K2M to Unveil 3D Printed Lamellar Titanium Technology™ at the 2015 North American Spine Society Annual Meeting
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
"With 3D printed Lamellar Titanium Technology, an innovative alternative to many traditionally manufactured PEEK and titanium designs now exists in the interbody space," said
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
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.
Find K2M on Facebook: https://www.facebook.com/K2MInc
Follow K2M on Twitter: http://twitter.com/K2MInc
Watch K2M on YouTube: http://www.youtube.com/user/K2MInc
This press release contains forward-looking statements that reflect our current views with respect to, among other things, our operations and financial performance. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption in operations at our headquarters facility or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations, voluntary corrective actions or agency enforcement actions; a recall of our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside
We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward looking statements and you should not place undue reliance on our forward-looking statements.
CONTACT: Media Contact:
Zeno Groupon behalf of K2M Group Holdings, Inc.Marcie Kohenak, 202-965-7811 Marcie.Kohenak@ZenoGroup.com Investor Contact: Westwicke Partnerson behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com
News Provided by Acquire Media