The domestic pharmaceutical and medical device sector has seen accelerated development in recent years, with numerous companies achieving leading breakthroughs in both the domestic and international markets.
Shanghai Huihe Medical Technology Co., Ltd. (referred to as "Huihe Medical"), which recently filed an IPO prospectus for the Science and Technology Innovation Board (STAR Market), is one such entity.
Huihe Medical focuses on the research and development of innovative medical devices in the pan-vascular intervention field.
Its self-developed transcatheter tricuspid valve annuloplasty system K-Clip, for treating tricuspid regurgitation, employs globally innovative technology.
It is currently the world's only tricuspid annulus reduction and repair device approved and registered by a major regulatory authority, and it has become the first approved tricuspid intervention medical device in China, currently enjoying a period of market exclusivity.
Examining the prospectus, the company's revenue has seen substantial growth, increasing from 2.8 million to 102 million yuan.
Despite this seemingly positive revenue performance, profitability has been poor, with cumulative losses exceeding 600 million yuan over three years.
Furthermore, the number of R&D personnel has decreased from 87 to 58, while the sales team has expanded from 13 to 54.
R&D expenses have also been reduced from 134 million yuan to 90.04 million yuan.
The company stated that this is due to "products successively obtaining registration certificates and achieving mass production, with commercialization maturing, leading to enhanced personnel efficiency management."
From this perspective, Huihe Medical has completed the critical transition from pure R&D to commercialization.
However, there is still a distance to go before product sales revenue can cover all costs.
Bearing the unique distinction of a global first, as this niche leader rushes towards an IPO, can it successfully list?
Core Product is Globally Unique and First Approved in China
Huihe Medical's breakthroughs and achievements in cardiovascular interventional medical devices are closely tied to the deep medical background of its founder.
Information shows that the founder of Huihe Medical is Lin Lin, born in 1980, who holds a master's degree from the Bioengineering Department of Shanghai Jiao Tong University.
At age 23, Lin Lin began working as a cardiology physician at Ruijin Hospital.
Two years later, he entered the corporate world, joining 3M China Co., Ltd., where he held positions including Senior Clinical Research Engineer, R&D Department Manager, and Marketing Department Manager.
In 2011, Lin Lin joined St. Jude Medical (Shanghai) Co., Ltd., eventually rising to the position of Marketing and Sales Director.
From October 2017 to April 2018, Lin Lin served as Co-founder and Vice President of Shanghai Jiecheng Medical Technology Co., Ltd.
In May 2019, Lin Lin founded Huihe Medical.
Among the companies Lin Lin worked for, besides tape, 3M also produces cardiovascular-related products such as stethoscopes and ECG monitoring electrodes.
St. Jude Medical primarily focuses on cardiovascular medical devices like pacemakers, defibrillators, and heart valves.
The co-founded Shanghai Jiecheng's business scope includes technology development services in medical technology and biotechnology, and its parent company, Suzhou Jiecheng Medical Technology Co., Ltd., is a well-known company in the domestic transcatheter aortic valve replacement (TAVR) field.
It is evident that Lin Lin possesses not only a medical professional education background and clinical experience but also experience in R&D, marketing, and sales management roles at several medical device companies, along with relevant entrepreneurial experience, making him a highly versatile and composite talent.
After its establishment, Huihe Medical focused on the R&D, production, and sales of medical devices in the pan-vascular intervention field.
In August 2023, its first product—a single-use coronary intravascular lithotripsy catheter—was approved for market launch, becoming the first approved domestic lithotripsy catheter product in China.
In May 2024, its developed single-use coronary intravascular lithotripsy catheter was approved.
Both products target the field of vascular calcification treatment.
Simultaneously, its developed visible polyvinyl alcohol embolization microsphere product was approved in 2024 for application in the field of tumor interventional embolization therapy.
However, Huihe Medical's true breakthrough lies in the approval of its K-Clip product.
This is a medical device for treating tricuspid regurgitation and is also the only approved tricuspid interventional therapy device in China, currently in a market exclusivity period.
According to media reports, this product was inspired by a wine opener and employs globally innovative annular reduction technology, creating a new therapeutic paradigm for tricuspid intervention.
In March 2025, Huihe Medical's K-Clip product was approved, and its business rapidly scaled up.
Data shows that Huihe Medical's revenue for 2023-2025 was 2.8037 million yuan, 26.9882 million yuan, and 102 million yuan respectively, indicating extremely rapid growth.
In 2025 alone, K-Clip product revenue reached 43.0713 million yuan, accounting for 42.43% of total revenue.
However, being in the early stages of commercialization, the company's sales expenses continue to rise, R&D expenses remain at a relatively high level, and coupled with a high equity incentive expense of 131 million yuan in 2025, Huihe Medical remains in a loss-making state.
Net profit attributable to the parent company for 2023-2025 was -201 million yuan, -190 million yuan, and -219 million yuan respectively, resulting in total losses exceeding 600 million yuan over three years.
For this IPO attempt, Huihe Medical is adopting the fifth set of listing standards applicable to medical device companies on the STAR Market, which stipulates an estimated market value of no less than 4 billion yuan and that the relevant product technology meets standard requirements.
In the first capital increase after Huihe Medical transformed into a joint-stock company in December 2025, the price per share of registered capital was 125 yuan, corresponding to a post-investment valuation as high as 4.55 billion yuan, meeting the market value requirement.
Concurrently, its core product has been approved for market launch, achieving staged results and possessing significant technological advantages, among other factors.
Can this IPO enable Huihe Medical to leverage the capital market to accelerate development and further consolidate its leading advantage?
K-Clip Gross Margin Exceeds 80%
Competition in the pharmaceutical and medical device industry hinges on R&D and commercialization capabilities.
Now that Huihe Medical's core product K-Clip has been approved for market launch and is in a period of market exclusivity, its future development depends on whether it can establish a market-leading advantage during this exclusivity period.
Globally, apart from Huihe Medical's K-Clip product, three other transcatheter tricuspid treatment products have been approved for market launch in major markets, including Edwards Lifesciences' products EVOQUE and PASCAL, and Abbott's product TriClip.
Among them, TriClip was approved in Europe in May 2020 and in the US in April 2024; EVOQUE was approved in Europe in October 2023 and in the US in February 2024; PASCAL was approved in Europe in August 2022.
The three companies employ different technological approaches, but all aim to restore tricuspid valve function through repair or replacement, making them direct competitors.
Edwards and Abbott's products have more mature clinical applications and stronger brand advantages, but they have not yet been approved in China.
In addition to international competitors already approved in other major markets, among domestic companies, JianShi Technology and ZhenYi Medical have already submitted registration applications for their related pipeline products in China.
Notably, in July of this year, JianShi Technology's transcatheter tricuspid valve replacement system LuX-Valve Plus successfully obtained EU certification, becoming the world's second tricuspid valve replacement product after EVOQUE.
This also indicates that domestic competitors are accelerating their pursuit, leaving limited market exclusivity time for Huihe Medical.
For Huihe Medical, currently in the early stage of commercial promotion, it needs to accelerate its layout in market education, hospital coverage, and inclusion in medical insurance reimbursement, rapidly increasing product market share before competing products are approved domestically.
From 2023 to 2025, Huihe Medical expanded its sales team, increasing sales personnel from 13 to 54.
Its sales expenses rose year by year to 7.1982 million yuan, 30.1536 million yuan, and 45.3238 million yuan respectively.
The sales expense ratio was 256.74%, 111.73%, and 44.63% respectively, primarily used for sales personnel compensation and equity incentives, as well as participation in academic conferences, industry forums, and other promotional activities.
Beyond conventional sales promotion, inclusion in medical insurance reimbursement will be a key factor determining the commercialization of Huihe Medical's K-Clip product.
According to the prospectus, K-Clip consists of a tricuspid valve annulus clip system and a delivery sheath kit.
In 2025, the sales unit price of the K-Clip tricuspid valve annulus clip system was 59,200 yuan, with a gross margin reaching 86.41%.
The unit price of the delivery sheath kit was 8,959.22 yuan, with a gross margin of 58.43%.
The combined K-Clip kit had a gross margin of 82.73%.
According to previous media reports, the terminal selling price of the K-Clip product ranges from 160,000 to 190,000 yuan.
Such a high price makes it difficult to popularize in markets beyond top-tier hospitals.
As per the prospectus, current K-Clip overall procedure volume and market size are concentrated in leading medical institutions with experience in valve intervention, mostly tertiary-grade hospitals.
Inclusion in medical insurance reimbursement can significantly reduce patients' out-of-pocket expenses and accelerate commercial application.
Currently, K-Clip is included in the medical insurance reimbursement scope in parts of Xinjiang, Qinghai, Shaanxi, and Shandong, but overall coverage remains limited.
Most provinces have not yet included it in their medical insurance catalogs, which also creates significant promotion pressure for the terminal sales of Huihe Medical's K-Clip.
In the short term, the commercial promotion of K-Clip is the core task for Huihe Medical.
In the long run, the expansion into international markets and the continued advancement of the R&D pipeline are key to determining Huihe Medical's long-term competitiveness.
Currently, Huihe Medical's K-Clip is steadily advancing European registration clinical trials and actively planning for overseas markets.
In its R&D pipeline, the K-Plus system, an extension based on K-Clip, has been submitted for registration.
The tricuspid valve leaflet repair product Tri-Cap is about to enter the clinical trial stage, and its developed transcatheter mitral valve Combo system for treating mitral regurgitation is under development.
However, whether it's commercial promotion, international market expansion, or R&D advancement, substantial funding is required for support.
Therefore, this STAR Market IPO, securing development funds through the A-share market, will be a crucial step affecting Huihe Medical's short-term and long-term development.
Overall, as the first domestic company to have an approved tricuspid interventional medical device, Huihe Medical has obtained an extremely valuable period of market exclusivity.
However, how to conduct market education for patients and physicians, promote the application of the new product, and increase market share as much as possible during the exclusivity period presents new challenges for Huihe Medical.
Whether Huihe Medical can successfully list this time and leverage the financing platform of the capital market to accelerate its development is undoubtedly worthy of attention.
Comments