Confirmatory Clinical Study to Support the Effectiveness, Safety of Oxiplex

Oxiplex is an absorbable, synthetic viscoelastic gel that is applied following partial discectomy, with the intent to reduce postoperative leg pain, back pain and neurologic symptoms.

"We are pleased that we now have several active sites around the US that are participating in this supportive study that will pave the way for US approval," said John Krelle, President and CEO of FzioMed. "We are on track to have the full complement of 20 sites enrolling within the coming weeks and are confident that the trial will be a success."

Multiple US and OUS peer reviewed studies have demonstrated the benefits of Oxiplex in a group of patients, who have higher levels of back and leg pain at baseline. These patients typically have an inferior outcome and commonly rely on additional methods of pain reduction for some time following an otherwise successful surgery. Oxiplex is designed to reduce these levels of pain and give patients greater satisfaction with the overall results of their surgery.

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