LEESBURG, Va., Sept. 30, 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 and techniques, today announced the U.S. commercial launch of the EVEREST® Deformity Spinal System at the Scoliosis Research Society (SRS) 50th Annual Meeting in Minneapolis, Minnesota. EVEREST Deformity is an expansion of the EVEREST family of products, which includes the EVEREST Degenerative and EVEREST Minimally Invasive Spinal Systems.
The EVEREST Deformity Spinal System includes state-of-the-art implant technology with several enhancing attributes to facilitate more efficient intraoperative use of the system. EVEREST Deformity features a top-loading pedicle screw in a variety of screw types and offers the ability to accommodate titanium and cobalt chrome rods in two different diameters. The Basecamp™ Deformity Rod Reducer, the system’s efficient and versatile instrumentation, provides surgeons with multiple options during surgery in one system to help address the most difficult correction maneuvers for complex spinal pathologies.
“The EVEREST Deformity system offers versatility and adaptability by providing surgeons with a variety of solutions to complex spine pathologies, including choices in rod diameter, rod material, construct configuration, and deformity correction techniques,” said Shay Bess, MD, chief of adult spinal deformity in the department of orthopedic surgery at the NYU Langone Medical Center’s Hospital for Joint Disease in New York. “The EVEREST Deformity system offers a streamlined and comprehensive approach and adapts to each surgeon’s preferred surgical technique, thereby allowing me to make the appropriate surgical decisions for my adolescent and adult patients.”
“EVEREST Deformity was developed to reduce intraoperative steps while simultaneously providing innovative instrumentation to help achieve deformity correction,” said Frank Schwab, MD, spine service chief at the Hospital for Special Surgery in New York. “The speed and control Basecamp provides exceeds my expectations and gives me the ability to reduce the rod and correct the spine in a controlled fashion.”
The system includes EVEREST Polyaxial and Uniplanar Screws, which feature a dual-lead thread pattern for faster insertion and increased pullout strength. The EVEREST set screw features a modified square thread design that facilitates set screw introduction. The mixed-metal tulip minimized head splay and demonstrated improved biomechanical performance when tested against an all-titanium alloy screw. (Data available upon request.)
Another key feature of the EVEREST Deformity Spinal System is the Basecamp Deformity Rod Reducer, which provides 60 mm of quick or controlled rod reduction. Basecamp replaces the need for reduction screws, offers segmental reduction of the rod, and provides intraoperative flexibility. Placement of multiple Basecamp Tubes allows for sequential reduction and correction of the spine.
“2015 has been a year of complex spine innovation for K2M, and we are excited to be launching the EVEREST Deformity Spinal System during the 50th anniversary meeting of the Scoliosis Research Society,” stated Eric Major, K2M’s President and CEO. “EVEREST Deformity is the fourth differentiated complex spine technology we have introduced in the past year. Along with EVEREST Deformity, we have introduced the MESA® 2 Deformity Spinal System, our flagship product for adolescent idiopathic scoliosis, the NILE™ Alternative Fixation Spinal System, our low-profile band fixation technology, and the CAPRI™ Corpectomy Cage System, our trauma- and tumor-focused system offering new, unique intraoperative functionality. Together, these complex spine technologies further enhance K2M’s position as a global leader in providing innovative solutions for complex spinal pathologies.”
For more information on the EVEREST Deformity Spinal System and K2M’s complete product portfolio, visit www.K2M.com.
About K2M
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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Forward-Looking Statements
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 the United States; control by and possible conflicts of interest with our controlling shareholder; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 18, 2015, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.
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 Group on behalf of K2M Group Holdings, Inc. Marcie Kohenak, 202-965-7811 Marcie.Kohenak@ZenoGroup.com Investor Contact: Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com
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