SAN LUIS OBISPO, Calif., July 8, 2025 /PRNewswire/ — Fziomed, Inc. (“Fziomed” or the “Company”), a recognized global leader in postsurgical adhesion prevention, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification and marketing authorization for Oxiplex^® gel, indicated for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Oxiplex is now the first and only FDA authorized intraoperative gel specifically designed for this indication.

“The FDA De Novo process is a rigorous regulatory pathway utilized when there is no substantially equivalent predicate device to reference,” said Paul Mraz, President and CEO. “To satisfy FDA’s benefit-risk criteria, Fziomed submitted Level 1 clinical evidence from multiple U.S. randomized clinical trials, along with international post-marketing studies, demonstrating Oxiplex’s strong safety profile and clinical benefit. With this robust clinical evidence and over 20 years of real-world use outside the United States, we are confident Oxiplex has the potential to become a new standard of care as an adjunctive therapy.”