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 that clinical data related to K2M spinal solutions will
be presented at EUROSPINE 2017, occurring October 11–13, 2017, in
Dublin. The Company will also showcase its comprehensive product
portfolio, 3D-printed spinal solutions, and Balance ACS™ (BACS™)
platform at Booth F20.
“Taking a comprehensive approach to spine surgery allows me to
address my patients’ individual treatment needs more precisely,”
said Robert Lee, FRSC, TR & Orth, a spine surgeon at Royal
National Orthopaedic Hospital NHS Trust in Stanmore, UK, and author
of five studies on K2M products to be presented this week. “Our
research supported favorable findings on surgical planning
software, minimally invasive surgical techniques, and 3D porous
CASCADIA™ interbody cages that utilize Lamellar 3D Titanium
Technology™.”
Data from five clinical studies on K2M’s CASCADIA Interbody
Systems featuring Lamellar 3D Titanium Technology, BACS Surgical
Planner, and RAVINE® Lateral Access System will be presented:
- 3D Porous Lamellar Titanium Lateral Interbody Cages: Subsidence
Rates Compared to PEEK and Early Clinical Outcomes, Lee R (Poster
26)
- Clinical and Radiographic Results Following the Use of Lateral
Interbody Cages to Restore Lumbar Lordosis in Revision Fusion
Surgery, Lee R (Poster 27)
- 3D Porous Lamellar Titanium versus PEEK and Solid Titanium
Interbody TLIF Cages: A Prospective Clinical and Radiographic
Comparison, Lee R, Wilson L (Poster 28)
- Minimally Invasive Anterior Column Reconstruction in Primary
Adult Degenerative Scoliosis Correction Surgery, Lee R (Poster
84)
- Reliability of Pre-Operative Surgical Planning Software in
Predicting Postoperative Alignment in Patients Undergoing Minimally
Invasive Multilevel Anterior Column Reconstruction for Positive
Sagittal Balance Deformity, Lee R (Poster 85)
K2M Chairman, President, and CEO Eric Major said, “We are
pleased by the amount of research on K2M products being presented
at this year’s EUROSPINE meeting. K2M is leading the way in 3D
spinal innovation—as evidenced by our market-leading 3D-printed
product portfolio and comprehensive Balance ACS platform—to help
surgeons treat many different spinal pathologies both in European
countries and across the
globe.” At
the meeting, K2M will showcase its comprehensive portfolio of
complex spine, minimally invasive, and degenerative solutions,
including the CASCADIA Interbody Systems featuring Lamellar 3D
Titanium Technology, the EVEREST® Minimally Invasive XT Spinal
System, the EVEREST Deformity Spinal System, the RAVINE Lateral
Access System, the MESA® Deformity Spinal System, the RHINE™
Cervical Disc 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. The Company 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; pricing pressures and our ability to compete effectively
generally; 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 in our main facility or information technology systems;
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 due; 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
K2M GROUP HOLDINGS, INC. (NASDAQ:KTWO)
Historical Stock Chart
From Aug 2024 to Sep 2024
K2M GROUP HOLDINGS, INC. (NASDAQ:KTWO)
Historical Stock Chart
From Sep 2023 to Sep 2024