CARLSBAD, Calif., Oct. 22, 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 porous titanium line of IdentiTi™ implants for lateral interbody fusion (LIF) procedures. The launch of the IdentiTi LIF Interbody Implant Systems follows successful alpha evaluations that began in January 2019. The Company has successfully commercialized all of the six IdentiTi Implant Systems slated for release in 2019.
The Company also announced the commercial release of the AMP™ Lateral Anti-Migration Plate, as well as the re-design and reconfiguration of its PEEK lateral interbody implant offering, Transcend™.
With the expected launch of SafeOp neuromonitoring next month, in November 2019, ATEC is on track to launch all 12 of its planned commercial launches for 2019, executing on its commitment to accelerate growth through clinical distinction.
“Each of these products has been purposefully designed to improve lateral spine surgery by the team that developed and pioneered the lateral approach years ago,” said Pat Miles, Chairman and Chief Executive Officer. “Along with the automated objective information that our SafeOp technology will afford when it launches in November, we are bringing meaningful improvement to lateral surgery outcomes. While we are proud of this year’s accomplishments, we know we are only just beginning to demonstrate the prowess of spine’s new Organic Innovation Machine.”
Dr. Luiz Pimenta, ATEC’s Chief Medical Officer and the spine surgeon widely recognized as the pioneer of the lateral approach said, “With the release of the IdentiTi LIF line, surgeons now have access to porous metal implants that more precisely mimic bone architecture and function. These new lateral solutions are representative of the sophistication ATEC is engineering to establish new standards for spine surgery, regardless of the surgical approach.”
The IdentiTi LIF and IdentiTi LIF-HL Porous Titanium Interbody Implant Systems
“Preclinical studies1 have shown that IdentiTi LIF’s porous surface provides enhanced initial stability, conforms to the vertebral endplates, and results in bony in-growth and osseointegration, factors critical to improved short and long-term outcomes,” affirmed Dr. Antoine G. Tohmeh, Director of Minimally Invasive Spine Surgery at Multicare Neuroscience Institute in Spokane, Washington. “ATEC’s IdentiTi LIF Implant Systems offer customizable treatment with a myriad of footprints and lordotic options, including 0, 10, 15, 20, and 30 degree hyperlordotic implants.”
1Data on file; ATEC Spine.
Key Features of the IdentiTi Porous Titanium 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:
- Subtractive manufacturing process creates a consistent porous titanium material that mimics the structure of cancellous bone and furthers product performance predictability with consistent and reproducible interconnected pore sizes;
- Proprietary pore structure designed to create surface roughness that facilitates immediate implant stability and surface adhesion;
- Reduced density (60% porous) enhances intraoperative and postoperative imaging;
- Stiffness similar to bone; and
- Intuitive, low profile, and exacting instruments designed to optimize the surgeon experience and facilitate outstanding patient outcomes.
The AMP Anti-Migration Plate
ATEC’s AMP Lateral Anti-Migration Plate is a modular lateral plate thoughtfully designed to embody simplicity with a zero-step screw locking feature that provides audible, tactile, and visible indicators of screw locking. Engineered with a lean profile and one and two-screw plate options, AMP is capable of unprecedented screw angulation and is fully compatible with IdentiTi LIF, IdentiTi LIF-HL, and Transcend Lateral Interbody Implants.
Dr. William Taylor, Professor of Neurosurgery at UC San Diego, said, “The AMP system is the perfect solution for when the anterior longitudinal ligament is released, whether intentionally in an anterior column realignment, or unintentionally. It seamlessly attaches in situ to any of ATEC’s lateral interbody implants.”
The Transcend Lateral Interbody Spacer
Transcend Lateral marks the first release out of ATEC’s new PEEK interbody implant portfolio. Transcend Lateral has been redesigned to better meet the needs of surgeons by providing continuity in lordotic options and a more refined distal tip that enhances insertion into the disc space. The chevron pattern on Transcend Lateral interbody implants provides anti-migration support for initial stability. Transcend and IdentiTi Lateral are designed to function with the same instrumentation, enabling surgeons to use either implant material without requiring proprietary instrumentation.
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.