[Orlando, FL, October 29, 2019} — 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. bioaccess™ will help ReGelTec with its institutional review board (IRB)/ethics committee approval and regulatory approval at Colombia’s regulatory agency (INVIMA). The clinical trial will take place at Centro Médico Cediul in Barranquilla, Colombia. Dr. Alfonso A. Spath, chief of the radiology department at Cediul, and Dr. Luis C. Imaz, pain management specialist, will lead the trial as principal investigator and sub-investigator, respectively.
ReGelTec is developing a gel that can be injected into the nucleus of a lumbar (or lower back) disc for patients who had surgery related to degenerative disc disease. The spinal implants are designed to return spacing and height that is lost during surgery to the disc when some of the nuclei are removed.
Since the gel is injected through a needle, surgery is not required for the follow-up procedure. The company’s product initially lights up on a sonogram, then a larger mass is formed that will stay in place in the disc. It’s over in about an hour.
About ReGelTec, Inc.
ReGelTec is a medical device startup company that is developing the next generation of minimally invasive spinal implants for lower back pain and degenerative disc disease. The startup was founded at Drexel University, where the chief technology officer (CTO) and co-founder Anthony Lowman previously conducted research at a lab focused on polymers. More information at www.regeltec.com.
bioaccess™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research clients with support services to ensure their first-in-human trials are a success in Colombia (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). More information at www.bioaccessla.com.
bioaccess™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210