Heart Valve Leader NewMed Medical Shifts to A-Share IPO, Enters Counseling Phase
NewMed
Artificial Heart Valve System Developer
Heart Future
Recently, information on the official website of the China Securities Regulatory Commission (CSRC) showed,Shanghai NewMed Medical Co., Ltd.Officially launched for the first time on January 8, 2026Development Bank(IPO) Listing Guidance, Guiding Institution isCITIC Securities. This progress means that this local enterprise, which has been deeply engaged in the field of interventional devices for structural heart disease, is entering a new stage of development.
Unlike most medical device companies that enter the market with a single product, NewMed's development path over the past decade has been more focused on...Interventional Treatment of Heart ValvesThe systematic product development. From the aortic valve to the mitral valve, tricuspid valve, and pulmonary valve, the company has gradually built up a multi-valve interventional solution covering "replacement + repair," achieving domestic technological breakthroughs at several key milestones.
# Financing History and IPO Experience: Supporting Long-term R&D Pathways
According to publicly available information,Since its establishment in 2015, NewMed has completed multiple rounds of equity financing, with a cumulative financing amountMore than 1 billion US dollars。
In 2021, the Series C financing round was led by Temasek, with an amount exceeding 100 million US dollars and a valuation reaching 4.6 billion yuan; in 2020, the Series B+ financing round raised 100 million yuan, with participation from Fortune Venture Capital; in 2018, the Series A financing round secured tens of millions of US dollars, led by Loyal Valley Capital and Tahoe Ventures. The investors include well-known institutions such as Temasek, Lilly Asia Ventures, Yunfeng Capital, Fortune Venture Capital, Orbimed, and Boyuan Capital.
These funds are mainly used for the research and development of core products, the advancement of clinical trials, and the establishment of production systems. Consistent with the industry characteristics of long R&D cycles and high technical barriers in structural heart disease devices, the company has maintained a high-intensity R&D investment over a long period.
NewMed is not making its first attempt to enter the capital market.In 2021 and 2022, the company submitted listing applications to the Hong Kong Stock Exchange twice, but ultimately did not complete the listing process.NewMed Medical Co., Ltd. submitted its initial IPO application to the Hong Kong Stock Exchange in August 2021 but failed to pass the hearing. In March 2022, it submitted the application again, planning to use 42.2% of the funds raised for the research and development and commercialization of its core product Prizvalve, 40.6% for other products under development, and 13.6% for production capacity development.
This shift to A-shares and the initiation of coaching registration is also seen by the industry as the company's renewed choice of capital market path after the approval of its core products and the gradual formation of its pipeline.
# Company Overview: Focusing on the Construction of Engineering Capabilities in Valve Interventions
NewMed, founded in 2015, is a national-level specialized and innovative "little giant" enterprise and a high-tech enterprise, focusing on the field of interventional treatment for structural heart disease. About 80% of the company's employees are engaged in research and development. It has established an ISO 13485 quality management system and has carried out medical-engineering collaboration with several institutions, including West China Hospital of Sichuan University, General Hospital of Northern Theater Command, and Beihang University.
To date, the company has filed over 400 patent applications, including more than 220 invention patents, with a patent layout covering key technical modules such as valve replacement, valve repair, delivery systems, and balloon catheters, ranking among the top in the global artificial heart valve patent landscape.
In terms of R&D organization, NewMed has established the "NewMed Singularity Innovation Center" and multi-center joint laboratories to promote continuous feedback between fundamental engineering capabilities and clinical needs, which has become a crucial support for its product iteration speed.
# Product System: Starting with Balloon-Expandable Valves, Moving Towards Full Valve Intervention
Prizvalve®Transcatheter Aortic Valve System
Prizvalve®The system isChina's First Balloon-Expandable Transcatheter Aortic Valve with Independent Intellectual Property Rights，In2024Year8Month received the approval from the China National Medical Products Administration (NMPA) Approved for Marketing。
The ProductUseBovine Pericardial Leaflet and Skirt DesignAnd it has a lower stent height, which can effectively reduce the pacemaker implantation rate, improve hemodynamics, and better adapt to vascular morphology, reducing the risk of post-implantation complications.
Prizvalve®The system has four models, with specifications and sizes respectively.20 mm、23 mm、26 mm、29 mm. Product features are as follows:
Using biocompatibleCobalt-Chromium AlloyAs the valve frame material, the inner and outer parts of the frame are sutured withPETThe skirt made of material can effectively reduce the occurrence of paravalvular leakage. The bioprosthetic leaflets, made from bovine pericardial material and treated with a unique anti-calcification process, offer durable usage.
The stent is designed to be shorter with strong radial support, and the delivery system isThrough the apex or through the femoral artery and femoral vein approachPuncture the atrial septum.
Adjustable bending delivery systemDuring the valve deployment process, coaxial adjustability can effectively address issues related to valve coaxiality.
Prizvalve®Not only can it be used for aortic valve and mitral valve stenosis, but also for related heart valve diseases such as bioprosthetic valve degeneration of the aortic valve, mitral valve, and tricuspid valve.Treatment.
Its upgraded versionPrizvalve ProInLaunch in 2025, optimizing bending performance and anatomical adaptability, shortening balloon length to suit patients with small left ventricles, equipped with a detachable loader and expandable sheath kit (approved in December 2024), reducing the risk of vascular injury.
Mi-thos®ViaCatheterMitral Valve Replacement System
Mi-thos®The transcatheter mitral valve replacement system isThe first domestic product to enter the National Innovative Medical Device Special Review ProgramTMVRProduct, applicable toPatients with severe symptoms of functional or organic mitral regurgitation。CurrentlyHas entered the registered clinical trial stage and is in the first tier of domestically produced products.
# Financial Performance: Stage Characteristics Dominated by R&D Investment
From the disclosed historical data, NewMed is still in the development stage focused on research and clinical investment.From 2020 to 2022, the company continued to be in a loss-making state, with accumulated losses exceeding 700 million yuan.R&D expenditure accounts for more than 80% of the cost structure.
In 2022, the company invested approximately 307 million yuan in R&D, mainly for advancing clinical trials of core products, engineering the R&D pipeline, and building the R&D team. During the same period, administrative expenses amounted to about 133 million yuan, primarily involving personnel salaries and professional service fees.
Before core products have formed scale-based revenue, this financial structure has certain commonality among innovative high-end medical device companies. As products like Prizvalve enter the commercialization phase, the company's subsequent operational performance still needs to be further observed through continuous information disclosure.
# Conclusion: From Product Pathway to Long-term Validation
The initiation of IPO tutoring does not signify the end of NewMed's development phase, but rather a milestone node after its product pathway has gradually become clear.
In the field of structural heart disease, which heavily relies on long-term clinical data and engineering stability, whether a company can ultimately build long-term value still depends on the product's performance in real clinical scenarios, the user experience of doctors, and systematic support capabilities. For NewMed, the real test may have just begun.
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Cardiovascular Device Full Disease Solution
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