ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain
BALTIMORE--(BUSINESS WIRE)-- ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL ® System for disc augmentation. The 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 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 launch of the HYDRAFIL-D U.S. study follows the company's receipt of CE Mark for the HYDRAFIL System based on promising results of clinical studies performed outside the United States on 75 patients.
The launch of the HYDRAFIL-D U.S. study follows the company's receipt of CE Mark for the HYDRAFIL System based on promising results of clinical studies performed outside the United States on 75 patients. The studies showed that patients treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability, with 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,' said Dr. Amirdelfan. '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, multicenter, single-blinded, randomized, controlled trial evaluating the safety and effectiveness of the HYDRAFIL System to support FDA approval. The 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 sixty patients complete their six-month follow-up visit. There are nine study sites currently enrolling patients in Birmingham, Ala.; Walnut Creek, Calif.; Greenwood Village, Colo.; Jasper, Ga.; Shreveport, La.; Edmond, Okla.; Tyler, Texas; Richmond, Virginia; and Calgary, Canada, with additional sites 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 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.
'I have been working with doctors and scientists for more than twenty 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,' said Tony Lowman, the inventor of HYDRAFIL and founder of ReGelTec. '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 innovative, minimally invasive treatment option.'
Patients interested in learning more about the HYDRAFIL-D Study can visit www.hydrafilstudy.com.
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 https://doi.org/10.1111/j.1526-4637.2010.01045.x
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