Shanghai-based Pulnovo won IDEs for its pulmonary artery denervation (PADN) catheter and generator. It can now evaluate its technology in studies for Group I and Group II pulmonary hypertension (PH) patients. With full CMS coverage approval, the company now has a pathway for its upcoming clinical trials in the U.S.

Earlier this year, the company brought in $100 million to support its pursuit of U.S. clinical evaluation.

Pulnovo designed its PADN technology to use radiofrequency ablation to target the pulmonary vascular endothelial sympathetic nerve. This can reduce pulmonary artery pressure and slow disease progression. The PADN system has FDA breakthrough device designation.