FDA Approves First Posterior Motion-Preserving Device as DDD Pipeline Advances
The FDA approved the first posterior motion-preserving device for degenerative disc disease, while DiscGenics, Angitia, and BioRestorative advanced late-stage trials. ReGelTec reported positive HYDRAFIL data and CE Mark approval.
In December 2025, the U.S. Food and Drug Administration (FDA) granted approval to Companion Spine's DIAM™ Spinal Stabilization System, making it the first posterior motion-preserving technology approved in the United States for treating moderate to severe primary low back pain caused by degenerative disc disease (DDD) at a single lumbar level (L2–L5). The device is indicated for patients who continue to experience symptoms despite undergoing at least six months of conservative, non-surgical treatment.
In June 2026, an independent Data Safety Monitoring Board (DSMB) completed a scheduled safety assessment of DiscGenics' Phase III IDCT (rebonuputemcel) trial and recommended that the study proceed as planned without any protocol changes. In April 2026, DiscGenics initiated new patient recruitment activities for the Phase III IDCT trial and broadened enrollment efforts to include individuals suffering from chronic low back pain related to lumbar DDD.
Angitia Biopharmaceuticals advanced its ongoing Phase III clinical trial of AGA111 in May 2026, evaluating the therapeutic efficacy of a single local injection administered into the intervertebral space in patients with DDD undergoing lumbar interbody fusion surgery.
BioRestorative Therapies completed patient enrollment in February 2026 in its FDA-authorized Phase II trial of BRTX-100, a stem cell therapy for chronic lumbar disc disease, with 99 participants enrolled. The company also reported a positive Type B meeting with the FDA, during which the agency endorsed the proposed Phase III study design for BRTX-100 and discussed a potential accelerated regulatory pathway.
ReGelTec Inc. published a study in Pain Physician in January 2026 reporting that its HYDRAFIL System for disc augmentation demonstrated sustained, clinically meaningful reductions in pain and disability scores among patients with DDD-related chronic low back pain. The system is performed as an outpatient procedure and provides a minimally invasive treatment option without requiring major surgery. ReGelTec obtained CE Mark approval under the European Union Medical Device Regulation (MDR) for the Class III HYDRAFIL System in May 2025.
Several other companies are developing DDD therapies, including Spine BioPharma, Mesoblast, Biosplice Therapeutics, Causeway Therapeutics, AnGes, Kuros Biosciences, and others. Emerging therapies in clinical trials include SB-01, BRTX-100, Rexlemestrocel-L, Lorecivivint, CWT 002, AMG0103, IDCT, KUR 113, and AGA111.