With the development of the economy and society and the accelerating trend of population aging, the incidence of cardiovascular diseases will further increase. As the absolute number of people with hypertension, dyslipidemia, diabetes, and obesity continues to rise, the mortality rate of cardiovascular diseases in China may further increase, and the inflection point of disease burden reduction has not yet appeared. Moreover, acute cardiovascular diseases have the characteristics of rapid onset and high fatality rate. Simply relying on technological advancements in hospitals cannot significantly reduce the incidence and mortality rates of cardiovascular diseases in China. Therefore, the focus should be on the development of prevention and detection of cardiovascular diseases to achieve early detection and early treatment.

POCT (Point-of-Care Testing) for cardiovascular diseases are mainly used for rapid quantitative or qualitative screening of common cardiovascular diseases such as myocardial infarction and heart failure. Examples include High-sensitivity cardiac troponin test(hs-cTNT), NT-proBNP test, and other biomarkers test. Under normal circumstances, cardiac biomarkers are mainly or exclusively present in the heart, but in abnormal situations, they are released in large quantities into the blood. Therefore, detecting cardiac biomarkers in the blood can sensitively and specifically indicate myocardial injury and its severity. POCT has significant advantages in terms of sample volume, sample types, reagent convenience, and operator requirements. For most cardiovascular diseases, rapid clinical diagnosis, risk assessment, prognosis judgment, and timely treatment are crucial for reducing mortality and controlling disease progression. Taking acute myocardial infarction as an example, the first four hours after onset are the golden time for rescue treatment, and the timing of treatment initiation is closely related to the efficacy and prognosis of acute myocardial infarction. For such diseases, early diagnosis is extremely important, and obtaining accurate diagnostic information quickly through POCT is a prerequisite for implementing effective treatment measures. POCT testing can significantly shorten the testing time and accurately determine the subtype of the corresponding disease through the detection of multiple cardiac markers, enabling targeted treatment. In terms of market size, the market size of the cardiovascular POCT reagent industry in China reached 5.969 billion yuan by 2021 and is continuing to rise.

The core members of our team, after understanding the field of POCT testing, want to provide the slightly advanced technical support for China's early screening industry for cardiovascular diseases and providing efficient and accurate solutions for early screening of cardiovascular diseases, benefiting human health.

2.1 Continuous Increase in Demand for Early Screening of Cardiovascular Diseases

As the prevention and control of cardiovascular diseases in China have achieved initial results, new challenges have emerged. Overall, the incidence and mortality rates of cardiovascular diseases in China are still on the rise. In particular, the mortality rate of cardiovascular diseases in rural areas has been consistently higher than that in urban areas in recent years. The total hospitalization costs for cardiovascular diseases are also rapidly increasing, and the burden of cardiovascular diseases in China is becoming a major public health problem that cannot be ignored.

Non-communicable diseases (NCDs) account for 71% of total deaths, with cardiovascular diseases being the leading cause of death, accounting for 44% of all NCDs and twice the number of cancer deaths. It is estimated that by 2030, the total number of deaths from cardiovascular diseases will exceed 23 million. Low-income and middle-income countries are most susceptible to the impact of cardiovascular disease-related deaths, and cardiovascular diseases are the third leading cause of death among women. With the rapid increase in factors such as hypertension, obesity, and type 2 diabetes in the current environment, the occurrence of cardiovascular diseases is becoming younger, and patients aged 30-50 are becoming increasingly common.

For most cardiovascular diseases, rapid clinical diagnosis, risk assessment, prognosis judgment, and timely treatment are crucial for reducing mortality and controlling disease progression. Taking acute myocardial infarction as an example, the first three hours after onset are the golden time for rescue treatment, and the timing of treatment initiation is closely related to the efficacy and prognosis of acute myocardial infarction. For such diseases, early diagnosis is extremely important, and obtaining accurate diagnostic information quickly through POCT is a prerequisite for implementing effective treatment measures. POCT testing can significantly shorten the testing time and accurately determine the subtype of the corresponding disease, enabling targeted treatment.

Due to the high risk of death and the need for timely rescue in cardiovascular diseases, early diagnosis is crucial. Therefore, the rapid diagnostic advantages of POCT reagents in the field of cardiovascular diseases have led to a sustained and rapid growth in the market size. On November 1, 2017, the former National Health and Family Planning Commission issued the "Guidelines for the Construction and Management of Chest Pain Centers (Trial)", which required secondary general hospitals or relevant specialty hospitals to establish chest pain centers. It also required emergency departments to be able to perform 24-hour bedside electrocardiograms and echocardiograms, rapid tests for cardiac troponin and D-dimer, and proposed medical quality control indicators for chest pain centers, including "the time from blood collection to obtaining reports for immediate testing items such as cardiac troponin, D-dimer, brain natriuretic peptide, blood gas analysis" and "the proportion of combined testing of D-dimer and cardiac troponin." The establishment of chest pain centers has significantly increased the demand for POCT testing for cardiovascular diseases. In terms of market size, the market size of China's cardiovascular POCT reagent industry was 59.69 billion yuan in 2021.

2.2 Continued Government Support for Early Screening of Cardiovascular Diseases

The National Health and Family Planning Commission clearly stated in the "Management Measures for Early Screening and Comprehensive Intervention Projects for Cardiovascular Diseases" issued in 2014 that appropriate technologies for screening and comprehensive intervention for high-risk populations with cardiovascular diseases should be studied and evaluated, and a sound prevention and control work system and long-term mechanism should be established and improved. In 2022, several regions in China initiated early screening and intervention projects for high-risk populations with cardiovascular diseases, which have promoted the early screening of cardiovascular diseases for millions of people. Therefore, it is expected that the Chinese government will continue to strongly support the development of solutions that facilitate convenient and rapid early screening.

2.3 Pain points in the cardiovascular disease diagnosis and treatment market

Cardiovascular disease examinations include routine electrocardiograms, Holter monitoring, echocardiography, cardiac troponin tests, comprehensive cardiopulmonary function tests, coronary angiography, and complete blood lipid tests. Current POCT testing services have a relatively small market share in these examinations. Over the past decades, with economic growth and improved living standards, cardiovascular diseases have become a major threat to the health of the Chinese population. According to the "2015 China Cardiovascular Report," cardiovascular diseases are the leading cause of death in both urban and rural residents, with 2 out of every 5 deaths attributed to cardiovascular diseases. Despite significant advances in medical technology in China, there are still many shortcomings compared to the growing demand for medical services. Prevention, diagnosis, treatment, and post-treatment management of cardiovascular diseases have become topics of common concern for doctors, experts, medical equipment personnel, and hospital leaders in the field of cardiovascular diseases.

The market for cardiovascular disease diagnosis and treatment still faces the following pain points:

1. Insufficient early warning and inadequate early screening for cardiovascular diseases
Cardiovascular diseases, often referred to as cerebrovascular diseases, may result from long-term poor dietary habits, factors such as hypertension and obesity, or the consumption of spicy or alcoholic foods. These factors can increase the viscosity of cardiovascular blood, leading to diseases such as arterial sclerosis and ischemia or bleeding throughout the body. Cardiovascular diseases, characterized by high recurrence rates, numerous complications, high morbidity, high disability, and high mortality, pose a significant threat to human health. Timely diagnosis and treatment in the early stages of disease development can effectively control cardiovascular diseases, significantly reducing mortality. Therefore, early screening for cardiovascular diseases is crucial. However, many patients currently do not pay enough attention to early screening for cardiovascular diseases. High-risk groups and patients with mild symptoms such as dizziness and palpitations often fail to recognize the risk of cardiovascular diseases. Their lack of awareness may lead to delayed medical visits, resulting in many patients missing the optimal control and treatment period and ultimately causing serious consequences.

2. Dispersion of clinical data and lack of post-hospital management
The large number of cardiovascular disease patients in China signifies a vast resource of clinical data. However, these data are not effectively collected, managed, utilized, and shared, severely restricting the development of clinical research and quality management in cardiovascular diseases. On one hand, the collection and management of clinical data heavily rely on manual processes and lack format standards. Even within the same hospital, data lacks integration and streamlining, being scattered across different information systems within the hospital, making data source management challenging. On the other hand, there is a lack of a shared platform for cardiovascular clinical data among medical institutions, leaving information isolated.

Additionally, while treating a large number of cardiovascular patients, Chinese doctors have accumulated rich experience in inpatient diagnosis and treatment. However, there has been a persistent lack of effective post-hospital examination and management in the field of cardiovascular diseases. Patients with cardiovascular diseases remain high-risk even after discharge, requiring monitoring and intervention of their post-discharge conditions. Currently, the recovery of patients after discharge is often less than ideal in China. Unnecessary worsening of conditions may occur, leading to high rates of patient readmission, causing a significant and avoidable consumption of medical resources and increasing the operating costs of the healthcare system.

3. Regional imbalance in cardiovascular disease diagnosis and treatment, inadequate prevention and control in rural areas
The "China Cardiovascular Health and Disease Report 2020" shows that the incidence of cardiovascular and cerebrovascular diseases in China is on the rise. Cardiovascular diseases account for a high proportion of deaths, with 45.50% in rural areas and 43.16% in urban areas. The burden of cardiovascular diseases is increasing, especially in rural areas, where the cardiovascular disease mortality rate has significantly increased. On one hand, improvements in living conditions in rural areas have increased the risk of cardiovascular diseases along with better diets and living standards. More importantly, the current medical conditions in rural areas are relatively lagging compared to urban areas, and most rural residents have low awareness of the prevention and treatment of chronic diseases. They lack the habit of seeking timely medical treatment, and few rural residents have the opportunity to undergo comprehensive examinations or regular screenings. Conditions such as hypertension, diabetes, and hyperlipidemia, known as the "three highs," form the basis of atherosclerosis, which is the basis of cardiovascular diseases. However, these conditions often have no obvious symptoms in the early stages. Without early detection and intervention, they can lead to serious cardiovascular diseases. Therefore, the incidence of cardiovascular diseases in rural areas is significantly higher than in urban areas, highlighting the urgent need to address this regional imbalance.

3.1 Large-scale Clinical Trials (CRO) and Registration Application for Three Types of Medical Devices

Our product falls into the category of medical devices, requiring over 1,000 clinical trials before applying for a license for three types of medical devices. After optimizing the production process for mass production, our team plans to entrust Taigerjietong Company to advance clinical sample testing (CRO). Currently, our team has cooperation agreements with several tertiary hospitals in Liaoning Province, including Dalian University Affiliated Zhongshan Hospital, Dalian Medical University Affiliated Second Hospital, and Liaoning Cancer Hospital. We expect to complete testing for 2,000 clinical cases within three to six months, with an estimated investment of twenty million RMB, rapidly advancing the progress of clinical trials and completing the application for a license for three types of medical devices.

3.2 Product Sales and Services

The production and sales model for this project plans to establish XXX Co., Ltd. as the core, building an integrated platform for POCT testing research, production, and sales. Initially, Huakang Medical Technology Co., Ltd. will select the raw material supply base and sign long-term contracts for raw material supply. Subsequently, Huakang Medical Technology Co., Ltd. will establish a cooperative relationship with Kangyuan Dagong Biotechnology (Dalian) Co., Ltd., signing a production agreement. Based on the core technology held by our team, Kangyuan Dagong Biotechnology (Dalian) Co., Ltd. will complete the product production.

Furthermore, our company will collaborate with major tertiary hospitals in Liaoning Province to sell the product. In this process, leveraging the technical advantages of the product, we aim to expand into a broader medical service field. Tertiary hospitals' service platforms have larger revenue and profit systems, and they exhibit characteristics such as regional monopoly and high public trust. They are in a strong position within the entire medical industry system, making them an ideal market breakthrough. After gaining a certain level of recognition and market share, we will start marketing to individual patients through online and offline channels. Offline sales will involve conducting public health screening promotions in communities and rural areas

3.3 Marketing Strategy

(1) Promotion by Prominent Key Opinion Leaders
The company has established solid cooperation with multiple top-tier hospitals and plans to promote the sensitivity, efficiency, and cost-effectiveness of cardiovascular disease POCT testing services through relevant academic conferences or medical knowledge dissemination sessions. In the initial phase of market entry, the project will be branded as "efficient, high-quality, and high-tech," emphasizing the characteristics of emerging technology. By partnering with top-tier hospitals, the project aims to showcase authoritative and reliable technological outcomes, expanding its competitive advantage and market share.

(2) Excellent Post-sales Service and Product Iteration
Our team is guided by the principle of "Priceless Life, Health Responsibility as Paramount" and is dedicated to safeguarding the health and lives of the public. We ensure product quality through rigorous production standards and offer different procurement options based on various testing platforms. We guarantee the quality and quantity of our products, maintain open communication with customers by actively addressing post-sales feedback, and make necessary adjustments to our products and services based on that feedback. Moreover, we regularly conduct market research to gain in-depth insights into the cardiovascular disease testing market, continuously iterate and upgrade our technology, and establish a sustainable research, production, and sales platform.

4.1 Organizational Structure

In the initial stages of the company, a straightforward organizational structure will be employed. The company will have one General Manager, two Deputy General Managers, and five departments, including the Technology Department, Marketing Department, Finance Department, Service Department, and Human Resources Department. The Technology Department will be further divided into Research and Development and Testing sections, while the Finance Department will have three service points.

4.2 Company Management Model

Once the company reaches maturity, regular meetings will be held by the General Manager with various departments to discuss the company's financial performance and future development plans. Additionally, project managers for each product will regularly report on project progress to the General Manager. The General Manager will have Deputy General Managers, the Finance Department, Technology Department, Service Department, Marketing Department, and Human Resources Department, with each department having its manager. Matrix management will be adopted to ensure a balanced distribution of management areas and responsibilities. Regular meetings involving department heads will be held to collectively discuss key business decisions. Technical support will be sourced from well-known national technical institutions, with some senior professors from XXX University acting as technical advisors.

4.3 Employee Development

Apart from our existing team members, the company will require additional professionals. Therefore, in the initial phase of entrepreneurship, after the first round of financing, we will conduct recruitment and expansion. Recruitment will be done through job fairs, online recruitment, and headhunting agencies. Each department will have its specific interview approach, assessing candidates' psychological qualities, professional competence, adaptability, and interpersonal skills. Technical department interviews will include both face-to-face and written tests to evaluate candidates' technical knowledge and their ability to handle unexpected situations.

After recruitment, an internship period will be established during which interns will be familiarized with the business environment and primary functions. After a two-month internship, a comprehensive assessment will be conducted, and those who pass will sign formal labor contracts with the company.

4.4 Five-Year Employee Planning

Employees are the foundation for the company's long-term market presence and development. In the initial stages of entrepreneurship, we will provide employees with maximum room for growth, nurturing a group of industry elites to lay the foundation for scaling the company and building the brand. As the company develops, we will continue to attract more talent to join our organization.

5.1 Cost Projections

Based on the unique technical features of our company and the characteristics of our product, the primary profit source is expected to be the sale of POCT cardiovascular disease screening reagent kits and accompanying instruments. Company operating expenses will be primarily divided into sales expenses, management expenses, R&D and financial expenses, detailed as shown in the table below.

5.2 Investment and financing plan

5.2.1 Investment and Equity Distribution
Given the unique technological advantages of this product, a sales rate of approximately 90% is expected. Leveraging our unique core technology advantages, the company can achieve a tenfold increase in sales volume within three years. According to the product's sales trends, the estimated market valuation of our company is 350 million RMB.

The company adopts a founder employee stock ownership plan. The project director of this project within the company holds 50% of the company's shares, giving them absolute control over significant strategic decisions and operational management of the company. The core members of the founding team hold 13% of the company's shares, while other core project members hold 11% of the company's shares.

External financing involves expert consultant teams who will hold 9% of the company's shares in the initial project development phase. Additionally, Great Fortune Asset Management Ltd. holds 7% of the company's shares. After angel round investments, the company's equity structure is as shown in the figure below.

Certainly, here's the translation of the content regarding the use of funds into English:

5.2.2 Use of Funds
For the funds raised in this round of financing, the company has three primary directions for their utilization:

A. Expansion of Product Manufacturing and Research Development (CDMO):** Outsourced to Kangyuan Medical Technology (Dalian) Co., Ltd., incurring approximately 10 million RMB in related expenses.

B. Clinical Trial Business (CRO) Development: Outsourced to Taige Jietong Company, mainly including the design and consultation of clinical trial protocols and case report forms, clinical trial monitoring, and data management. This will result in approximately 20 million RMB in related expenses.

C. Medical Device License Registration Application:Planned to be handled by Taige Jietong Company, incurring approximately 2 million RMB in related expenses, to be covered from the funds raised in this round of financing.