The so-called "Standard Five" refers to the fifth set of listing standards for the STAR Market, which is specifically designed for pre-profit and even pre-revenue companies planning to go public. Its detailed rules are:The estimated market value is no less than 4 billion yuan, and its main business or products need to be approved by relevant national departments, with a large market space and having achieved phased results so far; if it is a pharmaceutical industry enterprise, it needs to have at least one core product approved for Phase II clinical trials.。

In June 2022, the Shanghai Stock Exchange formulated the "Guidance No. 7 on the Application of the Sci-Tech Innovation Board Listing Review Rules — Application of the Fifth Set of Listing Standards for Medical Device Companies," providing a detailed guidance document for medical device companies that have not yet achieved profitability to apply for listing on the Sci-Tech Innovation Board.

However, from a practical perspective, it is extremely challenging for unprofitable medical device companies to achieve their STAR Market dream through "Standard Five."

Following the termination of Huamaitech's STAR Market IPO at the end of last year, another former star medical device company that applied under "Standard Five" has also ended its IPO journey.

Hanyu Medical mainly engages in the research, development, production, and commercialization of interventional devices for structural heart disease and electrophysiology products. The company’s product pipeline includes five innovative medical devices for repair targeting mitral regurgitation, tricuspid regurgitation, and congenital atrial septal defects, two innovative replacement medical devices respectively targeting mitral regurgitation and tricuspid regurgitation, as well as two electrophysiology products.

In the field of structural heart disease interventional devices, Shanghai Hanyu Medical Technology Co., Ltd.'s ValveClamp product is a mitral regurgitation interventional treatment device included in the special approval process for innovative medical devices, and is one of the star products in this field.

Currently, there are six transcatheter mitral valve repair products and one transcatheter mitral valve replacement product approved for marketing worldwide.

According to Hanyu Medical's disclosure, the company's only competitor is Abbott's MitraClip.

Currently, MitraClip is the world's only approved and widely used interventional device for mitral regurgitation, with a global cumulative total of approximately 140,000 surgeries, while the number of surgeries for other products is around 1,000, showing a very significant gap.

Hanyu Medical stated that, compared with the MitraClip product, the company's ValveClamp product has several advantages: including a cleverly designed surgical pathway, a unique clamping method, simple surgical operation, the ability to complete the surgery with ultrasound assistance, low hardware requirements, a unique closure ring design, and enhanced clamping effectiveness, among others.

Hanyu Medical has a close relationship with Shanghai Zhongshan Hospital, a major center for cardiac medicine in China. The company owns 12 invention patents, 9 of which were acquired from Shanghai Zhongshan Hospital. Moreover, the original patent for the company's main core product, ValveClamp, comes from team members at Zhongshan Hospital, including Pan Wenzhi and Ge Junbo.

The treatment of structural heart disease has been an extremely popular细分赛道in the medical industry over the past few years, and Hanyu Medical has unsurprisingly become an absolute star project in the previous一级市场.

Public information shows that Hanyu Medical completed at least 10 rounds of financing before its IPO, among whichCompleted a D+ round of financing amounting to 500 million in March 2021, with shareholders includingYunfeng Capital,CITIC Industrial Fund,Top-tier investment institutions in China, such as Yingke Capital.

However, Hanyu Medical's pace was still a step slower. After its peers such as Qiming Medical, Peijia Medical, and Xintong Medical successively achieved IPOs on the Hong Kong stock market, their stock prices eventually plummeted, bringing the capital story in the field of structural heart disease to an abrupt halt.

Hanyu Medical once submitted its prospectus to the Hong Kong Stock Exchange in April 2021, preparing for an IPO in Hong Kong. However, after passing the listing hearing of the Hong Kong Stock Exchange in 2021, Hanyu Medical ultimately decided to abandon its listing on the Hong Kong Stock Exchange.

AlthoughHanyu Medical did not publicly disclose the reason for giving up on the Hong Kong stock market, but the disastrous stock price performance of the aforementioned companies in the Hong Kong stock market may be one of the important factors that discouraged Hanyu Medical.

Although the valuation of the STAR Market has an overwhelming advantage over that of the Hong Kong stock market, since 2022, the invisible threshold for the "Standard Five" of the STAR Market has also become increasingly high.

For unprofitable medical device companies, the challenge is even greater: so far, only MicroPort EP has successfully listed on the STAR Market under "Standard Five," becoming the sole representative of medical device companies under "Standard Five."

In addition, surgical robot companiesSizherui Applied for the STAR Market Listing Under "Standard Five" and Successfully Passed the Review, but Its Registration Application Has Not Been Approved Yet Though Submitted over Half a Year Ago.