transforming the treatment of

Low Back Pain

QUICK, PERCUTANEOUS PROCEDURE WITH SHORT RECOVERY - PATIENTS UP AND WALKING IN 2 HOURS

EFFECTIVE PAIN RELIEF AND REDUCTION OF DISABILITY

DISC AUGMENTATION AND MOTION PRESERVATION

CURRENT SOLUTION

Years of development to refine and optimize HYDRAFIL®

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The ReGelTec Hydrafil system injects an implant for nucleus pulposus augmentation as a viscous fluid which sets up in situ into one solid cohesive hydrogel within the disc annulus that effectively seals the access site and minimizes the risk of expulsion.

The 1-year results published in Pain Physician report that in a 60-patient study the HYDRAFIL® injectable hydrogel significantly reduced chronic low back pain and disability within 1 month and results were maintained through 12 months.

  • Simple percutaneous procedure​

  • Biomechanical properties validated​

  • Mitigates risk of expulsion​

THE REGELTEC ROADMAP

HYDRAFIL®​ Development Roadmap

2025

Japanese Office granted a patent protecting the HYDRAFIL technology until 2040 and the 3rd U.S. patent issued with composition of matter claims.

2025

1st Patient Enrolled in the HYDRAFIL-D Study

2025

Selected to Participate in the 2025 MedTech Innovator

2025

Secured CE Mark for the HYDRAFIL System under the new European Union Medical Device Regulations.

2024

European Patent Office granted a patent protecting the HYDRAFIL technology until 2040.

2024

Completed 2-year follow-up visits on first 60 patients.

2023

Enrolled the 75th patient in the company’s clinical studies performed outside the United States.

2023

Completed 1-year follow-up visits on first 60 patients.

2022

Enrolled 20 patients in a clinical study in Calgary, Alberta, Canada.

2022

Increased authorized enrollment in Canadian clinical study to 35 patients

2021

Increased authorized enrollment in the Colombian clinical study to 40 patients. Increased authorized enrollment in the Colombian clinical study to 40 patients and added a second site in Cali, Colombia.

2020

Completed Series A Financing, enrolled 20 patient Early Feasibility Study in Barranquilla, Colombia to evaluate proof-of-principal, and received FDA Breakthrough Device Designation.

2018-2020

Pre-clinical studies initiated to confirm gel’s injectability and durability to 24+ months. Completed pre-clinical studies initiated to confirm gel’s injectability and durability to 24+ months and obtained initial U.S. Patent protecting the HYDRAFIL technology until 2039.

2014-2018

Continued development and testing of the hydrogel to address challenges with first generation

2018

ReGelTec incorporated to develop second generation hydrogel and raised Seed Round of financing

2004-2014

First generation hydrogel (Gelifex) developed and tested; Extensive R&D to refine  second generation for specific requirements

Get in Touch

​ReGelTec is a medical device company that is developing the next generation of minimally invasive spinal implants for lower back pain and degenerative disc disease.