Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex® for the Reduction of Pain and Symptoms Following Lumbar Surgery.
SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–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.
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 have been working with FDA for many years to bring this technology to the US,” said John Krelle, President and CEO of FzioMed, “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.
About FzioMed, Inc.
FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable surgical biomaterials based on its patented scientific technology. For more information, please contact John Krelle at firstname.lastname@example.org. You can also visit www.fziomed.com or contact email@example.com.
FzioMed®, Oxiplex®,Oxiplex/AP®, Laresse® and Dynavisc® are registered trademarks of FzioMed, Inc.