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 its MOJAVE™ PL 3D Expandable Interbody
System has received 510(k) clearance from the U.S. Food &
Drug Administration (FDA). MOJAVE PL 3D is a first-to-market,
FDA-cleared, 3D-printed expandable posterior-lumbar (PL) interbody
system that features K2M’s Lamellar 3D Titanium Technology™. 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.
The MOJAVE PL 3D Expandable Interbody System is a fusion device
designed to allow for independent control of the anterior and
posterior height in the lumbar spine, a new capability not
available with any other product in the market
today. Featuring infinite adjustment within the expansion
range, the implant may be locked at any desired height and lordosis
to aid in the restoration of sagittal balance.
“The ability to provide independent control of both the anterior
and posterior height separately is desirable for the restoration of
sagittal balance compared to existing devices that can’t
independently adjust both anterior and posterior height,” said
Steven Ludwig, MD, an orthopedic spine surgeon and professor of
orthopedics at the University of Maryland Medical Center in
Baltimore.
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 MOJAVE PL 3D endplates 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 endplates.
“We are proud to be the global leader in 3D printing of spinal
applications. We have developed internal 3D expertise that is
allowing us to accelerate the rate of spinal innovation. As the
first-ever, FDA-cleared, 3D-printed expandable interbody
technology, MOJAVE PL 3D exemplifies our leadership in this space
and provides surgeons the ability to expand the implant in-situ.
This is our second family of products featuring Lamellar 3D
Titanium Technology and builds upon the incredibly successful
CASCADIA™ 3D family of static 3D-printed interbody cages,” said K2M
President and CEO Eric Major. “Our continued innovation in 3D
solutions and our focus on 3D spinal balance, demonstrated by the
recent launch of our Balance ACS™ platform, solidifies our position
as a market leader and innovator in the industry. We look forward
to continuing to introduce new three-dimensional solutions to
surgeons who treat patients with spinal disorders.”
Balance ACS (BACS™) is a comprehensive platform applying
three-dimensional solutions across the entire clinical care
continuum to help drive quality outcomes in spine patients. BACS
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.
For more information about the MOJAVE PL 3D Expandable Interbody
System and Lamellar 3D Titanium Technology, visit www.K2M.com. For
more information about K2M’s Balance ACS platform, 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 the merits of our
products; pricing pressures and our ability to compete effectively
generally; collaboration and consolidation in hospital purchasing;
in adequate 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;
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; 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; 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, 212-299-8985
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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