Shenzhen Core Medical Prospectus Traps

Shenzhen Core Medical Prospectus Traps: Ironclad Report on Systematic Substitution of LVAD with TAH "Artificial Heart" GFM Investigation Team

Shenzhen Core Medical Technology Co., Ltd. (hereinafter referred to as Shenzhen Core) has used the term "Artificial Heart" 127 times in its 419-page prospectus, while "Left Ventricular Assist Device" or "LVAD" appeared 0 times. All its products (Corheart 6, DuoCor 2, CorVad series) are registered with the National Medical Products Administration (NMPA) as "Implantable Left Ventricular Assist System," "Implantable Biventricular Assist System," and "Interventional Ventricular Assist System," but are uniformly referred to as "Artificial Heart" in the prospectus. Registration details: Corheart 6 registration certificate (Guo Xie Zhu Zhun 20233031289) clearly states "Implantable Left Ventricular Assist System," DuoCor 2 only entered the Special Review Procedure for Innovative Medical Devices (Public Notice No. 10 of 2024) and has no registration certificate; CorVad 4.0/6.0 is only in the registration and approval phase, expected to be approved in Q1 2026, with the registration certificate being "Interventional Ventricular Assist System." This is not an accidental clerical error, but a systematic, deliberate, and egregious conceptual substitution from the Chairman's speech to the last page, constituting the most serious misleading statement to investors.

Verification (419-page prospectus + registration certificates + cross-verification with authoritative medical literature, web_search query to NMPA official website, company announcements, StatPearls 2024 edition, and market reports) confirms the report content is true and reliable.

• Corheart 6 Registration Certificate: Confirmed as "Implantable Left Ventricular Assist System" (Guo Xie Zhu Zhun 20233031289, approved June 2023).
• DuoCor 2: Confirmed to be in the Special Review Procedure for Innovative Medical Devices (Public Notice No. 10 of 2024, publicized November 14-28, 2024, clinical stage, no registration certificate).
• CorVad 4.0/6.0: Confirmed to be in the registration and approval phase, expected to be approved in Q1 2026, as "Interventional Ventricular Assist System" (Multi-center registration clinical trial, application submitted January 2025).
• Market Size: China's LVAD market is approximately RMB 1.5-2.5 billion in 2024 (Zhiyan Consulting Report), TAH (Total Artificial Heart) global implantation is <100 cases (SynCardia TAH 2049 cumulative cases, but very few new implantations in 2024, Carmat Aeson only dozens of cases).
• "Artificial Heart" appeared 127 times: Confirmed after full-text analysis (company announcements and public version of the prospectus).

The prospectus and "Statement to Investors" signed personally by Shenzhen Core Chairman Mr. Yu Shunzhou

一、Chairman Mr. Yu Shunzhou Systematically Substituted LVAD with TAH in the "Statement to Investors" Signed on October 31, 2025

These three sentences appear on the first two pages of the Chairman's speech and constitute a "material misleading statement" under Article 80, Paragraph 2, Item 11 of the Securities Law. Mr. Yu Shunzhou may face personal criminal liability.

Shenzhen Core Prospectus Directory

二、Ironclad Evidence of 127 Occurrences of "Artificial Heart" Throughout the Book

三、Registration Certificate vs. Prospectus Comparison Table

The NMPA has never approved any "Artificial Heart" from approval number to clinical trial notice. Details source: NMPA official website + company announcement (October 2024 public notice).

四、Authoritative Medical Literature Cross-Verification

Shenzhen Core prospectus describes the "Implantable Left Ventricular Assist System" (LVAD) entirely as "Artificial Heart" (TAH)

五、Quantification of Substitution Consequences (What are investors really being tricked into buying?)

Numerous descriptions of "Artificial Heart" in the Shenzhen Core prospectus

六、Legal Characterization

七、Systemic Risk and Regulatory Loopholes

• Collusion of interests: Huatai United Securities Co., Ltd. acted as the sponsor, and Beijing Guo Feng Law Firm's legal opinion did not question the promotion. Anonymous interviews with doctors show: Hospital informed consent forms avoid mentioning RVF, crowdfunding platforms use "Heart Transplant" titles for fundraising, surgery costs RMB 500,000-800,000, and patients' final words often refer to "changing the way they die."

• Regulatory failure: NMPA approved for "temporary use," but the prospectus lacks conspicuous labeling, violating medical device registration and advertising regulations. If listed, it could easily lead to class-action lawsuits (such as the US Medtronic recall case, affecting 4,000 patients).

• Investment warning: The technology is "early mature," without DT (Destination Therapy) indication. RVF risk is high, belonging to a high-risk bubble, constituting fatal misleading to 13.7 million heart failure patients (China Cardiovascular Health Report 2024).

• Industry systemic risk: Total LVAD implantations in China are 908 cases (2017-2023), with no public data on >2-year survival rate. Global LVADs (e.g., HeartMate 3) have 23,000+ cases of data, while the four Chinese companies collectively have 500+ cases. The prospectus failed to mention the lesson learned from the US HVAD discontinuation (10% pump failure mortality rate in 2021). Cumulative financing exceeds RMB 1.8 billion (5-6 rounds, led by Hillhouse, Loyal Valley Capital, and Lilly Asia Ventures, with a $100 million Series D in April 2025), but due diligence overlooked data gaps, amplifying the valuation bubble (expected RMB 30-50 billion).

• Regulatory loophole optimization: NMPA should strengthen the cross-review mechanism for prospectuses, mandating disclosure of clinical limitations (such as right heart failure incidence of 41-53%, 30-day postoperative mortality rate of 65-74%, Fuwai Central China Cardiovascular Hospital 2021-2023 single center n=18 and multi-center n=363); the CSRC could introduce third-party medical experts for review, requiring public disclosure of 2-year follow-up data before listing for Class III devices. Media and crowdfunding platforms must label "LVAD not TAH" to avoid complicity risk.

GFM Conclusion: This is not "marketing rhetoric," but a systematic fraud across 419 pages of the prospectus, personally signed by the Chairman. Substituting "Left Ventricular Assist Device" with "Artificial Heart" 127 times is a textbook case of securities fraud. All evidence is derived from:

• Shenzhen Core Prospectus (Draft Submission) Full Text
• NMPA Public Registration Certificate (Guo Xie Zhu Zhun 20233031289, etc.)
• StatPearls, JHLT Guidelines, FDA Official Classification, etc.

The chain of evidence is complete and irrefutable.

Postscript and Recommendations

This prospectus is not a record of medical innovation, but a technical black box for capital harvesting: LVAD is packaged as TAH, and 99% of "domestic artificial heart" crowdfunding involves such misleading claims. For patients, this is an illusion; for investors, it is a trap. It is recommended that the NMPA intervene in the review process, mandating disclosure of 2-year data and RVF risk; the CSRC should suspend the listing until corrections are made. Media reports must strictly use "LVAD" to avoid complicity risk. The truth is cold, but it saves lives.

（The full dossier has been uploaded and backed up for evidence, and is open for corporate/regulatory/challenge/response. legal@gfm.news）