Alphatec Advances InVictus™ MIS Spinal Fixation System With Commercial Launch of SingleStep™
07 Août 2019 - 3:00PM
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 InVictus
Minimally Invasive, or MIS, SingleStep K-wireless implant delivery
system. By completely eliminating the requirement for K-wires in a
percutaneous pedicle fixation procedure, SingleStep limits the
potential complications associated with inadvertent K-wire
advancement during traditional minimally invasive pedicle screw
placement techniques. SingleStep utilizes an all-in-one driver
designed to enhance surgical efficiency without compromising
accuracy.
“This release enhances the functionality and
distinction of ATEC’s newly-launched InVictus platform with
technology that has been engineered to profoundly improve the
elegance of percutaneous fixation,” said Pat Miles, Chairman and
Chief Executive Officer. “SingleStep enables increased
surgeon control of the variables surrounding percutaneous pedicle
screw placement. Spine’s new Organic Innovation
Machine™ continues to deliver on its commitment to bring
meaningful innovation to a market that yearns for it.”
InVictus MIS SingleStep
The commercial release of the InVictus MIS
SingleStep implant delivery system follows successful evaluations
that began in January 2019.
Compared to a traditional percutaneous
technique, InVictus MIS SingleStep is designed to reduce procedural
steps, instrument passes, screw insertion time, and fluoroscopy,
and completely eliminate guidewire management. SingleStep’s
innovative streamlined approach integrates seamlessly with SafeOp
neurophysiology to add safety, expedience and increased
predictability to percutaneous pedicle screw delivery.
“SingleStep represents an evolutionary leap in
percutaneous pedicle screw instrumentation,” stated Tyler G. Smith,
M.D. of Roseville Orthopedic Surgery and Sports Medicine in
California. “By removing steps in the sequence of targeting
and implantation, the result is an elegant system that is faster,
safer, and more reproducible. In a word, it is simple. It is easy
to make a product different, but the new ATEC has made the approach
better.”
Key Features of InVictus
MIS SingleStep
The InVictus SingleStep system has been designed
to improve surgical outcomes by simplifying minimally invasive
pedicle screw placement procedures.
Key features include:
- Limits the potential complications associated with inadvertent
guidewire advancement by eliminating the requirement for
K-wires;
- Novel ratcheting handle for swift pedicle screw delivery and
unprecedented, single instrument-pass functionality;
- Simplified approach reduces procedural steps by 50%,
streamlining screw insertion time and potentially reducing reliance
on fluoroscopy;
- Steerable stainless steel stylet seamlessly perforates the
pedicle; and
- Integration with SafeOp technology reinforces confidence during
stylet and screw insertion.
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.
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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