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™​

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.​

  • Simple percutaneous procedure​

  • Biomechanical properties validated​

  • Mitigates risk of expulsion​

THE REGELTEC ROADMAP

Hydrafil™​ Development Roadmap

2004-2014

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

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

2018-2020

Pre-clinical studies initiated to confirm gel’s injectability and durability to 24+ months

2020

Initiated Early Feasibility Study in Colombia for proof of principle (20 patients) and also completed Series A financing and received FDA Breakthrough Device Designation

2021

Increased authorized enrollment in the Colombian clinical study to 40 patients

2022

Started 20 patient clinical trial in Calgary, Alberta, Canada

2022

Increased authorized enrollment in Canadian clinical study to 35 patients

2023

Received approval for US IDE clinical trial.

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​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.