Du är här

2016-01-21

K2M Group Holdings, Inc.: K2M Receives CE Mark for Its Next-Generation RHINE(TM) Cervical Disc System

K2M's Cervical Artificial Disc Replacement Features Proprietary Molding Technology to Minimize Wear Between Polymer Core and Metal Endplates
LEESBURG, Va., Jan. 21, 2016 (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(TM) 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.
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: http://www.youtube.com/user/K2MInc

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 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.

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

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on b...

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.