Pulnovo Medical, a developer of devices for pulmonary hypertension (PH) and heart failure (HF), announced its PADN (Pulmonary Artery Denervation) catheter received two investigational device exemption (IDE) approvals from the U.S. Food and Drug Administration (FDA).

The first is an HDE study approved for patients with Group I PH patient, and a PMA study approved for patients with Group II patients, with CMS full coverage approval. This paves the way for upcoming clinical trials in the U.S.

Following the FDA’s breakthrough designation granted in 2021 for Groups 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 to treat these conditions.

The company said both trials are important to evaluate PADN in diverse populations with PH and HF.

PADN has received FDA HUD designation, is approved by the NMPA, and is CE marked. PADN presents more options for both Group I pulmonary arterial hypertension patients with limited response to existing drug therapies and Group II PH patients, who currently have no specifically approved treatment.

PADN products have over 1,000 clinical applications across countries like Portugal, Georgia, Singapore, Malaysia, and China. The results of these studies aim to generate valuable data to further evaluate PADN.

In April, Pulnovo Medical closed nearly $100 million Series C financing co-led by Qiming Venture Partners and existing shareholder Lilly Asia Ventures. The money will be used to advance Pulnovo Medical’s global clinical trials, international business expansion, and strategic initiatives.