PorOsteon Wins FDA Approval for Phusion Metal™ Cervical Cage

MENLO PARK, Calif., Jan. 8, 2015 /PRNewswire/ -- PorOsteon Inc., the worldwide leader in Nitinol-based porous metal technologies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new Phusion Metal^TM Cervical Cage, designed to maximize bone growth through a fully interconnected porous structure and matching the modulus of living cancellous bone.

PorOsteon is the exclusive manufacturer of medical devices composed of Phusion Metal^TM, a proprietary porous material developed to promote bone fusion. The Phusion Metal^TM Cervical Cage is designed to address important limitations of conventional spinal fusion devices, including excessive stiffness, cage migration, minimal bone apposition and poor incorporation. The Cervical Cage is the first of a family of surgical devices taking advantage of the unique properties of Phusion Metal^TM.

Founded by The Beta Group, PorOsteon’s mission is to design and manufacture a variety of fusion devices composed of advanced proprietary intermetallic materials. Phusion Metal’s unique and irregular porous morphology delivers the benefits of structural strength, potential for bone in-growth, bone through-growth, and relative low cost of manufacturing. Phusion Metal^TM addresses the biomechanical limitations of other synthetic materials by closely matching the elastic modulus and irregular pore structure of natural cancellous bone, while providing structural integrity afforded by a fully porous metal and biocompatibility inherent to Nitinol.

Dr. Gary Fanton, orthopedic surgeon at Stanford University and co-founder of PorOsteon, stated: “This bone fusion material is designed to not only contain autogenous bone graft, but to actually integrate into the surgically-corrected spinal column. Clinicians are realizing the immense importance of the materials used for bone fixation and fusion. Some of these materials are essentially solid plastic, metal, or ceramic that subsides, migrates, and actually displaces surface area necessary for optimal bone in-growth. Instead, our testing has demonstrated that fusion devices must achieve an engineered balance among porosity, strength, and elastic modulus. Phusion Metal^TM is the first implant material that addresses all three of these concerns effectively, representing a great improvement compared to conventional and surface enhanced interbody cage materials. Now implants can be designed with a material that is both surgeon and bone friendly. There will be no additional learning curve to use these implants, and they will address our primary concern in spinal surgery, obtaining a rapid and robust fusion.”

“The medical applications for Phusion Metal^TM go well beyond spinal fusion,” added Bob Zider, co-founder of both PorOsteon and Nitinol Devices and Components (NDC). “This clearance is reminiscent of the time when we first developed and introduced Nitinol cardiovascular stents at NDC. Those devices changed that market dramatically. We believe we can drive similar change to the spinal fusion market with the introduction of the Phusion Metal^TM Cervical Cage, as well as through the other products in development at PorOsteon including hip and knee applications, upper and lower extremities, small bones, SI joint fusion, along with craniomaxillofacial and dental implants.”

Indications
The Phusion Metal^TM Cervical Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Phusion Metal^TM Cervical Cage is intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Phusion Metal^TM Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

About PorOsteon
PorOsteon is a privately held company based in Menlo Park, CA, which is focused on developing its proprietary Nitinol-based Phusion Metal^TM for a wide range of musculoskeletal indications. For more information, please contact info@porosteon.com.

About The Beta Group
The Beta Group is a privately held technology development group founded by The Boston Consulting Group in 1983. Among its notable milestones, The Beta Group founded and developed Nitinol Devices and Components (NDC), invented Flexon® ophthalmic frames, the FOxs intra-arterial blood gas sensor, the Tornier Piton knotless bone anchor, the Avantek distortion-free lens system, the Ping Isoforce golf putters, and Personics, the first custom on-demand music provider. For more information, please visit www.betagroupllc.com or contact bondan@betagroupllc at The Beta Group.

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SOURCE PorOsteon Inc.