ReGelTec — OUS Data → CE Mark + FDA IDE Pivotal Trial; 2026 Peer-Reviewed Results

ReGelTec developed the HYDRAFIL® System, an injectable hydrogel nucleus replacement for treating chronic discogenic low-back pain. HYDRAFIL holds FDA Breakthrough Device Designation (2020). bioaccess® managed the out-of-U.S. first-in-human clinical work whose 75-patient data set supported CE Mark and an FDA-approved IDE for a U.S. pivotal RCT. HYDRAFIL remains investigational in the U.S.

Study facts

• Sponsor / company: ReGelTec
• Indication / area: Spine / Orthopedics
• Country: Colombia, Panama
• Study type: First-in-Human (FIH)

Key metrics

• OUS Patients: 75
• U.S. Pivotal RCT: 225 patients
• First U.S. Patient: Jun 2025
• Peer Review: Pain Physician (Jan 2026)

The challenge

Chronic discogenic low-back pain is a leading cause of disability worldwide. ReGelTec's minimally invasive injectable hydrogel needed disciplined out-of-U.S. clinical evidence to support CE Mark and an FDA IDE before a U.S. pivotal RCT — a path that would have been prohibitively slow and costly if run entirely in the United States.

bioaccess® solution

bioaccess® executed the out-of-U.S. first-in-human program across Panama and Colombia, coordinating with interventional spine specialists, managing device injection procedures under fluoroscopic guidance, and collecting pain scores, functional outcomes, and MRI follow-up data under ISO 14155-aligned protocols structured for FDA submission.

Results

• FDA Breakthrough Device Designation granted (2020) for the HYDRAFIL® System
• Out-of-U.S. clinical studies (75 patients) supported CE Mark
• CE Mark and OUS evidence base supported an FDA-approved IDE for the U.S. pivotal trial
• First U.S. pivotal-trial patient treated June 2025 (225-patient randomized controlled trial)
• Peer-reviewed OUS results published in Pain Physician, January 2026
• MRI follow-up confirmed hydrogel stability in the disc space

Frequently asked

What did bioaccess® do for ReGelTec?

bioaccess® executed the out-of-U.S. first-in-human program across Panama and Colombia, coordinating with interventional spine specialists, managing device injection procedures under fluoroscopic guidance, and collecting pain scores, functional outcomes, and MRI follow-up data under ISO 14155-aligned protocols structure

Where was the ReGelTec First-in-Human (FIH) study run?

The ReGelTec First-in-Human (FIH) study was executed in Colombia, Panama by bioaccess® in the spine / orthopedics area.

What was the outcome of the ReGelTec study?

Reported outcomes for ReGelTec's device: FDA Breakthrough Device Designation granted (2020) for the HYDRAFIL® System; Out-of-U.S. clinical studies (75 patients) supported CE Mark; CE Mark and OUS evidence base supported an FDA-approved IDE for the U.S. pivotal trial.

Run a similar trial: Clinical trials in Colombia · Clinical trials in Panama

First-in-Human Clinical Trials pillar · LATAM FIH Benchmarks 2026 · ← All case studies · Contact bioaccess®