Gradient Denervation Technologies

Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S.

The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary tension with associated heart failure. Paris, France-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina.

Dr. Marat Fudim and Dr. Richard Krasuski enrolled the first patient at Duke.

“We are excited to enroll the first US patient in this important study,” Fudim said in a news release. “Completion of this study is a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.”

PreVail-PH2 is enrolling patients with pulmonary hypertension due to left-sided heart disease. According to Gradient, no approved drug or device therapy exists for this group of pulmona…

Gradient Denervation Technologies announced that it closed a $15 million (€14 million) Series A financing round.

Paris-based Gradient develops a catheter-based solution for treating pulmonary hypertension. It expects the financing to support the ongoing clinical development and evaluation of the ultrasound-based device.

Asabys Partners led the round through its new fund, Sabadell Asabys II. Thuja Capital and founding investor Sofinnova Partners also participated in the round.

Gradient designed its novel technology to treat pulmonary hypertension by reducing sympathetic input into the pulmonary vasculature.

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