Sonorous Neurovascular Expands B-SILENT Study to Canada

The B-SILENT study (NCT07070089) focuses on the investigational use of the BosSTENT, a braided, self-expanding cerebral venous stent designed to treat symptomatic cerebral venous sinus stenosis. By addressing the underlying cause of pulse-synchronous tinnitus, the company aims to generate the clinical data required for a future CE Mark submission. Joel Harris, CEO of Sonorous Neurovascular, cited the Ottawa enrollment as a key indicator that the program is maintaining its projected trajectory. The company’s portfolio has recently gained regulatory traction, including an FDA Breakthrough Device Designation for the BosSTENT and 510(k) clearance for its BosCATH system. For patients suffering from debilitating tinnitus, the expansion into Canada represents a broadening of access to potential therapies for a condition that has historically offered few treatment alternatives.