LEESBURG, Va., Sept. 3, 2015 (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 technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the PYRENEES® Mono Cervical Plate System, the Company’s latest addition to the family of PYRENEES products. In addition to U.S. regulatory clearance, K2M also received a CE Mark for the system, which allows the Company to expand the global availability of the product.
The PYRENEES Mono Cervical Plate System offers a slim-profile design that allows for a single point of fixation per level for improved visualization in-situ. The posterior profile of the plate is designed to reduce plate migration in-situ during screw insertion. With screws manufactured from Titanium Alloy and plates manufactured from Commercially Pure Grade II Titanium, the system includes one- and two-level plates.
“Compared to a traditional two hole plate, the [PYRENEES Mono Plate’s] narrow profile offers easier use while working under a microscope and provides me with an opportunity to perform less lateral retraction than a wider cervical plate,” stated Dr. Mina Foroohar, neurosurgeon and president of Northwest Neurosurgery Institute in Arlington Heights, Illinois.
Dr. Douglas B. Moreland, neurosurgeon and clinical assistant professor of neurosurgery at the University at Buffalo in New York state, added, “The PYRENEES Mono Plate is very user friendly, as the plate is smaller and requires only one screw per level, which has allowed me to save time during both vertebral body prep for the plate and screw placement.”
PYRENEES Mono Cervical Plates do not have bend zones, allowing for precise plate contouring. The plates are designed with lordotic curvature to minimize intraoperative contouring, and all plates can be bent anatomically without compromising the ability of the screws to lock at any angle. Featuring K2M’s revolutionary tifix® Locking Technology, the PYRENEES Mono Cervical Plate System does not require an additional locking mechanism, as each screw head forms an autogenic lock to the plate upon insertion.
“We are excited to receive regulatory clearance and a CE Mark for our PYRENEES Mono Cervical Plate System, and have received positive surgeon feedback following the completion of the first surgical cases,” stated Eric Major, K2M’s President and CEO. “This latest addition to our degenerative portfolio is an important extension of our PYRENESS family, as it provides yet another option for surgeons addressing cervical fixation of the spine.”
The PYRENESS Mono Cervical Plate System is the third offering in the PYRENEES family of cervical plates, which also includes the PYRENEES Constrained Cervical Plate System and the PYRENEES Translational Cervical Plate System.
For more information on the PYRENEES Mono Cervical Plate System and K2M’s complete product portfolio, visit www.K2M.com.
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.
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 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.
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CONTACT: Media Contact Zeno Group on behalf of K2M Group Holdings, Inc. Marcie Kohenak, 202-965-7811 Marcie.Kohenak@ZenoGroup.com