Zhongke Yuanyi Submits IPO Prospectus: Pioneering Cardiovascular Digital Therapeutics with Clinically Certified Photoplethysmography-Based Continuous Blood Pressure Smartwatch

Cardiovascular disease is the “leading killer” threatening human life and health. One in every three deaths worldwide is caused by this condition. According to data released by the World Health Organization (WHO), the global number of patients with cardiovascular disease has exceeded 500 million, with China accounting for approximately 330 million of these cases.

As one of the most prevalent diseases, cardiovascular disease (CVD) encompasses a broad spectrum of conditions, and many patients present with multiple comorbid chronic diseases, posing complex challenges to CVD management. Despite significant advances in the prevention and treatment of CVD over the past half-century, it remains one of the leading causes of mortality and disability worldwide.

In China, cardiovascular disease is characterized by the “five highs and four lows”: high incidence, high mortality, high disability rate, high recurrence rate, and high treatment burden; coupled with low awareness, low treatment rate, low control rate, and low treatment adherence. How to address cardiovascular disease more cost-effectively and efficiently has become another formidable challenge urgently requiring resolution in the healthcare industry.

In the era of data-driven healthcare, wearable devices, as one of the primary data interfaces, have opened up new possibilities for cardiovascular disease monitoring. According to IDC data, the global market size for medical wearable devices was approximately $578 million in 2021. The global wearable device market is projected to reach $1.968 billion by 2026. This vast market potential has drawn domestic and international giants such as Apple, Huawei, and Xiaomi into intense competition. Cardiovascular medical wearables have emerged as a new growth hotspot.

An Emerging Digital Therapeutics Company Founded in 2022Zhongke Yuanyi (Xiamen) Biotechnology Co., Ltd. (hereinafter referred to as “Zhongke Yuanyi”)eager to give it a try, innovatively submittedA One-Stop Solution for Out-of-Hospital Cardiovascular Health Based on Medical Smartwatches and Digital Therapeutics.

Since its inception, Zhongke Yuanyi has been committed to becoming a global leader in cardiovascular health solutions. Its core founding team brings over a decade of background in cardiovascular medical research and more than ten years of cross-disciplinary experience in the development of medical wearable products.

Co-founder and CEO, Xu Bo,Postdoctoral Fellow at the University of Nebraska Medical Center (UNMC), with research focused on the central regulatory mechanisms of the cardiovascular system. Published 10 SCI-indexed academic papers in leading journals of the American Heart Association and the American Physiological Society, including five as first author. Committed to leveraging advanced technologies and products, such as medical wearables and digital therapeutics, to more effectively improve individuals’ cardiovascular health.

The rest of the core team members include Tsinghua University PhD holders with profound professional expertise, senior executives from ZTE Corporation who have fought tough commercial battles, and R&D professionals with domestic and international backgrounds and forward-looking vision. Each member brings unique strengths, creating a complementary skill set. The team is adept at keenly identifying clinical pain points and accurately and efficiently translating medical needs into industrial language.

A robust talent team brings profound industry insights and surging innovation momentum.

Driven by the 4P management framework for cardiovascular health—Preemptive, Predictive, Personalized, and Participatory—Zhongke Yuanyi has adopted a patient-centric approach. Targeting emerging opportunities in the niche market created by integrating home-use diagnostic devices with wearable technology for cardiovascular disease, the company has launched a medical wearable product solution centered on its 4G-enabled blood pressure and ECG smartwatch.

Attribution analysis of hypertension through accurate, continuous, and multi-dimensional blood pressure and health data collection and algorithmic analysis to achieve precise intervention for hypertension, thereby more effectively addressing the low rate of hypertension control.

Since its inception in R&D, Zhongke Yuanyi has built its foundation from the ground up, mastering key technologies and independently developing all core components. It is reported that Zhongke Yuanyi’s 4G blood pressure and ECG medical smartwatchClinically certified in Germany and tested to ISO 81060-3 standards, with certification from the German Metrology Commission.. To become Germany's leading supplier of Chinese medical wearable device hardware.

Zhongke Yuanyi adopts a progressive “three-step” strategy to enhance user stickiness and management effectiveness.

First, efficient and precise health monitoring is implemented. The 4G Blood Pressure and ECG Medical Watch by Zhongke Yuanyi provides medical-grade accuracy with continuous, 24/7 blood pressure monitoring. It tracks a wide range of multidimensional health indicators and daily behavioral patterns, including electrocardiogram (ECG), blood oxygen saturation, body temperature, heart rate, physical activity, and sleep. For patients, the watch enables real-time monitoring of stroke and myocardial infarction risks, delivering immediate dynamic alerts that significantly reduce harm from sudden-onset conditions. For physicians, the comprehensive and detailed patient data facilitates better understanding of patient status, thereby aiding in diagnosis.

Next, etiological analysis is conducted to enable precise and intelligent intervention. By leveraging multi-dimensional big data analytics on health information, the blood pressure digital twin model can analyze the causes of hypertension and provide targeted recommendations for improvement. For instance, if a patient’s elevated blood pressure is caused by sleep apnea syndrome, the system will automatically identify this underlying condition and intelligently recommend treatment for sleep apnea rather than directly prescribing antihypertensive medications such as nifedipine, thereby significantly enhancing the safety and efficacy of treatment.

Finally, we are creating a cardiovascular specialist on the wrist, seamlessly connecting patients and physicians. By wearing the smartwatch 24/7 with 4G data transmission, doctors can monitor patients’ conditions in real time, assess medication adherence, track blood pressure control, and evaluate cardiovascular risk factors, thereby improving patient compliance. Meanwhile, patients can promptly communicate with their doctors via the wearable device whenever they have questions.

“We are not just smart medical watches that allow users to self-monitor their blood pressure and electrocardiograms; we are a digital therapeutic system for cardiovascular diseases, comprising three components: medical watches, analytical algorithms, and health interventions,” summarized Xu Bo, founder of Zhongke Yuanyi.

Although Zhongke Yuanyi has been established for less than a year, leveraging its core team’s nearly decade-long accumulation in software and hardware R&D, the company has emerged as a dark horse in the smart wearable industry, withHaixi Institute of the Chinese Academy of Sciences, University Medicine Rostock (Germany), Weimar Medical School, Sana Healthcare GroupJointly completed multiple scientific research tests, obtained certification from the German Weights and Measures Commission through parallel comparison with traditional invasive blood pressure measurement, and successfully entered the German public health insurance system, becoming a pioneer for Chinese original technology in overseas internet medical practice.

In terms of market strategy, Zhongke Yuanyi has carved out a unique path by adopting a business model of “R&D and manufacturing in China, global sales.” It prioritizes hardware enablement for B-end clients in Europe, the United States, and China. By providing accurate, continuous, and multi-dimensional blood pressure and health data collection along with algorithmic analysis, the company meets the diverse needs of B-end clients across global markets—such as health insurance providers, medical institutions, and health management enterprises—in areas including cardiovascular health management for their users, digital marketing, and big data research.

Regarding the future of Zhongke Yuanyi, Xu Bo plans to provide hardware enablement for digital therapeutics companies specializing in chronic hypertension management through medical wearable products in the short term, aiming to become a professional global brand in the medical wearables industry within the next 3–5 years.