GlobeNewswire Inc.May 8, 9:00 AM ET▲ Positive
The company achieved a major clinical milestone by completing enrollment in its first U.S. pivotal trial, which is a critical step toward FDA approval. The completion of enrollment represents significant progress in commercialization efforts, and the company has already initiated the modular PMA application process. The technology has received FDA Breakthrough Device Designation and has demonstrated promising efficacy and safety across multiple international studies.