3D Systems (NYSE: DDD) today announced that the U.S. Food and Drug Administration has granted 510(k) clearance expanding the indications for its VSP® Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone stature, in addition to adults.
This morning’s news release indicates the approval means, Immediate commercial acceleration: Eliminates case-by-case compassionate-use approvals and hospital IRB reviews previously required for these adolescent patients, streamlining workflows and converting off-label usage into standard, reimbursable procedures at leading centers.
It also targets high-acuity, underserved segment:
• Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20 (American Cancer Society, SEER estimates).
• Additional 2,600 primary bone cancer cases in young adults (20–39) now fully in-scope.
• Thousands of complex lower-limb osteotomies and reconstructive procedures annually for congenital, developmental, and trauma-related deformities in adolescents.
VSP Orthopedics cases generate service fees for virtual planning combined with revenue from patient-specific 3D-printed anatomic models and single-use surgical guides produced on 3D Systems’ additive manufacturing platforms. Resulting revenues contribute to the strong, double-digit annual growth rates and highly accretive gross margins associated with 3D Systems’ Med Tech business.
DDD shares lost three cents, or 1.6%, to $1.88.
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