NextBioMedical Completes FDA Pre-Review of Technical Documents for NexSphere-F

NextBioMedical has completed the pre-review process of the Total Product Lifecycle Advisory Program (TAP) by the U.S. Food and Drug Administration (FDA) for its vascular embolization device, NexSphere-F, ahead of the official approval review.

According to NextBioMedical on July 27, the company proactively submitted major technical documents, excluding clinical results, to the FDA. The company underwent pre-review for its key non-clinical and quality data, including biological safety evaluation, animal testing, and sterilization validation data.

Through this pre-review process, the company was able to confirm the technical requirements demanded by the FDA in advance, thus minimizing uncertainties in the subsequent main review process. NextBioMedical plans to complete its ongoing U.S. clinical trials as scheduled and then submit a final approval application, including the clinical trial results. The current clinical trial is a randomized comparative study setting steroid injection therapy as the control group, aimed at evaluating the safety and efficacy of genicular artery embolization (GAE) using NexSphere-F.

A representative from NextBioMedical stated, "The close pre-review collaboration through the FDA's TAP program marks an important milestone that significantly advances the completeness of our regulatory strategy. Based on forthcoming objective clinical data and ongoing communication with the FDA, we will steadily pursue the procedures required for entry into the U.S. market."

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