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An experimental formulation of a hydrogel, injected into spinal discs, proved safe and effective in substantially relieving chronic low back pain caused by degenerative disc disease (DDD), according to new research. Hydrogels have been used for a number of years to treat DDD, but the current study is the first test of this particular gel in humans.
After six months, all participants in this small study reported significantly less low back pain—declining from an average self-reported pain level of 7.1 down to 2.0 on a scale of zero to 10. They also experienced greatly improved physical function, with average scores falling from 48 to six on a questionnaire to gauge the impact of low back pain in preventing patients from the ability to perform normal activities.
The gel used in this study, Hydrafil™, is a second-generation hydrogel developed by ReGelTec. In 2020, it received FDA’s breakthrough device designation.
The ReGelTec Hydrafil system injects an implant for nucleus pulposus augmentation as a viscous fluid which sets up in situ into one solid cohesive hydrogel within the disc annulus that effectively seals the access site and minimizes the risk of expulsion.
The research team enrolled 20 patients, aged 22 to 69, with chronic DDD low back pain. Each described their pain as four or higher on the 10-point scale. None had found more than mild relief from conservative care, which includes rest, analgesics, physical therapy and back braces.
Patients were sedated for the procedure, and the gel was heated to become a thick liquid. Guided by fluoroscopic imaging, researchers used a 17-gauge needle to inject the gel directly into the affected discs, where the gel filled in cracks and tears, adhering to the disc’s center and outer layer.
To date, ReGelTec has raised a total of $6 million in funding over two rounds. Their latest funding was raised in 2020 from a Series A round.
An experimental formulation of a hydrogel, injected into spinal discs, proved safe and effective in substantially relieving chronic low back pain caused by degenerative disc disease (DDD), according to new research. Hydrogels have been used for a number of years to treat DDD, but the current study is the first test of this particular gel in...
An experimental formulation of a hydrogel, injected into spinal discs, proved safe and effective in substantially relieving chronic low back pain caused by degenerative disc disease (DDD), according to new research. Hydrogels have been used for a number of years to treat DDD, but the current study is the first test of this particular gel in humans.
After six months, all participants in this small study reported significantly less low back pain—declining from an average self-reported pain level of 7.1 down to 2.0 on a scale of zero to 10. They also experienced greatly improved physical function, with average scores falling from 48 to six on a questionnaire to gauge the impact of low back pain in preventing patients from the ability to perform normal activities.
The gel used in this study, Hydrafil™, is a second-generation hydrogel developed by ReGelTec. In 2020, it received FDA’s breakthrough device designation.
The ReGelTec Hydrafil system injects an implant for nucleus pulposus augmentation as a viscous fluid which sets up in situ into one solid cohesive hydrogel within the disc annulus that effectively seals the access site and minimizes the risk of expulsion.
The research team enrolled 20 patients, aged 22 to 69, with chronic DDD low back pain. Each described their pain as four or higher on the 10-point scale. None had found more than mild relief from conservative care, which includes rest, analgesics, physical therapy and back braces.
Patients were sedated for the procedure, and the gel was heated to become a thick liquid. Guided by fluoroscopic imaging, researchers used a 17-gauge needle to inject the gel directly into the affected discs, where the gel filled in cracks and tears, adhering to the disc’s center and outer layer.
To date, ReGelTec has raised a total of $6 million in funding over two rounds. Their latest funding was raised in 2020 from a Series A round.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
