ReGelTec Inc. has treated the first patient in its HYDRAFIL-D FDA investigational device exemption clinical trial, launching a pivotal study that could bring a novel percutaneous hydrogel implant system to U.S. patients suffering from chronic low back pain caused by degenerative disc disease. The patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare, Inc. in Walnut Creek, California.
The U.S. trial initiation follows ReGelTec's recent receipt of CE Mark approval for the HYDRAFIL System based on compelling clinical data from 75 patients treated outside the United States. The European studies demonstrated that patients experienced clinically and statistically significant improvements in pain and disability, with more than 80% improvement in Oswestry Disability Index scores and greater than 70% reduction in Numeric Pain Rating Scale scores. These improvements were sustained for two years in the 63 patients who completed their two-year follow-up visit.
Addressing a Critical Treatment Gap
More than one in 10 U.S. adults suffer from chronic low back pain, with approximately 42% of this population—more than 10 million Americans—having degenerative disc disease. This condition represents the largest contributor to chronic low back pain, occurring when intervertebral discs in the spine deteriorate and lose their height and volume. The 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.
"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."
Innovative Minimally Invasive Approach
The HYDRAFIL System represents a novel approach to treating degenerative disc disease through an outpatient procedure performed under local anesthesia. The 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 pain signaling to the brain.
Dr. Olivier Clerk-Lamalice, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada, who has followed 35 patients treated with HYDRAFIL over three years, emphasized the system's clinical impact. "After following 35 patients treated with HYDRAFIL over the last three years, I've witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability. HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery."
Comprehensive U.S. Clinical Trial Design
The HYDRAFIL-D study is designed as 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. Nine study sites are currently enrolling patients across Birmingham, Alabama; Walnut Creek, California; Greenwood Village, Colorado; Jasper, Georgia; Shreveport, Louisiana; Edmond, Oklahoma; Tyler, Texas; Richmond, Virginia; and Calgary, Canada, with additional sites being added.
Company Vision and Development Timeline
Tony Lowman, the inventor of HYDRAFIL and founder of ReGelTec, reflected on the development journey: "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. 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."
Bill Niland, Co-Founder and CEO of ReGelTec, noted the significance of the CE Mark approval in driving the company's U.S. strategy: "Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec. We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally."
Patients interested in learning more about the HYDRAFIL-D Study can visit www.hydrafilstudy.com for additional information about enrollment opportunities and study locations.
