RICHARDSON, Texas--(BUSINESS WIRE)--A startup client of Ken Block Consulting (KBC) has received Breakthrough Device designation from the FDA for FLOXsp, the Spinal Cord Flow and Oxygenation System.
FLOXsp was developed by KBC client Neural Fiber Optic Systems, Inc. (NFOSYS) and is intended for short-term placement in the epidural space to monitor spinal cord blood flow and oxygenation before, during, and after surgical procedures where the spinal cord is at risk of injury due to ischemia. Spinal cord ischemia (SCI) can lead to paraparesis, paraplegia, tetraplegia, and other lifetime disabilities including chronic pain. Results of SCI are costly and can significantly reduce the length and quality of patient lives.
To help reduce the occurrence of SCI complications, NFOSYS President/CEO Thomas F. Floyd, MD, developed the FLOXsp device, which uses minimally invasive optical probes to measure acute changes in spinal cord blood flow and oxygenation as signs of impending SCI with an immediacy not possible with current electrophysiologic monitors. Dr. Floyd is a board-certified cardiac anesthesiologist and Professor of Anesthesiology and Pain Management at the University of Texas Southwestern Medical Center in Dallas. He emphasizes, “SCI is devastating. For decades, clinicians have searched for technology to reduce the risk of this complication. Our device may provide a much-needed solution designed to significantly improve patient outcomes.”
KBC successfully led NFOSYS through the appropriate Q-Submission process at FDA, resulting in the Breakthrough Device status for FLOXsp. KBC President Ken Block states, “Our team worked closely with our client and the FDA to achieve this valuable outcome. Breakthrough Device status will allow KBC and NFOSYS to meet frequently with the FDA, resulting in shorter time to market for the FLOXsp device.”
For more information on how KBC successfully guided NFOSYS into the Breakthrough Device program, contact Yulia Nikova, RAC, at 972.480.9554 or nikova@kenblockconsuting.com.
About Ken Block Consulting (KBC)
KBC provides medical device regulatory services to companies worldwide, with US, Europe, and Asia offices. Committed to delivering superior results, KBC empowers clients with the strategic approach and confidence necessary to succeed, adhering to a policy of confidentiality, trust, and transparency. For more information about Ken Block Consulting, call 972.480.9554 or visit kenblockconsulting.com.
