Next-generation 3D-printed expandable fusion device is the first and only to feature infinite adjustment within its expansion range to help restore sagittal balance in spine deformity patients
LEESBURG, Va., May 16, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced the U.S. commercial launch of its MOJAVE™ PL 3D Expandable Interbody System. Designed with K2M’s Lamellar 3D Titanium Technology™, MOJAVE PL 3D incorporates a porous structure in conjunction with rough surfaces, with the goal of allowing for bony integration throughout the endplates. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.
The MOJAVE PL 3D Expandable Interbody System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in June 2017, is a first-of-its-kind fusion device designed to allow for independent control of the anterior and posterior heights in the lumbar spine. Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.
“Advancements in expandable interbody technology are giving new hope to surgeons who treat sagittal imbalance, which often causes patients to live in chronic pain and discomfort,” said Michael P. Donahue, DO, Director of Spine Surgery and President at the Center for Advanced Orthopedics and Sports Medicine in Auburn Hills, MI. “The MOJAVE PL 3D Expandable Interbody System is a first-of-its-kind solution. Designed with Lamellar 3D Titanium Technology, it uses a breakthrough 3D-printing method to allow for bony integration throughout the implant, and its infinite adjustment tools allow me to precisely match the implant to the unique anatomies of my patients.”
K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the MOJAVE endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a rough surface architecture that pre-clinical data have associated with bone growth activity.
“The launch of the MOJAVE PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology marks a significant advancement in expandable interbody technology,” said K2M Chairman, President, and CEO Eric Major. “Its infinite adjustment and comprehensive height and lordotic expansion capabilities provide surgeons with a more flexible means to facilitate 3D sagittal balance in their patients. We are proud to reiterate our commitment to excellence in 3D spinal innovation by inventing new solutions, that when supported by our Balance ACS platform, allow spine surgeons worldwide to facilitate quality outcomes in their patients.”
Balance ACS® (or BACS®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.
K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.
This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “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.
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Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500