Research Supporting Favorable Findings on K2M’s RAVINE® Lateral Access System to Be Presented at SpineWeek 2016
LEESBURG, Va., May 16, 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, today announced that research on K2M’s RAVINE® Lateral Access System will be presented at the SpineWeek 2016 Annual Meeting, occurring May 16–20 in Singapore.
“The RAVINE Lateral Access System allows for a lateral approach to lumbar fusion, and the dual flat blade platform provides a secure means for accessing the disc space with increased visualization compared to traditional tubular lateral retractors,” said Mr. Robert Lee, presenting author of four RAVINE-focused studies and Consultant Spine Surgeon at the Royal National Orthopaedic Hospital in Stanmore, United Kingdom. “The four studies featured at SpineWeek help establish RAVINE’s potential value to surgeons treating degenerative spinal deformities through a true muscle-splitting transpsoas approach. RAVINE provides surgeons with minimally invasive options to correct anterior column malalignment whilst providing indirect neural decompression across multiple levels.”
Data from four RAVINE studies will be presented at SpineWeek 2016:
- Clinical and Radiological Results following Lateral (LLIF) Versus Transforaminal Lumbar Interbody Fusion (MI-TLIF), Lee R., Sedra F., Wilson L., Afsharpad A., Dala-Ali B: (Oral Presentation #283, Wednesday 18 May, 17.08, Room 5)
- Early Outcomes in the Use of Minimally Invasive Lateral Cages in Primary Adult Degenerative Scoliosis Correction Surgery – Minimum 6 Month to 2 Year Follow-Up, R.S. Lee: (Oral Presentation #361, Thursday 19 May, 16.34, Room 5)
- Accuracy of Pre-operative Surgical Planning in Predicting Postoperative Alignment in Patients Undergoing Minimally Invasive Multilevel Anterior Column Reconstruction for Positive Sagittal Balance; R.S. Lee: (Oral Presentation #460, Friday 20 May, 10.24, Room 4)
- Early Outcomes in the Use of Minimally Invasive Lateral Cages in Lumbar Revision Surgery, Minimum 6 Month to 2 Year Follow-Up; R.S. Lee: (SMISS Poster Presentation #20)
“K2M is pleased with the breadth of RAVINE research being shared at SpineWeek 2016,” said Eric Major, President and CEO of K2M. “We believe these data complement our focus on innovation within the global spinal market as evidenced by RAVINE’s compatibility with the CASCADIA™ Lateral Interbody Systemfeaturing Lamellar 3D Titanium Technology™, K2M’s innovative and proprietary technology that uses 3D printing with the goal of allowing for bony integration throughout an implant.”
The RAVINE Lateral Access System is a dual flat blade platform for a true muscle-splitting transpsoas approach that offers rigid fixation to the spine and an option for both a third and fourth blade. K2M’s lateral access system represents an innovative design departure from the tubular retractors, while providing tremendous adaptability to both patient anatomy and surgeon technique.
For more information on the RAVINE Lateral Access System, as well as 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.
Find K2M on Facebook: https://www.facebook.com/K2MInc
Follow K2M on Twitter: http://twitter.com/K2MInc
Watch K2M on YouTube: https://www.youtube.com/user/K2MInc
Forward-Looking Statements
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 Australian 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. 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
