China's First Artificial Heart Unicorn Seeks $1.7B IPO Amid $780M Losses

Smart Medical Device Network NewsRecently, according to inquiries, Shenzhen Core Medical Technology Co., Ltd. (hereinafter referred to as "Core Medical") has initiated the STAR Market.IPO`, plans to raise over`12100 million yuan, mainly used for the development of cutting-edge products in circulatory support and the construction of an artificial heart industrialization base.

However, according to inquiries by Intelligent Medical Device Network, as of now, the company has only one product generating revenue, and in the past few years, Core Medical has incurred losses exceeding5.5"100 million yuan! $"

According to Core Medical, heart failure (hereinafter referred to as"Heart Failure," as the "final battlefield" in the field of cardiovascular diseases, poses a profound challenge to global healthcare systems and human health welfare. Characterized by high readmission rates and high mortality rates, it affects nearly6,300The life, health, and safety of tens of thousands of patients.

Core Medical focuses on this significant clinical need, with"Core values of 'Innovation, Quality, Value', using original innovative technology to solve industry challenges, committed to providing more comprehensive, more innovative, and higher-quality artificial heart products."

Core Medical pioneered the"The Core Design Concepts of 'Time-Division and Zonal Dynamic Axial Full Magnetic Suspension Control Technology' and 'Axial Magnetic Flux Multi-Drive Motor Technology' Applied in the Field of Artificial Hearts. At this stage, the company has made a layout."5 Implantable and6 A range of interventional artificial heart products effectively meet clinical needs, covering long-term → short-term support, left-heart → biventricular support, and infant → adult support.

Currently, multiple core products of the company have been included in China's special review process for innovative medical devices, with the number of included products ranking first in China's artificial heart field.

Among themCorheart® 6As of2023 Year6 Approved for marketing in [Month], it is currently the smallest and lightest commercialized magnetically levitated implantable artificial heart globally, measured by terminal implant volume.2024 China's market share exceeded in year45%, ranking first in the industry, with a cumulative implant volume exceeding a thousand cases.

DuoCor® 2Expected to be the world's first magnetic levitation integrated implantable dual-heart assist system, this product represents a complete systematized design by the company for magnetic levitation dual artificial hearts. It is expected to address the global long-term treatment challenge of "total heart failure"; interventional artificial heart.CorVad® 4.0/6.0 The series is now in the registration approval stage and is expected to become the first approved intra-cardiac assist device product in China.

Core Medical emphasizes:"This offering will further drive the technological innovation and global progress of the artificial heart products, while also improving the corporate governance structure, enhancing brand value, and attracting top talents. The company aims to achieve long-term high-quality sustainable development and standardized operations, creating greater long-term value for shareholders and society."

According to the data, Core Medical is an innovator dedicated to providing more comprehensive, more innovative, and higher-quality artificial heart products.

Medical device enterprises. Since its establishment, the company has focused on the significant clinical needs of acute and chronic heart failure, relying on original innovation and key core technology breakthroughs, continuously promoting product iteration and upgrades in the artificial heart field.

The company pioneered theThe core design concepts of "Time-Partition Dynamic Axial Full Magnetic Suspension Control Technology" and "Axial Magnetic Flux Multi-Drive Motor Technology" have been applied to the artificial heart field, establishing a complete product matrix covering both implantable and interventional devices. This comprehensively meets clinical needs ranging from "long-term → short-term, left ventricular → biventricular, pediatric → adult," bringing a new paradigm of "Made in China" to the global artificial heart industry.

As of now, the company has laid out5 Implantable and6 Minimally Invasive Artificial Heart Products, Among Which1 The implantable product has been commercialized.2 Several interventional products are in the registration approval stage, and multiple artificial heart products are in the clinical stage.

The aforementioned products collectively possess3 Core products have been included in China's special review process for innovative medical devices, including the implantable left ventricular assist system.Corheart® 6, Implantable Dual-Heart Assist SystemDuoCor® 2 And Interventional Ventricular Assist SystemCorVad® 4.0/6.0 Series, ranking first in the number of products included in China's artificial heart field.

Corheart® 6 It is the company's first commercially available third-generation fully magnetically levitated artificial heart, which was2023 Year4 Month awarded by the Chinese Academy of Medical Sciences "China21 "Important Medical Achievement of the Century" award, it is currently the smallest and lightest commercialized magnetically levitated implantable artificial heart in the world, measured by terminal implant volume.2024 China's national market share exceeded45%, ranking first in the industry.

Magnetic Levitation Integrated Implantable Dual Heart Assist SystemDuoCor® 2 Now in clinical stage, it is expected to solve the long-term treatment problem of global "total heart failure"; interventional ventricular assist systemCorVad® 4.0/6.0 The series is expected to be released in2026 Expected to become the first approved intra-cardiac assist device in China in the first quarter of the year.

In terms of performance,2023Year,2024 Year,2025 Year1-6 Month, the operating revenue of Core Medical for each period was respectively1,655.03 10,000 yuan,9,368.84 Wan Yuan and7,047.76 Ten thousand yuan, the scale is still small.In terms of net profit,2022Year-2025In the first half of the year, Core Medical's net profit continued to incur losses, with total losses exceeding5.5100 million yuan.

In addition,The net cash flow from operating activities used by the company was respectively-8,091.43 Ten Thousand Yuan,-10,790.12 10,000 yuan,-8,894.81 Wan Yuan and-8,441.21 Ten thousand yuan. The company focuses on core technology development and product research.Development, commercialization, and other aspects still require a continuous investment of substantial funds.

It is reported that,China's implantable artificial heart industry is still in the early stages of development, and the commercial performance of products is influenced by multiple factors such as clinical adoption, discipline development, surgical technique promotion, and patients' payment capabilities. If the industry develops slower than expected or the clinical promotion of the company’s products encounters obstacles, there is a risk that the commercialization of new products may fall short of expectations.

In the field of medium- and short-term circulatory support, there are no approved interventional artificial heart products available on the market in China. The product independently developed by the companyCorVad® 4.0/6.0 The series is now in the registration approval stage and is expected to become the first approved intra-cardiac assist device in China. The company anticipates challenges in hospital entry, procedural promotion, market education, and brand building for the intra-cardiac assist device product.

And this timeIPOThe proposed fundraising exceeds12One billion yuan, mainly used for two core projects: The first is the R&D of cutting-edge products for circulatory support. Based on the company's existing R&D product pipeline, this project focuses on subsequent global R&D, clinical trials, and registration of related medical devices such as implantable artificial hearts and interventional artificial hearts, while also building an R&D base to support ongoing R&D activities.

The implementation of the project can enhance the company's independent innovation capabilities and R&D strength, strengthen technical reserves, help improve product structure, lay a foundational basis for the continuous iteration and upgrading of the company’s technology and products, increase the core competitiveness and profitability, play an active role in promoting the company’s performance growth and sustainable development, and enhance the company’s market position and technical advantages in the industry.

This project focuses on the company's main business operations, aligns with its future strategic planning and business layout, and represents a deepening and development of its existing business, closely related to the main business and core technology.

Next is the artificial heart industrialization base construction project. In response to the unmet market demands in the treatment of heart failure and other areas, the company plans to expand its production scale by building a new production base. This will further meet the needs of a wide range of clinical patients and facilitate the transformation and implementation of future R&D achievements.

The implementation of this project is conducive to accelerating the commercialization process of the company's products, thereby achieving the sustainable development of the company. The construction of this project is based on the company's main business, representing a deepening and expansion of the main business, and is highly relevant to the main business.

In addition, the core product of Shenzhen Core Medical Technology Co., Ltd.Corheart® 6 The implantable left ventricular assist system has been2023 Year6 Month ObtainedNMPA Approved for marketing, other core products are all in the research and development stage. Subsequent operations will continue to include R&D, clinical trials, registration applications, commercial production, sales, and other business activities.

As the research projects progress, products are registered and launched, and commercial scale expands, the company's demand for working capital will continue to increase. This project is necessary for the company’s business development, helping to optimize the capital structure, meet the funding needs of business operations, enhance the flexibility of the company’s business, and provide financial support to maintain a competitive edge.

Core Medical emphasizes that, relying on the world's first technological breakthrough and a deep technology platform covering the entire development cycle of artificial hearts, the company has built an industry-leading product matrix of implantable and interventional artificial heart series. Based in China and targeting the global market, the company continues to promote a global synchronized application strategy and build a clinical network covering well-known hospitals both domestically and internationally. It has now achieved commercial implantation of artificial hearts in Asia, Europe, and the Americas, committing to provide full disease-cycle heart failure solutions for heart failure patients worldwide.

Moreover, the company's operating revenue has achieved leapfrog growth, with its business scale showing a rapid expansion trend and demonstrating strong ongoing operational capabilities. In the future, the company will fully advance the internationalization of its implantable and interventional artificial heart products through steadfast technological innovation and solid product strength, helping more heart failure patients worldwide regain healthy lives and injecting core strength into the long-term development of human health.

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