VCBeat has learned that Anhui Tongling Bionics Technology Co., Ltd. (hereinafter referred to as “Tongling Bionics”) has alreadyIn the second quarter of 2022, the company completed a Series B financing round amounting to hundreds of millions of yuan, led by Songyuan Fund (SYCAPITAL) and initiated by Weigao Group. The funds raised will be primarily used for product research and development as well as factory construction.
Prior to this, Tongling Bionics, an innovative company providing full-lifecycle solutions for heart failure, was not only recognized by the Advanced Technology Institute of the University of Science and Technology of China (USTC) as its first equity-held incubated startup, but also secured multiple rounds of financing totaling tens of millions of yuan from prominent investment institutions including Hefei High-Tech Investment, CAS Venture Capital, Zhenshi Capital, and Zhejiang University Venture Capital.
According to available information, Tongling Bionics was established in 2016. It is a national high-tech enterprise founded full-time by Dr. Xie Qilian, a postdoctoral fellow from Imperial College London and a senior clinical expert. The company is dedicated to providing globally leading integrated diagnostic and therapeutic solutions for patients with heart failure.
In 2017, Tongling Bionics pioneered the research and development of percutaneous ventricular assist devices (pVAD) in China, and in the first half of this year, it became the first in the industry to complete the type testing of its miniature catheter-based heart pump.
Meanwhile, Tongling Bionics has also laid out R&D for a series of innovative products suitable for heart failure, including the Intra-Aortic Balloon Pump (IABP) system, external counterpulsation therapy system, non-invasive cardiac output monitor, and Extracorporeal Membrane Oxygenation (ECMO) equipment, aiming to create an integrated solution for the diagnosis, treatment, and rehabilitation of heart failure.
We believe that Tongling Bionics is highly favored by investment institutions because it targets the heart failure market, which has a total addressable market exceeding RMB 100 billion, and is a leading enterprise in this field. Its recognition by research institutions stems from its mastery of core technologies behind products such as percutaneous ventricular assist devices (pVAD), intra-aortic balloon pumps (IABP), external counterpulsation therapy systems, and non-invasive cardiac output monitors.
To date, Tongling Bionics has secured over 100 independent innovation patents and obtained a Freedom to Operate (FTO) analysis report issued by a reputable law firm, thereby ensuring the originality of its technology and patent security.。
Heart failure is widely recognized in the industry as the final battleground of cardiovascular disease.
In clinical practice, heart failure refers to impaired cardiac pumping function caused by various factors, resulting in cardiac output that is insufficient to meet the basic metabolic needs of systemic tissues.
Data indicate that cardiovascular conditions such as myocardial infarction, cardiomyopathy, myocarditis, hypertension, pulmonary hypertension, valvular heart disease, congenital heart disease, chronic anemia, hyperthyroidism, and arrhythmias can all lead to heart failure.
In terms of patient numbers, the recently released “Report on Cardiovascular Health and Diseases in China 2021” indicates that there are approximately 330 million patients with cardiovascular disease in China, including 8.9 million patients with heart failure. Furthermore, heart failure is prevalent among the elderly; among heart failure patients, 88% are aged over 65 years, and 49% are aged over 80 years. Therefore, as population aging intensifies, the incidence of heart failure in China will continue to rise.
From the perspective of disease severity, the five-year mortality rate for heart failure patients is as high as 30–70%. Dr. Xie Qilian, Chairman and General Manager of Tongling Bionics, has over 20 years of clinical experience in cardiovascular and critical care medicine. She observed in her clinical practice that approximately 70% of patients in hospital ICUs ultimately die from heart failure.
The high mortality rate of heart failure is attributed to the significant limitations inherent in current treatment modalities. Currently, clinical management of heart failure primarily relies on lifestyle modifications, pharmacological therapy, and surgical interventions. However, both lifestyle modifications and pharmacological therapy can only alleviate symptoms and are unable to cure the disease.
Surgical treatment options include heart transplantation, permanent implantable ventricular assist devices, and temporary percutaneous ventricular assist devices.
Among these, heart transplantation is currently recognized as the only effective treatment for patients with end-stage heart failure, but the severe shortage of donor hearts greatly limits the implementation of this procedure. Consequently, numerous companies have emerged in the market to develop artificial hearts. However, while permanently implantable ventricular assist devices can address the treatment needs of patients with end-stage heart failure when heart transplantation is not feasible or donor hearts are insufficient, their widespread adoption remains challenging due to the high surgical complexity and substantial costs.
To address the aforementioned issues, temporary percutaneous ventricular assist devices have emerged in the international market in recent years. Characterized by minimal invasiveness, fewer complications, and ease of operation, these devices have been widely adopted overseas.
Data indicates that temporary percutaneous ventricular assist devices primarily include innovative products such as the Intra-Aortic Balloon Pump (IABP) system, Extracorporeal Membrane Oxygenation (ECMO) equipment, and percutaneous Ventricular Assist Devices (pVAD).
Market research firm ReportLinker believes:The global market for innovative therapeutic devices for heart failure is projected to reach $14 billion (approximately RMB 94.1 billion) in 2025.。
Taking the U.S. company Abiomed as an example, its Impella series of percutaneous heart pumps has been used by more than 170,000 patients to date. Meanwhile, Abiomed has achieved a market capitalization exceeding RMB 100 billion, driven by the success of the Impella product line.
In China, companies such as Tongling Bionics have also invested in the research and development of interventional cardiac catheter pumps. However, unlike Abiomed, Tongling Bionics has not only innovatively developed a percutaneous ventricular assist device (pVAD) but also expanded its portfolio to include products such as intra-aortic balloon counterpulsation systems, thereby providing heart failure patients with full-lifecycle solutions spanning diagnosis, treatment, and rehabilitation.
In the field of heart failure, some companies focus on the R&D of percutaneous ventricular assist devices (pVADs), while others specialize in manufacturing heart failure monitoring equipment. Tongling Bionics stands apart by offering a full-lifecycle solution encompassing diagnosis, treatment, and rehabilitation.
According to reports, Tongling Bionics’ product portfolio includes percutaneous ventricular assist devices (pVAD), intra-aortic balloon pump (IABP) systems, external counterpulsation therapy systems, non-invasive cardiac output monitors, and extracorporeal membrane oxygenation (ECMO) equipment.
To date, Tongling Bionic’s non-invasive cardiac output monitor has received priority review from the Anhui Provincial Medical Products Administration and recently obtained its medical device registration certificate; the interventional cardiac catheter pump has completed type testing and is about to commence clinical trials; while products such as the intra-aortic balloon counterpulsation system are currently in the stage of submission for type testing.
Based on the progress of domestic pVAD companies, Tongling Bionics’ catheter-based heart pump is expected to become the first domestically produced pVAD product approved in China, filling a gap in the domestic market. Meanwhile, other products from Tongling Bionics are also in the first tier and advancing rapidly, with the potential to secure the first approvals in the industry and gain a first-mover advantage.
We believe that Tongling Bionics has been able to independently develop various innovative technologies and rapidly advance its product pipeline because its R&D team possesses strong innovation and technical capabilities.。
For example, Dr. Xie Qilian, Chairman and General Manager of Tongling Bionics, completed her postdoctoral research at the National Heart and Lung Institute, Imperial College London. With over 20 years of clinical experience in cardiovascular medicine and critical care, she has led more than 20 scientific research projects, including sub-projects under the National Key R&D Program. She has published over 80 academic papers in domestic and international journals and holds more than 60 invention patents in China and abroad.
Meanwhile, the core R&D team at Tongling Bionics comprises experts from renowned domestic and international universities, research institutions, and leading medical device companies, bringing extensive experience in the research, development, and design of devices such as ventricular assist devices and artificial lungs.
In addition, Tongling Bionics has established an expert advisory board comprising multiple academicians and professors. Leveraging the innovative achievements of these academicians, professors, and postdoctoral researchers, Tongling Bionics has been recognized as a National High-Tech Enterprise, a New R&D Institution in Anhui Province, a Hefei Enterprise Technology Center, a Provincial Postdoctoral Research Workstation, and an Anhui Province Intellectual Property Advantage Enterprise. Furthermore, the company has secured approval for more than ten national, provincial, and municipal projects, including the National Key R&D Program, the Anhui Province Central Government-Guided Local Science and Technology Development Special Fund Project, and the Hefei City Major Emerging Industry Special Project.
For this round of financing,Dr. Xie Qilian, Chairman and General Manager of Tongling Bionics“: This financing round marks a significant milestone in the development of Tongling Bionics. We extend our sincere gratitude to Weigao Group for its trust in Tongling Bionics. As a leading enterprise in China’s medical device industry, Weigao Group’s investment has provided us with tremendous encouragement and confidence.”Through this financing round, Tongling Bionics will accelerate the R&D of its core products, strengthen its product portfolio in the heart failure sector, and maintain its first-mover advantage in this niche market.“As a physician, my original aspiration was to address heart failure with a single catheter. Moving forward, Tongling Bionics will continue to focus on cutting-edge technologies and drive continuous innovation, providing globally leading integrated diagnostic and therapeutic solutions for patients with heart failure, thereby safeguarding human life and health.”
Wang Dong, Head of Investment at Weigao Group’s Songyuan FundTongling Bionics stated: “Tongling Bionics focuses on the field of acute and critical care, primarily centered on the treatment of heart failure, and strategically develops products that address urgent and essential clinical needs. Its core product, the percutaneous ventricular assist device (pVAD), has completed type testing, marking the fastest progress among domestic counterparts, with excellent performance across all metrics benchmarked against Abiomed Inc. in the United States. This device will play a crucial role in patient care for emergency high-risk PCI procedures and cardiogenic shock in the future. Meanwhile, Dr. Xie Qilian, the company’s founder, served as the Director of the Emergency Department at a provincial-level tertiary hospital for many years and possesses extensive experience in translating medical innovations into practical applications. The professional R&D team he established, integrating medical and engineering expertise, provides a solid foundation for subsequent product development and innovation. Weigao Group’s Songyuan Fund hopes to collaborate with Tongling Bionics to provide Chinese-innovated medical device products for the treatment and rehabilitation of acute and critical conditions in China.”