The gel is applied to neural tissues following spine surgery, creating a temporary physical barrier between adjacent tissues. In multiple studies, Oxiplex has been shown to reduce leg pain, back pain and neurologic symptoms.
Oxiplex is approved outside the U.S. in more than 70 countries and distributed as Oxiplex, Oxiplex/SP, MediShield and Interpose.
"Oxiplex continues to be the most trusted adhesion barrier for spine surgery around the world," said John Krelle, President and Chief Executive Officer. "Throughout these unusual times related to Covid-19, our employees have worked tirelessly to continue to provide this valuable product to our customers, allowing them to 'Preserve Surgical Excellence' following their surgeries."
Further, the U.S. Investigational Device Exemption study for Oxiplex has concluded enrollment. The study is examining effectiveness and safety in reducing pain and symptoms after lumbar surgery. FzioMed expects to submit Level 1 data to FDA by the end of 2020.