AlphaTec Announces Commercial Launch of its First IndentiTi™ Porous Titanium Interbody System

IndetiTi implants are 60% porous, which enhances intra-operative and post-operative imaging

CARLSBAD, Calif., March 28, 2019 (GLOBE NEWSWIRE) — 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 new IdentiTi-C Porous Titanium Interbody Implant System for Anterior Cervical Discectomy and Fusion (ACDF). 

The launch of the IdentiTi-C Interbody Implant System follows successful alpha evaluations that began in August 2018. It marks the first of six IdentiTi implant systems the Company expects to commercially introduce in 2019.

The IdentiTi line of implant systems, with enhanced imaging characteristics and porosity, are expected to provide superior performance to competitive titanium implant offerings. The IdentiTi line of implants will not only complement the Company’s current suite of PEEK implants, but will also allow ATEC to address the broader market of surgeons who prefer titanium. 

“With the release of its cervical IdentiTi porous titanium interbody cage, ATEC has ushered in a new age of excellence in cervical spine surgery,” Paul Sawin, MD, of Orlando Neurosurgery commented. “Surgeons have had to compromise between biology and mechanics with previous implant choices. ATEC’s IdentiTi porous titanium has an architecture that is conducive to new bone growth and a structural consistency that lends predictability to its mechanical behavior. Also, because it is 60% porous (or comprised of 60% air), the stiffness is similar to the surrounding bone, and the imaging characteristics with x-ray, CT, and MRI are excellent.”

“I commend the teams that collaborated to successfully launch this innovative technology ahead of schedule,” said Pat Miles, Chairman and Chief Executive Officer. “The IdentiTi-C Interbody Implant System significantly increases the sophistication of ATEC’s ACDF approach with meaningfully differentiated technology that improves surgical outcomes. This launch is only the beginning of the innovation we intend to deliver in 2019, a strong demonstration of our commitment to create value with clinical distinction.”

About the IdentiTi Porous Titanium Interbody Systems 

ATEC’s IdentiTi Porous Ti Interbody Systems offer implant options that take advantage of bone’s affinity for titanium. Because of their porosity, IdentiTi implants have a surface roughness that enhances stability. The implants are also designed to provide the biological, biomechanical, and imaging characteristics that surgeons seek in a fusion construct.

Key features include: 

  • Consistent, fully interconnected porosity throughout the implant, designed to mimic the structure and porosity of cancellous bone;
  • Pore structure (resulting in surface roughness) and an architecture that enables both immediate and long-term stability;
  • Reduced density (60% porous), allowing enhanced intraoperative and postoperative imaging;
  • Stiffness similar to bone;
  • Predictable performance associated with the subtractive manufacturing process, creating a porous titanium material with consistent and reproducible interconnected pore sizes; and
  • Instrumentation that is intuitive, low profile, and exacting, 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.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.