LAKE FOREST, Calif., Aug. 3, 2026 — Sonorous Neurovascular, a pioneering medical device company focused on innovative solutions for cerebral venous diseases and neurovascular interventions, today announced a significant clinical milestone: the first patient enrollment in Canada under its international B-SILENT study (NCT07070089). The enrollment took place at The Ottawa Hospital under principal investigator Dr. Robert Fahed, marking an exciting step forward for the study’s global expansion.
The B-SILENT study is evaluating the investigational use of the BosSTENT™, Sonorous’ braided, self-expanding cerebral venous stent, for the treatment of debilitating pulsatile (pulse-synchronous) tinnitus caused by symptomatic cerebral venous sinus stenosis. The study is designed to generate essential safety and performance data to support a future CE Mark submission.
This Ottawa Hospital enrollment marks the first in Canada under B-SILENT and reflects the study’s growing global momentum. Site engagement across France remains strong, with patient enrollment continuing to progress steadily. Together, these milestones underscore accelerating international interest in B-SILENT and reinforce its trajectory toward supporting a future CE Mark submission.
“Achieving our first enrollment in Ottawa is an important milestone for Sonorous Neurovascular and, most importantly, for patients living with debilitating pulsatile tinnitus,” said Joel Harris, CEO of Sonorous Neurovascular. “With four sites already actively enrolling in France and now our first Canadian enrollment complete, B-SILENT is advancing exactly as planned. We are grateful to Dr. Fahed and the team at The Ottawa Hospital for their partnership, and to our study teams across France and Canada for the continued momentum. This is an exciting step forward for the program and for the patients we aim to serve.”
“As Principal Investigator for the B-SILENT study at The Ottawa Hospital, I’m encouraged by the successful enrollment of our first patient. Pulsatile tinnitus can be a debilitating and often under-recognized condition, and studies like B-SILENT are important steps toward giving physicians new tools to help patients who have limited options today. I look forward to our site’s continued contribution to this study,” said Dr. Robert Fahed, The Ottawa Hospital.
Sonorous Neurovascular continues to advance its clinical programs with strong momentum across both U.S. and international regulatory pathways, building on the company’s recent FDA Breakthrough Device Designation for BosSTENT™ and 510(k) clearance for BosCATH™. Together, these milestones reflect Sonorous’ accelerating progress toward its mission of improving the lives of patients affected by pulsatile tinnitus and other venous outflow disorders through minimally invasive, purpose-built therapies.
About Sonorous Neurovascular
Sonorous Neurovascular is a clinical-stage medical device company headquartered in Lake Forest, California, dedicated to developing transformative technologies for the treatment of cerebral venous diseases. The company’s innovative portfolio, including the BosSTENT™ (recently granted FDA Breakthrough Device Designation) and BosCATH™, aims to provide safe, effective, and purpose-built solutions that improve patient outcomes. Sonorous is actively advancing international clinical research, including the B-SILENT study (NCT07070089) evaluating the investigational use of BosSTENT™ for debilitating pulsatile tinnitus at sites in France and Canada to support CE Mark submission. For more information, visit www.sonorousnv.com.
Contact:
James D. Nonato, Vice President
Sonorous Neurovascular
Email: [email protected]
Phone: +1 (888) 830 1445
SOURCE Sonorous Neurovascular
