CASCADIA(TM) AN & TL Interbody Systems Featuring K2M's New Technology Receive US FDA Regulatory Clearance and a CE Mark
LEESBURG, Va., Oct. 13, 2015 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it will introduce Lamellar Titanium Technology™, the Company's new and proprietary technology that uses 3D printing with the goal of allowing for bony integration throughout an implant, during the 2015 North American Spine Society (NASS) Annual Meeting in Chicago at Booth #1139.
K2M's Lamellar Titanium Technology uses an advanced 3D printing method to create structures that were once considered impractical with traditional manufacturing techniques. Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity.*
The first products to feature K2M's Lamellar Titanium Technology are the CASCADIA™ AN and TL Interbody Systems, for which the Company recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark.
"With 3D printed Lamellar Titanium Technology, an innovative alternative to many traditionally manufactured PEEK and titanium designs now exists in the interbody space," said Tom Morrison, MD, a neurosurgeon at Polaris Spine & Neurosurgery Center in Atlanta, Georgia. "I'm excited about the CASCADIA platform because it provides a balance of roughness and porosity that may allow the bone to grow into the implant."
K2M's Lamellar Titanium Technology incorporates titanium with a surface roughness of 3–5 microns that is designed to allow for direct bony ongrowth. This surface roughness has been shown, in peer-reviewed research and pre-clinical data*, to increase osteoblastic activity compared to smooth titanium and other biomaterials, such as PEEK.1
Additionally, research has provided an understanding that interconnected pores in the diametrical range of 300–700 microns are ideal for allowing bone ingrowth through porous biomaterials.1 K2M's Lamellar Titanium Technology incorporates 500 micron diameter pores that run through the walls of the implant, forming continuous channels from endplate to endplate to serve as a conduit for bony integration.*
The CASCADIA Interbody Systems have been designed with radiographic imaging quality in mind. The porosity inherent with the Lamellar Titanium Technology in conjunction with the proprietary design of the CASCADIA interbodies results in an approximately 70 percent porosity overall, and therefore a decreased radiographic signature when compared to equivalent traditional nonporous titanium designs.
"We are extremely excited to introduce Lamellar Titanium Technology, our new and proprietary technology that uses 3D printing," said Eric Major, K2M's President and CEO. "Because of this breakthrough technology, CASCADIA is an important addition to the interbody fusion market and strengthens our portfolio of products. These latest developments, coupled with the recent introduction of several complex spine offerings, reflect another strong year of innovation for K2M."
The CASCADIA AN and TL Interbody Systems are offered in a full range of implant sizes carefully designed to accommodate the vertebral anatomy.
For more information on Lamellar Titanium Technology, the CASCADIA Interbody Systems, and K2M's complete product portfolio, visit www.K2M.com.
* Pre-clinical data may not represent clinical results. 1 References available upon request.
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.
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Media Contact:Zeno Group on behalf of K2M Group Holdings, Inc.Marcie Kohenak, 202-965-7811 Investor Contact:Westwicke Partners on behalf of K2M Group Holdings, Inc.Mike Piccinino, CFA, 443-213-0500
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