K2M Receives CE Mark for Its Next-Generation RHINE(TM) Cervical Disc System
LEESBURG, Va., 2016-01-22 00:09 CET (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 it has received a CE Mark for the RHINE™ Cervical Disc System, allowing for sale and distribution of the product within Europe and other countries. The RHINE Cervical Disc is the Company’s next-generation cervical artificial disc replacement featuring proprietary molding technology and is K2M’s latest offering for the treatment of degenerative disc disease.
The RHINE Cervical Disc System features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel. Proprietary molding technology is incorporated to minimize wear between the polymer core and metal endplates.
“The RHINE Cervical Disc System is manufactured through a proprietary over-molding process of elastomeric polymer that differentiates the system from the competitive offering,” said Dr. Casey Lee, Orthopedic Surgeon and Principal Inventor of the RHINE Cervical Disc System. “We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe.”
The system’s streamlined instrumentation simplifies the surgical technique by integrating trialing and keel cutting into one instrument. A built-in adjustable stop allows for customized anterior or posterior positioning of the disc based on surgeon preference.
“The RHINE Cervical Disc System was developed through collaboration with a global surgeon design team,” said Dr. Richard Guyer, Orthopedic Surgeon, Co-founder of the Texas Back Institute, and Director of the Spine Fellowship Program in Roanoke, Texas. “The one-piece compressible polymer core design performed well in biomechanical testing when compared to the natural cervical disc, and this European launch represents evolution in cervical disc technology.”
The first single- and multi-level surgical procedures using the RHINE Cervical Disc System were recently completed in Belgium and Germany. Additionally, enrollment for a prospective, observational RHINE Cervical Disc Clinical Study will begin in the first quarter of 2016. Primary objectives of the study are to: obtain operative data and feedback; confirm device performance; and collect radiographic data and clinical outcomes. An estimated 166 participants are expected to be enrolled in the study at multiple clinical trial sites throughout Europe.
“We are excited to receive a CE Mark for our RHINE Cervical Disc technology, as it represents an important regulatory milestone event for K2M as we continue to build our product portfolio and penetrate the global spine market with innovative techniques and technologies,” stated Eric Major, K2M's President and CEO. “We look forward to further expanding our international product offering and will remain focused on the complex spine category across all of our international markets."
For more information on the RHINE Cervical Disc 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 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.
Zeno Group on behalf of K2M Group Holdings, Inc.
Marcie Kohenak, 202-965-7811
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Oxford Immunotec and QIAGEN N.V. Settle Patent Infringement Lawsuit15.12.2017 22:04 | Pressemelding
Agreement includes payment of $27.5 million to Oxford, royalty-free license to QIAGEN and dismissal of all pending litigation OXFORD, United Kingdom and MARLBOROUGH, Mass., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Ltd. (Nasdaq:OXFD) and QIAGEN N.V. (Nasdaq:QGEN) (Frankfurt Stock Exchange:QIA) announced today that they have reached a settlement in the lawsuit in the U.S. District Court for the District of Massachusetts in Boston (15-cv-13124-NMG) alleging patent infringement in relation to QIAGEN's QuantiFERON®-TB Gold and QuantiFERON®-TB Gold Plus products. Under terms of the agreement, all pending claims between Oxford and QIAGEN and the co-defendants have been resolved. As part of the settlement, Oxford has granted QIAGEN a royalty-free, non-exclusive license that extends to all current and future customers of QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus in exchange for a one-time, lump-sum payment of $27.5 million. The settlement includes general
Algeco Scotsman Announces Acquisition of Iron Horse Ranch15.12.2017 21:32 | Pressemelding
BALTIMORE, Dec. 15, 2017 (GLOBE NEWSWIRE) -- Algeco/Scotsman Holding S.à r.l. (together with its subsidiaries, the "Algeco Group") today announced the successful closing of the acquisition by the Algeco Group's subsidiary, Target Logistics Management, LLC ("Target Logistics"), of Iron Horse Ranch from funds managed by TDR Capital LLP ("TDR"). The acquisition solidifies Target Logistics' position as the single largest provider of turnkey workforce housing in the U.S., including a network of eight lodges and 2,119 beds in the Permian Basin. With the acquisition, Target Logistics' Permian Basin lodge network now includes Texas lodges in Pecos, Mentone, San Angelo and two in Odessa, along with two lodges in Carlsbad and Lovington, New Mexico. Additionally, Target Logistics adds Eagle Ford lodges in Cameron and Yorktown, Texas. Diarmuid Cummins, CEO Algeco Scotsman: "Today we announce the completion of the second of two strategic acquisitions which we flagged earlier
Elemica Named to Food Logistics Top 100 List15.12.2017 13:55 | Pressemelding
11th Consecutive Win for Delivering Value Across Clients' Supply Chains WAYNE, Pa., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Elemica, the leading Business Network for the process industries, announces the company has been named to Food Logistics magazine's FL100+ Award for the 11th year. The FL100+ list recognizes leading software and technology providers in the food and beverage industry. Elemica was chosen for helping agricultural and food ingredient businesses conduct more efficient and error free commerce across their community of suppliers, customers and logistics providers - delivering value through lower operating expenses and working capital costs. "We are honored to be included for the past eleven years on the Food Logistics FL100+ list for helping companies improve efficiencies and generate value from their supply chains," said John Blyzinskyj, CEO of Elemica. "Automating business processes, enabling end-to-end visibility, and providing a platform for
GSV Asset Management Announces Strategic Investment from HMC Capital-Led Group14.12.2017 21:03 | Pressemelding
WOODSIDE, Calif. and NEW YORK, Dec. 14, 2017 (GLOBE NEWSWIRE) -- GSV Asset Management, LLC ("GSV"), a modern merchant bank that identifies, advises, and invests in the fastest growing, most dynamic companies in the world - the Stars of Tomorrow - today announced a strategic investment from a group led by HMC Capital ("HMC"), a leading Latin American advisory and investment firm. While terms of the deal were not disclosed, the investment will result in a minority ownership interest for the HMC-led group in GSV Asset Management. Proceeds will be used to enhance GSV's ongoing investment activities, as well as to accelerate its strategic expansion into new business areas and geographies. "We are very excited to partner with HMC Capital, a multi-billion dollar asset manager that brings a range of complimentary capabilities to GSV Asset Management," said Michael Moe, founder of GSV. "GSV stands for Global Silicon Valley and our alliance with HMC reflects our shared commitment t
TrueCommerce Datalliance Releases Third 2017 Update for Vendor Managed Inventory Platform14.12.2017 19:28 | Pressemelding
Latest Software Update Enhances Browser, Productivity Experience CINCINNATI, Dec. 14, 2017 (GLOBE NEWSWIRE) -- TrueCommerce Datalliance, a leading vendor managed inventory service solutions provider, announced today that it released the third scheduled 2017 update to its VMI platform. The free update is part of TrueCommerce Datalliance's commitment to improving the functionality of its cloud-based supply chain software. Highlights of the release include several improvements to its system architecture and capabilities: Google Chrome is now officially supported Order Worksheets are now easier to view in Internet Explorer One-click access to recently changed or added items Mass Launch Order Preview lists all items suggested or added via allocation "We promise our customers three major updates every year," said Connie Shafer, TrueCommerce Datalliance Producti
ATTO announces support for Apple® Release of the new iMac Pro14.12.2017 18:37 | Pressemelding
ATTO's line of ThunderboltTM technology enabled products continue to revolutionize connectivity to storage AMHERST, N.Y., Dec. 14, 2017 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage and network connectivity and infrastructure solutions for data-intensive computing environments, today confirmed their continued commitment to the newly released line of product updates and innovations from Apple. With the powerful and new iMac Pro® now shipping, ATTO continues to support the new offerings from this industry leading manufacturer. "Our deep relationship with Apple over the last 30 years continues to drive our position as a leading force within the Apple community," said Timothy J. Klein, president and CEO at ATTO Technology. The iMac Pro sets a new standard for Apple design and performance and complements why users select ATTO products. As Apple pushes the boundaries of desktop computing, ATTO continues to provide industry leading products that op
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom