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[junkie-alert style=”grey”] FzioMed, Inc., a biomaterials company celebrating 21 years in business, has received approval from FDA to conduct a small confirmatory study of Oxiplex® in the United States. [/junkie-alert]
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.
John Krelle, President and CEO of FzioMed comments, “We have been working with FDA for many years to bring this technology to the US.” He elaborated, “And we are confident that a new level of cooperation with FDA will finally enable patients in this country to experience the benefits of Oxiplex following the large number of lumbar surgeries performed here.”
Multiple US and OUS studies have already demonstrated the benefits of Oxiplex® and this study will target patients with higher levels of back and leg pain who do not always experience the level of pain relief offered by surgery alone.
FzioMed is pleased to be working with Musculoskeletal Clinical Regulatory Advisers (MCRA) as both regulatory advisor and CRO on this study, which will be posted on Clinicaltrials.gov when open for enrollment.