FDA 510(k) Clearance for DEXA-C™ Cervical Interbody System CARLSBAD, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced it had received U.S. Food and Drug Administration (“FDA”) 510(k) Clearance for its DEXA-C, a new line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures. This approval is the first using Aurora's patented DEXA technology, which creates a series of implants manufactured with varying densities to match a patient's bone density and DEXA T-Score. By comparing and using a product that matches a patient's bone density, the technology should promote quicker bone growth and employ superior fixation.
Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine, stated, "This approval is the first of its kind in the world by offering an implant based upon a patient's bone density. It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score, which indicates a patient's bone density. Today's implant options are all designed as a one-size-fits-all solution. Because implant materials do not match well with patients that have lower bone mass or a lower T-Score, it is preferred to implant a device that has the best chance of long-term fixation and promotes bone growth."
Mr. Laszlo Garamszegi, Chief Technology Officer of Aurora Spine, added, "This is a breakthrough for Aurora as this first device using our proprietary DEXA patent opens the door for improved fixation that wasn't available up to now. We are working to commercialize these products utilizing our proprietary technology and manufacturing process to produce these DEXA-C fusion cages. We are excited to begin introducing this product, and we are working diligently in preparing additional products using our patented DEXA Technology."
Dr. Sebastian Koga, MD, FAANS, Chairman of Neurosurgery and Medical Director of the Ochsner Neuroscience Institute for the Ochsner North Shore Region, stated, "The DEXA cage is the newest and greatest innovation in interbody fusion. By matching the elastic modulus of the patient's vertebral bone, it is the first personalized implant in spine surgery, and it will reduce subsidence and increase fusion rates. This technology is the culmination of many incremental steps, including 3-D printing, lattice construction of allograft to mimic natural bone, and material improvements which reduce stress on the endplates. I believe the DEXA cage will completely replace PEEK and rigid metallic implants in the years ahead."