FzioMed, Inc., out of San Luis Obispo, CA, is reporting that Health Canada has approved the company’s Oxiplex® gel for use in lumbar spine surgery. The company’s bioabsorbable gel is composed of biocompatible medical polymers, carboxymethylcellulose (CMC) and polyethylene oxide (PEO). Designated as a medical device, the gel is applied to roots of spinal nerves during lumbar laminectomy.
It is touted to create a “temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain.” The company reports that its product has been successfully used in 49 countries (including the European Union) and in more than 100,000 surgeries.
Details about the technology:
Key characteristics of FzioMed’s biomaterial science:
Non-Animal and Non-Bacterial. FzioMed biomaterials contain no animal or bacterial by-products.
Biocompatible. Pre-clinical and clinical data have demonstrated the safety and biocompatibility of FzioMed biomaterials when used in a variety of surgical procedures. The polymers CMC and PEO have been used extensively for decades in the medical device and pharmaceutical industries. Over 90,000 spine surgery patients have been treated safely with our world-leading Oxiplex/SP Gel.
Bioabsorbable. FzioMed biomaterials are naturally absorbed by the body over time and cleared via normal processes. They do not need to be removed after application.
Tissue Adherent. FzioMed biomaterials can be formulated to adhere to tissues, so that they remain in place for a period of time for site-specific applications.
Versatile. FzioMed biomaterials can be formulated into a variety of bioabsorbable product types – gels, films, solutions, foams, sponges, and powders – with specific characteristics such as tissue adherence, elasticity, strength, viscosity and absorption. This allows us to tailor products for use in targeted medical applications.
Handling, Packaging & Storage. FzioMed products can be stored at room temperature and are provided sterile and ready to use. They require no mixing or assembly before use.