IdentiTi™-TLIF

ATEC Announces Commercial Launch Of IdentiTi™ TLIF Posterior Oblique Porous Titanium Interbody Implant System

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 its IdentiTi TLIF Posterior Oblique Titanium Interbody Implant System (“IdentiTi PO”) for transforaminal lumbar interbody fusion procedures.  The launch of IdentiTi (TLIF) PO follows successful alpha evaluations that began in January 2019 and marks the fifth of six IdentiTi Implant Systems to be launched this year by ATEC’s Organic Innovation Machine™.

“We continue to execute exceptionally well in our pursuit of increased market share through clinical distinction,” said Pat Miles, Chairman and Chief Executive Officer. “ATEC’s line of IdentiTi Implant Systems brings modernized technology to our portfolio that improves outcomes and elevates the sophistication of spine fusion.  The latest addition of IdentiTi (TLIF) PO provides that same sophistication to those preferring to place oblique implants during a TLIF approach.  It is incredibly exciting to see the investments we’ve made into innovation reach fruition and begin to accelerate growth organically.”

IdentiTi TLIF Posterior Oblique Porous Titanium Interbody Implant System

With a self-distracting bulleted nose, smooth medial-lateral surfaces, and rounded edges, IdentiTi PO has been thoughtfully engineered to improve implant insertion while protecting soft tissue and nerve roots. IdentiTi PO implants are also uniquely designed with anti-migration teeth and lordosis in the oblique plane to optimize surgical outcomes.

“IdentiTi PO was designed specifically for an oblique TLIF implant placement through either a minimally invasive or open approach,” said Dr. William Taylor, Professor of Neurosurgery at UC San Diego.  “The system has been engineered with an elegant inserter and a unique connection feature that facilitates the insert-and-rotate technique.  This emphasis on instrumentation allows the placement of highly lordotic implants while preserving endplates during insertion.”

The IdentiTi Line of Implant Systems

ATEC’s IdentiTi Implant Systems are designed to provide the biological, biomechanical, and imaging characteristics that surgeons seek in a fusion construct.  The subtractive process used to manufacture each IdentiTi Implant System results in more predictable mechanical performance and enhanced imaging characteristics. IdentiTi implants take advantage of bone’s affinity for titanium and, because of their porosity, have a surface roughness that enhances stability.  ATEC IdentiTi implants not only complement the Company’s current suite of PEEK implants, but also allow ATEC to address the broader market of surgeons who prefer titanium.

Key features of IdentiTi Implant Systems include:

  • Consistent, fully interconnected porosity throughout the implant designed to mimic the structure and porosity of cancellous bone;
  • Proprietary pore structure designed to create surface roughness that facilitates immediate implant stability and surface adhesion;
  • Reduced density (60% porous), which enhances intraoperative and postoperative imaging;
  • Stiffness similar to bone;
  • Subtractive manufacturing process, which creates a consistent porous titanium material that furthers product performance predictability with consistent and reproducible interconnected pore sizes; and
  • Intuitive, low profile, and exacting instruments designed to optimize the surgeon experience and facilitate outstanding patient outcomes. 

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.wpengine.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 subsequent quarterly and current reports, filed with the U.S. 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.

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