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.
ReGelTec, Inc., a medical device company developing a percutaneous treatment for chronic low back pain, announced today that eleven patients with degenerative disc disease have been enrolled in the Company’s Early Feasibility Study in Barranquilla, Colombia.
ReGelTec, Inc., a Baltimore-based medical device startup company that is developing the next generation of minimally invasive spinal implants for lower back pain and degenerative disc disease, has chosen Colombia and bioaccess™ as its CRO to conduct the first-in-human clinical trial of its HYDRAFIL System.