ATEC Announces Commercial Release of Distinct, Comprehensive TLIF Approach

Rhea-AI Summary

Alphatec Holdings, Inc. (ATEC) announced the launch of the Sigma TLIF Access System and InVictus Modular Pedicle Screw, aimed at enhancing the transforaminal lumbar interbody fusion (TLIF) clinical experience. These innovations integrate with the SafeOp Neural InformatiX system for a comprehensive spinal surgery approach. The Sigma TLIF Access System improves visualization and reproducibility of minimally invasive surgeries, while the InVictus system enhances fixation reliability. Both systems will be showcased at the virtual North American Spine Society meeting.

Positive

• Launch of Sigma TLIF Access System and InVictus Modular Pedicle Screw enhances surgical techniques.
• Integration with SafeOp Neural InformatiX system improves patient safety and outcomes.
• Innovative features designed for reproducibility and less invasive procedures.

Negative

• None.

• Sigma TLIF Access System, InVictus Modular Fixation System, and SafeOp Neural InformatiX System Clinically Differentiate the ATEC TLIF Approach
  
  
• Procedure-Specific Solutions Built from the Ground Up Deliver Less Disruptive and More Reproducible Surgery
  

CARLSBAD, Calif., Oct. 06, 2020 (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 releases of two new solutions designed to elevate the ATEC transforaminal lumbar interbody fusion (TLIF) clinical experience. The Sigma Access System and the InVictus Modular Pedicle Screw are novel technologies that fully integrate with the SafeOp Neural InformatiX system, the SingleStep implant delivery system and IdentiTi TLIF implants, to enable a comprehensive, intelligently designed TLIF approach.

“These new product releases further our commitment to architect complete surgical procedures, the core competency of the ATEC Organic Innovation Machine,” said Pat Miles, Chairman and Chief Executive Officer. “The Sigma TLIF Access System and InVictus Modular Screw solutions are not makeovers of existing products. These technologies have been crafted from the ground up to better meet the specific needs of the TLIF approach and effect a more predictable, less disruptive technique. These products are just two examples of the approach-based innovation that we are releasing in 2020. ATEC continues to move spine surgery forward, compelling surgeon adoption with distinct innovation that enhances intraoperative confidence and improves surgical outcomes.”

Developed to address the unique requirements of the TLIF technique, the Sigma TLIF Access System is ATEC’s first pedicle-based access system, elegantly engineered to provide direct visualization of key anatomical landmarks and improve the reproducibility of the MIS TLIF approach.  The Sigma TLIF Retractor incorporates a fiber optic light source to improve illumination and an integrated steerable jamshidi for unprecedented shank navigability.

Samuel A. Joseph, Jr., MD, orthopedic spine surgeon and founder of the Joseph Spine Institute in Tampa Bay, Florida, commented, “The Sigma TLIF Retractor’s intuitive features offer unique versatility. Independent cranial/caudal opening or optional disc space distraction for collapsed disc spaces were astutely built into the access system.  I can address unilateral pathology, or, if needed in complex cases, address bi-lateral symptoms through simultaneous bi-lateral approaches.”

Engineered to enhance the adaptability of the InVictus spinal fixation platform with the power of modularity, the InVictus Modular Pedicle Shank attaches directly to the Sigma TLIF Access System. InVictus Modular incorporates visual, tactile, and audible confirmation of tulip attachment to instill intraoperative confidence. Integrated seamlessly with Single Step technology, InVictus Modular extends the dependability and predictability of InVictus MIS fixation and can obviate the need for guide wires, which are commonly associated with surgical complications.

Dr. Andrew Roeser, MD, a Neurosurgeon at Houston Methodist Hospital in Texas, added, “The seamless integration of InVictus SingleStep & MIS MOD to the Sigma TLIF system make for a highly efficient and reproducible procedure.  By anchoring the retractor blades to the spine, I am able to visualize the same exposure every time, regardless of patient size. That is paramount to consistent clinical outcomes, and incredibly helpful when teaching residents in my O.R.  Although there is soft tissue covering the anatomy, each time I open the retractor, I can see the headless screws and know exactly the location of pertinent anatomy.”

The Sigma TLIF Access System and InVictus Modular Fixation System will be highlighted this week at ATEC’s virtual North American Spine Society, or NASS, booth. Click here, or visit booth 1525 for more information.

Key Features of the Sigma TLIF Access System

• Facilitates access to collapsed disc space through vertebral body distraction
• Improves illumination with integrated fiber optic light source
• Provides direct visualization of facet, pars, and lamina with modular shank and blade
• Enables customized exposure with independent cranial and caudal retraction
• Supports differing patient pathology with surgeon-guided medial blade
• Streamlines assembly with quick-connect engagement

Key Features of the InVictus Modular Fixation Device

• Leverages dependable helical flange tulip technology to reduce cross-thread potential and help eliminate tulip splay
• Boasts modular tulip interconnection strength 4.5x greater than the average pull-out strength of pedicle screws
• Adapts intraoperatively to surgical techniques with robust instruments and customizable modular implants designed to accept multiple rod diameters and materials 
• Advances the standard of Modular Fixation with a guidewire-less SingleStep^TM technique to deliver modular shank and SIGMA blade with one instrument pass
• Integrates with ATEC’s neural informatix system, SafeOp, to predictability provide surgeons with real-time, actionable information to detect and monitor the health of nerves at risk during posterior fixation
• Instills confidence with audible, tactile and visual confirmation of reproducible Tulip to Shank attachment

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc. (ATEC), 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 through clinical distinction. ATEC’s Organic Innovation Machine is focused on developing new approaches that integrate seamlessly with the SafeOp Neural InformatiX System to safely and reproducibly treat spine’s various pathologies and achieve the goals of spine surgery. Alphatec’s vision is to become the Standard Bearer in Spine. For more information, visit us 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 Jacobsen
Investor Relations 
(760) 494-6790
ir@atecspine.com 

Company Contact:

Jeff Black
Chief Financial Officer
Alphatec Holdings, Inc. 
ir@atecspine.com

FAQ

What is the Sigma TLIF Access System launched by ATEC?

The Sigma TLIF Access System is a new pedicle-based access system designed to enhance the transforaminal lumbar interbody fusion (TLIF) approach, allowing better visualization and reproducibility during surgeries.

What are the benefits of the InVictus Modular Pedicle Screw?

The InVictus Modular Pedicle Screw provides modularity and features that enhance fixation reliability and intraoperative confidence, reducing complications commonly associated with traditional guide wires.

How does the SafeOp Neural InformatiX system integrate with ATEC's new products?

The SafeOp Neural InformatiX system integrates with ATEC's Sigma TLIF Access System and InVictus Modular Fixation System to provide real-time, actionable information for monitoring the health of nerves during surgery.

When and where was the Sigma TLIF Access System and InVictus Modular Pedicle Screw showcased?

These products were highlighted during the virtual North American Spine Society (NASS) meeting.

What distinguishes ATEC's new surgical systems from existing products?

ATEC's new systems are not mere updates; they are completely re-engineered solutions crafted to meet the specific needs of the TLIF approach, enhancing predictability and reducing disruption in surgical procedures.