SonoClear AS Completes Clinical Enrollment for Breakthrough Device-Designated SonoClear® System

Company Advances Toward U.S. Regulatory Submission for Acoustic Coupling Fluid Designed to Enhance Intraoperative Imaging During Neurosurgery

OSLO, Norway, May 12, 2026 /PRNewswire/ -- SonoClear AS today announced the final clinical procedure has been completed in its study of the SonoClear System for use in intracranial ultrasound procedures in patients with neurological tumors.

Peter Balmforth, CEO of SonoClear, commented, "Having achieved this critical milestone, we are now completing our data analysis and preparing to submit for marketing clearance in the United States. We are grateful to the patients, investigators, and clinical teams who have contributed to the study."

The SonoClear System includes an acoustic coupling fluid developed to enhance intraoperative imaging during neurosurgical interventions. "With conventional irrigation fluids there are acoustic artifacts that obscure critical tumor remnants at the base of a resection cavity that make maximum tumor resection challenging. SonoClear System's tissue-mimicking properties were designed to address this issue," commented Prof. Geirmund Unsgård, SonoClear's Chief Medical Officer.

The primary investigator for the study, Prof. Dr. med. Jan Coburger of Ulm University Hospital, observed, "Importantly, this study evaluates the safety of the SonoClear System in routine intraoperative ultrasound use and compares its performance with standard irrigation fluids. Completing enrollment is an important step toward understanding the system's potential value across a broader clinical experience."

In July 2025 the SonoClear System was designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). Completing clinical trial requirements now brings the product closer to market availability in the U.S., subject to FDA clearance, to address a critical need for brain tumor patients. SonoClear intends to submit a 510(k) application to the FDA in the second half of 2026.

Prof. Dr. Constantin Roder, a neurosurgeon and participating clinical investigator at Universitätsklinikum Tübingen (University Hospital Tübingen), said, "When using the SonoClear System in multiple neurosurgical cases, the kit fit well into our normal operating room workflow. If our experience with SonoClear is reflected in the overall study results, then SonoClear could meaningfully enhance the image quality of intraoperative ultrasound at the end of resection."

About the SonoClear^® System

The SonoClear System is a sterile, biocompatible, and bio-excretable ultrasound acoustic coupling fluid designed for use during brain tumor resections. It is specifically engineered to match the acoustic properties of brain tissue, to eliminate the bright signal artifacts and visual noise caused by conventional irrigation fluids. By providing a clearer view of the surgical cavity, the system may enhance diagnostic accuracy, potentially improving the extent of tumor resection and reducing residual disease. The SonoClear System is not currently available for sale.

About the Clinical Need

Precise, real-time imaging is critical for neurosurgeons to distinguish tumor margins from healthy brain tissue. While intraoperative ultrasound is widely used, its accuracy is often compromised by standard irrigation fluids like saline, which create acoustic artifacts that obscure critical areas. By resolving these imaging constraints, an enhanced coupling fluid could support improved surgical decision-making, potentially leading to  improvement in patient survival, delayed tumor recurrence, and reduced healthcare costs by minimizing the need for repeat surgeries.

About SonoClear AS

SonoClear AS was spun out of the Ultrasound and Image-Guided Therapy Centre in Trondheim, Norway to develop technology that improves diagnostic accuracy in ultrasound-guided interventions. The company has the support of majority shareholders SINTEF Venture IV, Sarsia, CoFounder and Sparebank 1 SMN, along with family offices and private investors. For more information, please visit www.sonoclear.no.

CONTACTS

Peter Balmforth
CEO
[email protected]

Media:

Amy Martini
Martini Communications
[email protected]

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SOURCE SonoClear AS