Friday, July 10, 2015

News: K2M Expands Presence in Asia With Six Product Launches in Singapore and Hong Kong and Announces Participation at the IMAST 2015 Conference

LEESBURG, Va., July 8, 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 launch of six of its spinal systems in Singapore and Hong Kong. The Company is also participating in the 22nd International Meeting on Advanced Spine Techniques (IMAST), July 8-11 in Kuala Lumpur, Malaysia. During the meeting, K2M will showcase its extensive product portfolio (Booth #22) and will host four educational workshops for surgeons.

"Expanding access to our portfolio of products remains a strategic priority, and we are pleased to bring six of our innovative spinal systems to market in Singapore and Hong Kong," stated Eric Major, K2M's President and CEO. "K2M aims to be a global industry leader in complex spine and minimally invasive medical education, and is committed to advancing the knowledge of the latest procedures and technologies through participation at dynamic, international forums such as IMAST."

K2M to Expand Offerings in Asia
With the introduction of a number of its complex spine, degenerative, and minimally invasive spinal systems in Hong Kong and Singapore, K2M continues to expand the availability of its technologies around the globe. The offerings include K2M's flagship complex spine offering, the MESA® Deformity Spinal System, and two minimally invasive offerings, the EVEREST® Minimally Invasive Spinal System and the TERRA NOVA® Minimally Invasive Access System. The Company will also launch three of its degenerative spinal systems in the region: the EVEREST® Degenerative Spinal System, the ALEUTIAN® Transforaminal-Lumbar (TLIF) 2 Interbody System and the ALEUTIAN® Anatomically-Narrow (AN) Interbody System.

"We are pleased to be working with K2M to distribute several of their cutting-edge spinal technologies in Hong Kong and Singapore," said Seah Kerk Chuan, Executive Director of Transmedic Pte Ltd. "Tapping into our regional network will allow K2M to deliver innovative products that local spine surgeons need to treat challenging spinal pathologies."

K2M to Showcase Diverse Product Portfolio and Host Workshops at IMAST
To enhance surgeon knowledge of K2M's technologies, K2M will participate in IMAST by showcasing its comprehensive product portfolio and by offering four hands-on workshops for surgeons. Sponsored by the Scoliosis Research Society (SRS), IMAST gathers spine surgeons, residents, fellows, nurses, nurse practitioners, physician assistants, engineers and company personnel from around the world to discuss the latest topics and innovations in the spinal deformity field.

"We are proud to participate in this year's IMAST, an esteemed meeting that advances knowledge, technologies and techniques in complex spine surgery," said John P. Kostuik, MD, K2M's Chief Medical Officer and Co-founder, a Past President of the SRS, and a moderator for several of K2M's hands-on workshops at IMAST. "At K2M, we are dedicated to providing surgeons with training opportunities on the safe and effective use of our products so they can, in turn, improve the lives of patients around the world."

K2M will exhibit a wide range of its innovative products, including the NILE Alternative Fixation Spinal System, featuring low-profile implants—comprised of bands, clamps and set screws—and light ergonomic instruments, and the CAPRI Corpectomy Cage System, a vertebral body replacement device that allows for in-situ height expansion and endplate angulation.

K2M's hands-on workshops at IMAST will feature leading experts in the field who will address cutting-edge techniques for complex spinal pathologies. These workshops include:
  • Advanced Correction Techniques for Navigating the Curve in AIS 
    Thursday, July 9 (12:30-13:30), Room 404
    Faculty: Peter Newton, MD, Laurel Blakemore, MD, and John Ferguson, MD
  • MIS Strategies for Treating Sagittal Alignment in Adult Degenerative Deformity 
    Thursday, July 9 (17:30-18:30), Room 404
    Faculty: Robert Lee, BSc, MBBS, FRCS
  • Advances in the Treatment of Adult Degenerative Deformity 
    Friday, July 10 (07:30-08:30), Room 404
    Faculty: Han Jo Kim, MD, and Greg Mundis, MD
  • Spinal Tumor Care: Past, Present & Future
    Friday, July 10 (12:00-13:00), Room 404
    Faculty: Stefano Boriani, MD
For more information on K2M and its extensive product portfolio, visit

About K2M Group Holdings, Inc.
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.

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 registration statement, filed with the SEC on January 29, 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 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.

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Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA 443-213-0500 Media Contact:
Marcie Kohenak
Zeno Group on behalf of K2M Group Holdings, Inc.

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