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# FDA Accepts Invivo’s 1st Neuro-Spinal Scaffold HDE Module
- URL: https://www.fdaweb.com/fda-accepts-invivos-1st-neuro-spinal-scaffold-hde-module/
- Published: 2021-07-13T12:00:00.000Z
- Updated: 2026-09-14T17:05:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149699

FDA has accepted the first preclinical module submitted by Invivo for its humanitarian device exemption (HDE) application for the Neuro-Spinal Scaffold implant. The company [says](https://investors.invivotherapeutics.com/news-releases/news-release-details/invivo-therapeutics-announces-fda-acceptance-preclinical-module?ref=fdaweb.com) the remaining modules cover manufacturing and clinical data. All three must be accepted before an agency final approval decision.

Invivo says it is currently enrolling patients with acute spinal cord injury into its INSPIRE 2.0 pivotal trial of the scaffold involving 20 patients.