FZIOMED GANES FDA DE NOVO CLASSIFICATION MARKETING AUTHORIZATION FOR THE OXIPLEX® GEL in column surgery – Ortho Spine News

OXIPLEX is the only authorized intraoperative gel of the FDA indicated as a complement to lumbar spinal surgery to reduce postoperative pain in the legs and neurological symptoms.

OXIPLEX GEL has the potential to become a new care standard as complementary therapy.

San Luis Obispo, California, July 8, 2025 / Prnewswire / – Fziomed, Inc. (“Fziomed” or the “Company”), a renowned global leader in the prevention of post -surgical adhesion, announced today that the United States Food and Medicines Administration (FDA) has granted the classification of the classification of Novo and Marketing authorization for Marketing for Gel Oxiplex °, indicated for the reduction of food and medicines of medicines. subject to lumbar column procedures. OXIPLEX is now the first and only authorized intraoperative gel of the FDA specifically designed for this indication.

“The Novo FDA process is a rigorous regulatory route used when there is no substantially equivalent predicate device to refer,” said Paul Mraz, president and CEO. “To satisfy the risk criteria of the FDA benefits, the clinical evidence of level 1 presented by Fziomed presented multiple random clinical trials of the USA. UU., Together with international studies after commercialization, demonstrating that the strong oxiplex security profile and the clinical benefit

“OXIPLEX represents an important new complementary treatment for column surgeons in the United States to address a significant unsatisfied clinical need,” said Jeffrey Fischgrund, MD, president of the Department of Orthopedic of the Hospital of the University of William Beaumont (Royal Oak, MI) and principal researcher of the Oxioplex clinical studies. “Thanks to the commitment of our clinical sites, study coordinators and patients, this technology is now available to benefit patients with us.”

Fziomed oxiplex is a clear viscoelastic gel safe, easy to use, absorbable and clear applied to tissues and surgery anatomy during surgery, immediately before closing. In column surgery, OXIPLEX acts as a temporary physical barrier between adjacent tissues and has been demonstrated in multiple peer -reviewed publications to reduce postoperative pain in legs and neurological symptoms. OXIPLEX GEL has been available outside the United States since 2002 and has been used in more than 750,000 column procedures worldwide for postoperative adhesion prevention.

“This FDA Novo subsidy represents an important milestone for Fziomed,” said Gere Dizega, MD, medical director. “It is the culmination of extensive clinical and regulatory work, and the first step to make our intraoperative gel technologies platform available for US patients in a variety of surgical disciplines, such as the backbone, the tendon, the nerve, the health of women and general surgery.”

“We are excited to achieve this important milestone and bring oxiplex to the US market,” added Ron Haynes, executive and co -founder president. “This achievement highlights the strength of our science and the dedication of our world class team.”

About Fziomed, Inc.
Pioneer biomaterials Since 1996, Fziomed is a vertically integrated medical devices company exclusively focused on preserving surgical procedures in the spine, the tendon, the nerve, the abdominal, the pelvic and intrauterine procedures. Fziomed develops, manufactures and markets surgical biomaterials used by doctors to improve surgical results and is a world leader in post -surgical adhesion prevention.

Synthetic, clear and absorbable gel formulations of FZIOMED are based on the company’s patented double polymer technology platform that provides a temporary physical separation from tissues during the body’s natural healing process, reducing adhesion formation. The Fziomed adhesion barrier portfolio is marketed in more than 70 countries under several brand names and have been used clinically since 2002 in almost 1 million procedures worldwide.

Fziomed is based in San Luis Obispo, California, and has been appointed one of the best places to work in southern California during the last 3 consecutive years.

Visit Fziomed.com for more information about Fziomed and our leading products in the industry.

Fziomed Fuente, Inc.