Devices Orthopaedic Neurosurgery FDA Product Launch

 News Release - May 7, 2020

Camber Spine Technologies Announces Nationwide Launch Of SPIRA(R)-C Integrated And FORTICO Anterior Cervical Plate

KING OF PRUSSIA, Pa., May 7, 2020 -- (Healthcare Sales & Marketing Network) -- Camber Spine, a leading innovator in spine and medical technologies, today announced the FDA clearance and nationwide launch for two novel anterior cervical products: The SPIRA®-- C Integrated Interbody system, a stand-alone integrated fixation system, and the FORTICO™ Anterior Cervical Plating System, a two screw plating system that can integrate to the Camber Spine SPIRA®--C interbody implants as well as their COVERIS® peek cervical implants.

"Camber Spine has spent the last year in aggressive development to create two options for spine surgeons to address anterior cervical pathology. With the addition of SPIRA®--C Integrated, surgeons now have a zero profile, screw fixated interbody option for anterior cervical fusions with all the benefits of the SPIRA®- open architecture design. Additionally, the surgeon design teams impressed upon the engineers the need for having a minimally invasive cervical plate option in addition to the zero-profile system, which led to the development of the FORTICO™ plating system," stated Seth Anderson, Chief Innovation Officer. FORTICO™is a two screw, low profile cervical plate designed to match the anterior face of the SPIRA®- interbody system, it is approved as a cervical plating system. It has the unique ability to be attached to the interbody cage or used independently. The SPIRA®-C Integrated incorporates Camber Spine's proprietary technology Surface by Design®, a proven osteopromotive surface and its patented arch design for redistribution of load to maximize end plate contact and promote full arthrodesis. "These two additions will establish Camber Spine as a new leader in 3D printed, arched, open architecture cervical implants and cervical fixation options for the treatment of complex spine pathologies," continued Seth Anderson. Camber Spine also recently received additional issued patents from the US patent office on the SPIRA® technology, further strengthening its proprietary position in the open architecture 3D printed implant space. Currently, clinical studies at several prestigious spine centers are being conducted to continue proving that the SPIRA® technology is the best open architecture cage in the world.

FORTICO™

Current SPIRA® Technology studies underway

Surface Micro-Architecture Analysis Using Mesenchymal Stem Cell's on 3D-Printed Titanium Scaffolds. Authors: Celeste Abjornson, Ph.D., Director of Spinal Research, Hospital for Special Surgery (HSS): Nicole Utah, BS, Clinical Research Coordinator, HSS.

SPIRA®-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2. Authors: David Kaye, M.D., Spine Surgeon and Assistant Professor of Orthopaedic Surgery, Rothman Institute / Thomas Jefferson University Hospital, Arjun Sebastian, M.D., Mayo Clinic, Hamid Hassan Zadeh, M.D., University of Virginia, Michael Hisey, M.D.,Texas Back Institute.

Evaluation of Spinal Implants Using and Ovine Lumbar Spine Model. Authors: Thomas P. Schafer, VMD, Staff Veterinarian, University of Pennsylvania School of Veterinary Medicine; Harvey E. Smith, M.D., Chief Orthopedic Spine Surgery, Penn Medicine.

Source: Camber Spine Technologies

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