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ReGelTec, Inc., a clinical stage medical device company developing HYDRAFIL™, a percutaneous treatment for chronic low back pain, announced the presentation of Early Feasibility Study (EFS) results by Dr Alfonso Spath at the American Society of Spine Radiology annual meeting that took place February 19-21, 2021.
Dr Doug Beall, medical advisor for ReGelTec, presented at the American Society of Spine Radiology annual meeting on Hydrafil’s development history and the preliminary results of the Early Feasibility Study. Dr Alfonso Spath, Prinicipal Investigator, also presented during the meeting’s scientific session.
By restoring vertebral disc height with an injectable, durable hydrogel, ReGelTec aims to give interventional spine and pain clinicians an effective option for one of the most common causes of low back pain.
ReGelTec, Inc., a medical device company developing a treatment for chronic low back pain, has received breakthrough device designation for its HYRDAFIL System from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA).
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.