After the fifth set reboot, Core Medical, a leading artificial heart device company, aims for a Sci-Tech Innovation Board IPO with its first listing.

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In July this year, Zhuhai Tenomab Pharmaceutical Co., Ltd., an innovative drug company, was accepted for a STAR Market IPO under the fifth set of standards, marking an official breakthrough after more than two years of stagnation in the fifth set acceptance process.

Since the restart of the fifth set, innovative medical device companies' IPOs have made critical progress.

Recently, Shenzhen Coremed Technology Co., Ltd. (“CoreMed”) had its STAR Market IPO application accepted, becoming the first innovative medical device company to be accepted under the restarted fifth set of listing standards.

CoreMed focuses on artificial hearts. During the reporting period, it achieved a certain scale of revenue, with 2024 revenue reaching 94 million yuan, a year-on-year increase of more than fourfold, but net losses for the same period still reached 132 million yuan.

The exponential revenue growth was mainly driven by the continued volume increase after the launch of the CoreMed magnetic levitation implantable left ventricular assist system Corheart® 6, which brought considerable income.

In this IPO, CoreMed plans to raise 1.2 billion yuan for the construction of projects such as “cutting-edge circulatory support products” and “artificial heart industrialization base.”

However, CoreMed still faces many challenges.

On one hand, Corheart® 6 still sells for over 200,000 yuan, and the overall terminal surgery fee is as high as 700,000 yuan. With the limited payment capacity of domestic end-users, commercialization of Corheart® 6 may face pressure.

Moreover, the room for price reduction is relatively limited, as the cost price of Corheart® 6 is 70,000 yuan per unit. This means that if CoreMed wants to expand the growth space of Corheart® 6, exploring overseas markets such as the United States will still be an important path.

On the other hand, more new therapies such as atrial shunt devices are emerging in the heart failure field, which may pose growth challenges for artificial heart products in the future.

Overseas Expansion is Key

In August 2022, MicroPort EP (688351.SH) became the first innovative medical device company to land on the STAR Market under the fifth set of standards.

Since then, although several innovative medical device companies have attempted IPOs on the STAR Market under the fifth set, none have succeeded, and the “second stock” among fifth set device companies has stalled.

According to incomplete statistics from Xinfeng, apart from CoreMed, only two fifth set medical device companies are currently at the IPO stage: Harbin Sizherui Intelligent Medical Equipment Co., Ltd. and Shenzhen Beixin Life Technology Co., Ltd.

CoreMed’s products do have a certain degree of innovation.

Currently, CoreMed has laid out five implantable and six interventional artificial heart products, among which the implantable left ventricular assist system Corheart® 6, the implantable dual ventricular assist system DuoCor® 2, and the interventional ventricular assist system CorVad® 4.0/6.0 series have all been included in China’s special review process for innovative medical devices, mainly for the treatment of heart failure.

Corheart® 6 is CoreMed’s first third-generation fully magnetically levitated artificial heart approved and commercialized. It is currently the world’s smallest and lightest commercial magnetically levitated implantable artificial heart, which reduces the heart’s burden and the compression and damage to tissue.

Currently, Corheart® 6 weighs 0.8kg, nearly 50% lighter than the Abbott HeartMate 3, a similar competing product.

In June 2023, Corheart® 6 was approved and quickly achieved good commercial results, generating a total revenue of 164 million yuan from 2024 to the first half of 2025.

Judging by HeartMate 3’s sales, Corheart® 6 still has significant growth potential.

Currently, the global artificial heart market is dominated by HeartMate 3. According to Abbott’s financial report, in 2024, the heart failure segment centered on HeartMate 3 generated $1.279 billion in revenue (about 9.1 billion yuan).

However, it is still uncertain how much market share CoreMed’s Corheart® 6 can capture from HeartMate 3.

On one hand, Corheart® 6 faces competition not only from Abbott, but also from Chinese companies such as Tongxin Medical, Aerospace Taixin, and Yongrenxin.

Tongxin Medical’s fully magnetically levitated artificial heart device, Cifu VAD, was approved for marketing as early as 2021, making it the first fully magnetically levitated artificial heart device independently developed and marketed by a Chinese company.

On the other hand, Abbott’s HeartMate 3 revenue mainly comes from the United States, with the U.S. market accounting for more than 70% of its heart failure business segment revenue in 2024.

This means that if CoreMed’s Corheart® 6 wants to expand its performance, the U.S. market must be the primary target.

But in overseas markets, Corheart® 6 has only obtained regulatory approvals in Colombia and Ukraine. For Europe, registration applications have been submitted, with approval expected in 2027. No clinical trials have yet started in the U.S.

By comparison, Tongxin Medical, a competitor, has pushed VAD into clinical trials in the U.S., and is conducting “head-to-head” studies with Abbott’s HeartMate 3—this is the first large-scale comparison study of two fully magnetically levitated devices in the artificial heart field.

All this adds uncertainty to the future commercialization of Corheart® 6.

However, this may be part of CoreMed’s market strategy.

Although Corheart® 6 has not started trials in the U.S., CoreMed’s core products, the implantable dual ventricular assist system DuoCor® 2 and the interventional ventricular assist system CorVad® 4.0/6.0, have made progress in the U.S., with expected approval timelines around 2030.

Compared to Corheart® 6, which is an innovation based on HeartMate 3, these two products have unique features.

DuoCor® 2 can provide circulatory support for both the left and right ventricles simultaneously, and is likely to become the world's first magnetically levitated integrated implantable dual ventricular assist system; CorVad® 4.0/6.0 adopts an interventional procedure, allowing for higher flow rates, longer expected support time, and better hemocompatibility at the same diameter via a minimally invasive approach. It’s expected to be approved in China in Q1 2026, possibly becoming the nation's first approved interventional artificial heart product.

Based on the expected U.S. approval timelines, it will take longer for CoreMed’s performance to be fully realized.

Deconstructing the "Artificial Heart"

With CoreMed’s IPO prospectus now disclosed, the public has gained a deeper understanding of the cost structure of artificial hearts.

In 2024, CoreMed produced 403 Corheart® 6 devices, with a corresponding operating cost of 28.4271 million yuan.

Based on this, the average cost per unit of Corheart® 6 is about 70,000 yuan.

With high manufacturing costs, the factory price for Corheart® 6 in 2024 was 247,200 yuan per unit, with a gross margin close to 70%.

This price is a significant reduction compared to Abbott’s HeartMate 3, which sells for 1.5 million yuan. Even so, many patients still find it unaffordable.

According to public sources, including hospitalization and medication fees, an artificial heart implant surgery may cost up to 700,000 yuan.

Even CoreMed’s actual controller Yu Shunzhou admitted in media interviews that the price of artificial hearts in China exceeds what most patients can afford.

The only way to “bring down the price” is by increasing volume: scaling up production to share costs and reduce cost pressure.

But beyond limited end-user payment abilities, the artificial heart business faces other challenges.

At first glance, the large population of heart failure patients provides broad market potential for artificial hearts. According to Frost & Sullivan, there were 62.981 million heart failure patients worldwide in 2024, expected to increase to 71.511 million by 2033.

However, not all heart failure patients need artificial heart implants.

According to the American “Heart Failure Management Guidelines 2022”, for patients with advanced heart failure with reduced ejection fraction, NYHA class IV symptoms, and who are considered dependent on continuous IV inotropes or temporary mechanical circulatory support, long-term use of a left ventricular assist device implant can effectively improve functional status, quality of life, and survival, and thus receives a class I recommendation for artificial heart use.

Furthermore, there are various emerging treatment options in the heart failure field.

For example, the emerging minimally invasive interventional therapy of atrial shunts establishes a shunt between the left and right atria to reduce left atrial pressure, thereby alleviating heart failure.

To further expand in this field, Johnson & Johnson acquired atrial shunt maker V-Wave for $1.7 billion in 2024.

All of this brings additional challenges to the market expansion of “artificial hearts.”

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