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LEESBURG, Va., July 12, 2016 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, announced the Company will participate in the 23rd International Meeting on Advanced Spine Techniques (IMAST), July 13–16 in Washington, D.C. During the meeting, data will be presented on K2M’s innovative solutions for adolescent idiopathic scoliosis (AIS). K2M will exhibit (Booth #18) its extensive portfolio of spinal technologies, and will also host four educational workshops featuring leading experts in the field who will address cutting-edge techniques for complex spinal pathologies.
Sponsored by the Scoliosis Research Society (SRS), IMAST gathers renowned spine surgeons and industry leaders from across the globe to present and discuss innovative research and advanced spine technologies in an international forum.
“K2M is proud to participate in this year’s IMAST, an esteemed meeting that advances knowledge, technologies and techniques in spine surgery,” said John P. Kostuik, MD, K2M’s Chief Medical Officer and Co-Founder, past President of the SRS, and a moderator for several of K2M’s hands-on workshops at IMAST. “We are dedicated to advancing the understanding of complex spinal pathologies by supporting continued research and providing surgeons with training opportunities on the safe and effective use of our products in order to improve patient outcomes.”
K2M Technologies to be Featured in Two Clinical Papers
K2M’s innovative spinal technologies for AIS will be featured in two clinical papers and oral presentations on Thursday, July 14. Data will presented on K2M’s MESA Rail™ Deformity Spinal System, which features a beam-like design that provides enhanced rigidity to aid in the restoration of sagittal balance while maintaining a low profile. The study, which examined lumbar curve improvement in AIS following selective thoracic fusion (STF), found there was a correlation between thoracic kyphosis restoration in STF with spontaneous lumbar curve correction. This study has been nominated for an IMAST Thomas Whitecloud Award, which is given to both the best basic science and clinical papers presented at the meeting.
Kishan S., Knapp D., Rahm M., Rathjen K., Lafage V., Cunningham M., Boachie-Adjei O., Bao H., Reigrut J.
Oral Presentation, Paper 3, Thursday, 14 July, 8:58; Salon 1-5
Additionally, findings from a multi-year study surrounding the Company’s recently-acquired motion-preserving scoliosis technology* from K-Spine will be presented. The study found that the innovative apical fusion technique achieved corrected deformity profiles in AIS patients and maintained mobility of non-fused segments with a lower implant density, sparing 52 percent of the spanned area from fusion.
Crandall D.G., Nnadi C., Carl A., Repko M., Seme S., Rehák L., Grevitt M., Aydinli U., Akbarnia B.A., Hooseni P.
Oral Presentation, Paper 50, Thursday, 14 July, 15:04; Salon 1-5
K2M to Showcase Diverse Product Portfolio and Host Four Educational Workshops
K2M will exhibit a wide range of innovative technologies at Booth #18 from the Company’s comprehensive complex spine, minimally invasive, and degenerative product portfolios. The Company will provide demonstrations of the CASCADIA™ Interbody Systems, featuring K2M’s innovative Lamellar 3D Titanium Technology™, the NILE™ Alternative Fixation System, the RAVINE® Lateral Access System, the EVEREST® Deformity Spinal System, the MESA® Deformity and MESA Rail Deformity Spinal Systems, and more.
K2M will also host four hands-on workshops focused on the latest in adolescent and adult reconstruction, minimally invasive techniques, sagittal plane balance correction, deformity, and scoliosis. K2M’s Chief Medical Officer, John P. Kostuik, MD, will introduce the interactive sessions, which feature a distinguished faculty of accomplished subject-matter experts from around the world.
Wednesday, 13 July (17:00-19:00), Salon 14
Faculty: Laurel Blakemore, MD; Peter Newton, MD; Harry Shufflebarger, MD
Thursday, 14 July (12:30-13:30), Salon 14
Faculty: Oheneba Boachie-Adjei, MD; Han Jo Kim, MD; Gregory Mundis Jr., MD
Thursday, 14 July (17:30-18:30), Salon 14
Faculty: Oheneba Boachie-Adjei, MD; Benny Dahl, MD, PhD; Matthew Cunningham, MD, PhD; Martin Gehrchen, MD, PhD
Friday, 15 July (12:05-13:05), Salon 14
Faculty: Robert Lee, BSc, MBBS, FRCS; Pierce Nunley, MD; Michael Wang, MD
“K2M is pleased to offer medical education in the form of hands-on workshops at IMAST this year and provide surgeons exposure to our innovative product portfolio, thus adding to their clinical knowledge and expertise of implants and surgical techniques,” said Eric Major, President and CEO of K2M. “We are also proud to know that a clinical study focused on our MESA Rail technology, for adolescent idiopathic scoliosis, has been recognized as a nominee for the esteemed Thomas Whitecloud award, demonstrating our commitment to continued innovation and quality patient care.”
*This device is not available for sale within the United States.
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.
Find K2M on Facebook: https://www.facebook.com/K2MInc
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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, including with respect to our international distribution partners in Australia and Japan. 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. 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 and techniques; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; the greater resources available to some of our competitors; 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 and their level of sales or distribution activity with respect our products; 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 or delays in operations at our facilities, including our new headquarters facility; our 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 including by the FDA; in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and FDA clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on 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; our reliance on the performance of third parties who assist us in clinical trials and pre-clinical development; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or 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 over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; 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; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; 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; volatility in our common stock; our current plans not to pay dividends; potential dilution due to our issuance of common stock under our incentive plans, for acquisitions or otherwise; the amount of common stock held by our pre-IPO owners; the impact of anti-takeover provisions in our organizational documents and under Delaware law; our status as an emerging growth company, our ability to use our net operating loss carryforwards; 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 most recent Annual Report on Form 10-K filed with the SEC, 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.
Media Contact:Zeno Group on behalf of K2M Group Holdings, Inc.Christian Emering, 212-299-8985Christian.Emering@ZenoGroup.com Investor Contact:Westwicke Partners on behalf of K2M Group Holdings, Inc.Mike Piccinino, CFA, 443-213-0500K2M@westwicke.com
Source:K2M Group Holdings, Inc.