The Shared Lies of Chinese LVAD Companies

The Shared Lies of Chinese LVAD Companies: Pumping up an Assist Pump as an "Artificial Heart"? Analysis Report on Technical Misrepresentation and Promotional Fraud in Corporate Prospectuses GFM Investigation Team

Report Statement All content in this report is derived from public channels, including announcements from the National Medical Products Administration (NMPA), corporate official websites, financing announcements, the "China Cardiovascular Health and Disease Report 2024," the INTERMACS Global Database, Chinese multi-center clinical studies (such as Fuwai Central China Cardiovascular Hospital single-center n=18 and multi-center n=363), and medical expert consensus (such as the "China Left Ventricular Assist Device Expert Consensus 2023" and the "ISHLT Guidelines 2023"). The full text has undergone multi-source cross-validation, with no fabrication or speculation. The dossier has been permanently preserved and unalterable via blockchain, and challenges or lawsuits from companies, regulatory bodies, and investors are welcome.

Report Overview

This report focuses on the prospectuses or listing-related disclosure documents of the three leading Chinese Left Ventricular Assist Device (LVAD) companies—Suzhou Tonkinstar Medical Technology Co., Ltd. (hereinafter referred to as "Tonkinstar Medical"), Aerospace Tai-Sun Technology Co., Ltd. (hereinafter referred to as "Aerospace Tai-Sun"), and Chongqing EVAHEART Medical Device Co., Ltd. (hereinafter referred to as "EVAHEART"). The analysis is based on public data from 2025, including corporate official website announcements, financing news, NMPA approval documents, and industry reports, cross-validating medical definitions with clinical data. Similar to Shenzhen Core Medical, the disclosure documents of these companies contain systematic technical misrepresentation: packaging LVAD as a "Total Artificial Heart" (TAH), concealing complications such as Right Ventricular Failure (RVF), suspected of violating the Securities Law and medical device advertising regulations. The authoritative Chinese medical definition: TAH must completely remove the native heart and mechanically replace biventricular function 100% ( "China Left Ventricular Assist Device Expert Consensus 2023," "ISHLT Guidelines 2023"); LVAD is only a temporary pump for Bridge to Transplant (BTT), not a permanent replacement.

Report Basis: Corporate official websites, financing announcements, "China Cardiovascular Health Report 2024," INTERMACS Global Database, and Chinese multi-center studies. No fabricated content.

Medical Iron Rule: TAH vs LVAD Definitions

Medical consensus clearly distinguishes:

• Total Artificial Heart (TAH): Complete removal of the native heart, with the mechanical device 100% replacing biventricular pumping function. 0 cases in mainland China to date ("ISHLT Guidelines 2023," "China Expert Consensus 2023").

• Left Ventricular Assist Device (LVAD): Only assists the left ventricle, the native heart is preserved, and the right ventricle receives no direct support. Indication is limited to BTT, maximum 6 months (NMPA approval document standard).

The products of all four Chinese companies are LVADs, with no TAH registration certificates (NMPA Announcement No. 111 of 2025 confirms relevant medical device classification).

Shenzhen Core claims in external promotion that its product is the "world's smallest artificial heart" and "partially or fully replaces natural heart function"

Ironclad Analysis of Four Companies

Verification Sources: NMPA Announcement (No. 111 of 2025 confirms medical device classification); Corporate Official Websites (Tonkinstar Medical June 2025 BrioVAD announcement, Aerospace Tai-Sun August 2025 financing news, EVAHEART May 2025 Global Cardiovascular Technology Innovation Award report); Financing News (Sequoia China led investment in Tonkinstar >1 billion RMB, Loyal Valley Capital invested ≈900 million RMB in Aerospace Tai-Sun, Sinovac Biotech invested ≈800 million RMB in EVAHEART). Implantation volume based on industry total of 908 cases (2017-2023, 2025 Q3 update ≈500+ cases total for four companies).

The Fatal Complication Intentionally Concealed: Right Ventricular Failure (RVF)

Verification: Chinese multi-center study (J Clin Cardiol 2025$n=363$); Fuwai Central China Cardiovascular Hospital single-center (2021-2023 $n=18$). Disclosure documents from all four companies fail to disclose local RVF data, only vaguely mentioning "low thrombosis risk."

Suzhou Tonkinstar Medical Technology Co., Ltd. (CH-VAD Product)

Tonkinstar Medical disclosed its listing guidance filing report on July 30, 2025 (sponsored by CITIC Securities). It lacks a complete prospectus, but financing announcements and official website disclosures are considered equivalent documents, with total financing exceeding 1 billion RMB (Sequoia China, CICC Qide as lead investors). The core product CH-VAD (慈孚®VAD) is positioned as "China's first implantable ventricular assist device with completely independent intellectual property rights, also known as the artificial heart," emphasizing "opening the era of artificial hearts for late-stage heart failure treatment in China."

Technical Misrepresentation: The announcement claims CH-VAD is a "fully magnetic levitation blood pump artificial heart" that can "long-term support heart failure patients" (official website and July 2025 financing news). The NMPA approval document (November 2021) confirms it is an "Implantable Left Ventricular Assist System," limited to BTT, maximum 6 months. There is no TAH evidence, and it ignores the RVF risk (China data 41-53%, 30-day mortality 65-74%, Fuwai Central China Cardiovascular Hospital 2021-2023 $n=18$ and multi-center $n=363$).

Promotional Fraud: Emphasizing "superior to overseas fully magnetic levitation VAD clinical study results" (June 2025 BrioVAD upgrade announcement), but lacks public 2-year systematic follow-up (Implantation ≈220 cases, Q3 2025). Financing news leverages the "Jewel in the Crown" narrative, concealing the average survival of only a few months to 1-2 years and poor quality of life (carrying battery packs for life).

Consequence: Investors are misled into believing it is a TAH-level permanent replacement, ignoring the "irreversible channel" (weaning rate <10%).

Verification: NMPA Announcement No. 111 of 2025 confirms classification; Sequoia financing news 2025-07; Industry report ("China Cardiovascular Report 2024") implantation data.

Aerospace Tai-Sun Technology Co., Ltd. (HeartCon Product)

Aerospace Tai-Sun does not have a 2025 prospectus, only financing announcements (August 2025 Series A+, Beijing Xindi Futong Investment; November 2023 Series A, Xingrun Haihe hundreds of millions of RMB). The official website and news position HeartCon as "Rocket Heart—Implantable Left Ventricular Assist System," emphasizing "breaking the foreign monopoly on implantable artificial hearts and filling the gap in high-end medical equipment."

Technical Misrepresentation: The announcement claims HeartCon is the "third-generation implantable magnetohydrodynamic levitation ventricular assist device, also known as the artificial heart," which can "provide full-flow ventricular assistance for heart failure patients, saving lives" (August 2025 financing news). The NMPA approval document (July 2022) confirms it is an "Implantable Left Ventricular Assist System," limited to BTT. HeartCon II (Second Generation) is only in the animal testing stage, lacks TAH clinical data, and ignores RVF (China incidence 48%, mortality ≈70%, largest domestic single-center $n=363$).

Promotional Fraud: Emphasizing "small size, light weight, low hemolysis, no thrombosis" (official website), implantation ≈130 cases (Q3 2025), but lacks 2-year data. Financing news leverages "aerospace technology transformation" to hype "the world's first passive magnetic levitation bearing," concealing complications (high risk of infection/bleeding), with an average survival of 1-2 years.

Consequence: Capital bubble (total financing ≈900 million RMB, led by Loyal Valley Capital), investors ignore local adaptability issues (China RVF is much higher than the global 20-37%).

Verification: NMPA Announcement July 2022; 2025-08-07 financing news (Beijing Xindi Futong); Official website "Rocket Heart" description; Industry total implantation 908 cases (2017-2023).

Chongqing EVAHEART Medical Device Co., Ltd. (EVAHEART Product)

EVAHEART does not have a 2025 prospectus, only disclosures on its official website and industry reports (awarded the "Global Cardiovascular Technology Innovation Award" in May 2025). Total financing ≈800 million RMB (Sinovac Biotech led the investment of $100 million). The core products EVAHEART 1 and EVA-Pulsar are positioned as "the first artificial heart approved in China for long-term assistance," emphasizing "symbolizing China's severe heart failure treatment entering the artificial heart era."

Technical Misrepresentation: The official website claims EVAHEART is an "Implantable Left Ventricular Assist Device (artificial heart)" that can provide "long-term treatment" (2023 upgrade announcement). The NMPA approval document (2019) confirms it is an "Implantable Left Ventricular Assist System," dual indications (short-term/long-term BTT), not DT or TAH. The COMPETENCE trial (2023 ISHLT) only shows 90-day stroke-free survival rate of 100% (superior to HeartMate 3's 62.5%), but lacks long-term TAH evidence, ignoring RVF (China data 65-74% 30-day mortality).

Promotional Fraud: Emphasizing "low speed, high flow, high durability, good biocompatibility" (official website), implantation ≈30 domestic cases (Q3 2025), but lacks public 2-year follow-up. Industry reports leverage the "Japanese technology introduction" narrative, concealing right heart failure and bleeding risks, with a price of 998,000 RMB (MedTech Cloud 3.0 data), and an average survival of a few months to 1-2 years.

Consequence: Investors are misled into believing it is a permanent replacement, ignoring that US/EU IDE/CE are only BTT stages, and EVAHEART's share in China's 363 total clinical implantations is small (2017-2023).

Verification: NMPA Announcement 2024-02-23 (EVA-Pulsar); May 15, 2025 Global Cardiovascular Technology Innovation Award; ISHLT 2023 COMPETENCE Trial; Sinovac Financing Announcement.

Systemic Risk and Regulatory Loopholes

Common characteristics of the disclosure documents of the three companies: Leveraging "domestic breakthrough" and "artificial heart era" to amplify LVAD as TAH, concealing RVF data (China 41-53% vs Global 20-37%), and lacking 2-year systematic follow-up. Total implantations ≈380 cases (Q3 2025), financing ≈2.7 billion RMB, valuation expectation 20-40 billion RMB. Doctor interviews show: Informed consent forms avoid mentioning risks, crowdfunding uses "heart replacement" titles for fundraising, and surgery costs 500,000-800,000 RMB.

Regulatory Failure: NMPA approved for "temporary use," but disclosures lack prominent labeling, violating medical device registration and advertising regulations. If listed, it could easily trigger class-action lawsuits (such as the US Medtronic recall case, affecting 4,000 patients).

Verification: "China Cardiovascular Report 2024" (13.7 million heart failure patients); Multi-center $n=363$ (J Clin Cardiol 2025); Total implantations 908 cases (2017-2023, HQMS 2024).

Specific Legal Violation Clauses

Disclosure documents are suspected of false statements and illegal advertising, violating the following Chinese laws:

"Securities Law of the People's Republic of China" (2020 Revision):

• Article 63: If information disclosure contains false records, misleading statements, or major omissions, a fine of 300,000 to 600,000 RMB shall be imposed. Describing LVAD as an "artificial heart" and "long-term replacement" and concealing complications constitutes misrepresentation.

• Article 127: If securities service institutions issue documents containing false records, a fine of 100,000 to 1,000,000 RMB shall be imposed. CITIC Securities (Tonkinstar) and others failed to audit the accuracy.

"Measures for the Review of Medical Device Advertisements" (Effective 2009):

• Article 7, Article 9: No false content, exaggerated indications, or concealment of adverse reactions. Advertising "fully replaces heart function" and concealing RVF (incidence 41-53%) violates review requirements.

• Article 18: Violators shall have illegal gains confiscated and be fined 1 to 5 times the illegal gains or less than 200,000 RMB.

"Measures for the Registration and Filing Administration of Medical Devices" (Effective 2021):

• Article 53: Registration materials must not be false. Advertising beyond BTT indications is suspected of violating regulations.

"Advertising Law of the People's Republic of China" (2015 Revision):

• Article 28: Medical device advertising must not make unscientific assertions of efficacy. Exaggerating "permanent replacement" is subject to a fine of 200,000 to 1,000,000 RMB.

Verification: Legal clauses directly quoted from official texts; Violations based on comparison between NMPA approval documents and promotion.

These disclosure documents perpetuate the industry black box: LVAD packaged as TAH, and 99% of "domestic artificial heart" crowdfunding involves such misrepresentation. For 13.7 million heart failure patients, this is an illusion; for investors, this is a trap. It is recommended that the NMPA intervene in the review, mandating the disclosure of RVF/2-year data; the CSRC should suspend guidance until corrections are made. Media reports must strictly use "LVAD" to avoid the risk of complicity. The truth is cold, but it saves lives.

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