Alphatec Announces FDA Clearance of its Automated SafeOp Neuromonitoring System to Address Significant Unmet Needs in Spine S...
February 25 2019 - 9:00AM
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC)
announced today that it has received 510(k) clearance from
the U.S. Food & Drug Administration (FDA) for its
automated SafeOp neuromonitoring system for use in real-time
intraoperative nerve location and health assessment.
“I could not be more excited to integrate this
revolutionary technology into our growing number of spine
approaches,” said Pat Miles, Chairman and Chief Executive
Officer. “Many of us at ATEC were previously instrumental in
developing, validating, and marketing a neuromonitoring platform
that became foundational to a billion-dollar spine company. The
SafeOp solution is better. It has no peer and it elevates the
requirements for others to participate. Today, we have raised
the bar in delivering objective actionable information that drives
safer and more reproducible spine surgery.”
The next-generation technology of the SafeOp
system represents a significant advancement in two intraoperative
neurophysiological monitoring (IONM) modalities: somatosensory
evoked potential (SSEP), and electromyography (EMG). SSEP
assesses the functional health of the spinal cord and nerves,
while EMG enables surgeons to test nerves for their location,
proximity, and conduction. The SafeOp automated SSEP
technology has been successfully used in more than 1,000 surgeries
to identify potential nerve injury from patient positioning, and
has demonstrated reliability in monitoring peripheral nerves in
spine surgery. The current 510k clearance expands the system to
include more advanced algorithms for EMG.
“Surgeons yearn for information to enable better
surgery,” added Miles. “SafeOp not only provides actionable
intraoperative information regarding nerve location during access,
but for the first time, it also allows surgeons to monitor patient
nerve health, in real-time, during surgery. The development of this
system demonstrates ATEC’s commitment to revolutionize how the
world approaches spine surgery.”
The SafeOp system’s initial focus will be on
resolving the significant unmet clinical need in minimally invasive
lateral procedures, but it can and will be leveraged into multiple
ATEC surgical approaches.
“Neuromonitoring technology is critical for a
safe and reproducible lateral surgery,” said Luiz Pimenta, MD, PhD,
ATEC’s Chief Medical Officer and pioneer of the lateral surgery
approach. “The SafeOp system has not only improved the EMG
capability to find nerves, but now surgeons will be able to monitor
the health of nerves in the lumbar plexus throughout the entire
procedure. This technology will provide more surgeons with
the confidence to perform lateral surgeries and will improve
patient care.”
ATEC expects full commercial launch of the
SafeOp system in Spring 2019. It is the first solution delivered as
part of the Alpha InformatixTM platform, which ATEC plans to expand
to provide surgeons with intraoperative information beyond
neuromonitoring.
About the SafeOp Neuromonitoring System
The foundational technology of ATEC’s SafeOp
system was obtained as part of the acquisition of SafeOp Surgical,
Inc. in March 2018 and has been further developed over the past
year.
Key features of the SafeOp system include:
- A technologically advanced solution that combines real-time,
automated EMG and SSEP to enable objective assessment of nerve
location and nerve health throughout the entire surgical
procedure
- An EMG algorithm that provides high-speed, validated response
feedback unlike other solutions on the market that are more
susceptible to electrical noise in the operating room
- A SSEP processing that incorporates unique “signal-to-noise
ratio” technology and rapid processing, allowing SafeOp to
reproducibly monitor small nerves every 3 seconds, while other
systems on the market have up to 5 minutes of latency
- A solution that is uniquely equipped to address the L4/L5
spinal level in minimally invasive lateral surgical procedures, the
level most difficult to safely access but most commonly
treated
- Technology that is designed to integrate into ATEC’s broader
suite of solutions for unprecedented predictability and improved
spine outcomes
“Having spent much of my career developing
successful intraoperative neuromonitoring systems and working with
spine surgeons to understand their requirements in the operating
room, I can say that the SafeOp system is by far the most advanced
system on the market. I have been very impressed with the
system’s technical and user experience performance. We have
leaped ahead of other available technologies,” said Jim Gharib,
ATEC’s Senior Director, Adjunctive Technologies.
About Alphatec Holdings,
Inc.
Alphatec Holdings, Inc., through its
wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp
Surgical, Inc., is a medical device company that designs, develops
and markets spinal fusion technology products and solutions for the
treatment of spinal disorders associated with disease and
degeneration, congenital deformities and trauma. The Company
markets its products in the U.S. via independent sales agents and a
direct sales force.
Additional information can be found at
www.atecspine.com.
Forward Looking Statements
This press release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve risks and uncertainty. Such
statements are based on management's current expectations and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. The Company cautions investors that
there can be no assurance that actual results will not differ
materially from those projected or suggested in such
forward-looking statements as a result of various factors.
Forward-looking statements include references to the Company’s
planned commercial launches, product introductions and product
integration, surgeon and market acceptance of Company products,
solutions and platforms, and the Company’s ability to deliver key
product features. The important factors that could cause
actual operating results to differ significantly from those
expressed or implied by such forward-looking statements include,
but are not limited to: the uncertainty of success in developing
new products or products currently in the Company’s pipeline;
failure to achieve acceptance of the Company’s products by the
surgeon community; failure to obtain FDA or other
regulatory clearance or approval for new products, or unexpected or
prolonged delays in the process; continuation of favorable third
party reimbursement for procedures performed using the Company’s
products; the Company’s ability to compete with other products and
with emerging new technologies; product liability exposure; patent
infringement claims; and claims related to the Company’s
intellectual property. The words “believe,” “will,” “should,”
“expect,” “intend,” “estimate,” “look forward” and “anticipate,”
variations of such words and similar expressions identify
forward-looking statements, but their absence does not mean that a
statement is not a forward-looking statement. A further list
and description of these and other factors, risks and uncertainties
can be found in the Company's most recent annual report, and any
subsequent quarterly and current reports, filed with
the Securities and Exchange Commission. ATEC disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, unless required by law.
Investor/Media Contact:
Tina JacobsenInvestor Relations (760)
494-6790ir@atecspine.com
Company Contact:
Jeff BlackChief Financial OfficerAlphatec Holdings, Inc.
ir@atecspine.com
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