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
BalanceTM, today introduced Balance ACSTM (or BACSTM), a
comprehensive platform that applies three-dimensional solutions
across the entire clinical care continuum to help drive quality
outcomes for spine patients. BACS provides 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 BalanceTM as a critical
component to surgical success.
“Balancing the head over the pelvis and lower extremities is the
foundation of spine surgery,” stated K2M Chief Medical Officer John
P. Kostuik, MD. “The spine is a complex structure that provides
both stability and three-dimensional motion. Each spine segment is
an independent vertebrae that moves in the axial, coronal and
sagittal planes. Movement of each segment is part of the complex
integrated network of the comprehensive spine serving to provide
balance for the entire body, which enhances energy
preservation.”
K2M’s Balance ACS platform provides support to the full
continuum of spinal care. As part of this comprehensive platform,
K2M has launched the BACS System to provide the necessary
services—from preauthorization tools and preoperative planning to
3D anatomical modeling and postoperative reporting—to facilitate
quality outcomes and to support the intraoperative process. The
Company will also use predictive analytics to aid in surgeon
decision making and individualized care solutions for patients.
K2M will host physician workshops and symposiums on Balance ACS
at leading spine conferences in the United States and
internationally. These workshops will feature prominent spine
surgeons presenting on the latest research and clinical
applications of the Balance ACS platform.
“Since our inception, K2M has been a leader in developing
complex spine innovations, technologies and techniques to treat the
most complicated spinal pathologies,” stated K2M President and CEO
Eric Major. “However, we recognize that three-dimensional spinal
balance, and ultimately Total Body BalanceTM, cannot be achieved
through surgical spine implants alone; it requires a holistic
approach to enable healthcare providers to manage the entire
patient experience throughout the continuum of care. As a leader in
three-dimensional deformity correction and 3D-printed spinal
implants, we are uniquely positioned to take on this endeavor, and
today, are excited to introduce our comprehensive platform for
achieving Total Body BalanceTM: Balance ACS.”
An integral part of K2M’s new platform is the advancement of new
capabilities to complement the Company’s leadership as an innovator
of spinal products. To further enhance the Balance ACS platform,
the Company announced a partnership with 3D Systems Corporation
(NYSE:DDD), originator of 3D printing and a shaper of future 3D
solutions. K2M and 3D Systems have entered into a comprehensive
development agreement that includes an exclusive software solutions
partnership, as part of the BACS System, to aide in balancing the
spine across all three planes. In addition, K2M entered into a
separate supply agreement with 3D Systems for production capacity
to support the production of its highly successful CASCADIATM
Interbody Systems featuring Lamellar 3D Titanium TechnologyTM.
The Company has also acquired the e-FellowTM service-based
technology that provides automated solutions to surgeons and
healthcare systems to effectively collect real-time data and
monitor patient outcomes. The technology is an intuitive and
powerful healthcare software platform assisting patients and their
physicians in obtaining insurance preauthorization and quantifying
patient care.
“Rapid innovation has been essential to K2M’s ability to drive
organic growth at above-market rates and has fueled tremendous
market share growth since the Company’s inception. With our Balance
ACS platform, we recognized the opportunity to leverage our core
competency of complex spine and minimally invasive offerings, as
well as our leadership in comprehensive 3D-printed solutions, to
address the full spectrum of spinal care. We are excited to
announce our expanded relationship with 3D Systems—a trusted
partner through the development and manufacturing of our CASCADIA
Interbody Systems featuring Lamellar 3D Titanium Technology—and
look forward to incorporating 3D-printed technology into future
product development activities. These strategic initiatives, as
well as contributions from our recent e-Fellow technology
acquisition, reinforce our dedication to providing spine patients,
surgeons and healthcare systems with the products, services and
tools needed to achieve a complete patient experience and,
ultimately, three-dimensional Total Body BalanceTM,” Major
added.
For more information about Balance ACS and K2M, visit
www.BACS.com and www.K2M.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 BalanceTM. 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, 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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