Year-long dataset evaluating percutaneous disc augmentation technology shows the HYDRAFIL System improved back and leg pain and disability scores exceeding clinical significance benchmarks at one-month post-procedure and maintained them through one-year follow-up
BALTIMORE–(BUSINESS WIRE)–#backpain—ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced the publication of a journal article in Pain Physician demonstrating that its HYDRAFIL System for disc augmentation safely generated lasting clinically significant improvements in pain and disability scores in patients with chronic low back pain due to degenerative disc disease. The HYDRAFIL System is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an invasive surgery.
The article, “Feasibility and Safety of Treatment of Painful Lumbar Degenerative Disc Disease with an Injectable Hydrogel Implant at One Year Follow-up,” evaluated the safety and efficacy of the HYDRAFIL System in 60 chronic low back pain patients treated at either one- or two-disc levels across three clinical sites in Canada and Colombia. HYDRAFIL implants were successfully placed into all 83 intervertebral discs treated without complications during the procedure or at discharge. Statistically and clinically significant improvements in function, low back pain and low leg pain were observed within one-month post-procedure and maintained at 12 months follow-up. Scores in the Oswestry Disability Index (ODI) improved by >80% and Numeric Pain Rating Scale (NRS) for Back Pain by >70% at one year.
“These peer-reviewed results represent an important milestone in the development of the first nucleus augmentation technology for degenerative disc disease,” said Dr. Douglas Beall, Chief of Radiology Services at Clinical Radiology of Oklahoma and a medical advisor to ReGelTec. “The improvements in pain and function observed at one year, along with an acceptable safety profile, support the continued evaluation of the HYDRAFIL System in the ongoing pivotal study designed to support FDA approval of the device for patients who currently have limited minimally invasive treatment options.”
More than one in 10 U.S. adults suffer from chronic low back pain.1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease2, a condition that is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg.
Performed in an outpatient procedure under local anesthesia, ReGelTec’s HYDRAFIL System delivers a permanent hydrogel into a degenerated disc via a needle to fill cracks and fissures and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain.
“We are excited to be advancing an innovative approach with the potential to help the millions of patients suffering from degenerative disc disease,” said Peter Boyd, chief executive officer of ReGelTec. “This publication and the ongoing HYDRAFIL-D pivotal study currently enrolling patients in the U.S. and Canada reflect the company’s commitment to a disciplined, evidence-driven approach to generating data to support regulatory review of the HYDRAFIL System and the long term success of the product.”
ABOUT REGELTEC, INC.
ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec’s HYDRAFIL System is an outpatient disc augmentation procedure where a permanent hydrogel is delivered into a degenerated disc via a needle to fill cracks and fissures and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit https://regeltec.com/.
1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174.
2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233, https://doi.org/10.1111/j.1526-4637.2010.01045.x
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