Huihe Medical Withdraws STAR Market IPO Application, Review Terminated

Shanghai, September 24 — The IPO review status of Shanghai Huihe Medical Technology Co., Ltd. ("Huihe Medical") on the Shanghai Stock Exchange's STAR Market has been changed to "terminated," effective September 24. The company and its sponsor withdrew the issuance and listing application. In accordance with Article 63 of the Shanghai Stock Exchange Rules for Review of Stock Issuance and Listing, the exchange has terminated the review process.

Business Overview

Huihe Medical is primarily engaged in the research, development, production, and sale of innovative medical devices in the field of pan-vascular intervention. Leveraging years of technical expertise, a precise understanding of clinical needs, and rapid engineering capabilities, the company has since 2023 obtained regulatory approvals for a series of innovative products in structural heart intervention, vascular intervention, and tumor intervention, forming a diversified product portfolio.

Structural Heart Intervention

• The company independently developed the globally innovative annuloplasty ring reduction technology, leading to the approval of its core product, K-Clip®.
• K-Clip® is currently the only tricuspid annuloplasty repair device approved by a major global regulatory authority, and the only domestically approved interventional treatment device for tricuspid regurgitation in China.
• It has established a new treatment paradigm for tricuspid regurgitation and filled a procedural gap in domestic interventional tricuspid therapy.
• Since receiving NMPA approval in March 2025, K-Clip® has been commercially implanted in over 100 hospitals across China, maintaining strong commercialization momentum.

Vascular Intervention

• Huihe Medical developed the first domestically approved intravascular shockwave catheter product in China, capable of delivering full-circumferential and full-axial shockwaves.
• The product has gained a strong clinical reputation since its market launch.

Tumor Intervention

• The company developed the first domestically produced radiopaque drug-loaded microsphere product in China.
• It is used in drug-eluting interventional treatments for hypervascular solid organ malignancies, such as liver cancer and lung cancer.
• The product has already won bids in a provincial-level centralized procurement alliance led by Gansu Province.

Sales Model

Huihe Medical operates under a distribution model:

• The company is responsible for overall market education, medical support, and national/provincial network access.
• Distributors handle market promotion, end-user sales, and logistics within designated authorized regions.
• The company has established a professional and efficient sales team and a relatively complete domestic sales network.
• It is actively advancing CE certification for its core products to gradually expand its global sales network.

Financial Highlights

| Period | Revenue (RMB) | Net Profit (RMB) | |--------|---------------|------------------| | FY2023 | 2.8037 million | -201 million | | FY2024 | 26.9882 million | -190 million | | FY2025 | 102 million | -219 million |

Note: All figures are for the respective fiscal years.