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Gradient Denervation Technologies is developing a minimally invasive, ultrasound-based catheter device for the treatment of pulmonary hypertension in heart failure patients. The company’s lead program has received FDA Breakthrough Device Designation and is currently enrolling patients in an early feasibility study (PreVail-PH2). Initial first-in-human studies began in 2023. There are no approved drug or device therapies for this patient group in the US[8][9].
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