K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a
global leader of complex spine and minimally invasive solutions
focused on achieving three-dimensional Total Body Balance™, today
announced the completion of 300 surgical cases using the RHINE™
Cervical Disc System*. The announcement was made during the 12th
Annual Meeting of the German Spine Society, occurring November
30–December 2, 2017, in Stuttgart, where the Company will exhibit
its comprehensive product portfolio and the Balance ACS® (BACS®)
platform at Stand #73.
The RHINE Cervical Disc System* is an artificial disc
replacement that 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
system’s instrumentation simplifies spinal surgery 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 was designed to mimic the
characteristics of a normal healthy disc,” said Dr. Ardavan
Ardeshiri, a neurosurgeon and spine surgeon at the Hessing Klinik
in Augsburg, Germany, and an Investigator of the RHINE Cervical
Disc Prospective Observational Clinical Study. “The product design,
combined with easy-to-use modular instrumentation and a simple
surgical technique, provides surgeons with an advanced solution for
cervical disc replacement.”
The RHINE Cervical Disc Prospective Observational Clinical Study
is presently gathering additional operative data and feedback to
confirm device performance, including radiographic data and
clinical outcomes.
“K2M is proud to acknowledge the 300 surgeries that have been
completed using our RHINE Cervical Disc System*,” said K2M
Chairman, President, and CEO Eric Major. “RHINE, which received a
CE Mark last year, is an advancement in cervical disc technology,
and its continued commercialization and clinical validation in
Europe is an important piece of our corporate strategy. We look
forward to showcasing RHINE, our Balance ACS platform, and many of
our innovative spinal solutions at this year’s meeting of the
German Spine Society.”
K2M to Exhibit Spinal Innovations and Balance ACS
Platform
In addition to the RHINE Cervical Disc System*, K2M will
showcase differentiated spinal technologies from its comprehensive
complex spine, minimally invasive, and degenerative portfolios.
These products include the 3D-printed CASCADIA™ Interbody Systems
featuring K2M’s Lamellar 3D Titanium Technology™, the EVEREST®
Minimally Invasive XT Spinal System, the NILE® Alternative Fixation
and NILE Proximal Fixation Spinal Systems, the MESA® Deformity
Spinal System, the SAHARA® AL Expandable Stabilization System, and
more.
K2M will also feature its Balance ACS platform, which provides
solutions focused on achieving balance of the spine by addressing
each anatomical vertebral segment with a 360-degree approach to the
axial, coronal, and sagittal planes, emphasizing Total Body Balance
as an important component of surgical success. K2M will demo
the BACS Surgical Planner, a surgical image measuring
technology that assists in planning and preoperative implant
selection.
For more information on K2M’s complete product portfolio, visit
www.K2M.com. For more information on Balance ACS, visit
www.BACS.com.
*This product is intended for export and is not sold or offered
for sale in the United States.
About K2M
K2M Group Holdings, Inc. is a global leader of complex spine and
minimally invasive solutions focused on achieving three-dimensional
Total Body Balance. Since its inception, K2M has designed,
developed, and commercialized innovative complex spine and
minimally invasive spine technologies and techniques used by spine
surgeons to treat some of the most complicated spinal pathologies.
K2M has leveraged these core competencies into Balance ACS, a
platform of products, services, and research to help surgeons
achieve three-dimensional spinal balance across the axial, coronal,
and sagittal planes, with the goal of supporting the full continuum
of care to facilitate quality patient outcomes. The Balance ACS
platform, in combination with the Company’s technologies,
techniques and leadership in the 3D-printing of spinal devices,
enable K2M to compete favorably in the global spinal surgery
market. For more information, visit www.K2M.com and connect with us
on Facebook, Twitter, Instagram, LinkedIn and YouTube.
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.
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 in the future; our
ability to demonstrate to spine surgeons the merits of our products
and retain their use of our products; pricing pressures and our
ability to compete effectively generally in our industry;
collaboration and consolidation in hospital purchasing; inadequate
coverage and reimbursement for our products from third-party
payors; lack of long-term clinical data supporting the safety and
efficacy of our products; 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 to our products; proliferation of
physician-owned distributorships in the industry; decline in the
sale of certain key products; loss of key personnel; our ability to
enhance our product offerings through research and development; our
ability to manage expected growth; our ability to successfully
acquire or invest in new or complementary businesses, products or
technologies; our ability to educate surgeons on the safe and
appropriate use of our products; costs associated with high levels
of inventory; impairment of our goodwill and intangible assets;
disruptions to our corporate headquarters and operations facilities
or critical information technology systems, distributors or surgeon
users; our ability to ship a sufficient number of our products to
meet demand; our ability to strengthen our brand; fluctuations in
insurance cost and availability; our ability to comply with
extensive governmental regulation within the United States and
foreign jurisdictions; our ability to maintain or obtain
regulatory approvals and clearances within the United States and
foreign jurisdictions; voluntary corrective actions by us or our
distribution or other business partners or agency enforcement
actions; recalls or serious safety issues with our products;
enforcement actions by regulatory agencies for improper marketing
or promotion; misuse or off-label use of our products; delays or
failures in clinical trials and results of clinical trials; legal
restrictions on our procurement, use, processing, manufacturing or
distribution of allograft bone tissue; negative publicity
concerning methods of tissue recovery and screening of donor
tissue; costs and liabilities relating to environmental laws and
regulations; our failure or the failure of our agents to comply
with fraud and abuse laws; U.S. legislative or Food and Drug
Administration regulatory reforms; adverse effects of medical
device tax provisions; potential tax changes in jurisdictions in
which we conduct business; our ability to generate significant
sales; potential fluctuations in sales volumes and our results of
operations over the course of the year; uncertainty in future
capital needs and availability of capital to meet our needs; our
level of indebtedness and the availability of borrowings under our
credit facility; restrictive covenants and the impact of other
provisions in the indenture governing our convertible senior
notes and our credit facility; continuing worldwide economic
instability; our ability to protect our intellectual property
rights; patent litigation and product liability lawsuits; damages
relating to trade secrets or non-competition or non-solicitation
agreements; risks associated with operating internationally;
fluctuations in foreign currency exchange rates; our ability to
comply with the Foreign Corrupt Practices Act and similar laws; our
ability to implement and maintain effective internal control over
financial reporting; potential volatility in our stock price; our
lack of current plans to pay cash dividends; our ability to take
advantage of certain reduced disclosure requirements and exemptions
as a result of being an emerging growth company; increased costs
and additional regulations and requirements as a result of no
longer qualifying as an emerging growth company as of December 31,
2017; potential dilution by the future issuances of additional
common stock in connection with our incentive plans, acquisitions
or otherwise; anti-takeover provisions in our organizational
documents and our ability to issue preferred stock without
shareholder approval; potential limits on our ability to use our
net operating loss carryforwards; 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 and our Quarterly Report filed with the SEC on August
2, 2017, 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.
Unless specifically stated otherwise, our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures, investments or
other strategic transactions we may make.
Media Contact:Zeno Group on behalf of K2M Group Holdings,
Inc.Christian Emering,
212-299-8985Christian.Emering@ZenoGroup.com
Investor Contact:Westwicke Partners on behalf of K2M Group
Holdings, Inc.Mike Piccinino, CFA,
443-213-0500K2M@westwicke.com
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