FzioMed announced the inclusion of Dynavisc on the Australian Register of Therapeutic Goods (ARTG). Dynavisc is an absorbable, clear, viscoelastic gel that is applied to tendons and peripheral nerves to reduce fibrosis and the formation of adhesions following surgery. Dynavisc received a CE mark in January 2012 and is sold in the EU through independent distributors. Dynavisc, is a sister product to Oxiplex(R) and Medishield(TM) (distributed by Medtronic), which have been marketed for more than ten years in 70 countries to reduce the incidence of adhesions and for the reduction of pain after spine surgery. Oxiplex is not yet approved in the United States despite having demonstrated safety and effectiveness in clinical studies involving more than 500 patients. A Citizen Petition under 21 CFR 10.33 is still under review by FDA.

FzioMed, Inc. announced the approval of Oxiplex in Russia. Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery immediately prior to wound closure. Based on four studies involving more than 500 patients, and nearly 10 years of commercial use benefitting more than 300,000 patients outside the U.S., Oxiplex has proven itself to be an effective surgical adjuvant that significantly reduces the effects of Failed Back Surgery Syndrome (FBSS) such as leg pain and neurological symptoms following surgery. After a rigorous process in the large country in the world, the Roszdravnadzor regulatory body has approved the sale of Oxiplex to physicians so that patients can experience the well-documented benefits of this adjunct to lumbar spine surgery. Oxiplex is not yet approved in the United States despite having demonstrated safety and effectiveness in clinical studies involving more than 500 patients. A Citizen Petition under 21 CFR 10.33 is still under review by FDA.

FzioMed has filed a petition for reconsideration with the U.S. Food and Drug Administration, under Section 515(g)(2)(a) of the Food Drug Cosmetic Act, Section 562 of the FD&C act and Part 10.33 of Title 21 Code of Federal regulations, which denied approval of its premarket approval application (PMA) for Oxiplex(R) Gel. Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery immediately prior to wound closure. Based on four studies involving more than 500 patients, and nearly 10 years of commercial use benefitting more than 300,000 patients outside the U.S., Oxiplex has proven itself to be an effective surgical adjuvant that significantly reduces the effects of Failed Back Surgery Syndrome (FBSS) such as leg pain and neurological symptoms following surgery. Available in nearly 70 countries, including those in the European Union, Australia, Canada, Brazil, Mexico and South Korea, the United States is the only country to deny an application for approval of Oxiplex.