Xstim Inc.

Xstim, Inc. manufactures the Xstim Spine Fusion Stimulator, a Class III FDA-approved electrical stimulation device designed to promote bone healing and fusion success following lumbar spinal fusion surgery. The device uses capacitive coupling technology to deliver low-level electrical impulses to the fusion site through hydrogel electrodes placed 4–6 inches apart adjacent to the surgical site. Clinical evidence demonstrates upregulation of bone morphogenetic proteins (BMPs) and multiple growth factors, with reported fusion success rates up to 85% in one- or two-level lumbar fusions. The technology is based on peer-reviewed research showing that specific electrical stimulation signals enhance bone healing phases within 30 minutes of exposure, with optimal effects at 24 hours. The Xstim device is compact, lightweight, and portable, designed for discreet, patient-driven treatment during the post-operative recovery and rehabilitation period. The company targets orthopedic surgeons, spine surgery centers, and patients recovering from lumbar fusion procedures. Regulatory approval includes FDA PMA (Premarket Approval) P230025. The product represents a non-invasive adjunct therapy aimed at improving clinical outcomes and reducing fusion failure rates in spine surgery patients.