Sonorous NV Taps New CEO as Breakthrough Tinnitus Stent Advances

LAKE FOREST, CA – March 27, 2026 – Sonorous NV, Inc., a medical device company at the forefront of treating a debilitating form of tinnitus, has announced a significant leadership transition, appointing industry veteran Joel Harris as its new Chief Executive Officer. The change comes as the company gains critical momentum with its flagship product, the BosSTENT™, which recently earned a coveted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Joel Harris, formerly the company's President, will replace founder David Ferrera, who has stepped down. Simultaneously, current board member Paul Brooke has been elected Chairman of the Board. This management shuffle signals a pivotal shift for Sonorous Neurovascular, moving from a phase of foundational research and development to a strategic push towards commercialization and broad market access.

A Strategic Shift in Leadership

The appointment of Joel Harris is a clear indicator of Sonorous's future direction. With over 35 years of experience in the medical device industry, Harris brings a deep reservoir of expertise in sales, marketing, and executive leadership. His career includes significant roles such as Vice President of Operations and Corporate Development at TeleHealth Services and Senior Director at Pfizer Inc., with a background in management consulting at Ernst & Young focused on post-merger integration. This track record suggests a leader adept at navigating the complex path from clinical trials to commercial success.

In a statement, the new Chairman, Paul Brooke, emphasized the company's readiness for its next chapter. "Sonorous is entering an exciting phase of clinical and regulatory progress," Brooke said. "With Joel Harris as CEO and our executive team, we are confident the team will deliver meaningful innovation to patients without distraction." The Board also thanked David Ferrera for his "foundational contributions as founder," acknowledging his role in establishing the company and its core technology.

This transition is common in the life cycle of medical technology firms, where a founder's vision gives way to an operational and commercial specialist tasked with scaling the business. Harris's immediate focus will be on capitalizing on the company's recent regulatory and clinical achievements to bring its innovative device to patients.

"I am honored to lead Sonorous at this important time," said Joel Harris in a statement. "We remain focused on advancing the BosSTENT™ and transforming outcomes for patients."

The Promise of the BosSTENT™

At the heart of Sonorous's strategy is the BosSTENT™, a device designed to treat pulsatile tinnitus, a rare and distressing condition where individuals hear a rhythmic pulsing or whooshing sound synchronized with their heartbeat. Unlike the more common ringing in the ears, pulsatile tinnitus often has a specific vascular cause, namely symptomatic venous sinus stenosis—a narrowing of the large veins in the brain that disrupts normal blood flow.

Sonorous has pioneered the BosSTENT™ as the first braided, self-expanding cerebral venous stent designed specifically for this purpose. For years, physicians have resorted to using other stents off-label, such as those designed for carotid arteries, which are not optimized for the delicate and tortuous anatomy of the cerebral venous sinuses. The BosSTENT™ aims to provide a dedicated, on-label solution with unique features including enhanced visibility for precise deployment, excellent conformability to the vessel walls, and the ability to be resheathed and repositioned during the procedure.

Research published in journals such as the Journal of NeuroInterventional Surgery has highlighted the device as a "novel, dedicated, braided stent," with early studies reporting successful deployment and complete resolution of pulsatile tinnitus symptoms in patients. This technology represents a significant step forward in providing a targeted, minimally invasive treatment for a condition that has historically lacked specific therapeutic options.

Navigating the Regulatory Gauntlet

The leadership change is timed perfectly with a series of major regulatory victories for Sonorous. On February 5, 2026, the company announced it had received Breakthrough Device Designation from the FDA for the BosSTENT™. This program is reserved for medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. The designation provides Sonorous with prioritized FDA review, enhanced communication with the agency, and potential eligibility for increased Medicare reimbursement through New Technology Add-on Payments (NTAP) upon market approval, which can accelerate adoption.

Beyond U.S. borders, the company has also secured crucial authorizations to begin its pivotal European study, titled "BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus (B-SILENT)". French regulatory bodies ANSM and CPP have given the green light for the study, which is essential for a future CE Mark submission in Europe. Furthermore, Health Canada has approved the inclusion of Canadian sites, broadening the study's scope and potential patient pool.

These regulatory milestones validate the clinical importance of the BosSTENT™ and lay a clear pathway toward market entry in North America and Europe. The B-SILENT study will be critical in gathering the necessary safety and performance data to secure these final approvals.

A New Horizon for Patients and Investors

With new, commercially-focused leadership at the helm, a breakthrough device in its pipeline, and a clear regulatory pathway, Sonorous Neurovascular appears poised for significant growth. The combination of these factors offers a new horizon of hope for patients suffering from the debilitating effects of pulsatile tinnitus, a condition that can severely impact quality of life.

For investors and the broader medical community, the company's trajectory will be watched closely. The successful execution of the upcoming pivotal trials and the subsequent commercial launch of the BosSTENT™ could not only establish a new standard of care but also solidify Sonorous's position as a leader in the neurovascular device market.

Under Joel Harris's leadership, the company's focus will now shift from pioneering a concept to delivering a product. The coming months will be crucial as Sonorous advances its IDE submission in the U.S. and begins patient enrollment in its international studies, moving one step closer to transforming the lives of patients who currently have limited options.