The Shared Narrative of Chinese LVAD Companies

News Commentary: The Shared Narrative of Chinese LVAD Companies: A Conflict Between Capital and Medical Reality Under the Guise of Conceptual Substitution —Writing at the Conclusion of the Seven-Part "Artificial Heart" Series GFM Investigation Team

When we arrange the seven reports along a timeline, the answer has actually been on the table all along, but no one has ever been willing to state it so directly: there is fundamentally no "domestically produced artificial heart" in China.

What we have is merely a group of companies, investment institutions, sponsors, law firms, and the grey regulatory area that tacitly allows all this to happen, who package the "Left Ventricular Assist Device" (LVAD) as a "Total Artificial Heart" (TAH).

This is not the moral decline of a few individual companies; this is a collective conspiracy within the entire sector.

The Same Script, Performed by Four Companies

Shenzhen Core Medical called the LVAD "artificial heart" 127 times in its 419-page prospectus;

Suzhou Tonkinstar Medical promoted CH-VAD as "opening the era of artificial hearts in China";

Aerospace Tai-Sun referred to HeartCon as the "third-generation implantable artificial heart";

Chongqing EVAHEART called EVA-Pulsar "the first artificial heart approved in China for long-term assistance."

Four companies, four products, four NMPA approval documents, all uniformly state "Implantable Left Ventricular Assist System," with the indication being solely "Bridge to Transplant" (BTT). None have obtained "Destination Therapy" (DT), and none dare to remove the native heart and truly achieve permanent replacement in the sense of a "Total Artificial Heart."

Yet, in roadshow PPTs, WeChat official accounts, crowdfunding pages, and investor groups, they share the same set of rhetoric:

• "The Jewel in the Crown of Medical Devices"

• "Overtaking in the Curve" "Domestic Substitution"

• "Lifelong Carry" "Living like a Normal Person"

• "World's Smallest Artificial Heart"

These phrases precisely target three cores: national sentiment, capital greed, and patient despair.

The Misconceptions of the "Domestically Produced Artificial Heart"

Who is Paying for This Conceptual Substitution?

1. Patients and Families

The surgery costs 500,000–800,000 RMB, plus 20,000–40,000 RMB per month post-surgery for medications and consumables. The average survival time in China's real-world data is less than 18 months, with a Right Ventricular Failure (RVF) incidence of 41–53%, and a 30-day mortality rate as high as 65–74%.

But the title they see on the Waterdrop Crowdfunding page is always: "Save him, give him a Chinese artificial heart."

2. Retail Investors

What they are buying is not the multi-trillion-RMB track of the "artificial heart," but the 1.5–2.5 billion RMB Chinese and 2.5 billion USD global LVAD market, which has been forcefully inflated to the "trillion-RMB level by 2030."

The valuation jumps from 2 billion to 30 billion, and then to 50 billion, relying not on data, but on the four words "artificial heart."

3. Regulatory Credibility

When the approval document states "limited to Bridge to Transplant," but the prospectus states "long-term replacement," and the sponsor, law firm, and accounting firm all sign "no objection," this is not oversight; this is collective selective blindness.

This is not a technical problem; it's a collapse of institutional narrative

To this day, only two genuine Total Artificial Hearts (TAH) can barely be called commercialized globally:

• SynCardia TAH: Cumulative implantations of 2049 cases, with almost zero new implantations in 2024;

• Carmat Aeson: Dozens of cases in Europe, currently undergoing bankruptcy restructuring.

Neither model has made a profit, neither has achieved "living like a normal person," and both are still paying the price for thrombosis, infection, and drive line breakage.

Yet, Chinese companies have already begun collecting the valuation premium for the "artificial heart" before even reaching that stage.

This is not leading; this is pre-emptively overdrawing.

The Healthcare Edition of the Post-Truth Era: Silence is More Costly Than Lies

The most terrifying thing is never the lie itself, but that everyone knows it is a lie, yet no one is willing to expose it:

• Doctors know it's only an LVAD, but dare not write "may merely change the way of death" on the informed consent form;

• Investors know it's not a TAH, but it doesn't stop them from writing "domestically produced artificial heart" into their due diligence reports;

• Regulators know the approval restrictions, but the 127 mentions of "artificial heart" in the prospectus also pass the review smoothly;

• Media knows the truth, but "first implantation of a domestically produced artificial heart" always attracts more traffic than "another case of LVAD bridge failure."

Silence becomes part of the conspiracy.

What Can We Do?

1. Mandatory Name Change: All companies must use the legal name on the NMPA registration certificate—"Implantable Left Ventricular Assist System"—in all public promotions, prospectuses, and crowdfunding pages, prohibiting the four words "artificial heart," unless the native heart has truly been removed.

2. Mandatory Disclosure of Real-World Data: The incidence of Right Ventricular Failure, 30-day mortality rate, 1-year survival rate, and 2-year survival rate must be as conspicuous as the lung cancer image on a cigarette packet.

3. Establish a Dedicated LVAD Patient Registry System: Like INTERMACS in the United States, enrollment must be mandatory, public, and transparent. Failure to report should result in the cancellation of medical insurance payment qualifications.

4. Accountability Mechanism for CSRC and Sponsors: If the product name in the prospectus is inconsistent with the registration certificate, the sponsor and law firm should bear direct joint liability.

Conclusion

After completing seven reports, we have not defeated any company, nor have we denied any technology. We have merely torn away the sugarcoating labeled "artificial heart" to let everyone see what kind of pump is truly underneath.

True progress is never afraid of being seen clearly.

True hope is never built upon conceptual substitution.

The day we can candidly tell a patient:

"This is not an artificial heart; it is only a Left Ventricular Assist Device. It might save you for a time, but it cannot save you for a lifetime."

On that day, we will truly deserve the phrase, "The Rise of Domestic Medical Devices."

This is not the final chapter, but the starting point.

Because 13.7 million heart failure patients are still waiting for a future not packaged in lies.

Global Finance Media, Investigative Reporting Team

(The full dossier has been uploaded and backed up for evidence, and is open to companies/regulators/challenges/responses. legal@gfm.news)