ATEC Announces Commercial Launch of the SafeOp Neural InformatiX System™
November 26 2019 - 9:00AM
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a
medical device company dedicated to revolutionizing the approach to
spine surgery, announced today the commercial release of the SafeOp
Neural InformatiX System (“SafeOp”), which has been designed to
seamlessly integrate critical neural information into ATEC
procedural solutions.
The commercial launch of the SafeOp System
follows successful alpha evaluations that began earlier this year,
and is the last of 12 planned commercial launches for 2019,
delivering on ATEC’s commitment to accelerate growth through
clinical distinction.
“Today, we are launching the first reflection of
the innovation that we expect to deliver through the SafeOp
platform: a powerful technology that meets an unmet need for
objective, intraoperative neural information during surgery,” said
Pat Miles, Chairman and Chief Executive Officer. “SafeOp’s
unprecedented combination of nerve identification and nerve health
information will be the cornerstone of ATEC clinical distinction.
By providing surgeons with the information they require, when they
require it, SafeOp profoundly improves the clinical experience in
some of spine’s most broadly performed procedures.”
The SafeOp Neural InformatiX System has been
engineered with electromyography (EMG) and somatosensory evoked
potentials (SSEP) to provide surgeons with actionable information
regarding both the location and the health of nerves at risk during
surgery. The system integrates seamlessly into operating rooms with
a small footprint and wireless connectivity.
Dr. William Taylor, Professor of Neurosurgery at
UC San Diego and lateral surgery pioneer, said, “I have been
looking for years for a way to monitor the health of the femoral
nerve in the lateral approach. SafeOp’s automated SSEP technology
is the first to provide real-time feedback about the integrity of
that critical neural structure to help surgeons avoid injury and
improve outcomes.”
For lateral lumbar procedures, SafeOp’s EMG
nerve detection provides information regarding the direction and
the proximity of relevant neural anatomy during the surgical
approach. In addition to the reliable access afforded with
EMG, the system employs real-time SSEP nerve monitoring.
Through a combination of cutting-edge signal amplifiers and
filters, proprietary waveform classifiers, and predefined
parameters, SafeOp SSEP delivers an unparalleled ability to
reproducibly monitor nerve health. That capability uniquely equips
surgeons with actionable information to assist in mitigating
femoral nerve complications, the greatest challenge to the adoption
of lateral surgery.
SafeOp also improves the safety and
reproducibility of posterior fixation procedures, which encompass
roughly 90% of all spine fusions. Integrated into the
Invictus™ Posterior Fixation approach, SafeOp’s dynamic EMG
technology delivers nerve detection with industry-leading speed and
reliability during screw placement, reducing the risk of pedicle
breach.
Key Features of the SafeOp Neural
InformatiX System and Proprietary Peripheral Devices
- Triggered EMG for Fast, Reliable
Nerve Identification- Proprietary Validated Response
Thresholding (VRT) algorithm, designed to deliver industry-leading
nerve detection while reducing the incidence of false positive
responses- Industry-leading speed, with stimulation that ramps
from below threshold at a frequency 4x faster than competitive
systems- Compelling reliability, as acquired threshold
responses are validated with subsequent stimuli for reproducible
results- Visual and audible communication of discrete
threshold values
- Saphenous SSEP for Femoral Nerve
Integrity Monitoring- Leverages novel waveform-averaging
technology to provide objective, real-time nerve health
information- Actionable SSEP information with audible and
visual alerting of response changes, numeric display of SSEP
amplitude and latency, and response trend indicators
About Alphatec Holdings,
Inc.
Alphatec Holdings, Inc., through its
wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp
Surgical, Inc., is a medical device company dedicated to
revolutionizing the approach to spine surgery. ATEC 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.
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:
Josh BergInvestor Relations (760)
494-6790ir@atecspine.com
Company Contact:
Jeff BlackChief Financial OfficerAlphatec Holdings, Inc.
ir@atecspine.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/02682042-5414-4a34-aff2-fdf55875bd06
Alphatec (NASDAQ:ATEC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Alphatec (NASDAQ:ATEC)
Historical Stock Chart
From Sep 2023 to Sep 2024