DirectSync Surgical has recently introduced patient-powered smart implants for spinal fusion, which have received Breakthrough Device Designation from the US Food and Drug Administration (FDA).
The interbody device provides localized electrical stimulation and post-operative diagnostics, potentially offering more effective treatment for patients.
Furthermore, DirectSync Surgical has completed a NIH Phase II SBIR grant for pre-clinical bone growth assessment and is in the process of completing a second NIH Phase I SBIR grant to integrate diagnostics for monitoring key healing metrics.
The company is currently seeking funding to raise a Seed Round to accelerate its efforts to begin first-in-human clinical trials.