AlphaTec Announces Commercial Launch of TLIF IndentiTi™ Posterior Curved Porous Titanium Interbody Implant System
Innovative machine marks the fourth of twelve new product launches planned for 2019, and the third of sic IndentiTi implant systems the Company expects to commercially introduce in 2019
CARLSBAD, Calif., May 30, 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 IdentiTi-PC Porous Titanium Interbody Implant System for Transforaminal Lumbar Interbody Fusion Procedures (TLIF).
“The commercial launch of IdentiTi-PC demonstrates continued solid progress against our commitment to accelerate growth by compelling the spine market and engaging surgeons with clinical distinction,” said Pat Miles, Chairman and Chief Executive Officer. “This marks the fourth of twelve new product launches planned for 2019, an extraordinary level of development by any measure. We have built the spine market’s new organic innovation machine.”
The launch of the IdentiTi-PC Interbody Implant System follows successful alpha evaluations that began in August 2018. It marks the third of six IdentiTi implant systems the Company expects to commercially introduce in 2019.
The IdentiTi line of implant systems are manufactured using a subtractive process, which begets more predictable, proprietary porosity and results in enhanced imaging characteristics. The implants are expected to perform better than 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.
“The IdentiTi-PC proprietary pore structure is similar to that of cancellous bone. The porosity creates a roughness that improves initial stability through surface adhesion and facilitates bone apposition,” remarked Geoffrey Cronen, MD, of Florida Medical Clinic Orthopaedic Surgery. “ATEC’s product development machine has surpassed all expectations with its speed to market while holding the highest standards. It has been remarkable to observe.”
Key Features of 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;
- Proprietary pore structure designed to create surface roughness that enhances immediate implant stability and facilitates surface adhesion;
- Reduced density (60% porous) enhances intraoperative and postoperative imaging;
- Stiffness similar to bone;
- Subtractive manufacturing process creates a consistent porous titanium material that furthers product performance predictability with consistent and reproducible interconnected pore sizes across the IdentiTi family of implants; 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.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 Copany’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.