Paris-based Gradient also said the FDA approved an expansion of its early feasibility study of its hypertension treatment.
The company develops a minimally invasive, ultrasound-based catheter device for treating pulmonary hypertension (PH) with associated heart failure. The FDA gave the green light to begin the early feasibility study in March.
Now, the company can expand its PreVail-PH2 study based on results from the initial cohort. It continues enrolling patients with WHO Group 2 PH at centers across the U.S. The company also has recruitment underway for additional centers with heart failure and PH expertise.
Meanwhile, Rowe, described by the company as a “serial entrepreneur,” joins the board ahead of the trial’s expansion.
“Gradient is at a critical point in our development as we build our clinical experience with our ultrasound-based pulmonary artery denervation technology,” says Martin Grasse, Gradient CEO. “I’m delighted to have Stan joining us and am looking forward to leveraging his deep experience to help guide the company in our next phase.”
Rowe’s track record includes developing multiple medical technologies through his current incubator, Nidus Biomedical. He also led a previous incubator, called NXT Biomedical.
Previously, Rowe served as chief scientific officer of Edwards Lifesciences and co-founded and led Percutaneous Valve Technologies as CEO. PVT developed the first TAVR device, later acquired by Edwards, according to a news release.
“I’m very excited to join Gradient and work with the company to bring this technology to patients,” said Rowe. “Gradient’s early experience with pulmonary denervation is promising and I see great potential for this system to provide a new treatment option for these underserved patients.”
