H&H Healthcare Files for STAR Market IPO Amid Over RMB 600 Million in Losses Over Three Years

Basking in the halo of a “cardiovascular medical device unicorn,” Shanghai H&H Healthcare Technology Company Ltd. (hereinafter referred to as “H&H Healthcare”) has attracted significant attention for its STAR Market IPO journey. On June 30, the official website of the Shanghai Stock Exchange showed that H&H Healthcare’s STAR Market IPO application had been accepted. H&H Healthcare is primarily engaged in the research and development, production, and sales of innovative medical devices in the pan-vascular intervention field and has been selected as a key serviced unicorn enterprise in Shanghai. However, the prospectus reveals that H&H Healthcare has not yet achieved profitability, with cumulative losses exceeding RMB 600 million during the reporting period, while the number of its R&D personnel has continued to decline. In terms of designed capacity and actual output, the capacity utilization rate of the company’s core products is not high; nevertheless, the company still plans to raise funds to expand production capacity under these circumstances.

Not yet profitable

H&H Healthcare is a high-tech enterprise with original technologies and global innovation capabilities in the field of pan-vascular intervention, primarily engaged in the independent research and development, production, and sales of innovative medical devices for pan-vascular intervention. Currently, the company has developed independently researched and developed innovative products with promising commercial prospects in areas such as structural heart intervention, vascular intervention, and tumor intervention, forming a relatively rich portfolio of marketed products.

In the field of heart valve disease, H&H Healthcare’s transcatheter tricuspid annuloplasty system, K-Clip, received approval for market launch from the National Medical Products Administration (NMPA) in March 2025. This system comprises a tricuspid annulus clipping system and a delivery sheath kit. In the vascular intervention sector, the company developed the C-Wave intravascular lithotripsy catheter, the first domestically produced intravascular lithotripsy catheter approved in China. Its peripheral artery indication was approved by the NMPA for sales in August 2023, and its coronary artery indication was approved for sales in May 2024. In the field of oncological intervention, the company’s polyvinyl alcohol embolization microspheres, Vispearl, obtained product registration certification in 2024, becoming the first radiopaque drug-eluting microsphere product in China.

As a medical device company planning to adopt the fifth set of listing standards, H&H Healthcare has not yet achieved profitability. Financial data shows that from 2023 to 2025, H&H Healthcare respectively achieved operating revenues of approximately RMB 2.8037 million, RMB 26.9882 million, and RMB 102 million; the corresponding net profits attributable to shareholders were approximately -RMB 201 million, -RMB 190 million, and -RMB 219 million; the corresponding net profits attributable to shareholders after deducting non-recurring items were approximately -RMB 206 million, -RMB 194 million, and -RMB 68.1863 million. As of the end of the reporting period, the company's accumulated uncovered losses amounted to RMB 738 million.

Among these, K-Clip and C-Wave are the company's core products. In 2025, K-Clip accounted for approximately 42.43% of revenue; C-Wave accounted for approximately 34.71%; polyvinyl alcohol embolization microspheres accounted for approximately 20.16%; and catheter sheath kits accounted for approximately 2.71%.

Regarding the reasons for continued losses, H&H Healthcare explained in its prospectus that this was mainly because the company has been continuously focused on the independent research and development and production of innovative medical devices in the field of pan-vascular intervention since its establishment, with substantial upfront R&D investment required for such projects.

Furthermore, during the reporting period, the net cash flow from operating activities remained consistently negative. From 2023 to 2025, the net cash flows from operating activities were -RMB 98.046 million, -RMB 73.9687 million, and -RMB 55.3829 million, respectively.

Lin Xianping, an associate professor at Zhejiang University City College and executive deputy secretary-general of the China Urban Expert Think Tank Committee, stated that the company’s commercialization is still in its early stages; although revenue has been rising year by year, high expenditures on research and development, promotion, and other areas may continue to erode profits.

Continuous Decline in the Number of R&D Personnel

Building on its core product, the K-Clip, H&H Healthcare has also laid out a pipeline of products under development, including the K-Plus, Tri-Cap (transcatheter tricuspid valve clipping system), and the transcatheter mitral valve Combo system.

However, during the reporting period, the number of R&D personnel at H&H Healthcare showed a year-on-year decline. From 2023 to 2025, the company’s R&D staff count was 87, 69, and 58, respectively, accounting for 37.5%, 30%, and 25.22% of the total workforce. Meanwhile, the number of sales personnel increased annually, rising from 13 in 2023 to 42 in 2024 and 54 in 2025, with their proportion of the total workforce amounting to approximately 5.6%, 18.26%, and 23.48%, respectively.

In terms of the educational background composition of H&H Healthcare’s R&D personnel, as of the end of the reporting period, the Company had 1 PhD holder, 18 Master’s degree holders, 26 Bachelor’s degree holders, and 13 employees with an associate degree or below, accounting for 1.72%, 31.03%, 44.83%, and 22.41% respectively.

During the same period, the company’s R&D expenses continued to decline. From 2023 to 2025, the company’s R&D expenses were approximately RMB 134 million, RMB 108 million, and RMB 90.0459 million, respectively, with R&D expense ratios of 4,769.5%, 399.17%, and 88.68%, respectively. Among these, employee compensation amounted to RMB 41.8423 million, RMB 37.0047 million, and RMB 28.5595 million, accounting for 31.29%, 34.35%, and 31.72% of the R&D expenses, respectively.

In this regard, H&H Healthcare stated in its prospectus that the employee compensation included in its R&D expenses has decreased year by year, primarily because the company’s products successively obtained registration certificates and achieved mass production during the reporting period, leading to increasing commercial maturity. Taking into account factors such as product portfolio and future business planning, the company strengthened workforce efficiency management, resulting in a reduction in the number of R&D personnel.

From the perspective of Zhang Yue, Chairman of Aoyou International, the company’s multiple pipelines under development still require continuous investment; a reduction in R&D personnel could slow down product development and registration progress, causing the company to miss the market window.

Fundraising for Production Expansion Draws Attention

In this IPO, H&H Healthcare plans to raise RMB 1.11 billion, which will be allocated to the construction of a new production center (RMB 430 million), new product development (RMB 210 million), overseas clinical trials and registration (RMB 220 million), and replenishment of working capital (RMB 250 million).

The company stated in its prospectus that, upon the completion and full production of the investment projects funded by this capital raising, it will significantly expand the production capacity of its structural heart interventional products.

Among these, the new production center construction project mainly focuses on expanding, upgrading, and integrating the production conditions for current and pipeline products. The products involved include the transcatheter tricuspid annuloplasty system K-Clip and its upgraded version K-Plus, the transcatheter tricuspid clip system Tri-Cap, the transcatheter mitral annuloplasty system L-Clip, and the transcatheter mitral clip system D-Clip.

It is worth noting that the Company did not directly disclose capacity utilization rates in its prospectus; however, a comparison of production volumes against designed production capacities reveals that the capacity utilization for core products is relatively low. Specifically, the annual designed production capacity for the Transcatheter Tricuspid Annuloplasty System is 5,000 sets. In 2025, the production volume of the Transcatheter Tricuspid Annuloplasty System – Tricuspid Annulus Clip System was 1,435 units, with sales volume of 657 units; the production volume of the Transcatheter Tricuspid Annuloplasty System – Delivery Sheath Kit was 1,072 units, with sales volume of 469 units.

Zhang Yue stated that when H&H Healthcare’s newly built production capacity becomes operational, if hospital coverage of core products and volume growth under medical insurance fall short of expectations, while products in the pipeline fail to gain approval on schedule to provide follow-up momentum, the pressure from idle capacity may intensify further, with corresponding depreciation and amortization continuing to weigh on profits. However, the company’s capacity is designed as a flexible production layout shared across multiple products. If subsequent pipeline products are launched sequentially and overseas markets gradually expand, the capacity can be absorbed and allocated across multiple product lines. The ultimate level of risk depends on the alignment between the pace of commercialization and the approval rhythm of the product pipeline.

In response to the relevant issues, a Beijing Business Today reporter sent an interview request to H&H Healthcare, but no reply had been received by the time of publication.