Yanhe Intelligence Files IPO Prospectus: Pioneering Medical-Grade Wearables with 2020 Overseas Sales Exceeding One Million

In recent years, the wearable market has become increasingly vibrant.

On the capital front, since August 2020, there have been 20 acquisitions and financing deals in the wearable device sector, with a total value approaching $2.4 billion. On the regulatory front, the NMPA and FDA jointly granted medical certifications for 32 wearable devices in 2020, doubling the number approved in 2019. On the corporate front, companies such as Amazon, Apple, Fitbit, and Huawei have entered the market, intensively launching new products or technologies. The wearable device market is witnessing a boom.

From the perspective of Sheng Yibing, founder of Yanhe Intelligence, this is another positive feedback after she went all-in on entering the wearable market three years ago.

In 2018, Sheng Yibing returned to China after completing his studies abroad, eager to put his expertise to use. After conducting in-depth research on the domestic market, he found that with the continuous growth of the wearable device market in recent years and the increasing public attention to personal health, medical-grade smart wearable devices will account for a larger share of the future market.

Smartwatches for health monitoring are suitable for fitness enthusiasts, heart disease patients, children, and special populations. They not only meet the demand for dynamic continuous measurement but also offer significant premium pricing potential and high shipment volumes.

Smartwatches, as devices for acquiring human health data, have long been held in high regard for their applications in the medical field, particularly in the area of cardiovascular diseases. A survey conducted by Sheng Yibing’s team revealed that the current integration of smart wearable devices into the medical sector generally suffers from a lack of precision; most blood pressure values are estimates derived from photoplethysmography (PPG) sensors alone or from a combination of PPG and electrocardiogram (ECG) data.

To this end, Sheng Yibing’s team decided to start with medical-grade smartwatches and established Yanhe Intelligence (Hangzhou) Technology Co., Ltd. (hereinafter referred to as “Yanhe Intelligence”), positioning itself as a manufacturer of medical-grade vital signs monitoring devices to provide users with more reliable vital signs monitoring data.

The YHE medical-grade smart blood pressure watch is the flagship product of Yanhe Intelligence, representing China’s first smartwatch to integrate a pump-based blood pressure monitoring system with photoplethysmography (PPG) technology.

Yanhe Intelligent Air-Pump Blood Pressure Monitoring System utilizes medical-grade pressure sensors to achieve medical-level accuracy in blood pressure monitoring through oscillometric measurement. The system features an inflatable bladder on the inner side of the wristband. Users can initiate a one-touch measurement by pressing the blood pressure button on the display. Prior to the generation of the pulse wave, the internal air pump inflates the bladder at a rate exceeding 10 mmHg/s. Under identical conditions, inflation rates vary depending on individual differences and wearing conditions.

When the first pulse wave is generated, the system automatically adjusts the inflation rate based on the identified individual characteristics of the subject to acquire sufficient pulse waves. When the pulse wave disappears or its peak falls below a certain threshold, the cuff-based blood pressure measurement is completed, and rapid deflation is initiated. According to Yanhe Intelligence, the current second-generation Yanhe smartwatch has an average error of less than 5 mmHg, which is within the medical standard requirements stipulating that the mean error shall not exceed 5 mmHg and the standard deviation shall not exceed 8 mmHg.

In terms of blood oxygen monitoring, since deoxyhemoglobin and oxyhemoglobin in arterial blood exhibit different absorption characteristics to light of varying wavelengths, photoplethysmography (PPG) utilizes photoelectric sensors to acquire pulse data. Through a series of algorithms, the signals from different light wavelengths are decomposed into direct current (DC) and alternating current (AC) components, and the blood oxygen saturation level is then calculated using the SpO₂ formula, thereby achieving complementary precise measurement and continuous monitoring.

Introduction to Yanhe Intelligence: The Yanhe smartwatch can analyze blood pressure and blood oxygen levels to provide feedback on conditions such as heart rate variability, obstructive sleep apnea-hypopnea syndrome, atrial fibrillation, premature cardiac contractions, and arteriosclerosis. The Yanhe smartwatch is expected to formally submit its application for Class II medical device certification in April 2021.

In addition to blood pressure and blood oxygen monitoring, the Yanhe smartwatch offers consumer-oriented features such as activity tracking, sleep analysis, calorie counting, GPS positioning, and call notifications. Users can independently monitor and assess their health via the accompanying app, access historical monitoring data at any time, and gain insights into their vascular health status.

It is understood that Yanhe Intelligence will continue to focus on the R&D of medical-grade vital signs monitoring devices, continuously expanding application scenarios such as nursing homes, hospitals, and households, while also diversifying device forms by incorporating additional sensors, such as temperature sensors.

Furthermore, Yanhe Intelligent has minimized the volume of the watch’s airbag to reduce the size of the display, thereby enhancing wearing convenience and comfort, all while ensuring accurate blood pressure monitoring tailored to the body characteristics of Asians.

Yanhe Intelligence emphasizes that, to meet the needs for multi-dimensional collection and management of users’ vital sign data and for health guidance, it is developing an intelligent personal health vital signs monitoring and management platform.

By leveraging precise, multi-dimensional physiological data generated by Yanhe smartwatches, the platform automatically generates real-time, comprehensive, non-sensitive user health profiles. It analyzes and mines potential correlations between medical health data and disease onset, enabling early prediction of diseases—particularly high-prevalence chronic conditions such as hypertension and cardiovascular diseases—as well as trend forecasting of health status. On this basis, it provides personalized health management and diagnostic and treatment plans.

Meanwhile, by establishing comprehensive health big data profiles for users, this platform conducts integrated assessments and analyses of the overall health status of users across different categories, thereby providing a scientific basis for decision-making and data support for guiding user health management and enabling personalized user management.

Furthermore, Yanhe Intelligence has devoted considerable effort to balancing monitoring accuracy with miniaturization in its smartwatches. To ensure precision, researchers require a robust background in human anatomy and precise control over cardiovascular dynamics and biomedical signals. To this end, Yanhe Intelligence has assembled an R&D team comprising PhDs and Master’s graduates from prestigious universities both domestically and internationally, focusing on medical sensors and medical AI algorithms. Regarding miniaturization, the company has specifically customized micro-components.

In 2020, after completing its angel round of financing, Yanhe Intelligence secured an additional RMB 4 million in overseas crowdfunding. Its market presence expanded to more than 30 countries and regions, including the United States, Japan, and Australia, with sales exceeding RMB 1 million.

Yanhe Intelligence stated that in 2021, it would initiate applications for European CE certification and NMPA certification, continue to expand its overseas distributor network, and further enhance the volume and dimensional scope of its big data platform to provide users with more professional health guidance and recommendations. Additionally, Yanhe Intelligence is exploring collaborations with B-end institutions such as medical facilities, striving to deliver more comprehensive services to patients.