ReGelTec — Colombia First-in-Human Study → FDA IDE for the U.S. HYDRAFIL-D Pivotal Study
ReGelTec developed the HYDRAFIL® System, an injectable hydrogel nucleus replacement for treating chronic discogenic low-back pain. HYDRAFIL holds FDA Breakthrough Device Designation (2020). In October 2019 ReGelTec announced it had chosen Colombia and bioaccess® as its CRO for the HYDRAFIL first-in-human trial at Centro Médico Cediul in Barranquilla. ReGelTec has said that sharing 1-year data on its first 60 patients, a feasibility cohort enrolled in Canada and Colombia, helped it obtain FDA authorization of the IDE for its U.S. pivotal study in September 2023. HYDRAFIL remains investigational in the U.S.
Study facts
- Sponsor / company: ReGelTec
- Indication / area: Spine / Orthopedics
- Country: Colombia
- Study type: First-in-Human (FIH)
Key metrics
- Colombia EFS: 20 patients
- U.S. Pivotal RCT: 225 patients
- First U.S. Patient: Jun 2025
- Peer Review: Pain Physician (2025)
The challenge
Chronic discogenic low-back pain is a leading cause of disability worldwide. ReGelTec needed first-in-human clinical evidence for its injectable hydrogel before a U.S. pivotal study.
bioaccess® solution
The early feasibility study ran in Barranquilla, Colombia, where 20 patients were treated from August to December 2020 (Beall et al., J Vasc Interv Radiol 2024). The Colombia patients were later reported with Canadian patients in a 60-patient feasibility cohort (Clerk-Lamalice et al., Pain Physician 2025).
Results
- FDA Breakthrough Device designation granted December 2020 for the HYDRAFIL® System
- 20 patients treated in the Barranquilla early feasibility study, August–December 2020
- FDA authorized the IDE for the U.S. HYDRAFIL-D pivotal study in September 2023, after ReGelTec shared 1-year data on its first 60 patients
- First HYDRAFIL-D patient treated June 2025 (NCT06011551, 225 patients planned, U.S. and Canada)
- 60-patient Canada and Colombia feasibility cohort published in Pain Physician (2025)
Frequently asked
- What did bioaccess® do for ReGelTec?
- The early feasibility study ran in Barranquilla, Colombia, where 20 patients were treated from August to December 2020 (Beall et al., J Vasc Interv Radiol 2024). The Colombia patients were later reported with Canadian patients in a 60-patient feasibility cohort (Clerk-Lamalice et al., Pain Physician 2025).
- Where was the ReGelTec First-in-Human (FIH) study run?
- The ReGelTec First-in-Human (FIH) study was executed in Colombia 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 December 2020 for the HYDRAFIL® System; 20 patients treated in the Barranquilla early feasibility study, August–December 2020; FDA authorized the IDE for the U.S. HYDRAFIL-D pivotal study in September 2023, after ReGelTec shared 1-year data on its first 60 patients.
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