significant "late-mover advantage."

Our Leftear left atrial appendage occluder product rapidly completed clinical trial enrollment of 200 patients within 11 months, from October 2018 to September 2019. Compared to other cardiovascular implantable medical devices, our product's clinical trial enrollment speed is among the fastest. The participating hospitals in this clinical trial are all nationally renowned tertiary hospitals, including: Fudan University Affiliated Zhongshan Hospital, Tongji University Affiliated Shanghai Tenth People's Hospital, Tongji University Affiliated Shanghai East Hospital, Peking University First Hospital, Zhejiang University Second Affiliated Hospital, Xiamen University Cardiovascular Hospital, Sichuan University West China Hospital, Xi'an Jiaotong University First Affiliated Hospital, Tianjin Medical University General Hospital, and nine other experimental centers. The fact that our product can undergo clinical trials in these top-tier hospitals demonstrates the high level of recognition our product receives. Postoperative follow-up statistics show excellent treatment results, and we expect to obtain the product registration certificate by the end of 2021.

Our company's products under development are mainly distributed in four categories: cardiovascular implantable products (including Leftear left atrial appendage occluders, biodegradable patent foramen ovale [PFO] occluders, transcatheter biological mitral and tricuspid valves, left ventricular isolation systems [volume reduction umbrellas], etc.), cardiovascular interventional products (including percutaneous vascular suture devices, patent foramen ovale [PFO] suture devices, etc.), sheath products (including adjustable bending sheaths, delivery sheaths, etc.), and intelligent monitoring and rehabilitation products (wearable intelligent ECG monitoring garments).

Our company has established a "Postdoctoral Research Station." In May 2018, Tongji University School of Medicine established a "Postdoctoral Innovation Practice Base" at Guangdong Pulse Medical Technology Co., Ltd. This is the first postdoctoral innovation practice base established by Tongji University School of Medicine outside of Shanghai. Several doctoral students from Tongji University have been dispatched to Pulse Medical to conduct research. The establishment of the postdoctoral innovation practice base has enhanced our company's scientific research and innovation capabilities, and through exchanges and cooperation with clinicians, it has further promoted the improvement of our product innovation capabilities.

In December 2019, our company officially became a high-tech enterprise through the certification of the Guangdong Provincial Department of Science and Technology.

Our company has successfully hosted two "Cardiovascular Industry Innovation and Transformation Summit Forums": the "2017 Guangdong-Hong Kong-Macao Greater Bay Area Cardiovascular Industry Innovation and Transformation Summit Forum" in June 2017, and the "2020 China (Guangdong) Cardiovascular Industry Innovation and Transformation Summit Forum" in January 2020. At these two summits, leading experts in the field of cardiovascular medicine from home and abroad gathered to deliver insightful speeches and conduct in-depth discussions on hot topics, challenges, and cutting-edge issues in minimally invasive interventional treatment of cardiovascular diseases.

The participating experts delivered numerous keynote speeches that significantly impacted the treatment of cardiovascular diseases and the development of medical devices. These included: Academician Gao Runlin, Chinese Academy of Engineering, former president of Beijing Fuwai Cardiovascular Hospital of the Chinese Academy of Medical Sciences, and former president of the Asia-Pacific Society of Interventional Cardiology; Academician Ge Junbo, Chinese Academy of Sciences, director of the Institute of Biomedical Sciences at Fudan University, director of the Shanghai Cardiovascular Institute, and director of the Department of Cardiology at Zhongshan Hospital affiliated with Fudan University; Academician Chen Yihan, Chinese Academy of Sciences, vice president of Tongji University, and director of the Department of Cardiology at Tongji University; Professor Huo Yong, director of the Department of Cardiology and Heart Center at Peking University First Hospital; Professor Xu Yawei, Fellow of the American College of Cardiology (FACC) and director of the Heart Center at Shanghai Tenth People's Hospital affiliated with Tongji University; Professor Chen Wei, deputy director of the Department of Cardiology at Shanghai Tenth People's Hospital affiliated with Tongji University, who has performed over 2,500 minimally invasive interventional cardiovascular surgeries (known in the industry as the "King of Minimally Invasive Interventional Cardiology"); Professor Zhang Jian, director of the Heart Failure Center at Beijing Fuwai Cardiovascular Hospital of the Chinese Academy of Medical Sciences and deputy director of the National Clinical Research Center for Cardiovascular Diseases; and Fellow of the American College of Cardiology.(FACC)、Professor Wang Yan, President of the Cardiovascular Hospital Affiliated to Xiamen University and Director of the Xiamen Key Laboratory of Cardiovascular Diseases; Mr. Wang Baoting, former Director of the Medical Device Supervision Department of the China Food and Drug Administration (CFDA); Professor Chen Jiyan, Director of the Department of Cardiovascular Medicine, Guangdong Provincial People's Hospital; Professor Liu Xiaocheng, President of Tianjin TEDA International Cardiovascular Hospital, former Vice President of the Chinese Academy of Medical Sciences, and former Vice President of Peking Union Medical College; Professor Lin Yixian, Director of the Hong Kong Asian Heart Centre, Chairman of the Asia-Pacific Structural Heart Disease Youth Club, and Founder of the Hong Kong Society for Congenital and Structural Heart Disease; and Mr. Zhang, Secretary of the Party Committee of the School of Medicine, Tongji University, and Executive Vice Dean of the Institute for Advanced Studies in Translational Medicine, Tongji University. Professor Jun; Professor Luo Jianfang, Chief Physician of the Vascular Disease Diagnosis and Treatment Center, Guangdong Provincial People's Hospital; Professor Wu Guifu, Chief Physician of the Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University; Professor Liu Zhigang, Vice President of Tianjin TEDA International Cardiovascular Hospital; Professor Dong Peng, Director of the Department of Cardiology, Aviation General Hospital of China Medical University; Mr. Deng Xiwei, Member of the European Society of Cardiology (MESC) and the International College of Cardiology (ICA), President of the Macau Interventional Cardiology Society, and Chief Physician of the Macau Xixin Medical Center; Senior Engineer Xu Bo, Director of the Interventional Catheterization Laboratory, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences; Professor Liu Zheng, Chief Physician of the Cardiology Center, Shanghai Tenth People's Hospital Affiliated to Tongji University, and others. Their insightful keynote speeches played a significant guiding role in the innovation and transformation of the cardiovascular industry in China and the world!

Pulse Medical's goal: Based in China and with a global vision, to build a world-class R&D base for high-end cardiovascular implantable medical devices, providing the highest quality high-end medical devices for cardiovascular patients in China and around the world! We will work tirelessly with global medical giants to achieve this goal!

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