K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a
global medical device company focused on designing, developing and
commercializing innovative and proprietary complex spine and
minimally invasive spine technologies and techniques, today
announced it has received 510(k) clearance from the U.S. Food and
Drug Administration (FDA) to expand its CASCADIA™ Lateral Interbody
System featuring Lamellar 3D Titanium Technology™, the Company’s
innovative technology that uses 3D printing with the goal of
allowing for bony integration throughout an implant. The CASCADIA
Lateral Interbody System line extension clearance strengthens K2M’s
minimally invasive surgery (MIS) portfolio and the Company’s
leadership in the 3D printing of spinal devices, as evidenced by
its having the most comprehensive 3D-printed spinal portfolio
available on the market.
"CASCADIA is an exciting innovation for lateral spine fusions,”
stated Greg T. Poulter, MD, an orthopedic spine surgeon at
OrthoIndy. “The unique engineering and 3D printing allows the
implant to have the biocompatibility and ongrowth characteristics
of titanium, while allowing a stiffness that more closely matches
bone. The graft volume and surface area for fusion are generous and
the new size options for lordosis allow me to address each
patient's individual sagittal plane requirements. CASCADIA has
become my go-to implant for lateral interbody fusions."
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.
Lamellar 3D Titanium Technology incorporates a porous structure
along with rough surfaces to allow the potential for bony
integration throughout the implant. K2M’s CASCADIA interbodies
utilize this technology to create a 70% porous implant with an
increased bone graft volume and similar stiffness when compared to
K2M PEEK designs.
The CASCADIA Lateral Interbody System is part of the Company’s
MIS portfolio, designed to promote less invasive access to the
spine. The system functions as an invertebral body fusion device to
provide support and stabilization of the lumbar segments of the
spine. Its reverse hourglass implant design promotes increased
endplate contact—compared to an ALEUTIAN® PEEK implant—without
sacrificing internal bone graft volume. The system includes a full
range of implant sizes and heights that are carefully designed to
accommodate vertebral anatomy, and it is intended to work in
conjunction with the RAVINE® Lateral Access System to
offer a full line of instrumentation for the far lateral transpsoas
approach.
“K2M is proud to strengthen our industry-leading portfolio of
FDA-cleared, 3D-printed spinal solutions, thus reinforcing our
market leadership and competitive advantage in this space,” stated
K2M President and CEO Eric Major. “MIS procedures and 3D printing
are core competencies for K2M, as indicated by the breadth and
depth of our product offerings. We continue to be committed to our
legacy of innovating the highest quality products with the ultimate
goal of creating improved treatments for surgical patients around
the globe who suffer from debilitating complex spinal
deformities.”
The complete CASCADIA portfolio also includes the CASCADIA TL,
AN, AN Lordotic Oblique, and Cervical Interbody Systems. For more
information on Lamellar 3D Titanium Technology, CASCADIA Interbody
Systems, 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 StatementsThis 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, including with respect to our international
distribution partners in Australia and Japan. 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; our ability to successfully demonstrate
the merits of our technologies and techniques; pricing pressure
from our competitors, hospitals and changes in third-party coverage
and reimbursement; competition and our ability to develop and
commercialize new products; the greater resources available to some
of our competitors; 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 and their level of sales or distribution
activity with respect our products; 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
or delays in operations at our facilities, including our new
headquarters facility; our 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 including by the FDA; in the United States
and foreign jurisdictions; failure to obtain or maintain regulatory
approvals and FDA clearances; requirements for new 510(k)
clearances, premarket approvals or new or amended CE Certificates
of Conformity; medical device reporting regulations in the United
States and foreign jurisdictions; voluntary corrective actions by
us or our distribution or other business partners or agency
enforcement actions; a recall of our products; withdrawal or
restrictions on 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; our reliance on the performance of third parties
who assist us in clinical trials and pre-clinical development; the
results of clinical trials; procurement and use of allograft bone
tissue; environmental laws and regulations; compliance by us or our
sales representatives with FDA regulations or 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 over the course of the
year; uncertainty in our future capital needs; failure to comply
with restrictions in our revolving credit facility; 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; foreign currency
fluctuations; our ability to comply with the Foreign Corrupt
Practices Act and similar laws associated with our activities
outside the United States; possible conflicts of interest with our
large shareholders; 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; volatility in our common stock; our
current plans not to pay dividends; potential dilution due to our
issuance of common stock under our incentive plans, for
acquisitions or otherwise; the amount of common stock held by our
pre-IPO owners; the impact of anti-takeover provisions in our
organizational documents and under Delaware law; our status as an
emerging growth company, our ability to use our net operating loss
carryforwards; 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 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.
Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com
Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com
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