ReGelTec’s HYDRAFIL IDE Trial Begins in California

ReGelTec Inc. has treated the first patient in its U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial for the HYDRAFIL System, its chronic lower back pain solution. The outpatient procedure offers interventional pain physicians and patients a new way to reduce pain and improve daily function without the need for an invasive surgery.

The first patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare Inc. in Walnut Creek, Calif.

The HYDRAFIL-D study’s start follows the company’s CE Mark approval for the HYDRAFIL System based on promising study results of 75 patients treated outside the United States. The studies showed that patients treated with HYDRAFIL experienced clinically and statistically significant pain and disability improvements; data indicated more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.

“An overwhelming majority of my chronic low back pain patients either do not want or are not good candidates for invasive spine surgeries, yet they continue to feel debilitated, without many treatment options,” Dr. Amirdelfan stated. “The early data on HYDRAFIL is compelling and promising for our subjects. I am excited to be working with ReGelTec and the other principal investigators to enroll the HYDRAFIL-D Study and evaluate the impact of HYDRAFIL on patients with degenerative disc disease.”

The HYDRAFIL-D study is a 225-patient, single-blinded, randomized, controlled trial evaluating the safety and effectiveness of the HYDRAFIL System to support FDA approval. The multicenter study will measure improvements in pain and disability, reliance on opioid medications, and the need for invasive medical procedures in patients with chronic low back pain due to degenerative disc disease. The protocol includes an interim safety analysis when the first 60 patients complete their six-month follow-up visit. There are nine study sites currently enrolling patients: Birmingham, Ala.; Walnut Creek, Calif.; Greenwood Village, Colo.; Jasper, Ga.; Shreveport, La.; Edmond, Okla.; Tyler, Texas; Richmond, Virginia; and Calgary, Canada. Additional sites are being added.

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 disease,² a condition in which intervertebral spinal discs deteriorate and lose their height and volume, causing chronic low back pain. 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.

“I have been working with doctors and scientists for more than 20 years to develop a treatment for chronic low back pain, and in HYDRAFIL, we believe we’ve built a low-risk, effective option to fill a major market need,” ReGelTec Founder and HYDRAFIL inventor Tony Lowman said. “We look forward to fully enrolling the trial and securing FDA approval for the HYDRAFIL System so that patients in the United States with degenerative disc disease can benefit from this minimally invasive treatment option.”

ReGelTec is a clinical-stage privately held biomedical company developing and commercializing a percutaneous hydrogel implant for treating chronic low back pain due to degenerative disc disease. The firm is based in Baltimore.

References
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