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Surgalign Announces FDA 510(k) Clearance of the Cortera™ Spinal Fixation System – The Company’s New Flagship Posterior Fixation Platform

admin by admin
August 25, 2022
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Surgalign Announces FDA 510(k) Clearance of the Cortera™ Spinal Fixation System – The Company’s New Flagship Posterior Fixation Platform

DEERFIELD, Unwell., Aug. 24, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA) a world medical expertise firm centered on elevating the usual of care by driving the evolution of digital well being, right this moment introduced FDA 510(ok) clearance of the CorteraTM Spinal Fixation System. This new flagship product from Surgalign is a key piece to the foundational portfolio designed to drive the Firm’s future progress over the subsequent 10 years and to allow market share good points within the estimated $2.2B US posterior fixation market.

“The Cortera system is a testomony to the spine engineering expertise and experience we’ve assembled in very quick order, as we moved from zero engineers in america following the RTI divestiture two years in the past, to roughly 30 right this moment,” acknowledged Terry Wealthy, President and CEO of Surgalign. “Due to our staff and unbelievable surgeon companions, we progressed from firm inception to FDA 510(ok) clearance with a really polished system in roughly 16 months. We’re excited with the prospects the Cortera system brings to Surgalign, and people around the globe who depend on our expertise to drive higher affected person outcomes.”

At its core, Cortera is a 5.5/6.0mm rod pedicle screw system, that has each open and MIS modules. The system boasts a feature-rich screw design that maintains a relatively low profile and a newly designed locking mechanism.

“Cortera resulted from the fruits of efforts by a number of the most skilled and educated surgeons, engineers, and challenge staff members on the earth. The system is palms down probably the most exact, elegant and complete screw that at present exists in my view.” stated Dr. Jeremy Smith, Chief of Backbone, Hoag Orthopedic Institute. “I discover the system has an advanced sophistication that gives a high-quality consumer expertise and enhanced scientific efficiency in difficult pathologies.”

The Cortera system was strategically designed to maximise adoption within the spine market—right this moment and for the way forward for evolving strategies and expertise. Cortera is yet one more system that demonstrates how spinal implants shall be deployed with applied sciences just like the Firm’s HOLO PortalTM surgical steering.

“What excites me about Cortera is how the system was forward-thinking to the expertise evolution we’re witnessing now in spine surgical procedure,” stated Dr. Craig Meyer, a Cedars-Sinai MIS Fellowship skilled spine surgeon, working towards in Columbia, MO. “That is an thrilling time to be a spine surgeon and {hardware} methods like Cortera will facilitate our speedy evolution of strategies to carry out spinal surgical procedure when built-in with applied sciences like HOLO Portal.” 

The Firm will combine the Cortera system with the HOLO Portal surgical steering system designed to create an unequalled consumer expertise for pedicle screw navigation. The Firm is planning further implants and devices so as to add to the Cortera system over the subsequent 3-4 years to increase functions of the system right into a majority of posterior fixation spinal procedures.

The Cortera Spinal Fixation System restricted market launch is anticipated to positively contribute to This fall 2022 outcomes and within the coming years. The Firm expects Cortera will assist speed up adoption of the HOLO Portal surgical steering system by providing surgeons and hospitals two state-of-the-art applied sciences packaged collectively to carry out spinal fusion procedures.

About Surgalign Holdings, Inc.
Surgalign Holdings, Inc. is a world medical expertise firm dedicated to the promise of digital well being to drive transformation throughout the surgical panorama. Uniquely aligned and resourced to advance the usual of care, the corporate is constructing applied sciences physicians and different well being suppliers will look to for what is really potential for his or her sufferers. Surgalign is targeted on creating options that predictably ship superior scientific and financial outcomes. Surgalign markets merchandise all through america and in roughly 50 international locations worldwide via an increasing community of prime impartial distributors. Surgalign is headquartered in Deerfield, IL, with business, innovation and design facilities in San Diego, CA, Warsaw and Poznan, Poland, and Wurmlingen, Germany. Be taught extra at www.surgalign.com and join on LinkedIn and Twitter.

Ahead Wanting Assertion
This press launch accommodates forward-looking statements based mostly on administration’s present expectations, estimates and projections about our merchandise, firm, and business, our administration’s beliefs, and sure assumptions made by our administration. Phrases resembling “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and different variations of such phrases and related expressions are supposed to establish such forward-looking statements. These statements usually are not ensures of future efficiency and are topic to dangers and uncertainties, together with the dangers described in our public filings with the U.S. Securities and Alternate Fee (SEC). Our precise outcomes could differ materially from the anticipated outcomes mirrored in these forward-looking statements. Copies of the corporate’s SEC filings could also be obtained by contacting the corporate or the SEC or by visiting Surgalign’s web site at www.surgalign.com or the SEC’s web site at www.sec.gov.

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