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 it has received 510(k) clearance from the U.S. Food
& Drug Administration (FDA) and a CE Mark for its CAYMAN®
United Plate System following completion of its first surgical
cases. CAYMAN United is designed for rigid fixation to K2M’s
CASCADIA™ Lateral 3D Interbody System featuring Lamellar 3D
Titanium Technology™, the first and only 3D-printed cage with
modular fixation capabilities. K2M was the first leading spine
company to market a 3D-printed titanium interbody device and offers
the most comprehensive portfolio of 3D-printed spinal devices on
the market.
“The CAYMAN United Plate System, which firmly fixates to K2M’s
CASCADIA Lateral 3D implants, is a notable advancement,” said
Robert Lee, FRCS (Tr&Orth), a spine surgeon at Royal National
Orthopaedic Hospital NHS Trust in Stanmore, UK. “Its streamlined
technique and versatile insertion options provide an elegant
solution for my minimally invasive lateral cases, while also
utilizing a 3D-printed device to encourage bony integration
throughout the implant.”
The CAYMAN United Plate System’s single level, 1- and 2- hole
plate configurations precisely match all CASCADIA Lateral 3D height
and lordosis options, allowing surgeons to customize the construct
using a lateral approach. Single-level plate sizes minimize
retraction required for placement and an assembly alignment feature
keys into the CASCADIA implants to resist rotation. Versatile
insertion options allow for plate assembly with a central assembly
screw prior to implantation, or in-situ after the cage has been
placed.
“We are excited to receive FDA clearance and a CE Mark for our
CAYMAN United Plate System, designed to enhance our CASCADIA
Lateral 3D Interbody System and making it the first and only
3D-printed cage available on the market with modular fixation
capabilities,” said K2M Chairman, President, and CEO, Eric Major.
“As a leading innovator of 3D-printed spinal solutions, we remain
committed to developing advanced technologies that when
complemented by our comprehensive Balance ACS platform, help
surgeons facilitate 3D spinal balance in their patients.”
K2M's Lamellar 3D Titanium Technology uses an advanced 3D
printing method to create structures that are impossible with
traditional manufacturing techniques. Starting with a titanium
powder, the CASCADIA implants are grown through the selective
application of a high-energy laser beam, incorporating complex
internal geometries and rough surface architecture that
pre-clinical data have associated with bone growth activity.
Balance ACS® (or BACS®) provides surgical solutions focused
on achieving balance of the spine by addressing each anatomical
vertebral segment with a 360-degree approach of the axial, coronal,
and sagittal planes, emphasizing Total Body Balance as an important
component of surgical success.
For more information on the CASCADIA Lateral 3D Interbody System
featuring Lamellar 3D Titanium Technology and the CAYMAN United
Plate System, visit www.K2M.com. For more information on Balance
ACS, visit www.BACS.com.
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 and hospital customers the merits of our products
and to retain their use 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 payers; 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
maintain adequate working relationships with healthcare
professionals; 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 or those of our suppliers, 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
remediate the material weaknesses in our IT general controls; 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 associated with
the exit of the United Kingdom from the European Union; 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 a fiscal 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; 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;
increased costs and additional regulations and requirements as a
result of being a public company; 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; 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, 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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