BiVACOR Files IPO Prospectus for Its Pioneering Magnetically Levitated Total Artificial Heart

End-stage heart failure is known as the "cancer of heart diseases," and the only effective treatment is heart transplantation. However, due to the extremely limited availability of donor hearts, heart transplantation cannot become a medical treatment accessible to the general public. Driven by this pressing clinical need, scientists have been continuously striving over the past few decades to develop "artificial hearts."

BiVACOR is regarded as another highly promising artificial heart device company, alongside Syncardia and Carmat. The company has developed the first "magnetically levitated" total artificial heart. Compared to conventional artificial hearts, its product features several first-of-their-kind technologies, such as being the first artificial heart to operate without pneumatic systems, mechanical pumps, or multiple chambers designed to facilitate blood flow.

On May 20, BiVACOR announced the completion of a $19 million Series B financing round led by Cormorant Asset Management and One Ventures. Additionally, BiVACOR received a $3 million Small Business Innovation Research (SBIR) grant from the U.S. National Institutes of Health (NIH). The company stated that these investments will fund its preclinical validation activities and the recruitment of key team members to support its research.

Heart failure is a devastating disease. Due to the lack of effective curative therapies, a diagnosis of heart failure essentially means death. While existing treatment modalities may potentially slow disease progression, they ultimately cannot prevent heart failure-related mortality. For patients with advanced heart failure, heart transplantation remains the only means of survival.

However, there are tens of millions of heart failure patients globally, with 11 million in the United States and Europe alone and 1.1 million new cases annually; the number of heart failure patients in China is also increasing at a rate of 500,000 new cases per year. According to projections, the incidence of heart failure is expected to increase by 25% by 2030.

However, the global supply of donor hearts is extremely limited. It is reported that only about 4,000 donor hearts are available worldwide each year, while the number of patients with end-stage heart failure continues to rise. Consequently, heart transplantation remains far from being a widely accessible medical solution for the general public. Driven by this pressing need, researchers have been continuously striving to develop "artificial hearts" over the past few decades.

In fact, the origins of artificial hearts may date back much earlier than commonly anticipated. In December 1982, a cardiac patient named Clark received the first-ever implantation of the Jarvik-7 artificial heart and successfully survived for 112 days. This demonstrated that cardiac function could be effectively replicated by a fully artificial machine, marking a monumental medical advancement for humanity.

Forty years later, thousands of patients with end-stage heart failure are relying on artificial hearts to sustain their lives. Data shows that since June 2006, nearly 30,000 patients in North America have undergone artificial heart implantation. Since 2013, over 2,500 patients in the region have received artificial heart implants annually, surpassing the number of heart transplant recipients. In terms of patient survival, artificial heart implantation is comparable to heart transplantation. Follow-up data for the internationally mainstream third-generation artificial heart, HeartMate 3, indicates a 2-year patient survival rate of 79%, which is very close to the 80% rate for heart transplantation.

According to data from the National Institutes of Health (NIH), approximately 100,000 patients in the United States could immediately benefit from ventricular assist devices (VADs) or total artificial hearts (TAHs), with the European market being of a comparable scale. This represents a massive and underserved market.

From an engineering perspective, the human heart is a marvel. Within the thoracic cavity of an average adult, the heart beats approximately 100,000 times per day. The circulation of blood from the brain down to the fingers and toes is driven by the "unsung heroes": the heart, functioning much like a pump, and the highly elastic arterial vessels. The heart comprises four chambers, each side containing one atrium and one ventricle, which work in concert to pump blood throughout the body.

Nature’s exquisitely engineered design has long been the envy of engineers. Since the 1950s, countless scientists have strived to develop artificial hearts, yet the results have consistently fallen short of expectations. Prior to 2021, Syncardia, headquartered in Arizona, USA, was the only company worldwide to obtain regulatory approvals from the United States, Canada, and Europe, and to bring artificial hearts to commercial use across these three regions.

Subsequently, French medical device company Carmat’s artificial heart product received approval from European regulatory authorities, and the company announced that it would be launched on the market in the second quarter of 2021.

BiVACOR, as an artificial heart device R&D company aside from these two, has also attracted considerable attention. Headquartered in Houston, Texas, BiVACOR was co-founded in 2008 by Daniel Timms, John Fraser, and William Cohn.

In fact, as early as 2001, while pursuing his doctorate at the Queensland University of Technology, Daniel Timms conceived the idea of developing an artificial heart device in his home garage.

Timms initially launched this project in his hometown in Australia, with the development team collaborating with researchers from Germany, Japan, and the United States. Originally established as a student project, the company received substantial support from the Queensland University of Technology and has since evolved into a globally recognized enterprise.

In 2016, BiVACOR was awarded the Ignite Ideas Fund from Queensland University of Technology. With this funding, Timms' team was able to develop a prototype patient controller for the pulsatile operation of the rotary total artificial heart in women and children.

In 2018, BiVACOR received funding from the Queensland Biomedical Assistance Fund. Leveraging this support, the Timms team set out to develop the drive controller for the dual-chamber total artificial heart that powers the device.

At different stages of the project, to fully leverage the specialized resources of global collaborators, the BiVACOR development team has established laboratories across various locations worldwide.

Over the years, the core design principle of the BiVACOR magnetic levitation artificial heart has remained largely unchanged, but the device has undergone multiple iterative upgrades. In 2019, the device had completed animal trials and was prepared for human clinical trials.

In the same year, BiVACOR entered into a collaboration with NASA's Johnson Space Center. Leveraging NASA's expertise in Probabilistic Risk Assessment (PRA), the agreement allows NASA, within the scope of work, to provide initial technical support to BiVACOR to help assess the risks associated with medical components that must operate in extreme environments.

Currently, the BiVACOR team is headquartered in the United States (Los Angeles and Houston) and Australia (Melbourne and Brisbane), and focuses on translating experimental prototypes into commercial products.

The BiVACOR Total Artificial Heart (TAH) is the first long-term therapy for patients with severe biventricular heart failure. The BiVACOR device is an implantable total artificial heart based on rotary blood pump technology. Similar in size to an adult fist and weighing only 512 grams (slightly heavier than a natural adult heart), it is small enough to be implanted in many women and some children, yet still capable of providing sufficient cardiac output for an exercising adult male.

The most innovative design feature of the BiVACOR TAH lies in its simple structure utilizing a motor and a rotating disc, capable of simultaneously pumping blood throughout the body. Employing magnetic levitation (MAGLEV) technology, the rotating disc is fully suspended within a magnetic field. Operating on principles analogous to those of maglev trains, the system enables fine-tuning of circulatory control through differential fluid output.

The left and right impeller blades mounted on either side of the rotating hub in the BiVACOR TAH enable the device to simultaneously support both the left and right ventricles of the heart. The larger component operates at a higher pressure to pump blood to the systemic circulation, while the smaller component operates at a lower pressure to pump blood to the pulmonary circulation. Even in the absence of valves or a flexing ventricular chamber, pulsatile flow can be achieved by rapidly modulating the impeller's rotational speed. Each side is capable of pumping over 15 L of blood per minute, adequately meeting the physiological demands of patients who wish to engage in moderate physical activity.

Additionally, the contactless suspension of the BiVACOR TAH provides a larger blood clearance, thereby minimizing blood trauma and eliminating mechanical wear, ultimately delivering a durable, reliable, and biocompatible heart replacement.

In addition to "magnetic levitation" technology, the BiVACOR TAH also features a critical flow balancing system, which enables it to dynamically adapt to any changes in the patient's physiological condition.

Compared to other total artificial hearts, the BiVACOR TAH utilizes a 3D-printed titanium pump with excellent biocompatibility. Additionally, the specialized wide clearance within the pump housing minimizes blood cell damage and reduces the risk of thrombosis.

By employing "magnetic levitation" technology, the BiVACOR TAH avoids friction and mechanical wear among internal components, thereby extending its service life to at least 10 years. In contrast, currently marketed artificial hearts primarily serve as a bridge to subsequent heart transplantation rather than as a permanent cardiac replacement, and consequently do not offer a long operational lifespan.

In 2019, the BiVACOR TAH completed a short-term animal trial. After being implanted in a cow for 90 days, the animal not only remained healthy but was also able to move normally and continue gaining weight at a normal rate. It could even jog for half an hour.

However, as of now, the BiVACOR TAH has not yet undergone actual human trials. The company stated that this $22 million funding round will be used to continue testing the BiVACOR device, further expand the company's workforce, conduct benchtop and preclinical validation activities, and actively prepare for its first-in-human trial.

In 2015, after more than a decade of dedicated research, Suzhou Tongxin Medical Device Co., Ltd. independently developed the world's smallest third-generation fully magnetically levitated artificial heart. Weighing less than 180 grams, it is approximately the size of a table tennis ball and comparable in weight to a smartphone. To date, 25 clinical trial cases of the fully magnetically levitated artificial heart have been completed at Beijing Fuwai Hospital and Wuhan Union Hospital, with two cases proving unsuccessful.

Despite garnering high recognition from domestic and international peers, this fully magnetically levitated artificial heart, featuring complete proprietary intellectual property rights, can currently only be used in a limited number of patients through clinical trials or under humanitarian exemptions.

Due to various reasons, the market launch of the fully magnetically levitated artificial heart remains a distant prospect. However, artificial hearts are already commercially available in China. In November 2020, Sichuan Provincial People's Hospital successfully performed China's first implantation surgery using an officially marketed artificial heart on a patient with end-stage heart failure. This device is the "Yongrenxin" artificial heart, jointly developed and manufactured through a Sino-Japanese partnership, and remains the only artificial heart product approved by the National Medical Products Administration (NMPA) for clinical application.

In January 2021, "Xinqing Medical", another artificial heart R&D company based in Suzhou, completed a Series B financing round exceeding RMB 100 million, dedicated to the research and development of medical devices for short- to mid-term life support. Xinqing Medical took only three years to advance a fully magnetically levitated extracorporeal artificial heart to clinical trials. At the International Society for Mechanical Circulatory Support (ISMCS) conference held in Italy in 2019, the company presented the device's superior performance and excellent hemocompatibility, earning recognition from international experts.

Whether domestically or internationally, for both R&D enterprises and patients, there is still a long road ahead in the development of artificial hearts. This endeavor involves not only cutting-edge and highly complex R&D technologies but also numerous challenges regarding the clinical application of artificial hearts. Heart failure is one of the few expansive market segments in the cardiovascular sector with a potential exceeding tens of billions. Driven by population aging and the prolonged course of underlying cardiovascular diseases, the inflection point for the heart failure device therapy market is imminent. However, cardiac medical devices carry high risks, involve significant technical barriers, and are subject to stringent standards and regulatory requirements, ranking them among the most challenging innovations globally. We still need more time and accumulated experience.