Rewriting the 100-billion-yuan heart failure treatment landscape: How does a Chinese medical device company capture the spotlight of the global cardiovascular sector?

On the landscape of heart failure treatment, there has long been an unconquered "no man's land" that is extremely difficult to address.

The lesions of such patients extend from the left heart to the pulmonary circulation, causing continuous elevation of pulmonary circulation pressure and resistance, further transmitting the pressure to the right heart, so that the entire heart and both ends of the pulmonary circulation are under pressure at the same time. However, existing treatments often only cover part of the pathological mechanisms. With the continuous progression of the disease, mature treatment regimens targeting this complex pathophysiological process have long been scarce.

Now, an original interventional technology from China is trying to make a breakthrough in this "no man's land".

On the morning of local time August 30, on the main B3 stage of the Messe Munich Exhibition Center, Professor CHEN Shaoliang from Nanjing First Hospital brought the PADN-HF-PH study to the Hot Line stage of ESC Congress 2026. The study specifically targets patients with pulmonary hypertension caused by heart failure who have long lacked effective treatment options, and was simultaneously published as a paper in the globally top journal New England Journal of Medicine (NEJM). This is also the first globally innovative medical device technology from Asia to be published on NEJM.

In the global cardiovascular medical community, Hot Line is the key entry point for important research to enter the core evidence-based system.

For PAM Medical behind this technology, this appearance also points to a larger proposition: whether an original Chinese technology can evolve from solving clinical challenges to defining new treatment pathways.

The company has been working on Pulmonary Artery Denervation (PADN) for 12 years. From original technology R&D, to clinical evidence generation, registration and access, international verification, and then to commercial implementation, it is trying to establish a new treatment modality for patients who have long lacked clear treatment pathways.

According to the PADN-HF-PH study announced by Professor CHEN Shaoliang on site, the possibility of PADN changing the treatment options for patients with heart failure-related pulmonary hypertension is further increasing.

The randomized controlled evidence presented this time shows that after adjustment, the 2-year follow-up incidence of clinical deterioration in the PADN combined with GDMT group was 25.7%, while that in the GDMT group was as high as 51.1%; PADN combined with GDMT reduced the risk of clinical deterioration by 51% (HR 0.49, 95% CI 0.30–0.82; P=0.006). 

This means that a patient population that previously lacked clear treatment pathways is beginning to have the possibility of systematic intervention. If this clinical benefit can be translated into clinical practice, obtain continuous supervision and verification, and be further incorporated into clinical guidelines, a potential market with previously blurred boundaries will gradually take shape. 

As a result, a highly industry-concerned question has also emerged. When Chinese medical device enterprises enter clinical fields where there are no mature answers globally, can they take the lead in defining treatment modalities relying on original innovation, and get the global medical community to accept this Chinese-originated solution?

01 Breakthrough: Entering the "No Man's Land" of Heart Failure Treatment

The commercial imagination of PADN is first built on a long-standing unmet clinical need.

The difficulty for such patients lies in the coexistence of problems on both the heart and pulmonary vessels, which is hard to be fully covered by existing treatment methods.

At present, heart failure treatment is based on guideline-directed medical therapy, namely GDMT; traditional pulmonary hypertension drugs mainly target the mechanisms related to pulmonary vessels.

For some patients with heart failure-related pulmonary hypertension, especially those with both elevated pulmonary vascular resistance and elevated left ventricular filling pressure, addressing only one end separately can hardly cover all pathological mechanisms. 

The superposition of the two sets of mechanisms has long put this population in a "treatment vacuum": the disease burden is clear, but targeted mature solutions are very limited.

PAM Medical thus chose a device interventional path. 

PADN, namely Pulmonary Artery Denervation. Its core idea is to inhibit the overactivation of pulmonary artery sympathetic nerves through a minimally invasive interventional radiofrequency ablation, so as to intervene in pulmonary vascular remodeling and the progression of cardiopulmonary diseases. 

More intuitively, PADN regulates the sympathetic nerve regulatory pathway of pulmonary vessels that was rarely directly intervened by devices in the past through one interventional operation, adding treatment options beyond drugs for patients. 

The PADN-HF-PH study was thus launched. This prospective, multi-center, randomized controlled registrational clinical trial was led by Academician HAN Yaling from the General Hospital of Northern Theater Command as the principal investigator, and enrolled 264 patients at 25 clinical centers across China. Patients were randomly divided at a 1:1 ratio into two groups: "PADN procedure + GDMT for heart failure" and "receiving GDMT for heart failure alone". 

The primary endpoint of the study directly targeted clinical deterioration events, including worsening heart failure requiring intravenous medication, rehospitalization, significant decline in exercise capacity, need for cardiopulmonary transplantation, and all-cause mortality.

In the results announced at Hot Line this time, in addition to the primary clinical endpoint, the PADN-HF-PH study also presented changes in patients' exercise capacity, functional status and related indicators. 

The data shows that at 12 months, the 6-minute walking distance of patients in the PADN combined with GDMT group had a net improvement of 24.8 meters compared with the GDMT group; the risk of significant decline in exercise capacity was reduced by 63%. At the same time, the study also observed improvements in indicators such as NT-proBNP and KCCQ, providing further support for the clinical benefits of PADN. 

As a result, the evidence-based evidence of PADN has further extended from previous hemodynamics and exercise tolerance to multiple dimensions such as clinical deterioration, recurrent events and patients' functional status. 

From an industrial perspective, this type of study answers two levels of questions.

The first level is whether the technology has real and sustainable clinical value.

Whether an innovative device can enter the treatment system ultimately depends on whether clinical evidence can continuously prove the benefits to patients. 

The second level is whether a new market can be formed with the establishment of treatment pathways. 

In fields with mature existing solutions, new entrants face a stock market with relatively clear boundaries. In fields that have long lacked effective solutions, once a new treatment modality is continuously verified, the treatment pathway for patients itself may be redefined.

Patients who were originally scattered outside the boundaries of existing treatments are thus included in a clearer treatment pathway.

This is exactly the important industrial feature of First-in-Class medical devices — the market size often takes shape gradually along with the establishment of a new treatment paradigm. 

Therefore, what PADN needs to verify next is whether this treatment pathway can enter the global clinical system, and finally translate clinical needs into a sustainable market.

02 Advancement: From Chinese Evidence to Global Verification

To move from concept to market, original medical devices need to cross a long verification chain.

Entering clinical practice is only the starting point. The intensity of evidence-based research, replicability across different populations, regulatory recognition and physician acceptance jointly determine how far a technology can ultimately go.

PADN has been moving along this path for 12 years.

The early PADN-5 study accumulated basic evidence-based evidence for this technology. The related study verified the clinical value of PADN in improving patients' hemodynamics and exercise tolerance, and was published in JACC: Heart Failure.

After the domestic evidence is established, the next hurdle is replicability. Whether the same treatment method can obtain consistent results after entering different countries, different patients and different medical environments is the key to determining whether it can be truly popularized. 

For medical devices, this point is particularly important. Differences in patient characteristics, physician operating habits and medical systems may all affect the ultimate performance of a technology.

Therefore, international multi-center clinical verification has become a necessary hurdle for original devices to enter the global market.

The PADN-Columbus international multi-center study first released at EuroPCR 2026 is an important node in this process. 

Compared with previous clinical verification dominated by Chinese patients, PADN-Columbus expanded the scope of evidence to international patients for the first time.

It is understood that among CpcPH patients, the study observed simultaneous decreases in two hemodynamic indicators: pulmonary vascular resistance and pulmonary capillary wedge pressure, and further showed a trend of improved functional status and clinical prognosis benefits.

While international clinical verification is expanding outward, regulatory access and academic recognition are also advancing simultaneously.

After the product was approved in China, PADN is further promoting commercialization in Europe, and continuing to carry out global verification through the US PULSE-LHD IDE clinical trial. This technology has also been cited in 7 domestic and foreign clinical guidelines including the 2022 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension.

Connecting these nodes, we can see a clear path for the globalization of original medical devices. 

The first step is to prove that the technology is feasible. 

The second step is to verify whether the clinical benefit is stable, and repeatedly verify it in different patient populations and medical environments. 

The third step is to enter the regulatory systems of different countries and regions.

The fourth step is to promote physicians to form awareness, so that the new treatment modality can gradually enter clinical practice. 

The four links are prerequisites for each other, and all require time accumulation. When this chain is gradually opened up, commercialization will have a stable foundation.

This is exactly the significance of ESC Hot Line to PAM Medical: it further pushes PADN into the global core evidence-based and academic evaluation system.

At the same time, the company's global verification is still ongoing. The first batch of patients have been enrolled in the US PULSE-LHD IDE clinical trial; PAM Medical has also promoted commercialization in Europe, the Middle East, Asia and South America, and continues to expand into larger markets through US clinical trials.

From PADN-5, PADN-Columbus, to the PADN-HF-PH that appeared on ESC Hot Line this time, to China's product approval, commercialization in Europe and other markets, and the advancement of US IDE clinical trials, PAM Medical has gradually built a complete chain of "original technology — clinical evidence — regulatory access — academic recognition — commercialization". 

This chain also reveals that the core of medical device globalization is far more than just exporting products to overseas markets.

The deeper level of globalization is the process in which a technology gradually enters the global medical community to define diseases, evaluate technologies and establish treatment pathways; product globalization is the commercial result presented by this process in the end. 

For a Chinese medical device company starting with original innovation, this is the path with the highest difficulty, the longest cycle, and the most potential to form long-term barriers.

03 Expansion: From Clinical Value to Global Market

As clinical verification and global access gradually advance, the commercialization proposition of PADN has become prominent.

How can a First-in-Class medical device company translate clinical value into commercial value?

First of all, it is necessary to go through a long investment period.

Innovative medical devices have long R&D cycles and high clinical trial costs. After targeting the global market, the company also needs to continuously promote the construction of regulatory, evidence-based and commercial systems in multiple countries. 

Before generating large-scale revenue, such companies often have to bear long-term investment.

Since 2013, PAM Medical has continuously received support from professional investment institutions. The latest round is in April 2026, when it completed a $100 million Series D financing, led by Medtronic, the world's largest medical device giant. Existing investors including EQT, Qiming Venture Partners, Gaorong Capital, Orbimed and Lilly Asia Ventures continued to follow the investment, and HSG and many other well-known global institutional investors participated in this round.

What deserves more attention than the financing amount and the lineup of investors is the judgment logic behind the continuous capital investment.

The first level of logic comes from the unmet clinical needs, which has been detailed earlier. The second level of logic comes from the scarcity of original technologies. 

Traditional medical device startups can often refer to overseas verified products and business models, and the core challenges are more focused on engineering, cost and channels. The First-in-Class path lacks mature answers that can be directly copied, and enterprises need to complete technology verification, clinical verification, regulatory promotion and market education on their own.

Higher risks and longer cycles also make time accumulation itself a competitive barrier.

For PADN, the assets accumulated over the past 12 years have gone far beyond a single product. Clinical data, registration experience, guideline recognition, as well as domestic and foreign research centers and physician networks, together constitute the infrastructure that latecomers cannot replicate in a short period of time. 

With the product approved in China, the continuous advancement of commercialization in Europe, the Middle East, Asia and South America, and the continuous progress of the US PULSE-LHD IDE clinical trial, the focus of PADN's commercial proposition is shifting.

If the early stage needs to answer whether the technology is feasible, the more critical issue at this stage is how many patients this technology can cover, how many countries it can enter, and ultimately how large a market it can form. 

As clinical verification and global access gradually advance, the next growth proposition of PADN is gradually shifting to indication expansion, and the third level of growth space has also emerged. 

Whether PADN only corresponds to one indication, or can continuously expand its boundaries around pulmonary hypertension, heart failure and more related cardiopulmonary diseases, will directly determine its long-term development potential. 

For platform-type device technologies, how many patients the same underlying technology can cover and how many treatment scenarios it can enter often determine the upper limit of a company's long-term value. Therefore, continuously expanding indications will become an important growth logic for PAM Medical in the next stage.

Looking at it from a broader perspective, the change represented by PADN may not only be the birth of a single product. 

For a long time, Chinese medical device enterprises have faced a world that has already been defined. How to treat diseases, how to evaluate products, and how to divide the market, most of the mature paths come from overseas.

What Chinese enterprises are better at doing is to complete catch-up, substitution and efficiency improvement along the existing coordinates.

What First-in-Class innovation truly changes is precisely this set of coordinate relationships.

When a Chinese company enters a clinical "no man's land" where there is a lack of mature answers globally, what it has to answer is no longer just whether the original technology is effective, but whether it can rely on accumulated randomized controlled clinical evidence to make a patient group that previously lacked clear treatment pathways be re-recognized, bring a new treatment modality into the evaluation and treatment system of the global medical community, and thus delineate new market boundaries.

This is also the part of PADN that is worth observing more than commercialization itself. Over the past 12 years, PAM Medical has gradually brought an original technology into clinical research, guidelines, regulatory systems and global medical evaluation systems; next, what it aims for is to participate in defining the global market.

The so-called breaking into the "no man's land" may have its real value right here.

There is no ready-made road there. The first person to make it through not only blazes a trail, but also calibrates the direction for the entire industry to move forward.

In the future, Chinese original medical device enterprises represented by PAM Medical will further evolve from participants in the global market to initiators and co-builders of new treatment pathways. 

And this is exactly the most striking opening chapter of China's medical device industry entering a new stage of original innovation.