FzioMed has enrolled patient number 50 in clinical study to support the effectiveness and safety of Oxiplex for the reduction of pain and symptoms following lumbar surgery.
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.
Oxiplex is approved in more than 70 countries as an adhesion barrier, supported by peer reviewed, published studies.
“We are pleased that we now have nineteen out of 20 active sites around the US that are participating in this supportive study that will pave the way for US approval,” said John Krelle, President and CEO of FzioMed. “We anticipate full enrollment and study results by early 2020.”
Multiple US and OUS peer reviewed studies have demonstrated the benefits of Oxiplex in a group of patients, who have higher levels of back and leg pain at baseline. These patients typically have an inferior outcome and commonly rely on additional methods of pain reduction for some time following an otherwise successful surgery.
Oxiplex is designed to reduce these levels of pain and give patients greater satisfaction with the overall results of their surgery.
FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable adhesion barriers based on its patented polymer technology. For more information, please visit www.fziomed.com.
FzioMed, Oxiplex, Oxiplex/AP, Oxiplex/IU, Dynavisc, Interpose, and Laresse are registered trademarks of FzioMed.
Source: Company Press Release