FDA OKs Fziomed’s Oxiplex Gel in Spine Surgery

Fziomed, a company focused on postsurgical adhesion prevention, has won U.S. Food and Drug Administration (FDA) de novo classification and marketing authorization for Oxiplex gel to reduce postoperative leg pain and neurological symptoms in adults undergoing lumbar spine surgeries.

Oxiplex is now the first, only FDA-authorized intraoperative gel designed for this indication. The absorbable, clear viscoelastic gel is applied to tissues and surrounding anatomy during surgery, immediately before closure. It acts as a temporary physical barrier between adjacent tissues.

It’s been demonstrated in multiple peer-reviewed publications to reduce post-op leg pain and neurological symptoms. Oxiplex has been available outside the U.S. since 2002 and has been used in over 750,000 spine procedures worldwide to prevent post-op adhesion.

“The FDA De Novo process is a rigorous regulatory pathway utilized when there is no substantially equivalent predicate device to reference,” said Paul Mraz, Fziomed’s 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.”

Mraz was appointed as the company’s president and CEO in 2023.

Fziomed’s synthetic, clear, absorbable gel formulations are based on the company’s proprietary dual-polymer technology platform that provide a temporary, physical separation of tissues during the body’s natural healing process.

“This De Novo grant from FDA represents a major milestone for Fziomed,” said Gere diZerega, MD, Fziomed’s medical director. “It is the culmination of extensive clinical and regulatory work, and the first step in making our platform of intraoperative gel technologies available to U.S. patients across a range of surgical disciplines—such as spine, tendon, nerve, women’s health, and general surgery.”

“We are excited to achieve this important milestone and bring Oxiplex to the U.S. market,” added Ron Haynes, Fziomed’s executive chairman and co-founder. “This achievement highlights the strength of our science and the dedication of our world-class team.”