NuMed Medical Abandons Hong Kong IPO After Three Attempts, Shifts to STAR Market with China's First Balloon-Expandable TAVR and Plans RMB 1.364 Billion Raise

Author | Yang Licheng

Edited by Wang Yimo

On June 29, NewMed’s initial public offering (IPO) on the STAR Market was accepted by the Shanghai Stock Exchange. This cardiac device company, which had previously filed three times for a Hong Kong listing without success, plans to list on the A-share market under the fifth set of listing criteria.

Achieved a technological breakthrough with the first domestically produced balloon-expandable TAVR, yet remains plagued by challenges such as immature commercialization, consecutive annual losses, and historical patent disputes.

Transition to Market Launch

The completion of this IPO marks a pivotal shift in NewMed’s capital strategy.

According to the prospectus, NewMed initiated its A1 application for listing on the Main Board of the Hong Kong Stock Exchange in 2021. After three rounds of submissions, the company terminated its HKEX listing plan due to external environmental factors and strategic development considerations. Five years later, it has set its sights on listing on the STAR Market, with CITIC Securities serving as the sponsor and BDO China Shu Lun Pan Certified Public Accountants responsible for the audit work.

The proposed issuance involves no fewer than 75.3141 million shares, with total fundraising amounting to RMB 1.364 billion. Capital allocation prioritizes R&D, with RMB 768 million (56.3% of the total proceeds) designated for the construction of an R&D center. The remaining funds will be sequentially allocated to establishing a valve production base, setting up catheter accessory production lines, and building a marketing network. Finally, RMB 100 million will be used to supplement working capital and repay bank loans. This overall strategy closely aligns with the full value chain encompassing R&D iteration, capacity implementation, and market promotion.

In terms of equity structure, NewMed has no controlling shareholder, with founder Yu Qifeng serving as the actual controller. Holding 17.53% of the shares directly, he is the largest single shareholder. By leveraging Qidian Life to control the voting rights of four employee stock ownership platforms, he cumulatively controls 38.53% of the company's voting rights.

Yu Qifeng holds a dual academic background in materials science and biomedical engineering. He previously served in core R&D roles at MicroPort Medical, Medtronic Peak, and Leo Medical. In 2015, he founded NewMed Medical, leveraging his comprehensive industry experience to build a core R&D team. However, this also led to patent ownership litigation with MicroPort Medical. The final judgment awarded two electropolishing patents to MicroPort Medical. Although the company stated that the patents involved in the lawsuit were unrelated to its core valve products, the case still constitutes a historical compliance deficiency.

In terms of compensation, Yu Qifeng’s 2025 remuneration amounted to RMB 1.276 million, which is lower than the RMB 1.3004 million and RMB 1.7665 million received by two directors, placing his compensation package in the mid-to-high range among pre-profit companies.

On the capital front, NewMed has raised over RMB 1 billion in cumulative equity financing since its establishment more than a decade ago, with top-tier dollar-denominated investors such as Temasek, OrbiMed, and Lilly Asia Ventures all taking stakes. While this reflects strong recognition in the primary market, the lack of self-sustaining revenue generation capability has consistently constrained its development.

As of the end of 2025, NewMed’s retained earnings stood at -RMB 1.404 billion, leaving it reliant on continuous equity financing to cover operating expenses. Its listing on the STAR Market has opened up public financing channels, enabling the company to sustain long-term R&D investment.

Applying under the fifth listing standard of the STAR Market, targeting the RMB 4 billion estimated market capitalization threshold, aligns with the application logic for pre-revenue, hard-tech innovative medical device companies and represents the mainstream choice for enterprises in the structural heart disease sector.

Product Portfolio

The core valuation logic of NewMed lies in transcending the homogenized competition among self-expanding products in China’s TAVR sector, strategically positioning itself along the globally dominant balloon-expandable technology route to achieve a breakthrough for Chinese-made devices, and building a product portfolio anchored by marketed products and reinforced by a pipeline of multiple blockbuster candidates.

Prizvalve®, the core commercialized product, is China’s first approved balloon-expandable transcatheter aortic valve replacement (TAVR) system. It received market approval in August 2024. The second-generation upgraded version, Prizvalve Pro®, was launched in June 2025, featuring an optimized steerable outer sheath and a tear-away loader to accommodate critically ill patients with tortuous vasculature and complex anatomical structures.

From a global perspective, balloon-expandable TAVR holds a 60% market share, dominated by the Edwards SAPIEN series, owing to its advantages such as ease of precise positioning, excellent coronary artery protection, and a low rate of post-procedural permanent pacemaker implantation.

The domestic market has long been dominated by manufacturers of self-expanding valves, such as Venus MedTech and MicroPort CardioFlow. According to NTCVR data, the total number of TAVR procedures performed in China in 2025 was 18,600, with self-expanding valves accounting for 87% of the market. The penetration rate of balloon-expandable valves increased from a historical cumulative 6.3% to 13%, indicating significant potential for further market education.

As of May 2026, NewMed’s two balloon-expandable valve models had cumulatively been commercially implanted in over 1,100 cases. Financial data from the prospectus shows that revenue from valve products in 2025 amounted to RMB 46.4673 million, accounting for 80.93% of the total annual revenue, thereby forming the core foundation of its revenue stream.

The R&D pipeline targets high-growth blue-ocean sectors, building a mid-to-long-term growth trajectory. In the mitral valve field, Mi-thos® is a transcatheter mitral valve replacement (TMVR) system with one of the most advanced clinical progressions in China. It completed Asia’s first TMVR implantation at Zhongshan Hospital Fudan University in 2019 and has now finalized enrollment in its confirmatory clinical trial, positioning it to potentially secure China’s first TMVR registration certificate.

In the heart failure sector, Huanmei®’s percutaneous left ventricular assist system, benchmarked against Johnson & Johnson’s Impella product, features biomimetic pulsatile flow and a dual-sensor safety architecture. It has simultaneously completed clinical enrollment, with regulatory submission planned for 2027.

In addition, the Prizvalve VIV valve-in-valve product and the dry-stored Prizvalve Elite® are strategically positioned to address reoperations for valve degeneration and simplify storage and transportation scenarios, respectively, establishing a phased iteration roadmap across the near, medium, and long term. Multiple products are highly likely to receive centralized regulatory approvals in 2027.

NewMed’s financial performance exhibits the typical characteristics of innovative medical device companies: rapid revenue growth without profitability. From 2023 to 2025, NewMed’s revenues were RMB 6.5234 million, RMB 28.0642 million, and RMB 58.0084 million, respectively, representing a three-year compound annual growth rate (CAGR) of approximately 200%. Revenue was supplemented by accessory products leveraging their early regulatory approval advantages. The gross profit margin of its core business rose from 40.65% to 72.56%, reflecting the benefits of scaled production and product portfolio upgrades.

However, NewMed’s net profit attributable to shareholders of the parent company over the past three years was RMB -292 million, RMB -149 million, and RMB -108 million, respectively, resulting in a cumulative loss of nearly RMB 550 million. High period expenses were the primary cause of these losses.

The total period expenses for the three years were RMB 307 million, RMB 182 million, and RMB 180 million, respectively. The selling expense ratio has remained persistently high, reaching 96.11% in 2025. In that year, expenditures on promotion and advertising services amounted to RMB 21.3533 million, which were used for market education activities such as academic conferences and physician training.

The cumulative R&D investment over the past three years amounted to RMB 304 million, which was fully expensed without any capitalization. This, coupled with the amortization of significant equity incentives from earlier periods, has continued to compress profit margins.

Adopting a distribution model for product placement results in limited control over channels and may also give rise to compliance risks in commercial promotion.

Three Major Challenges

NewMed’s IPO process reflects a microcosm of the domestic substitution trend for locally produced interventional devices in structural heart disease within China. While the long-term growth logic of this sector is solid, practical constraints such as the company’s commercialization shortcomings, policy disruptions, and peer competition necessitate a prudent assessment of its investment value.

Industry development opportunities are clearly identifiable. The aging population continues to drive up the domestic base of patients with valvular heart disease, while traditional open-heart surgery involves significant trauma and poor tolerance among elderly patients, thereby accelerating the penetration rate of minimally invasive procedures such as TAVR and TMVR.

The overall penetration rate of TAVR in China is less than 5%, leaving room for several-fold growth compared to the mature levels of over 20% in Europe and the United States. NewMed’s balloon-expandable valve strategy is well-supported by clinical evidence, with its current 13% market share expected to exceed 30% within three years.

There are currently no domestically approved products for mitral valve replacement and interventional ventricular assist systems, representing a blue-ocean market. Upon successful regulatory approval, Mi-thos® and Huanmei® can capture the first-mover advantage.

From a policy perspective, China has opened green channels for the priority review of three categories of high-end innovative medical devices, accelerating the registration process for product pipelines. Meanwhile, the relaxation of the fifth set of listing criteria on the STAR Market continues to provide financial support to pre-profit, hard-tech enterprises, driving the industry as a whole into an accelerated phase of commercialization.

Potential risks at both the industry and operational levels warrant continued market attention. The implementation of centralized volume-based procurement (VBP) policies will constrain corporate profitability. The TAVR product category has already undergone national price negotiations and multi-provincial alliance-led VBP. The unit price of the company’s Prizvalve® product was reduced from RMB 60,600 in 2024 to RMB 56,600 in 2025. As the scope of centralized procurement continues to expand, there is a possibility of further compression in product gross margins. Although the company currently maintains a high gross margin level, its long-term profitability remains subject to potential fluctuations.

There is significant uncertainty regarding the commercialization timeline of NewMed’s multiple pipelines under development. Although the Mi-thos® and Huanmei® products have successfully completed clinical enrollment, Class III medical devices are subject to stringent registration and review requirements. Risks such as failure to meet predefined clinical trial endpoints and delays in the approval process remain possible. As the company relies heavily on third-party CROs to conduct its clinical trials, potential hazards including the authenticity of trial data and the leakage of core technical information also warrant close attention.

The competitive landscape in the current market segment continues to intensify. In the balloon-expandable valve sector, overseas industry leaders such as Edwards occupy mature markets, while BaiRen Medical has also completed its R&D layout for related products. In the self-expanding valve sector, leading enterprises have established comprehensive hospital distribution networks through years of operation. Coupled with the company’s currently high level of marketing expenditure, if revenue growth fails to keep pace with the expansion of marketing costs, the company may find itself in a situation where it must rely on continuous capital investment to secure market share.

Furthermore, NewMed currently has an asset-liability ratio of 54.94% and carries substantial accumulated deficits. Its cash flow for daily operations and R&D expansion relies primarily on equity financing. Should the progress of its STAR Market IPO application fall short of expectations, the pace of implementing existing R&D projects and expanding upstream and downstream production capacity will likely slow down.

Overall, NewMed has broken free from homogeneous competition by leveraging the differentiated positioning of its balloon-expandable TAVR system. By building a comprehensive product platform that aligns with the diversification trend in structural heart disease treatment, it has emerged as a representative Chinese enterprise transitioning from imitation to original innovation in medical devices.

However, technological value is not equivalent to commercial value. The current product is still in the introduction phase, and neither surgical volume nor hospital coverage has achieved economies of scale. Three major challenges—promotion costs, R&D investment, and price reductions due to centralized procurement—remain to be gradually resolved.

This STAR Market IPO serves as a key lever for the company to expand production capacity, accelerate market penetration, and advance its pipeline R&D. Capital infusion will alleviate short-term cash flow pressures and amplify its technological advantages. However, investors need to distinguish between technical barriers and profitability, with a focus on tracking three key metrics: the increasing penetration rate of balloon-expandable valves, the registration progress of core products in development, and the input-output efficiency of sales expenses.

The structural heart disease sector is a “long slope, deep snow” track, but companies still require prolonged validation to navigate their growth cycles. This IPO marks only the starting point of development, and the inflection point toward profitability still needs to be substantiated by subsequent operational data.

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       Original Title: NewMed Medical Fails Third HKEX Listing Attempt, Pivots to STAR Market: Launching Domestic Balloon-Expandable TAVR, Seeking RMB 1.364 Billion in Fundraising