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)
ReGelTec, Inc.
323 W Camden Street, Suite 600, Baltimore, MD 21201
Patents
Method and apparatus for implanting a hydrogel prosthesis for a nucleus pulposus
US-8475532-B2
View DetailsMethod and apparatus for implanting a hydrogel prosthesis for a nucleus pulposus
US-7850730-B2
View Details
Method and apparatus for implanting a hydrogel prosthesis for a nucleus pulposus
US-8475532-B2
View DetailsMethod and apparatus for implanting a hydrogel prosthesis for a nucleus pulposus
US-7850730-B2
View DetailsProducts
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
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.
Formation of distribution agreements and collaborative regulatory planning with regional partners to support local clinical studies and market access efforts.
Co-development and in-house prototype formulation, characterization, and early manufacturing activities performed in company facilities in collaboration with university research programs and students.
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.
Formation of distribution agreements and collaborative regulatory planning with regional partners to support local clinical studies and market access efforts.
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
News & Updates
ReGelTec Inc. has treated the first patient in its FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® System for disc augmentation.
ReGelTec has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation, with clinical data showing significant improvements in pain and disability scores.
ReGelTec received FDA breakthrough device designation for its HYDRAFIL System, accelerating its pathway to market and reimbursement.
ReGelTec Inc. has treated the first patient in its FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® System for disc augmentation.
ReGelTec has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation, with clinical data showing significant improvements in pain and disability scores.
ReGelTec received FDA breakthrough device designation for its HYDRAFIL System, accelerating its pathway to market and reimbursement.