$XTNT 6.10 BREAKING FDA APPROVAL! Short interest 68%
Xtant Medical Receives FDA 510(K) Clearance for InTice(TM)-C Porous Titanium Cervical Interbody System ACCESSWIRE ACCESSWIRE•May 21, 2018 BELGRADE, MT / ACCESSWIRE / May 23, 2018 / Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development of regenerative medicine products and medical devices, announces U.S. Food and Drug Administration (FDA) 510(k) clearance for InTice™-C Porous Titanium Cervical Interbody System.
InTice-C is designed using OsteoSync Ti, a best-in-class, cost-effective, highly porous titanium scaffold material for improved implant fixation. The material more closely resembles the bioscaffold of cancellous bone, and further combines Xtant Medical's hardware and biologic portfolios. In addition to InTice-C serving as a bioactive scaffold, it is also cleared for use with Xtant's proprietary allograft lines, including OsteoSponge®, 3Demin® Cortical Fibers, and OsteoVive™ viable cell allograft.
"InTice-C represents Xtant's latest addition to our spinal implant portfolio and is our first spinal implant to be engineered using a best-in-class porous titanium material," stated Dr. Gregory Juda, Chief Scientific Officer and General Manager of Xtant Medical. "The porous architecture of the titanium was designed to improve implant fixation, both prior and post fusion. We expect a positive reception of this technology from our surgeon customers in the cervical spine market."
The InTice-C Is designed to provide cervical intervertebral body fusion options for each patient's varied anatomy. It is offered in multiple footprint, height and endplate options. The commercial pure titanium structure offers continuous pore interconnectivity from the top to the bottom as well as from the outer perimeter to the large central graft cavity of the implant. This optimizes vascularization to the fusion site allowing the implant to be a participant in the fusion process. The implant utilizes machined endplate structures in conjunction with the inherent texture of the porous titanium to provide migration resistance. The implant is offered in individual sterile packages. InTice-C was developed in collaboration with Sites Medical.
InTice-C will help the Company further penetrate the $285 million dollar cervical spine market. Xtant's other cervical interbody options include Calix®-C, Calix-C PC, Atrix-C®, and Irix®-C, which offer PEEK, PEEK with a plasma-coated titanium, a structural biologic solution, and a standalone cervical option, respectively.
About Xtant Medical
Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.
