Pulnovo Medical has announced that its PADN catheter and generator has received two Investigational Device Exemption (IDE) approvals—HDE study approved for patients with Group-I PH patients, PMA study approved for patients with Group-II PH patients, with CMS full coverage approval, paving the way for upcoming clinical trials in the United States.

Following the FDA's BDD designation granted in 2021 for Group- I, II and IV, the newly-obtained IDE approvals will advance clinical studies targeting Groups-I and II into the IDE stage. These trials focus on different patient groups—Group I (Pulmonary Arterial Hypertension, PAH) and Group II (PH due to left heart disease)—with the aim of validating the efficacy and safety of PADN technology in the treatment of these conditions. Both clinical trials are important for evaluating the use of PADN in diverse populations with pulmonary hypertension and heart failure. This IDE approval, coupled with the full coverage by CMS in the US, has significantly advanced the clinical application and market acceptance of the PADN system, providing critical data to support Pulnovo Medical's further commercialisation efforts in the US.

PADN has received FDA HUD designation, is approved by the NMPA, and is CE-marked. Pulmonary Artery Denervation (PADN) offers more options for both Group-I PAH patients with limited response to the existing drug therapies and Group-II pulmonary hypertension patients, who currently have no specifically approved treatment. With over 1,000 clinical applications across countries such as Portugal, Georgia, Singapore, Malaysia and China, PADN products have consistently demonstrated a strong safety profile and therapeutic efficacy in real-world settings.

The IDE approval marks a critical step in Pulnovo Medical's commitment to deliver innovative, high-quality solutions for patients with pulmonary hypertension and accelerating the global expansion of PADN technology. The results of these studies will generate valuable data to further validate the potential of PADN. Progress in these clinical trials is expected to bring meaningful benefits to patients, including improved exercise tolerance in daily life and a better overall quality of life.