ReGelTec Receives FDA Breakthrough Designation for its HYDRAFIL™ System

BALTIMORE–(BUSINESS WIRE)–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.

The Breakthrough Device program is intended to help patients receive faster access to technologies that can provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. Under the program, the FDA will provide ReGelTec with priority review and interactive communication regarding device development and clinical trial protocols continuing through the premarket review process.

“I am very happy that the FDA has recognized the potential of HYDRAFIL to treat one of the most prevalent, debilitating, and costly conditions that I see in my practice in patients with chronic low back pain and degenerative disc disease,” said Douglas Beall, MD the chairman of the company’s medical advisory board. “This designation will allow us to more rapidly move clinical work to the US and expand our clinical trials, building on the promising results of the Early Feasibility Study.”

The Company has completed procedures with 20 patients as part of an ongoing Early Feasibility Study in Barranquilla, Colombia, an increase from the previously announced 11 patients. All patients are now in the follow up phase with indications of significant pain relief and reduction of disability at 30 and 90 day follow up visits. The percutaneous procedures have proceeded smoothly with patients awake and under local anesthesia in an outpatient clinic. Patients were up and walking within one to two hours of the injection, and most were sent home on standard over the counter pain medication.

Additionally, the Company is pleased to announce that its Series A financing is fully subscribed with a total of $4M raised to support the ongoing clinical and development work.

“It is exciting to see the potential of this technology recognized by the FDA, coupled with the clinical success of our Early Feasibility Study”, says Dr Anthony Lowman, co-founder and CTO of ReGelTec. “Our years of development work point to this being an effective alternative for patients suffering from chronic low back pain.”

ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL™, a percutaneous treatment for low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals who had recently sold their former company Harpoon Medical, Inc. to Edwards Lifesciences. Once approved, the HYDRAFIL™ System will offer a non-surgical treatment option to patients suffering from chronic back pain due to degenerative disc disease.