Shanghai-based Cardiovascular MedTech Innovator Niuvation Medical Files for STAR Market IPO, Seeking RMB 1.364 Billion

On June 29, 2026, the official website of the Shanghai Stock Exchange disclosed thatShanghai NewMed Medical Co., Ltd. (hereinafter referred to as "NewMed") has had its IPO application on the STAR Market accepted.The company plans to raise funds.RMB 1.364 billion, with CITIC Securities as the sponsor. NewMedAfter Three Unsuccessful Attempts to List on the HKEX, Turning to the STAR Market of A-Shares, usingThe Fifth Set of Listing Standards(with an estimated market capitalization of no less than RMB 4 billion), marking another significant IPO case in the domestic cardiac interventional device sector.

# Company Overview: A Decade of Dedication, from "Technology Follower" to "Domestic Leader"

NewMed was established inMarch 2015, headquartered in Shanghai, is a company focused onInterventional Artificial Heart ValveandInterventional Ventricular Assist Systema high-tech enterprise engaged in R&D, production, and sales. Founder, Chairman of the Board, and General ManagerYu QifengPh.D., formerly held positions at leading medical device companies such as Shanghai MicroPort Medical and Beijing Medtronic Peak, founded NewMed in 2015.

According to publicly available information,Since its establishment in 2015, NewMed has completed multiple rounds of equity financing, with a cumulative fundraising amount ofOver RMB 1 billion。

These funds are primarily allocated to the research and development of core products, the advancement of clinical trials, and the establishment of production systems. Consistent with the industry characteristics of structural heart disease devices—namely, long R&D cycles and high technical barriers—the company has maintained intensive R&D investment over an extended period.

# Core Product: The First Domestically Produced Balloon-Expandable TAVR, Breaking the Foreign Monopoly

1. Prizvalve® Series: The First Chinese-Made Balloon-Expandable Valve, Breaking the "Zero" Barrier

NewMed's core commercialized products arePrizvalve^®Transcatheter Aortic Valve Systemand second-generation productsPrizvalve Pro^®。Prizvalve^®Approved in August 2024, it is the first domestically produced balloon-expandable TAVR product., featuring a short stent made of cobalt-nickel-chromium-molybdenum alloy, bovine pericardial leaflets, and an inner and outer sealing skirt design.Prizvalve Pro^®Approved in June 2025, primarily upgrading the delivery system—the optimized adjustable-curve outer sheath allows for a greater deflection angle, valveThe membrane loader features a new tear-away design, enabling adaptation to patients with complex anatomy characterized by a narrower aortic arch and more tortuous access routes.

Balloon-Expandable vs. Self-Expanding: Differentiated Competition in Technical Approaches

In the global TAVR market,Balloon-expandable products account for approximately 60% of the market share(represented by the Edwards SAPIEN series), but in the Chinese marketThe market has long been dominated by self-expanding valves (Venus Medtech, MicroPort CardioFlow, Peijia Medical, etc.). The core advantages of balloon-expandable valves lie in:Precise and Controllable Release, balloon inflation is completed in a single step to achieve "zero displacement," with highly predictable implantation depth;Lower Permanent Pacemaker Implantation Rate, the short stent design reduces compression on the conduction system;Lower Incidence of Paravalvular Leak, rigid stents combined with balloon dilation achieve better circumferential apposition;Superior Coronary Protection, short stentThe stent preserves access for subsequent coronary intervention.

According to NTCVR data,Approximately 18,600 TAVR procedures were performed in China in 2025, of which the proportion of self-expanding valves87%, but the proportion of balloon-expandable valve implantations has increased from 6.3% in the cumulative data to13%, indicating that clinical acceptance is rapidly increasing.

2. R&D Pipeline: A Three-Tier Strategy for Comprehensive Cardiac Care

NewMed has deployed three generations of products across the three major fields of aortic valve replacement, mitral valve replacement, and interventional ventricular assist devices, forming a product portfolio ranging from classic to cutting-edge solutions:

• Aortic Valve Field, in addition to the marketed Prizvalve®/Prizvalve Pro^®In addition,Prizvalve VIV™ (Valve-in-Valve)Completion of enrollment in the confirmatory clinical trial has been achieved, with approval anticipated in 2027 for reintervention following degeneration of previously implanted bioprosthetic valves;Prizvalve Elite^®(Dry Valve)Utilizing advanced dry-state preservation technology, it eliminates the need for aldehyde-based wet-state preservation solutions and is expected to receive approval in 2029.

• Mitral Valve Field，Mi-thos^®(Transapical Self-Expanding Valve)Particularly noteworthy—this product wasCompleted Asia’s First Transcatheter Mitral Valve Replacement in May 2019(Zhongshan Hospital, Fudan University), isDomesticThe First TMVR Product to Enter the Pivotal Clinical Trial Stage, having completed enrollment in the pivotal clinical trial, it is poised to become the first TMVR valve system approved in China. In addition, the company is also developing the transapical balloon-expandable valve Mi-thos Elite.^®Transfemoral Balloon-Expandable Mi-thos Pro Valve^®, expected to be approved in 2030.

• Ventricular Assist Device Field，Huanmei^®(Interventional Left Ventricular Assist System)Benchmarking against Johnson & Johnson's Impella^®The series has completed confirmatory clinical enrollment and is expected to receive approval in 2027. This product employs bionic adaptive pulsatile flow assistance technology, featuring a dual-safety architecture that integrates fiber-optic pressure sensing feedback with pump motor signal parameter estimation.

# Financial Data: Commercialization in Early Stages, Continued Losses but Marginal Improvement

NewMed’s financial data from 2023 to 2025 exhibits the typical characteristics of an innovative medical device company:Revenue is growing rapidly, but profitability has not yet been achieved, with losses narrowing year by year.

Operating RevenueSurging from RMB 6.5234 million in 2023 to in 2025RMB 58.0084 million, with a three-year compound annual growth rate of approximately200%. Among them, the valve products achieved revenue in 2025RMB 46.4673 million, accounting for80.93%, becoming the absolute core product; revenue from auxiliary products amounted to RMB 10.95 million.

Net ProfitThe three years were -303 million yuan, -163 million yuan, and-129 million yuan, cumulative loss of approximatelyRMB 595 million, the loss in 2025 narrowed by 20.4% year-on-year.Net Profit Attributable to Shareholders of the Listed Company After Deducting Non-recurring Gains and Losses-297 million yuan, -158 million yuan, and-118 million yuan。

R&D InvestmentRemained at a high level, with the figures for the three years being RMB 123 million, RMB 90 million, andRMB 90 million, accounting for the proportion of revenue from1,892.19%Decreased to 155.51%, reflecting a relative decline in R&D intensity following the expansion of the revenue base.Gross Profit Margin of Core BusinessRapidly increased from 40.65% to72.56%, scale effects and optimization of product structure have become evident.

As of the end of 2025, the company's undistributed profits were -1.404 billion yuan.，Debt-to-asset ratio: 54.94%; self-sustaining cash flow has not yet been achieved, with reliance on financing support.

# Use of Proceeds: Simultaneous Expansion of Production Capacity, R&D, and Marketing

Proposed Fundraising AmountRMB 1.364 billion, among the five major investment areasR&D Center Construction ProjectExclusivity768 million yuan, accounting for as high as56.3%, indicating that the company remains in a period of high-intensity R&D investment.

• Valve System Production Base Construction ProjectInvested RMB 277 million (20.3%), established in Shanghai Zhangjiang Science City (no separate environmental impact assessment required).
  

• Marketing Network Construction ProjectAn investment of RMB 153 million (11.2%) was allocated to expand the commercialization team and enhance coverage of end-user hospitals.
  

• Construction Project for the Production Base of Catheter Products and AccessoriesAn investment of RMB 66 million (4.9%) is allocated to the project located in Juanhu Science and Technology City, Haining, Zhejiang Province. The remaining RMB 100 million will be used to supplement working capital and repay bank loans.

# Industry Observation: The "Deep Water Zone" of Domestic Substitution in the Structural Heart Disease Sector

NewMed’s IPO journey reflects the typical growth trajectory of the domestic cardiac interventional device industry:

• From “Following” to “Running Side by Side.”Prizvalve^®Its approval marks a breakthrough for domestic companies in the globally mainstream technology route of balloon-expandable TAVR.

• From "Single-Point Breakthrough" to "Platform Layout".Starting with aortic valves and expanding into mitral valve replacement and ventricular assist devices, the company has built a dual-track platform centered on "valves + heart failure," aligning with the broader trend in structural heart disease treatment evolving from "anatomical repair" to "functional support."

• From "Capital-Driven" to "Commercial Validation."The company has raised over $1 billion in cumulative financing, backed by top-tier institutions such as Temasek, OrbiMed, and Lilly Asia Ventures. However, the disparity between its initial commercialization revenue scale (RMB 58 million) and its substantial R&D investment (cumulatively exceeding RMB 300 million) remains the core contradiction.

Three Key Highlights:OneYes2027willMi-thos: A "Banner Year" for the Company's Product Approvals^®(TMVR), Prizvalve VIV™ (Valve-in-Valve), Huanmei^®(Ventricular Assist Device) If successfully approved, it will simultaneously unlock three major incremental markets; secondly,Rate of Increase in Penetration Rate of Balloon-Expandable Valves, whether it can be increased from the current 13% to over 30% will directly determine the ceiling of the company's TAVR business; thirdly,Capability to Respond to Centralized Procurement, Under the overarching trend of healthcare insurance cost containment, cost control capabilities are equally as important as the technological differentiation moat.

# Conclusion

NewMed’s STAR Market IPO is yet another testament to the “hardcore innovation” of domestically produced cardiac interventional devices.The First Domestic Balloon-Expandable TAVRThe technological breakthroughs are commendable; however, challenges such as persistent losses, limited scale in the early stages of commercialization, and uncertainties surrounding volume-based procurement policies cannot be overlooked.

For investors, this represents both an opportunity to share in the high-growth dividends of the structural heart disease sector and a test of innovative medical device companies"Long Cycle, High Investment, High Risk"ShangA profound test of understanding of the business model.