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ReGelTec, Inc., a medical device company developing a percutaneous treatment for chronic low back pain, announced today that it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The company’s leading product is HYDRAFIL™, a patented hydrogel that is heated prior to injection into the nucleus of a degenerated disc via a 17-gauge needle. When HYDRAFIL cools to body temperature it forms a contiguous implant within the nucleus to augment the disc, restore the biomechanical properties of that spinal segment, and alleviate pain.