NewMed Medical Advances Hong Kong IPO to Drive Innovation in Structural Heart Disease Interventions

Shanghai NewMed Medical Co., Ltd., specializing in the research, development, and commercialization of transcatheter artificial heart valve systems (hereinafter referred to as "NewMed"), has officially launched its Hong Kong IPO. On August 4, the International Department of the China Securities Regulatory Commission (CSRC) disclosed the application materials submitted by NewMed for the *Approval for Overseas Initial Public Offering of Shares (Including Ordinary Shares, Preference Shares, and Other Types of Shares and Share Derivatives)*. Once accepted, it indicates that NewMed will soon file its prospectus with the Hong Kong Stock Exchange.

According to Tianyancha, NewMed has completed five rounds of financing to date. In July of this year, NewMed completed its joint-stock reform, with a current registered capital of RMB 660 million.

Founded in 2015, NewMed specializes in the research, development, and industrialization of interventional artificial heart valve systems (for heart valve diseases). The company operates R&D and production bases spanning over 10,000 square meters in Shanghai, Beijing, Chengdu, and other locations. These facilities include R&D laboratories, physical, chemical, and microbiological testing platforms, as well as Class 10,000 GMP clean production workshops. The company's projects have received R&D funding support from programs such as the Ministry of Science and Technology's 13th Five-Year Plan projects and the Shanghai Municipal Science and Technology Commission's Science and Technology Support Program. To date, NewMed has filed a cumulative total of over 160 patents.

Currently, NewMed's primary business focuses on a comprehensive suite of interventional treatment solutions for structural heart disease, including transcatheter mitral valve replacement (TMVR) and repair (TMVr), transcatheter aortic valve replacement (TAVR), and interventional adjunct devices; additionally, the company has multiple innovative products in the structural heart disease field currently under development, which will provide comprehensive solutions for patients in the future.

It is understood that valvular heart disease is a type of structural heart disease that can be treated through surgical intervention. To date, surgical treatments for valvular heart disease are categorized into: conventional open-heart surgery (SAVR), minimally invasive valve surgery, and transcatheter valve therapy (TVT). Among these, four treatment methods utilizing TVT technology are respectively known as: transcatheter aortic valve replacement (TAVR), transcatheter pulmonary valve replacement (TPVR), transcatheter mitral valve replacement (TMVR), and transcatheter tricuspid valve replacement (TTVR).

With breakthrough advancements in transcatheter valvular intervention technologies, transcatheter valve replacement and repair techniques have become a key focus in the international R&D of cardiovascular devices, with TAVR emerging as the primary competitive battleground in the heart valve sector. Currently, three industry giants—Edwards Lifesciences, Medtronic, and Boston Scientific—hold over 90% of the global TAVR market, while Chinese manufacturers generally remain in the early stages of development.

It is reported that, compared to TAVR products from other Chinese manufacturers that primarily adopt a self-expanding design, NewMed's Prizvalve product features a balloon-expandable design, offering potential advantages such as a lower postoperative pacemaker implantation rate; additionally, balloon-expandable aortic valves also demonstrate significant advantages in treating bioprosthetic valve degeneration with regurgitation. Currently, the company's Prizvalve has been successfully utilized for valve-in-valve therapy in several investigational clinical cases.

In June this year, NewMed's independently developed innovative product, the Valveclip-M Transcatheter Mitral Valve Repair System (abbreviated as the “Valveclip-M System”), was approved by the National Medical Products Administration (NMPA) to enter the Special Review Procedure for Innovative Medical Devices, i.e., the “Green Channel”. This is the third product from NewMed to enter the “Green Channel”, following the Mi-thos® Transcatheter Mitral Valve Replacement System and the Prizvalve® Transcatheter Aortic Valve System. NewMed has thus become the only enterprise with three “Green Channel” approvals in the field of valve replacement and repair.

It is reported that the Valveclip-M system is a transfemoral mitral valve edge-to-edge repair device independently developed by NewMed. Currently, the Valveclip-M system has initiated registration clinical trials and is expected to obtain regulatory approval and be commercialized in the near future.

According to Tianyancha, NewMed has completed five rounds of financing, with investors including Temasek, Yunfeng Capital, Chuangban Fund, OrbiMed, Fortune Capital, Boyuan Capital, Zhangke Lingyi Capital, Junzi Capital, and others.

The latest round of financing occurred this March, with NewMed completing a Series C round of over USD 100 million. The proceeds will be used to accelerate the company's R&D of interventional devices for structural heart disease, and to advance the clinical trials and regulatory registration of its mitral valve replacement and repair products, as well as balloon-expandable aortic valve replacement products. Following the completion of this financing, NewMed completed its conversion into a joint-stock company in July this year, with its registered capital increasing by RMB 660 million on July 13. Regarding the shareholding structure, Chairman and shareholder Yu Qifeng is the largest shareholder of NewMed, directly holding 23.23% of the shares.