ReGelTec is developing HYDRAFIL™, a patented hydrogel injected via a 17-gauge needle into the nucleus of a degenerated disc; the hydrogel is heated prior to injection and forms a contiguous implant as it cools to body temperature. HYDRAFIL is designed to augment the disc, restore the biomechanical properties of the spinal segment, and alleviate pain in patients with degenerative disc disease. The company has completed procedures on 20 patients in an Early Feasibility Study in Barranquilla, Colombia, with patients in follow-up showing indications of significant pain relief and reduced disability at 30- and 90-day visits. Procedures have been performed outpatient with patients awake under local anesthesia; most patients were walking within one to two hours and discharged on over-the-counter pain medication. ReGelTec recently received FDA Breakthrough Device designation, which will provide priority review and interactive communication regarding device development and clinical trial protocols through the premarket review process. The company says it plans to more rapidly move clinical work to the U.S. and expand clinical trials while advancing development.

Total raised

$4M

Funding rounds

1

Latest round

Series A

Latest activity

Dec 2020