BALTIMORE--(BUSINESS WIRE)--ReGelTec, Inc., a medical device company focused on the development and commercialization of spinal implants for chronic back pain, announced that it has received a patent from the United States Patent Office covering HYDRAFIL™, a hydrogel injected into the nucleus of a person’s intervertebral disc via a 17 gauge needle. HYDRAFIL™ should provide a non-surgical treatment option for the millions of patients with chronic low back pain due to degenerative disc disease. A clinical study to evaluate the thirty minute percutaneous procedure to restore disc height and alleviate discogenic back pain has been approved in Colombia South America.
“I started developing hydrogel polymers to treat chronic back pain in the early 2000’s and, for the first time, we’ve come up with a formulation that both mimics the biomechanics of the healthy nucleus and can be injected into the disc via a small gauge needle” said Dr. Anthony Lowman, Provost and Professor of Biomedical Engineering at Rowan University, Chief Scientific Officer at ReGelTec and lead inventor on the patent. The new patent family adds to Dr. Lowman’s portfolio of twenty-one patents issued across six different patent families in multiple jurisdictions that ReGelTec purchased from Depuy Synthes, and extends the company’s patent protection until 2039. Dr. Lowman explained that “the new HYDRAFIL™ formulation is injected as a viscous liquid at 65° C through a fine gauge needle into the nucleus of the disc and solidifies as one contiguous implant at body temperature, effectively filling the space and restoring the natural biomechanics.”
“ReGelTec is hitting on all cylinders,” said Bill Niland, the company’s CEO who has successfully founded and exited three previous healthcare companies. “In addition to expanding our patent portfolio, the large animal study is going well and the company just received regulatory approval to begin an Early Feasibility Study of the HYDRAFIL™ System at CEDIUL Hospital in Barranquilla, Colombia.” The Early Feasibility Study will enroll up to twenty people with low back pain due to degenerative disc disease. “A number of companies have tried to develop nucleus augmentation technologies but there have always been problems with expulsions, we are going to show that HYDRAFIL™ can be safely injected into the nucleus of a degenerated disc, is not expulsed from the disc and alleviates pain.”
Dr. Thomas Schaer, the head of Penn Vet’s Translational R&D at New Bolton Center said “I have worked on numerous nucleus replacement technologies over the last twenty years for a number of different companies and have never been able to inject a hydrogel directly into the intervertebral disc via a small gauge needle without the implants expulsing over time. Our HYDRAFIL™ animal work to date is very promising; the one-year radiograph from the first goat has no implant migration, expulsion or signs of endplate damage, so I am excited to see this technology moving forward.”
ABOUT REGELTEC, INC:
ReGelTec, Inc. is a development 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. The HYDRAFIL™ System will offer patients suffering from chronic back pain due to degenerative disc disease a non-surgical treatment option when traditional conservative care has failed.