Chinese Fully Magnetically Levitated Artificial Heart Developer Tongo Medical Files for STAR Market IPO, Seeking Over RMB 1 Billion

Recently,BrioHealth Solutions("BrioHealth Solutions")Submitted the prospectus for listing on the STAR Market. The company plans to raise funds.RMB 1.064 billionThe funds will be mainly used for global clinical trials of the implantable left ventricular assist system (LVAS), next-generation product development, production base construction, and replenishing working capital.

From the perspective of technology and product pathways, this is more likeMade in ChinaFully Magnetically Levitated Artificial HeartAfter completing the domestic listing, it has officially enteredGlobal Clinical Validation and Registration CycleA crucial step.

# A Company Focused Solely on "Artificial Hearts"

BrioHealth Solutions was founded in 2008 and has always focused on an extremely narrow but highly technical threshold direction since its establishment——Ventricular Assist Device (VAD), often referred to as "artificial heart" in clinical contexts.

In the high-end medical device system, VAD is widely regarded as one of the "crown-level products." Its system highly integrates mechanical engineering, electronic control, software algorithms, fluid mechanics, and biomedical engineering, imposing nearly extreme requirements for reliability, biocompatibility, and long-term stability. The ability to continuously advance the research and development and clinical application of such products is often considered an important manifestation of a country's high-end medical device engineering capabilities.

BrioHealth Solutions has not pursued a multi-product line expansion strategy, but instead opted for long-term investment in a single technological focus, resulting in a development pace that reflects the typical "Long R&D cycles, slow commercialization start, high verification costs"Characteristics."

# Fully Magnetically Levitated LVAS: From Engineering Breakthrough to Clinical Reality

The core product of BrioHealth Solutions is its self-developedFully Magnetically Levitated Implantable Left Ventricular Assist Device。

This system provides continuous circulatory support for end-stage heart failure patients through a fully magnetically levitated blood pump. The key advantage of the fully magnetically levitated design, compared to traditional mechanical bearing structures, lies inThere is no mechanical contact between the rotor and the bearing, which theoretically can significantly reduce the risk of blood shear damage and thrombosis., improving the safety and stability of long-term implantation.

In November 2021, the product was approved for marketing by the National Medical Products Administration, becoming one of the few fully magnetically levitated implantable artificial heart products in China to achieve independent research and development and complete registration. This milestone marks BrioHealth Solutions' critical transition from an engineering prototype to a clinical product.

According to the information disclosed in the prospectus, this product has been clinically applied in multiple medical institutions in China. Although its revenue scale is still limited, it shows a gradual increase in adoption. For such high-end implantable devices,"Whether it can operate safely and continuously" is often more decisive than "sales velocity."。

# Fundraising Purpose: Spending Money Where "Time is Most Valuable"

The IPO raised funds forRMB 1.064 billion, almost entirely centered around the core product line.

Among them,RMB 695 millionTo be used for "The Research and Development Project of the Implantable Left Ventricular Assist System——BrioVAD Global Clinical Trials and Registration Program. This arrangement is the core of the entire fundraising plan. For artificial hearts, the true determinant of a product's lifecycle and market boundaries is not the marketing approval from a single country, but ratherMulticenter, Long-term Follow-up Global Clinical Evidence System。

190 million yuanWill be invested in the next-generation LVAS R&D project for the continuous iteration of product structure, target user groups, and performance parameters.130 million yuanFor the construction of production bases to support the potential increase in installation scale in the future; the rest50 million yuanUsed to supplement working capital and enhance the operational flexibility of the company.

Overall, this is not a financing plan aimed at "expanding product categories and scaling up," but rather a highly focused one.Clinical Validation and Technical IterationThe funding utilization structure aligns with the fundamental principles of the artificial heart sector.

# Behind the Revenue Growth Lies the Inevitable Cost of Long-Term High Investment

From the financial data, BrioHealth Solutions is still in a significant loss stage.

2022–2024Revenue increased from RMB 8.61 million to RMB 77.35 million, but net losses for the same period were RMB 189 million, RMB 306 million, and RMB 372 million, respectively.; In the first half of 2025, the company achievedRevenue of 72.07 million yuan, net loss of approximately 193 million yuan。

This "revenue growth with ongoing losses" structure is not unusual. For highly complex implantable devices like artificial hearts, which have extremely long clinical validation cycles, the costs of research and development, clinical trials, production system establishment, and post-operative follow-ups are often significantly front-loaded in the early stages of commercialization. Globally, most companies in this field have gone through multiple phases of financial pressure before reaching scaled application.

The more critical issue is not about "whether there is a loss," but ratherWhether the loss revolves around a clear product and clinical main lineFrom the information disclosed so far, the cost investment of BrioHealth Solutions is basically in line with its technical advancement pace.

# Founder-led Governance Structure

The controlling shareholder and actual controller of BrioHealth Solutions is the company's founder.Chen ChenChen Chen has a long-term background in engineering and biomedical engineering research, and has held core technical positions in multiple overseas artificial heart and high-end medical device companies.

Through direct shareholding and the arrangement of a voting agreement, Chen Chen collectively controls approximately30.95%The voting rights have a decisive impact on the company's strategic planning, major business decisions, and technology research and development directions. ThisHighly Concentrated on the Control Structure of the Founding Technology Route, which is not uncommon in the high-end medical device field, especially for products with long R&D cycles and low fault tolerance in direction.

At the same time, the company's shareholder structure also includes institutional investors such as Sequoia and Gaorong, which have long been focused on hard technology and medical device sectors, providing a certain capital support foundation for its subsequent development.

# Conclusion: From "China-Made Breakthrough" to "Global Validation"

The STAR Market IPO of BrioHealth Solutions does not mean that its commercialization has been completed, but rather that it has entered a new phase——From Domestic Engineering and Clinical Breakthroughs to Systematic Validation under International Standards。

In the next few years, what will truly determine its long-term value will no longer be just "whether it goes public," but rather:
Whether high-quality global clinical trials can be completed;
Whether the safety and stability of the fully magnetic levitation structure can be proven in long-term follow-up;
Whether it can transform high-intensity R&D investment into sustainable clinical and industrial capabilities.

In a track like artificial hearts, time is never an advantage, but a cost.
And going public is precisely to continue paying this cost.