San Luis Obispo, CA – A new absorbable gel, Oxiplex®, is demonstrating significant potential in alleviating post-operative pain and neurological symptoms following lumbar spine surgery, according to results from a recently completed clinical study. The findings, released today by Fziomed, Inc., offer hope for patients experiencing persistent discomfort after procedures to address herniated discs.
The prospective, randomized, double-blinded, multi-center study, published this month in Spine (Volume 51, Issue 6), evaluated 134 patients. Researchers found that those receiving Oxiplex in addition to standard surgical care experienced higher rates of substantial and complete leg pain relief, as well as improvements in neurological function, compared to patients who underwent surgery alone. Importantly, the study revealed no differences in safety or adverse events between the two groups.
“Patients who present with both severe leg pain and significant back pain are historically more demanding to treat surgically,” explained Dr. Kee Kim, study co-author and Chief of Spinal Neurosurgery at UC Davis Health in Sacramento, CA. “This study shows that adding Oxiplex at the time of surgery can meaningfully increase the likelihood of achieving greater pain relief and reducing residual neurological symptoms in this challenging patient population.”
Oxiplex is designed to act as a temporary physical barrier between tissues during the healing process. Applied directly to nerves and surrounding tissues during surgery, the absorbable gel aims to reduce inflammation and minimize nerve exposure to inflammatory mediators. The technology has been used in over 800,000 spine procedures worldwide since 2002, though primarily outside of the United States until recently.
How Oxiplex Works
The gel’s mechanism focuses on addressing the inflammatory environment immediately following surgery. According to Stephanie Cortese, Senior Vice President of Science and Technology at Fziomed, “These results reinforce the importance of addressing the inflammatory microenvironment immediately following lumbar spine surgery. By reducing nerve exposure to early inflammatory mediators, Oxiplex has the potential to improve longer-term outcomes for patients who might otherwise experience persistent residual pain despite a technically successful surgery.”
Fziomed’s Oxiplex is a clear, simple-to-employ gel supplied sterile in a 3 mL syringe with a flexible applicator. It’s intended to be placed around neural tissues following lumbar spine surgery to specifically target leg pain and neurological symptoms. The company highlights its dual-polymer formulation, noting it contains no pharmaceutical agents and is free from human, animal, or bacterial materials.
FDA Authorization and Future Implications
The promising clinical results come after a significant regulatory milestone for Fziomed. In July 2025, the U.S. Food and Drug Administration (FDA) awarded De Novo classification and marketing authorization for Oxiplex, making it the first intraoperative gel specifically authorized for this purpose in the United States. The De Novo pathway is reserved for novel devices with no existing comparable predicate device, requiring robust clinical evidence to demonstrate safety, and efficacy. Fziomed provided Level 1 clinical evidence, gathered from U.S. Randomized clinical trials and international post-marketing studies, to secure the FDA’s approval.
Jeffrey Fischgrund, MD, Chairman of the Orthopedic Department at William Beaumont University Hospital and a principal investigator of the Oxiplex clinical studies, stated that the gel represents a “significant advancement” for spine surgeons in the U.S., addressing a critical unmet clinical need.
Fziomed’s Commitment to Post-Surgical Care
Fziomed, founded in 1996, has established itself as a leader in postsurgical adhesion prevention, focusing on a range of procedures including spine, tendon, nerve, abdominal, pelvic, and intrauterine surgeries. The company has been recognized as one of the Best Places to Work in Southern California for the past three consecutive years.
The company’s technology has been used in over 800,000 procedures globally, and the recent FDA authorization is expected to broaden its accessibility to patients in the United States. Further research is ongoing to explore the potential benefits of Oxiplex in other surgical applications.
As the adoption of Oxiplex expands, clinicians will continue to evaluate its long-term impact on patient outcomes and the potential to reduce the incidence of chronic pain following spine surgery. The availability of this new tool offers a promising avenue for improving the quality of life for individuals undergoing these procedures.
Disclaimer: This article provides informational content about medical research and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider for any questions you may have regarding a medical condition.
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