Pulse Medical Submits IPO Prospectus: Building a Full-Chain Cardiovascular Medical Device Platform

Chronic diseases are like a slow-acting poison, constantly eroding patients' lives. Cardiovascular diseases are like the poison within“Red-crowned Crane’s Crest,” a condition more detrimental than other chronic diseases, with a mortality rate even higher than that of tumors. According to the latest data, cardiovascular diseases have a higher mortality rate than tumors and other diseases, accounting for over 40% of resident disease-related deaths.

Cardiovascular disease is the leading chronic disease in China and the primary cause of death among the Chinese population. Academician Ge Junbo, Chairman of the Chinese Cardiovascular Health Alliance, once stated, “While the overall mortality rate from cardiovascular disease in the United States has reached a downward turning point, the mortality rate from cardiovascular disease in China continues to climb. It is imperative that we urgently enhance the overall awareness and scientific prevention and control of cardiovascular disease in China.”

In 2019, the Two Sessions included chronic diseases in the Government Work Report for the first time, emphasizing the importance of prevention and control of chronic diseases and incorporating cardiovascular outpatient medications into medical insurance reimbursement. Due to the severe hazards posed by cardiovascular diseases, the government has attached great importance to this issue, making the prevention and control of cardiovascular diseases a renewed focus.

How can companies specializing in cardiovascular diseases help the public prevent such conditions? What innovative solutions are available for diagnosis and treatment? What new technologies are emerging in rehabilitation? With these questions in mind, a reporter conducted an exclusive interview with Guangdong Pulse Medical Technology Co., Ltd. (hereinafter referred to as “Pulse Medical”), a developer of high-end cardiovascular medical devices and consumables.

Pulse Medical, established in 2014 and located in the National High-Tech Industrial Development Zone of Zhuhai within the Guangdong-Hong Kong-Macao Greater Bay Area, is a high-tech enterprise dedicated to the research and development, production, and sales of cardiovascular medical devices.

Ruan Chengmin, Chairman of Pulse Medical, stated: “The company plans to build a comprehensive cardiovascular medical product industry chain encompassing ‘prevention + diagnosis + treatment + rehabilitation.’ Our confidence in this strategic layout stems from our robust technical R&D team.”

Currently, Pulse Medical employs over 20 R&D personnel, many of whom hold doctoral or master’s degrees. The company boasts not only a medical team well-versed in clinical medicine but also outstanding R&D and process engineers with more than ten years of industry experience. Ruan Chengmin stated, “This team is a high-caliber, high-quality group of multidisciplinary talents who are not only familiar with the development needs of the industry but also proficient in product manufacturing, sales, and management technologies.”

“Medical product R&D and design must avoid working in isolation; Pulse Medical’s products have truly realized the principle of ‘originating from clinical practice and applied in clinical practice.’” Ruan Chengmin remarked, “We adhere to the integration of medicine and engineering. All our products stem from clinical needs while also tapping into potential market demands. Meanwhile, our R&D personnel continuously track and study advanced technologies both domestically and internationally, gaining in-depth understanding of industry development trends and market dynamics at home and abroad. Furthermore, the team fully leverages technical innovations such as nickel-titanium alloy processing techniques and emerging materials to enhance product innovation, thereby serving a broader patient population.”

Ruan Chengmin stated, “Pulse Medical collaborated with Shanghai Tenth People’s Hospital of Tongji University to develop a left atrial appendage (LAA) occluder designed to prevent stroke caused by non-valvular atrial fibrillation. From the outset of product design, Pulse Medical incorporated feedback from clinicians. During clinical application, physicians identified limitations in foreign-made devices. In response to these clinical insights and considering the anatomical characteristics of Asian patients’ cardiac structures, Pulse Medical’s engineering team developed the domestically produced novel Leftear LAA occluder, optimizing it in terms of occlusion efficacy, surgical indications, expansion of one-stop procedural applications, and minimally invasive patient puncture.”

The development of the new product has undergone multiple stages, including design and R&D, design verification, animal testing, type testing, First-in-Human (FIH) studies, and clinical trials. Despite numerous challenges, the product has been granted multiple national invention patents, with plans to conduct further research and subsequent clinical studies.

According to the latest scientific evidence, left atrial appendage occlusion is safe and effective in preventing stroke. Furthermore, the market prospects for left atrial appendage occluders in China are promising, particularly against the backdrop of import substitution, where domestically produced medical devices hold greater competitiveness.

Ruan Chengmin stated, “The occluder we developed features a trapezoidal disc design to prevent residual leakage. Additionally, its ‘wine cork’-style design ensures feasibility for one-stop ablation and occlusion procedures without affecting surrounding tissues. Furthermore, we have downsized the delivery system to better align with Asian anatomical structures. Compared to existing products, I believe the new occluder developed by Pulse Medical provides more complete occlusion while sparing adjacent tissues.”

The clinical protocol for this product enrolled a total of 200 cases, and the enrollment phase of the clinical trial has been fully completed. Ruan Chengmin stated, “Based on the current surgical outcomes from clinical enrollment, this product can effectively close the left atrial appendage, and its safety profile meets the requirements for clinical use. The product can be used in the vast majority of patients with atrial fibrillation to effectively prevent stroke.” Pulse Medical and the team from Shanghai Tenth People’s Hospital will present the relevant clinical data for the first time at the CSI Focus LAA 2019 conference, organized by Professor Horst Sievert, Chair of International Structural Heart Disease, in November.

Ruan Chengmin revealed, “At the recently concluded 8th China Innovation and Entrepreneurship Competition, we competed with our Leftear Left Atrial Appendage Occluder System and ultimately advanced to the semi-finals of the biomedical industry finals. This marked the debut of the Leftear Left Atrial Appendage Occluder in a national-level competition. We are deeply honored that Pulse Medical was recognized as an ‘Outstanding Enterprise’ in the Growth Group of the 8th China Innovation and Entrepreneurship Competition.”

In fact, Pulse Medical has established a long-term industry-academia-research collaboration with Shanghai Tenth People’s Hospital. As its industry-academia-research practice base, Pulse Medical is responsible for the commercial translation and implementation of multiple products from the hospital. Meanwhile, Tongji University School of Medicine has set up a “Postdoctoral Innovation Practice Base” at Pulse Medical, jointly committed to the translational application of clinical research.

In addition to the left atrial appendage occluder, another product worth mentioning is the Xinkai wearable ECG monitoring device.

There are already numerous ECG monitoring devices on the market. The surge in popularity of these devices is straightforward: given the large population of patients with cardiovascular diseases, ECG waveforms often exhibit changes prior to sudden cardiac death. Through real-time monitoring and intelligent diagnosis, early warnings can be issued to patients. While ECG monitoring has a price, life is priceless. Consequently, many manufacturers have entered the ECG monitoring sector, hoping to capture a share of the market.

In a market where ECG monitoring products face fierce competition, what is Pulse Medical’s strategy for entering the fray? Ruan Chengmin told reporters, “Precision—our strength lies in precise detection. The vast majority of products on the market are single-lead, whereas our devices feature eight- or twelve-lead configurations. The twelve-lead model is a medical-grade product that delivers highly accurate monitoring.”

“Our wearable ECG monitoring device, XinKai, is easy and convenient to wear. It provides 24/7 monitoring of heart rate waveforms, with continuous monitoring lasting up to 96 hours. Its intelligent diagnostic algorithm enables early warnings for cardiac conditions, such as atrial fibrillation. Monitoring data can be displayed in real time on the user’s smartphone and uploaded to a cloud-based diagnostic service platform as needed. Through cloud analysis, results are provided in real time to both the user and authorized family members, thereby enabling cloud-based cardiac health management.”

According to Ruan Chengmin, Xin Kai completed the prototype development of its 8-lead and 12-lead smart ECG monitoring garments in early 2019. Resembling ordinary clothing, these garments do not restrict the wearer’s movements in any way. Currently, Xin Kai is conducting prototype testing and refinement to optimize product performance. The next step will be small-batch trial production.

In addition, Pulse Medical has other products under development, such as a volume reduction umbrella system for the treatment of heart failure caused by ischemic heart disease. Ruan Chengmin told reporters, “Our C-reducer volume reduction umbrella system features an internationally unique ‘breaststroke-like’ deployment design and a ‘barbed’ structural design, which can reduce ‘side leakage’ and myocardial injury. Meanwhile, this volume reduction umbrella allows for repositioning. Furthermore, it provides better occlusion and fixation effects, making it more suitable for the cardiac structural characteristics of the Asian population.”

Ruan Chengmin stated, “Over the next three years, the company’s product pipeline is robust. A series of medical devices, including the next-generation patent foramen ovale (PFO) occluder, left ventricular isolation system, mitral valve intervention devices, and PFO interventional suturing devices, will sequentially enter animal studies and clinical trials.”

Such a rich technical reserve is due to Pulse Medical's strong team and robust capabilities. In addition, both R&D and process engineers have over ten years of experience in the development of congenital heart defect occluders and delivery systems.

In terms of hard capabilities, Pulse Medical operates a 1,600-square-meter production facility, which includes over 500 square meters of Class 10,000 cleanroom space, a Class 10,000 sterile testing laboratory, a microbial limit testing laboratory, and a positive control testing laboratory. The company also features advanced research infrastructure, including independent physical and chemical testing laboratories.

Ruan Chengmin told reporters, “Pulse Medical attaches great importance to the protection of intellectual property rights and has applied for multiple trademarks and patents. To date, the company has filed a total of 33 patent applications, with several invention patents already granted.”

Regarding post-launch sales, Ruan Chengmin stated, “In fact, prior to founding Pulse Medical, I spent over two decades in sales and agency roles for medical devices and equipment, establishing a well-connected and mature sales network across China. Therefore, we will build our own sales channels. That said, during the initial launch phase, we will also collaborate with distributors, leveraging their networks to reach hospitals in regions where we have less presence.”

Regarding future plans, Ruan Chengmin revealed, “We will focus on the main thread of structural heart disease, leverage our advantages, and develop more related products. The market capacity is sufficiently large, and we will seize market share as quickly as possible. From another perspective, the pie is big, so there is no need to worry about the number of competitors. We just need to identify the market accurately and clarify our positioning.”

According to the VCBeat Dongguan Knowledge Base, in March 2019, Pulse Medical secured RMB 30 million in Series A funding from the renowned venture capital firm Chende Capital, valuing the company at RMB 200 million. Currently, Pulse Medical is on the verge of completing its Series A+ round, with the proceeds earmarked for follow-up studies and regulatory registration of its left atrial appendage occluder, market promotion, expert resource engagement, and team expansion. Ruan Chengmin revealed, “We anticipate initiating Series B funding next year to launch clinical trials and regulatory registration for new products, as well as to begin market预热 (pre-heating) and promotion.”