Lanfan Medical Invests $145M in CH Biomedical to Enter Heart Failure Market with Fully Magnetically Levitated Artificial Heart CH-VAD

Just one year after acquiring Biosensors International, the world’s fourth-largest manufacturer of coronary stents, listed company Blue Sail Medical has further increased its investment in the cardiac device market. On June 18, Blue Sail Medical (SZ.002382) announced that the company and several senior executives had jointly invested RMB 101.6 million to acquire a stake in Suzhou BrioHealth Solutions Co., Ltd. (“BrioHealth”), a developer of artificial hearts. Upon completion of the transaction, they will hold a 10.16% equity interest in BrioHealth. The two parties will collaborate to advance the clinical development, regulatory registration, and market expansion of the fully magnetically levitated artificial heart “CH-VAD” in global markets. (Previous coverage of BrioHealth by VCBeat:BrioHealth Solutions: As an Alternative to Heart Transplantation, How Far Do Artificial Hearts Still Have to Go?）

Artificial hearts are a groundbreaking life-saving invention, primarily used in clinical settings to treat patients with end-stage, refractory heart failure.

Heart failure is known as the "cancer of heart disease," claiming hundreds of thousands of lives globally each year. Public data shows that the global number of heart failure patients has reached 26 million. Once diagnosed with heart failure, approximately 50% of patients die within five years; after progressing to advanced-stage heart failure (NYHA Class III and IV), about 50% die within two years.

Announced at the 2018 China International Heart Failure Conference, there are at least 10 million heart failure patients in China, making it one of the countries with the largest population of heart failure patients in the world. Heart failure is not an independent disease but rather the terminal stage of various cardiac conditions. Currently, heart transplantation is recognized as the only effective treatment for patients with end-stage heart failure; however, the severe shortage of donor hearts greatly limits the implementation of this procedure. Data shows that approximately 300 heart transplants are performed annually in China. Even in the United States, where the highest number of such surgeries are conducted, only slightly over 2,000 heart transplants are performed each year. Given that hundreds of thousands of new heart failure cases emerge annually, heart transplantation cannot serve as a widely accessible medical solution for the general population.

The advent of artificial hearts has brought hope for a new lease on life to many patients with end-stage heart failure. As one of the most complex and sophisticated medical devices, artificial hearts are often referred to as the “crown jewel of medical devices” due to the significant technical challenges involved in their development. The capability to research and develop such devices also serves as an indicator of a country’s technological prowess in high-end medical equipment.

Artificial hearts have currently become one of the standardized treatments for heart failure recommended by international guidelines. They assist or replace the pumping function of the natural heart by delivering blood into the human circulatory system via a mechanical pump. Most patients with heart failure exhibit left ventricular dysfunction, and many require only left ventricular assist device (LVAD) therapy to effectively bridge the waiting period for heart transplantation or to achieve long-term survival with the artificial heart. In some cases, after a period of mechanical circulatory support, native cardiac function may fully recover, allowing for the explantation of the artificial heart.

International research and development of artificial heart technology began in the 1950s, undergoing a transformation from pulsatile blood pumps introduced to the market in the 1990s to rotary blood pumps launched since the turn of this century. Due to their significant damage to blood components, high incidence rates of hemolysis and thrombosis, bulky device size, and poor durability, pulsatile blood pumps are now rarely used in clinical practice.

Rotary blood pumps are characterized by the support method of their rotors, evolving from mechanical contact bearings and hydrodynamic bearings to fully magnetically levitated bearings. Mechanical contact bearings, submerged in blood, transmit supporting forces to the impeller rotor through direct mechanical contact. This causes severe damage to blood components at the bearing site and results in a high incidence of intrapump thrombosis, necessitating emergency surgical replacement of the pump. Hydrodynamic bearings utilize specifically designed surfaces (bearing pairs) on both the impeller rotor and the pump housing. When the impeller reaches a certain rotational speed, a thin layer of blood is drawn into the clearance of the bearing pair, establishing a hydrodynamic lubrication mechanism that separates the rotor from the pump housing, thereby eliminating mechanical contact. However, the blood serving as the lubricant is subjected to shear stresses far exceeding normal physiological levels, causing significant hemolysis and leading to a higher incidence of stroke in patients.

Fully magnetically levitated blood pumps utilize a series of magnets and energized coils arranged within the rotor and pump housing to achieve stable rotor suspension through magnetic forces. This support mechanism does not rely on blood as a lubricant and enables a significantly larger levitation gap than that of hydrodynamic bearings, thereby substantially reducing shear stress levels experienced by the blood. However, fully magnetically levitated blood pumps involve complex multidisciplinary technologies, making design optimization highly challenging, particularly with regard to miniaturization. Since the 1980s, although numerous institutions worldwide have invested efforts in their development, the vast majority abandoned their projects midway. To date, only Abbott’s Thoratec Corporation and BrioHealth Solutions have persisted in overcoming the challenges of developing ultra-compact, fully magnetically levitated artificial hearts, ultimately achieving success through their respective proprietary foundational patents and entering clinical application.

In October 2018, Thoratec, a subsidiary of Abbott, launched the HeartMate 3, a fully magnetically levitated artificial heart, in the United States. Two-year follow-up results from clinical trials confirmed that the HeartMate 3 offers significant clinical advantages over the HeartMate II, the world’s best-selling artificial heart device that utilizes mechanical contact bearings, positioning it as the successor to the HeartMate II. Furthermore, extensive clinical studies have demonstrated that the HeartMate 3 also holds significant advantages over the HVAD, produced by HeartWare (a Medtronic company), which employs hydrodynamic bearings. Consequently, the HeartMate 3 has emerged as a powerful new tool for treating refractory end-stage heart failure, fully showcasing the performance benefits of full magnetic levitation technology.

Due to the high technical barriers and the need for long-term technological accumulation associated with fully magnetically levitated artificial hearts, only Abbott and BrioHealth Solutions have currently developed technologies mature enough for clinical application. It is expected that these companies will face no challenges from other developers for at least the next five years. BrioHealth Solutions holds complete independent intellectual property rights for its product, the CH-VAD.

The advanced nature of artificial hearts is primarily reflected in aspects such as hemocompatibility, surgical invasiveness, anti-infection performance of percutaneous cables, and device reliability. Compared with the HeartMate 3, the CH-VAD features a smaller blood pump volume, thereby reducing surgical invasiveness. Its percutaneous cable contains fewer wires and is thinner, which lowers the risk of infection and helps enhance product reliability. Furthermore, compared to the HeartMate 3, the CH-VAD exhibits higher magnetic levitation stiffness and superior blood flow field quality (characterized by low shear stress and adequate flow washout). In vitro testing has demonstrated better hemocompatibility, suggesting that the CH-VAD may offer superior hemocompatibility; however, this advantage ultimately requires validation through clinical trials. Consequently, based on the R&D achievements of the CH-VAD, BrioHealth Solutions has become the only company worldwide capable of competing technologically with Abbott in the realm of next-generation artificial hearts, and is well-positioned to launch more advanced products.

CH-VAD

In 2016, the “CH-VAD” product entered the national “green channel” for special approval of innovative medical devices, while its registration with the U.S. FDA was also being advanced concurrently.

From June to October 2017, the team led by Academician Hu Shengshou at Fuwai Hospital obtained ethical approval via humanitarian exemption and sequentially applied the CH-VAD to treat three critically ill patients, achieving successful outcomes in all cases. Currently, the first patient has been living with the artificial heart for two years, maintaining a normal and healthy quality of life. The second patient successfully underwent heart transplantation after five months of mechanical circulatory support. The third patient achieved complete recovery of native cardiac function after five and a half months of support, allowing for the successful explantation of the device. These three cases represent the three distinct strategic outcomes of artificial heart usage, pioneering the application of such devices in China and fully demonstrating the superior performance of the CH-VAD through successful clinical implementation.

“CH-VAD” received clinical trial approval from the National Medical Products Administration (NMPA) in late 2018. In March 2019, the first subject was successfully enrolled. Four clinical cases have been completed at Beijing Fuwai Hospital and Central China Fuwai Hospital; all four patients have been discharged and are in good condition.

Since merging with Biosensors International last year, Blue Sail Medical has established a development strategy focused on deepening its presence in the cardiovascular and cerebrovascular fields. The company has been strategically positioning itself in both high-value and low-to-mid-value consumables segments. The high-value consumables segment primarily offers cardiac stents and interventional cardiac surgery-related devices, operated through its Singapore-based subsidiary, Biosensors International. With business operations in over 90 countries worldwide, it ranks fourth globally in the cardiac stent market. The low-to-mid-value consumables segment mainly features a medical protection product line, including medical gloves, health protection gloves, first aid kits, and medical dressings, with its flagship PVC gloves holding a 22% global market share. This investment in BrioHealth Solutions will further expand Blue Sail Medical’s technological frontier in the cardiac sector, enrich its product portfolio, and enable early entry into the heart failure market, which holds significant growth potential.

Blue Sail Medical (SZ.002382)

For decades, very few implantable artificial hearts have advanced to clinical trials. Among existing companies in the field, only Thoratec (a subsidiary of Abbott) and HeartWare (a subsidiary of Medtronic) have obtained U.S. FDA market approval for their products, with these two firms collectively commanding over 90% of the global market. Both Abbott and Medtronic have invested heavily to enter this sector.

In July 2015, St. Jude Medical, recognizing the potential of the HeartMate 3—which was then undergoing European CE clinical trials—announced its acquisition of Thoratec, a manufacturer of cardiac-related medical devices, for approximately $3.4 billion in cash. Subsequently, after failing to outbid St. Jude for Thoratec, Medtronic acquired HeartWare in June 2016 for a total transaction value of approximately $1.1 billion to maintain its overall competitiveness in the cardiovascular device industry. Shortly thereafter, Abbott acquired St. Jude Medical for $25 billion, expanding its portfolio to cover every key segment of the cardiovascular market. This move reshaped the global cardiovascular landscape, propelling Abbott to second place in the market, closely trailing Medtronic.

Today, Abbott, through its subsidiary Thoratec, owns the older-generation mechanical contact-bearing artificial heart HeartMate II and the newer-generation fully magnetically levitated artificial heart HeartMate 3. Medtronic’s HeartWare possesses only the hydrodynamic bearing-based artificial heart HVAD.

The sales of the HeartMate II and HVAD reached nearly $1 billion, demonstrating remarkable market potential. Following the launch of Abbott’s fully magnetically levitated artificial heart, the HeartMate 3, in October 2018, its heart failure business achieved double-digit growth. The first-quarter report of 2019 showed that revenue from its heart failure segment amounted to $184 million, representing a significant increase of 20.9%, making it the fastest-growing area within Abbott’s cardiovascular portfolio. It is evident that the market prospects for fully magnetically levitated artificial hearts are immense.

BrioHealth Solutions is the only company in the world, aside from Abbott, to possess mature fully magnetically levitated artificial heart technology. The development cycle—from R&D and product finalization to animal trials and fatigue testing—is exceptionally long, given the extreme complexity of the technology and the need for continuous exploration. Due to a lack of comprehensive technical expertise, other companies are unlikely to enter this field or surpass BrioHealth in the near term. BrioHealth Solutions is not only capable of challenging Abbott’s technological monopoly but also possesses the capacity for sustained innovation, thereby maintaining its position at the international technological forefront.

This investment by Blue Sail Medical in Suzhou BrioHealth Solutions will accelerate the global market expansion of China-made fully magnetically levitated artificial hearts, positioning the company at the forefront of global technological advancements in artificial heart development, while also creating a new growth engine for Blue Sail Medical.