Vivest Medical Secures Nearly RMB 100 Million in Series A+ Financing to Advance Dual-Center Strategy of WCD and AED for Sudden Cardiac Death Prevention

VCBeat has learned that Suzhou Weiweisi Medical Technology Co., Ltd. (VIVEST MEDICAL, hereinafter referred to as “Vivest Medical”) has completed a Series A+ financing round of nearly RMB 100 million. The round was led by Oriza Holdings, with Nuowei Medical participating as an investor, and existing investors Northern Light Venture Capital, Bohua Capital, and Blue Sail Medical continuing to follow on. Previously, Vivest Medical announced in April 2021 that it had completed a Series A financing round of nearly RMB 100 million. It is reported that the funds raised in this round will be used for the regulatory registration and filing of its Wearable Cardioverter Defibrillator (WCD) product, the establishment of a data management center for the treatment of sudden cardiac death, research and development of new technologies, and mass production of Automated External Defibrillator (AED) products.

Suzhou Weiweisi Medical Technology Co., Ltd. is an innovative medical technology enterprise specializing in the prevention and treatment of ventricular arrhythmias and cardiac rhythm data services. Targeting malignant arrhythmias, the company is committed to providing globally leading, comprehensive solutions covering the entire continuum of care—prevention, monitoring, treatment, and rehabilitation—to build a non-invasive platform for the prevention and management of ventricular arrhythmias and sudden cardiac death.

Currently, relying on its technical strength and innovation capabilities, Weiweisi Medical has developed a Wearable Cardioverter Defibrillator (WCD) and an Automated External Defibrillator (AED).According to reports, Weiweisi Medical holds full independent intellectual property rights for two of its products, and WCDIt is a pioneering product with independent intellectual property rights in China, and has already been in 2020Year 12Approval for Entry into the Innovative Medical Device Review Channel: The Launch of Domestically Produced WCDs and AEDs Will Break Monopolies and Enhance China’s Capacity for the Prevention and Treatment of Out-of-Hospital Sudden Cardiac Death.

Oriza Holdings, the investor in this round, has long-term strategic layouts and professional expertise in the field of innovative cardiovascular devices. Managing Partner Yang ZhiwenOriza Holdings stated: “We believe that Weiweisi’s Wearable Cardioverter Defibrillator (WCD) product addresses a significant unmet need in the field of cardiac disease treatment in China. There are nearly ten million patients with low ejection fraction annually due to conditions closely associated with sudden cardiac death, such as ischemic cardiomyopathy, structural heart disease, and heart failure. We anticipate that Suzhou Weiweisi Medical Technology Co., Ltd. will become the second company globally to launch a WCD. As investors, we place greater emphasis on the team’s vision for transforming the WCD into a data service platform for cardiac rhythm management in the future. This initiative will significantly advance the development of out-of-hospital treatment protocols for patients with heart failure and atrial fibrillation, as well as foster the emergence of integrated therapeutic approaches, including related pharmaceutical research. Through comprehensive patent due diligence, we have learned that the team has leveraged innovative technologies to achieve full independent intellectual property rights, successfully mastering this ‘crown jewel’ technology for the treatment of malignant arrhythmias within a short timeframe. This demonstrates their exceptional execution capabilities and independent R&D creativity. We look forward to their swift promotion of product registration and market launch, thereby saving more lives.”

Zheng Jie, founder of Weiweisi Medical, stated: “The wearable automated external defibrillator continuously monitors patients’ electrocardiograms (ECG) 24 hours a day via an ECG monitoring system. When ventricular arrhythmia signals are detected, the device issues an alert. If the patient is unconscious or unresponsive, the device automatically activates its fully automatic defibrillation mode, re-evaluates for ventricular arrhythmia, and, upon confirming that the patient remains unconscious or unresponsive, administers conductive gel and delivers a shock.”

Compared with defibrillator products on the market, wearable automated external defibrillators (AEDs) offer advantages such as ease of wear, flexible usage cycles, low cost of use, and reliable defibrillation efficacy, holding significant importance for the remote prevention and treatment of ventricular fibrillation in high-risk populations for sudden cardiac death.

In addition to wearable automated external defibrillators, Weiweisi Medical has also launched automated external defibrillators (AEDs). These devices are deployed in high-traffic public venues such as airports, hotels, train stations, sports facilities, and schools, for use by trained personnel to provide emergency treatment to individuals experiencing sudden cardiac arrest in public settings.

Zheng Jie stated, “Compared to wearable automated external defibrillators, AEDs are moreEmphasizing Portability and Reliability. From the perspective of product application scenarios, AEDs are more suitable forPublicofSudden Cardiac Death Prevention, wearable cardioverter-defibrillators are more suitable for ensuring the safety of high-risk populations. Therefore, the promotion and application of AEDs and wearable cardioverter-defibrillators will respectively ensure the prevention and control of sudden cardiac death in public settings and the safety of high-risk patients with sudden cardiac death at home, thereby helping China enhance its out-of-hospital prevention and control capabilities for sudden cardiac death.”

According to the publicly available data from the "Report on Cardiovascular Health and Diseases in China 2019," there are approximately 330 million patients with heart disease in China, including 8.9 million with heart failure, 11 million with coronary heart disease, and 245 million with hypertension. In terms of harm, the incidence rate of sudden cardiac death in China is 41.84 per 100,000 people. Data from the National Tenth Five-Year Plan key research project shows that the number of sudden deaths caused by cardiac issues reaches as high as 544,000 per year, ranking first globally. When a patient experiences cardiac arrest, the cerebral cortex can tolerate hypoxia for only 4 minutes; thereafter, vital organs such as the brain will undergo necrosis due to lack of oxygen. If cardiac arrest lasts longer than 4–6 minutes, irreversible damage to brain tissue will occur; if it exceeds 10 minutes, brain death will result.The golden window for treating patients with cardiac arrest isreferred to asClinical“"The Golden Four Minutes"”。

Constrained by the therapeutic time window, providing effective defibrillation protection for patients at high risk of out-of-hospital cardiac arrest has remained a significant challenge. To address this issue, multiple clinical guidelines and expert consensus statements worldwide have recommended the use of wearable cardioverter-defibrillators (WCDs) for defibrillation protection. For instance, the "2020 Chinese Expert Consensus on Ventricular Arrhythmias" recommends the application of WCDs for the prevention and treatment of cardiac arrest, the prevention of cardiac arrest in patients with ischemic heart disease and acute coronary syndrome, as well as for the treatment and prevention of various arrhythmic conditions, including heart failure.

In addition, Professor Zhang Shu from Fuwai Hospital, Chinese Academy of Medical Sciences, has proposed a uniquely Chinese approach to the prevention of sudden cardiac death: "Level 1.5 Prevention." This strategy builds upon internationally recognized indications for primary prevention by incorporating four high-risk factors: non-sustained ventricular tachycardia, frequent premature ventricular contractions, reduced ejection fraction, and syncope or presyncope. Enhanced monitoring and preventive measures are recommended for patients who meet the criteria for primary prevention and present with at least one of these four high-risk factors, aiming to prevent sudden cardiac death.

The concept of “Stage 1.5 prevention” was proposed because the number of patients in China who meet the indications for primary prevention significantly exceeds those eligible for secondary prevention; however, few patients utilize preventive devices for the prevention of sudden cardiac death, and existing medical resources are insufficient to meet the needs of all patients who qualify for primary prevention.

Furthermore, level 1.5 prevention helps identify high-risk populations and prevent sudden cardiac death through the use of preventive medical devices.

The Improve SCA Study, led by Professor Zhang Shu, demonstrates that tier 1.5 primary prevention of sudden cardiac death can significantly reduce the risk of its occurrence. This study will help developing countries allocate limited medical resources more effectively to high-risk populations for sudden cardiac death.

Therefore, leveraging the fully automated defibrillation and comprehensive data chain recording capabilities of wearable cardioverter defibrillators (WCDs), Weiweisi Medical aims to support Tier 1.5 prevention of sudden cardiac death by providing WCD therapy and electrocardiographic data services to high-risk populations in the future.

In the future, Weiweisi Medical will extend the development of the world’s first sudden cardiac death risk assessment system through the promotion of wearable automated external defibrillators (AEDs) and data services for ventricular arrhythmia management, providing patients with arrhythmias a full-process solution encompassing monitoring, prevention, treatment, and rehabilitation. By leveraging this sudden cardiac death risk assessment system, Weiweisi Medical can transform the passive emergency treatment of ventricular arrhythmias and sudden cardiac death into precision therapy for ventricular arrhythmia rhythm management that integrates both prevention and treatment.