Health Canada has approved FzioMed, Inc.’s Oxiplex(R) gel for use in lumbar spine surgery.Oxiplex is an absorbable gel that is applied to spinal nerve roots during lumbar laminectomy, laminotomy and discectomy procedures. Oxiplex creates a temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain.

Oxiplex is now approved in 49 countries and has been used in nearly 100,000 surgeries. Health Canada’s approval of Oxiplex for spine surgery was based on final data from a U.S. multi-center, randomized, blinded, controlled study involving 352 patients. The company has filed a Pre-Market Approval Application with the FDA seeking approval to market Oxiplex in the U.S.

Read the full story here.