Japanese Cardiac Surgeon’s Quest to Build Fully Wireless Artificial Heart

This article features one of the companies selected for the 13th cohort of 1stRound, an entrepreneur support program operated by UTokyo Innovation Platform (UTokyo IPC), announced on October 6, 2025.

Currently, approximately 64 million heart failure patients exist worldwide (Global Burden of Disease Study 2019). Among them, about 3.6 million severe patients requiring artificial hearts or heart transplants are newly diagnosed each year, according to research by the European Society of Cardiology (ESC). For these patients, artificial hearts represent their last lifeline, but the power cable penetrating the skin causes infections in approximately 22% of patients (Left Ventricular Assist Device Infections: A Systematic Review, PMC, 2018), sometimes claiming lives. Unable to bathe and forced to constantly carry batteries, patients describe this existence as having “lost their normal life.”

Helioverse Innovations is tackling this challenge head-on. The company is developing humanity’s first fully implantable wireless power system and a catheter-deployable miniaturized artificial heart. Founder and CEO Dr. Taiyo Kuroda has abandoned his career as a cardiac surgeon to stake his life on this ambitious project, pursuing the realization of a dream he has held since age 5: “a world where people live with mechanical hearts and no one dies from heart disease.”

With a strong foundation as a spinout from Cleveland Clinic, one of the world’s premier cardiovascular institutions; a world-class technical team including Japan’s Murata Manufacturing; and the conviction that “the next innovation will come from Japan”—a 36-year dream is now set in motion.

Spinout from Cleveland Clinic to Startup

Taiyo Kuroda became fascinated with artificial hearts at just 5 years old. The boy who embraced the grand dream that “one day humanity will live with mechanical hearts and no one will die from heart disease” later chose the path of medicine, walking a career as a cardiac surgeon involved in artificial heart treatment in Japan.

However, through his clinical experience in Japan, Kuroda keenly felt the limitations of artificial heart technology and that fundamental innovation was necessary to break through them. In 2021, he made the decision to move to the US to fulfill his 36-year dream.

His destination was Cleveland Clinic in Ohio. This hospital boasts an overwhelming track record of ranking #1 in the U.S. for cardiology and cardiovascular surgery for 30 consecutive years (1995 to 2024) in U.S. News & World Report evaluations. In 2021, Kuroda successfully joined the hospital’s historic artificial heart development team.

Kuroda’s assignment involved animal experiments with total artificial hearts using 90-kilogram cattle. Completely removing the heart and replacing it with a mechanical one—this was truly bringing science fiction to reality. State-of-the-art facilities and a world-class research environment. For many researchers, it would have seemed like an ideal setting.

I couldn’t see a future where we could quickly deliver devices to the patients waiting for me in Japan. I felt there were significant hurdles between research and commercialization. (Kuroda)

Medical device development requires enormous time and costs. Especially for ultra-high-risk devices like artificial hearts, obtaining FDA (U.S. Food and Drug Administration) approval often takes more than 10 years. At the pace of academic research, the day when the patients Kuroda had met as a physician would be saved might never come. So he made a major decision.

I had to fully commit and do this as a business. The market is only in the US. (Kuroda)

In October 2024, Kuroda established Helioverse Innovations Inc. in Ohio, USA. The company spun out from Cleveland Clinic’s artificial heart research, building on the technology and knowledge cultivated there. Currently, Kuroda is working on this project without salary, fully committed to the mission. The depth of his commitment is palpable.

Meanwhile, he made the strategic decision to base technology development in Japan. He also established a Japanese entity to function as a research and development center. Although it’s a startup born in the US, the reason for establishing a base in Japan——which will be detailed later——is that Japanese companies possess world-class technological capabilities in areas such as wireless power transfer and motor technology.

As I pursued various technologies, I discovered that Japan has the most reliable technologies. (Kuroda)

The relationship with Cleveland Clinic continues. Discussions are underway to position the institution as a core facility for future clinical trials, serving as a cornerstone of the strategy to expand from the nation’s #1 facility. Maintaining good relationships with academic institutions while securing business freedom and speed of decision-making—this was the path Kuroda chose.

The Power Cable Problem

The history of artificial hearts dates back to the 1960s. Since then, technology has made steady progress. Particularly over the past 25 years, the evolution has been remarkable, with dramatically improved outcomes, making artificial hearts a mainstream option as bridge therapy to heart transplantation or as long-term treatment.

Currently, according to research by the European Society of Cardiology, approximately 3.6 million patients worldwide are newly diagnosed each year who would die without an artificial heart or heart transplant. However, heart transplantation faces the fundamental problem of donor shortage. Especially in Japan, only about 80 procedures are performed annually (Japan Heart Transplantation Study Group, 2022 data), and many patients must wait for heart transplants with artificial hearts. From registration on the transplant waiting list to receiving a transplant takes 3 to 5 years (Fukui Cardio Vascular Center). The situation in the US is similar, with many patients on waiting lists living with artificial hearts while awaiting their turn for transplantation.

Despite technological progress, artificial hearts still face serious challenges. The most significant is the power cable penetrating the skin.

Current artificial hearts require external power to drive the pump implanted in the body. Therefore, a cable several millimeters in diameter protrudes from the abdominal skin, connecting to external batteries or controllers. This structure causes various problems.

The most serious is infection. Many patients develop bacterial infections at the site where the cable penetrates. Since there is a permanent hole in the skin, which normally serves as a barrier protecting the body from the outside world, this is in some ways an inevitable result. If infection becomes severe, it can cause sepsis and, in the worst cases, claim lives. Saving a life with an artificial heart only to lose it to infection—this is an extremely frustrating situation for both medical professionals and patients.

It’s not just the infection risk. Because of the protruding cable, patients have restricted bathing. Even showering requires special waterproof covers, and soaking in a bathtub is impossible. Especially for Japanese people, where bathing in a hot tub is a deeply cherished daily ritual and cultural cornerstone, the inability to bathe causes unimaginable stress. Additionally, patients must constantly carry external batteries. Simple batteries last only about two weeks, and if longer-term support is needed, surgery to replace them with larger implantable batteries becomes necessary. Even during sleep, patients must be mindful of cables and batteries, restricting even the freedom to turn over naturally.

Actual patients say, “The artificial heart is so difficult to bear, please remove it as soon as possible and give me a heart transplant.” Our user interviews confirmed the same sentiment. They want us to do something about this power cable. (Kuroda)

The voices of patients that Kuroda heard directly through user interviews were more desperate than statistical data. Artificial hearts save lives. But that life-saving comes at great cost to quality of life. Patients endure this restriction-filled existence while waiting for the day they can receive a heart transplant.

Medical professionals also recognize this problem. Treating infections requires antibiotic administration, daily wound care, and in some cases artificial heart replacement surgery. The physical and mental burden on patients is substantial, and the increase in medical costs is serious. The costs of infection treatment and repeat surgeries can be enormous. In the US, infection treatment can cost tens of thousands to hundreds of thousands of dollars. Since the company’s device reduces infection risk by 98%, these additional medical costs would essentially disappear. Therefore, even though the device itself is priced 15% higher, total medical costs would be significantly reduced. It becomes a superior choice for insurance systems, patient out-of-pocket expenses, and above all, patient quality of life.

This power cable problem can be called the “Achilles’ heel” of artificial heart technology. No matter how much pump performance improves or durability increases, as long as this cable exists, patient quality of life cannot fundamentally improve. And the life-threatening risk of infection does not disappear. Kuroda decided to tackle this challenge head-on. He committed to seriously pursuing wireless power transfer technology—something everyone considered “ideal but difficult to achieve.”

Three Innovations and Japanese Technology

What Helioverse Innovations is developing is a next-generation device that overturns conventional wisdom about artificial hearts. Its features are summarized in three revolutionary elements:

1. Low-Invasive Catheter Implantation: Current artificial heart surgery is a major operation that involves cutting the sternum vertically more than 20 centimeters. The bone is cut with a saw, the heart is exposed, connected to a cardiopulmonary bypass machine, the heart is stopped, and then the artificial heart is attached. Surgery takes several hours, and the burden on the patient’s body is extremely heavy. Post-operative recovery also requires a long period, and for elderly or weakened patients, the surgery itself poses a major risk.
   
   Helioverse Innovations’ device is designed for catheter access through a 3-4 centimeter incision between the ribs. Ultimately, the goal is miniaturization to a level where a catheter can be inserted through a shoulder blood vessel. This is similar to the procedure for placing a stent in treating myocardial infarction.
   
   This minimally invasive approach has multiple benefits: shortened surgery time, reduced burden on the patient’s body, faster post-operative recovery, and for medical institutions, improved efficiency through reduced operating room occupancy time.
   
2. Physiological Blood Flow Through Intra-Aortic Placement: Conventional ventricular assist devices primarily used a method where the pump inlet is inserted into the apex of the heart and the outlet is sutured to the aorta with an artificial blood vessel. In other words, blood is taken out of the heart, passed through the pump, and returned to the aorta—creating a “bypass.”
   
   However, Helioverse Innovations’ approach is fundamentally different. The design places the pump directly inside the aorta, so blood exits the heart, is immediately assisted by the pump within the aorta, and flows to the whole body. Because there’s no need to create a bypass, blood flow becomes more physiological (closer to the natural state). This pump is an axial-flow type, with an impeller rotating at high speed inside to draw in and propel blood.
   
3. Fully Implantable Wireless Power System: This is the company’s greatest challenge and most innovative element. The power required by an artificial heart reaches about 1,000 times that of a pacemaker. Wirelessly supplying this large amount of power stably and continuously has been considered “ideal but unrealistic.”
   
   Helioverse Innovations takes the bold approach of implanting the power unit itself that performs wireless power transfer inside the body. This power unit is charged from an external charging device via electromagnetic induction or similar methods, and drives the pump with the stored power. By completely eliminating the power cable, infection risk is theoretically reduced by 98%.
   
   In this technology development, the participation of a global wireless power transfer specialist from Murata Manufacturing has been significant. Tatsuya Hosotani from Murata Manufacturing (Visiting Professor at Doshisha University) is the developer of wireless power transfer technology called the DC resonance method and established the Wireless Power Management Consortium (WPM-c) in 2013, leading corporate team activities.
   
   The fact that an engineer from a world-class electronic components manufacturer personally offered cooperation speaks to the technical significance and feasibility of this project. Furthermore, the company plans to integrate power electronics technology as a Japan-first innovation. Heat generation is a serious problem for implantable devices because it can damage surrounding tissue. This technology aims to achieve both safety and efficiency.

The team composition is also strong. When Kuroda expressed his determination to “stake his life,” veteran researchers who were about to retire from Cleveland Clinic joined the team, saying “we want to do this with you.” Those who had been involved in artificial heart development at the world’s premier medical institution for many years chose not to pursue a stable retirement but to bet on a high-risk startup. Kuroda’s vision and passion moved people to that extent.

The Japanese team composition is also impressive. Top-level cardiologists and cardiac surgeons have joined. Kuroda’s seniors and juniors, his surgical mentors, and specialists in hemodynamic analysis—top-class talent from Japan’s cardiovascular medical community has gathered.

Furthermore, although the company name is not disclosed, they are in discussions with a major Japanese automaker on developing small, high-efficiency motors. They are also collaborating with a major pump manufacturer. Medical pumps have different advanced requirements from industrial pumps. Designing pumps that meet requirements such as not damaging blood, not creating blood clots, and stable long-term operation requires specialized knowledge.

Regulatory compliance specialists also joined the team early on. This is a strategic decision learned from past lessons.

Many companies in the past have stumbled on regulatory compliance. So we decided to consider regulatory compliance from the design stage. Specialists in U.S. and Japanese regulations, business specialists, and even legal specialists have now joined our team. (Kuroda)

Medical devices, especially ultra-high-risk devices like artificial hearts, face extremely high hurdles to obtain FDA approval. Attempting to address regulatory requirements after the fact often forces fundamental design changes and can cause development to collapse.

Partnerships with academic institutions are also well-established. Joint research with Waseda University is being conducted on problem identification through simulators. Mock circuit simulation that replicates actual internal circulation allows optimization of various parameters before actual manufacturing, greatly improving development efficiency. They are also collaborating with the National Cerebral and Cardiovascular Center (NCVC) on hemodynamic analysis and animal experiments.

NCVC is Japan’s core institution for cardiovascular disease research, and being able to conduct animal experiments there is also significant in terms of paving the way for future clinical trials in Japan. “We rapidly cycle through prototyping with partner companies, simulation analysis at Waseda University, and animal experiments at NCVC,” says Kuroda—a truly startup-like asset-light and agile development approach.

Large corporations have elemental technologies, but decision-making for high-risk new businesses tends to be slow. On the other hand, startups have fast decision-making and are challenging, but resources are limited. Establishing a complementary relationship between the two has become a major strength for Helioverse Innovations.

Strategy in a “Winner-Takes-All” Market

Helioverse Innovations’ business strategy is as meticulously crafted as its technology development. The current artificial heart market is valued at $1.7 billion annually but is predicted to grow to $3.38 billion by 2033 (Towards Healthcare, 2025). Heart failure patients are increasing globally, and demand is rising especially in developed countries with aging populations. Simultaneously, as medical infrastructure is developed in emerging countries, penetration to patient populations that previously could not receive treatment is also expected.

The company estimates it can capture about $1 billion, or approximately 30%, of this $3.38 billion market. This is not an unrealistic figure. The artificial heart market has characteristics close to “winner-takes-all,” where the best device tends to capture most of the market.

The company’s device is priced at $120,000 per unit (approximately 18 million yen). This is about 15% higher compared to current major artificial hearts. However, the story changes when considering total cost. Infections caused by power cables require antibiotic treatment, readmission, and sometimes repeat surgery, and these costs are enormous.

In the US, infection treatment can cost tens of thousands to hundreds of thousands of dollars. Since the company’s device reduces infection risk by 98%, these additional medical costs essentially do not occur. Therefore, even though the device price itself is 15% higher, total medical costs are significantly reduced. It becomes a superior choice for insurance systems, patient out-of-pocket expenses, and above all, patient quality of life.

Artificial hearts currently on the market can be classified into conventional long-term implantable devices, catheter-deployable short-term devices, and fully implantable devices under development, but the company’s device is the only one satisfying all three elements: “minimally invasive,” “long-term use,” and “no power cable.” This represents an overwhelming competitive advantage.

Since its establishment in October 2024, the company has organized itself in an extremely short period. Currently, it receives support from programs such as NEDO’s (New Energy and Industrial Technology Development Organization) Research and Development-Type Startup Support Program.

The ultimate milestone is to advance to clinical trials in the U.S. by 2030. This is by no means an easy goal. From prototype to animal experiments, pre-clinical trials, FDA application, and the start of clinical trials usually takes more than 10 years. However, Kuroda considers this ambitious timeline realistic, backed by the relationship with Cleveland Clinic, early participation of regulatory specialists, and Japanese technological capabilities.

Positioning Cleveland Clinic as the core facility for clinical trials is strategically sound. Success stories at the premier medical institution accelerate adoption at other medical facilities. Also, since Cleveland Clinic accepts patients from around the world, there is the advantage of accumulating data on diverse patient populations.

The basic strategy is to target the US market first. This is based on multiple reasons including market size, regulatory environment, pricing freedom, and investment environment. The US is the world’s largest medical device market, with a high per-capita artificial heart usage rate. The FDA approval process is rigorous, but once approved, global credibility is obtained. Since many countries conduct their own approvals referencing FDA approval, FDA approval effectively becomes the global standard.

The Wireless Power Management Consortium (WPM-c) has expressed support for making Helioverse Innovations a unicorn. However, what’s interesting is the company’s attitude toward unicorn status.

Honestly, we’re not aiming for unicorn status at all. However, the artificial heart market is special—there’s a large market, but only one company can sit on the throne. (Kuroda)

This statement strikes at the essence of the artificial heart market. In typical startup markets, multiple competing companies exist and each holds a certain market share, which is considered healthy. However, the artificial heart market doesn’t follow this logic. Why? Because treatment outcomes are a matter of “life or death.”

Data on survival rates of patients with artificial hearts is extremely objective and clear. As clinical data accumulates, which device is best is shown in numbers. Suppose there’s Device A with a 70% survival rate and Device B with a 68% survival rate. Which would a physician choose? The answer is obvious. They would always choose A. There’s no room to consider balance with price. In situations where life is at stake, economic arguments are meaningless. Patients, families, and physicians all choose the device with the highest survival rate. This is naturally correct from a medical ethics standpoint.

This market characteristic is also reflected in the current market structure. The situation where two global medical device giants, Abbott and Johnson & Johnson, occupy most of the market is truly close to “winner-takes-all.” However, neither company developed artificial hearts from scratch. They entered the market by acquiring startups with superior technology.

As another case, Kuroda mentions Medtronic. The medical device giant acquired HeartWare in 2016 to enter the artificial heart market, but due to high device failure rates and increased neurological adverse events, withdrew from the market in 2021, just 5 years later. Fifteen Class I (most serious) recalls since approval also had an impact. This demonstrates both the high risk of artificial heart development and the situation where existing major companies are blocked by entry barriers.

If our device comes to market, we can take a significant portion of the market. If that happens, we’ll be profitable. As a result, we’ll become a unicorn. We’re not trying to become a unicorn——it just happens naturally. Honestly, the title of unicorn doesn’t matter to me. I just want to deliver devices to the people who are waiting as soon as possible. (Kuroda)

For exit strategy, they’re considering IPO only. While there are examples of industry majors acquiring startups, such as Abbott’s acquisition of St. Jude Medical (January 2017, $25 billion) and Johnson & Johnson’s acquisition of Abiomed (December 2022, $16.6 billion), the timing is very late-stage. Often it’s after FDA approval, market expansion, and proven track record. This is because, due to ultra-high risk, major companies are reluctant to step in early. Helioverse Innovations must also reach the final stage on its own.

Aiming for the Revival of a Technology Nation

Kuroda spent his junior high school years in the US and moved there again in 2021, now entering his fifth year. Through that experience, he has felt the brand value of Japan firsthand. While news about “Japan’s decline” due to low economic growth rates and declining birthrate/aging population has increased in recent years, Kuroda still believes Japan’s potential is high.

And he points out that the history of artificial hearts supports his conviction.

The previous innovation in artificial hearts came from a Japanese company called Terumo. It dramatically improved outcomes. I believe the next innovation also lies in Japan. (Kuroda)

The day when Helioverse Innovations brings the fully wireless artificial heart to practical use and saves patients worldwide—at that time, Japan’s technological capabilities and the Japanese spirit of challenge will be recognized by the world once again.

Toward the start of clinical trials in the US in 2030, and then practical application. Until that day, Kuroda’s struggle continues. But it is a struggle filled with hope. Toward a future where Japanese technology, the US market, and patients worldwide all connect as one.