ReGelTec, Inc
ReGelTec, Inc. is a clinical stage medical device company developing innovative minimally invasive spinal implants and treatments for chronic low back pain caused by degenerative disc disease. The company focuses on hydrogel-based solutions, including the HYDRAFIL system, which aims to restore disc height, reduce pain, and improve patient mobility through a percutaneous, outpatient procedure. ReGelTec is engaged in clinical trials, regulatory approvals, and strategic partnerships to bring its treatments to market.
Industries
Nr. of Employees
small (1-50)
Products
Percutaneous hydrogel disc augmentation system
An investigational system comprising a thermally-responsive hydrogel implant and a percutaneous delivery mechanism that is heated for injection through a fine-gauge needle, sets in situ to restore disc height and biomechanical function, and is intended for outpatient use to reduce pain and preserve motion.
Percutaneous hydrogel disc augmentation system
An investigational system comprising a thermally-responsive hydrogel implant and a percutaneous delivery mechanism that is heated for injection through a fine-gauge needle, sets in situ to restore disc height and biomechanical function, and is intended for outpatient use to reduce pain and preserve motion.
Services
Clinical trial execution and site support
Operational support for investigator-led and company-sponsored clinical studies including patient enrollment, trial site coordination, and long-term follow-up data collection for early feasibility and IDE pivotal studies.
Regulatory and commercialization partnerships
Formation of distribution agreements and collaborative regulatory planning with regional partners to support local clinical studies and market access efforts.
Collaborative device development with academic partners
Co-development and in-house prototype formulation, characterization, and early manufacturing activities performed in company facilities in collaboration with university research programs and students.
Clinical trial execution and site support
Operational support for investigator-led and company-sponsored clinical studies including patient enrollment, trial site coordination, and long-term follow-up data collection for early feasibility and IDE pivotal studies.
Regulatory and commercialization partnerships
Formation of distribution agreements and collaborative regulatory planning with regional partners to support local clinical studies and market access efforts.
Collaborative device development with academic partners
Co-development and in-house prototype formulation, characterization, and early manufacturing activities performed in company facilities in collaboration with university research programs and students.
Expertise Areas
- Percutaneous spinal implant development
- Hydrogel biomaterials for nucleus augmentation
- Minimally invasive outpatient procedure development
- Clinical trial management for medical devices (EFS, IDE, pivotal)
Key Technologies
- Thermally-responsive injectable hydrogels
- Percutaneous needle-based delivery (17-gauge compatibility)
- Imaging-guided implantation (fluoroscopy and sonographic guidance)
- Crosslinked polymer hydrogel formulations