Medtronic Leads Strategic Investment

Pulnovo Medical, a China-based innovative medical device company, has secured a $100 million Series C funding round led by Medtronic (MDT). The round also included participation from prominent biotech VCs such as OrbiMed, Lilly Asia Ventures, and HSG, the successor to Sequoia China. Simultaneously, the companies have entered into a global commercialization collaboration agreement. Medtronic's investment signifies recognition of the innovation and commercial value of Pulnovo's PADN (Pulmonary Artery Denervation) system, going beyond mere capital injection. Medtronic intends to leverage its extensive global marketing infrastructure to establish a leading position in the pulmonary vascular intervention market.

Mechanism and Clinical Results of PADN Technology

Pulnovo's core asset, the PADN system, is a minimally invasive medical device that utilizes catheter-based radiofrequency ablation to selectively block the sympathetic nerves in the pulmonary artery, thereby reducing blood pressure. The device has already received NMPA approval in China and the CE mark in Europe, and has been successfully used in over 1,500 procedures globally. Furthermore, following its designation as a Breakthrough Device by the FDA in 2021, it received two Investigational Device Exemption (IDE) approvals in September 2025 for clinical trials in the United States. As a result, HDE studies targeting Group 1 pulmonary arterial hypertension (PAH) patients and PMA pivotal clinical trials targeting Group 2 PAH patients with left ventricular disease (PH-LHD) are expected to accelerate in the United States.

High-Growth PAH Market and Medtronic's Strategic Choice

The global PAH market is currently valued at approximately $8.2 billion and is projected to grow to $11.2 to $13.9 billion by 2034, driven by an aging population and advancements in diagnostic technology. Existing drug therapies only alleviate patient symptoms and have limitations in improving long-term outcomes, creating a significant unmet need for new interventional procedures. In particular, the absence of approved treatments for Group 2 PAH patients, who progress to right heart failure, means that Pulnovo's PADN technology could capture a dominant market position if it demonstrates clinical efficacy. Medtronic made a strategic decision to invest and secure commercial rights in order to capitalize on this untapped market early on.

Intensifying Competition and Long-Term Investment Risks

While Pulnovo is currently leading the market, competition from other technology companies is also intensifying. Gradient Denervation Technologies, a French company, is rapidly catching up to Pulnovo in the U.S. market with its Gradient™ system, which uses ultrasound energy for nerve ablation and has entered the FDA TAP program. Furthermore, the emergence of new drug options, such as Winrevair, an innovative therapy from Merck (MRK) that received FDA approval in 2024, is raising the bar for medical device interventions to demonstrate superiority over drug therapies. Ultimately, Pulnovo's key survival strategy will be to fully utilize Medtronic's extensive distribution network and regulatory capabilities to rapidly complete global pivotal trials and establish itself as a standard of care.