Fziomed, Inc., a global leader in postsurgical adhesion prevention, 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. This milestone makes Oxiplex the first and only FDA-authorized intraoperative gel specifically designed for this indication.
Rigorous Regulatory Pathway
"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 of Fziomed. To satisfy FDA's benefit-risk criteria, the company 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.
The approval represents the culmination of extensive clinical and regulatory work supported by over 20 years of real-world use outside the United States. "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 added.
Addressing Unmet Clinical Need
Jeffrey Fischgrund, MD, Chairman of the Orthopedic Department at William Beaumont University Hospital (Royal Oak, MI) and principal investigator of the Oxiplex clinical studies, emphasized the clinical significance of this approval. "Oxiplex represents an important new adjunctive treatment for spine surgeons in the United States to address a significant unmet clinical need," he said. "Thanks to the commitment of our clinical sites, study coordinators, and patients, this technology is now available to benefit U.S. patients."
Product Characteristics and Mechanism
Fziomed's Oxiplex is a safe, easy-to-use, absorbable, clear viscoelastic gel applied to tissues and surrounding anatomy during surgery, immediately prior to closure. In spine surgery, Oxiplex acts as a temporary physical barrier between adjacent tissues and has been shown in multiple peer-reviewed publications to reduce postoperative leg pain and neurological symptoms.
The gel formulations are based on the company's proprietary dual-polymer technology platform that provides a temporary, physical separation of tissues during the body's natural healing process, thereby reducing adhesion formation.
Global Experience and Market Expansion
Oxiplex gel has been available outside the United States since 2002 and has been used in more than 750,000 spine procedures worldwide for postoperative adhesion prevention. Fziomed's portfolio of adhesion barrier products are marketed in more than 70 countries under various brand names and have been used clinically since 2002 in nearly 1 million procedures worldwide.
"This De Novo grant from FDA represents a major milestone for Fziomed," said Gere diZerega, MD, 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."
Company Background
Pioneering biomaterials since 1996, Fziomed is a vertically integrated medical device company focused exclusively on preserving surgical excellence in spine, tendon, nerve, abdominal, pelvic, and intrauterine procedures. The company develops, manufactures, and commercializes surgical biomaterials used by clinicians to improve surgical outcomes and is a global leader in postsurgical adhesion prevention.
Ron Haynes, Executive Chairman and co-Founder, expressed enthusiasm about the achievement: "We are excited to achieve this important milestone and bring Oxiplex to the U.S. market. This achievement highlights the strength of our science and the dedication of our world-class team."
Fziomed is headquartered in San Luis Obispo, California, and has been named one of the Best Places to Work in Southern California for the past 3 consecutive years.
