Sonorous Neurovascular Receives FDA 510(k) Clearance for BosCATH™ Neurovascular Catheter

LAKE FOREST, Calif., April 22, 2026 /PRNewswire/ -- Sonorous Neurovascular, a pioneering medical device company focused on innovative solutions for cerebral venous diseases and neurovascular interventions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BosCATH™, a next-generation neurovascular catheter designed to enhance access, delivery, and procedural efficiency in complex cerebral venous and arterial anatomies.

This regulatory milestone follows the company's recent receipt of FDA Breakthrough Device Designation for its BosSTENT™, a braided self-expanding cerebral venous stent intended to treat symptomatic cerebral venous sinus stenosis associated with debilitating pulsatile tinnitus.

BosCATH is engineered to provide physicians with superior trackability, support, and navigability in challenging neurovascular procedures. The device complements Sonorous' innovative portfolio and is specifically designed to support delivery of advanced therapies such as the BosSTENT™ in tortuous venous anatomy.

"This 510(k) clearance for BosCATH, combined with our recent Breakthrough Device Designation for BosSTENT, represents important progress in our mission to deliver purpose-built devices that address significant unmet needs in neurovascular care," said Joel Harris, CEO of Sonorous Neurovascular. "We extend our sincere thanks to the entire Sonorous R&D and Regulatory teams for their outstanding dedication and expertise. In particular, we recognize Jake Le, Vice President of R&D, for his exceptional leadership in driving product development from concept to successful 510(k) clearance."

The clearance allows Sonorous to commercialize BosCATH in the United States, expanding treatment options for interventional neuroradiologists and neurosurgeons.

Sonorous has also initiated the international B-SILENT study (NCT07070089) in France and Canada to evaluate the investigational use of the BosSTENT™ for the treatment of debilitating pulsatile tinnitus caused by symptomatic cerebral venous sinus stenosis. This clinical study is designed to generate essential safety and performance data to support a future CE Mark submission.

Sonorous Neurovascular continues to advance its clinical programs with strong momentum across both U.S. and international regulatory pathways. The company remains dedicated to 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