The U.S. Food and Drug Administration has awarded breakthrough device designation to the SonoClear System, marking a significant advancement in neurosurgical imaging technology. The designation recognizes the system's potential to address critical limitations in ultrasound-guided brain tumor resection, where precise visualization of tumor margins can determine surgical success and patient outcomes.
Addressing Critical Imaging Challenges
The SonoClear System consists of an acoustic coupling fluid and sterile transfer kit engineered specifically for intracranial ultrasound procedures. Unlike standard irrigation fluids such as saline and lactated Ringer's solution, which create acoustic artifacts that obscure critical anatomical details, the SonoClear System features tissue-mimicking properties designed to eliminate these visual impediments.
"Standard irrigation fluids create visual artifacts that can obscure the surgical site precisely when clarity is most critical: at the end of the procedure when surgeons need to verify whether any tumor remains," explained Prof. Geirmund Unsgaard, neurosurgeon and SonoClear founder. The company developed what Unsgaard describes as "a simple solution that works with all intraoperative ultrasound systems and allows neurosurgeons to clearly see the tumor, enabling improved decision-making in surgery."
Clinical Evidence and Expert Validation
Clinical investigations have demonstrated the system's ability to enhance diagnostic accuracy during intraoperative ultrasound imaging. Prof. Francesco DiMeco, director of neurological surgery at the Neurological Institute Carlo Besta in Milan, Italy, and professor of neurosurgery at the University of Milan, served as a principal investigator in studies evaluating the SonoClear System.
"Toward the end of a resection, with SonoClear fluid in the cavity, I could clearly see whether there was any tumor remnant, which is not always the case when we use standard irrigation fluids as a couplant," DiMeco noted. "This gives me confidence that I can achieve a maximum safe resection using intraoperative ultrasound combined with the SonoClear System."
Early phase I data has shown the system's capacity to deliver improved image clarity, according to the company. Studies indicate that using the SonoClear System with intraoperative ultrasound enhances diagnostic accuracy, potentially improving the extent of resection and reducing residual disease.
Market Impact and Regulatory Pathway
SonoClear AS becomes the first fully Norwegian-owned company to receive FDA breakthrough device designation. The company recently completed an oversubscribed investment round, securing sufficient funding to support final product testing, clinical evaluations required for FDA 510(k) submission, and market conditioning activities in both the U.S. and Europe upon regulatory clearance.
"With breakthrough designation, the FDA recognizes a select number of devices with the potential to positively impact patients facing life-threatening conditions," said Peter Balmforth, CEO of SonoClear AS. "We are currently conducting additional clinical investigations to evaluate SonoClear System against the current standard of care."
Technical Specifications and Clinical Need
The SonoClear System is biocompatible, bio-excretable, sterile, and unit-dose packaged. Its acoustic properties are engineered to match those of brain tissue, minimizing the bright signal artifacts and enhanced echogenicity that conventional irrigation fluids create in surgical cavities.
Neurosurgical resection remains the primary treatment modality and standard of care for brain tumors, requiring precise intraoperative decision-making to optimize patient outcomes. The imaging constraints imposed by current irrigation fluids limit the clarity needed for precise tumor margin identification, hindering surgeons' ability to make optimal treatment decisions based on visualization in the resection cavity.
By improving the diagnostic accuracy of intraoperative ultrasound, the enhanced acoustic coupling fluid has the potential to support better surgical decision-making, potentially contributing to improved survival outcomes, delayed tumor recurrence, and reduced healthcare costs by helping minimize the need for repeat surgeries and adjunctive treatments.
