DEERFIELD, Sick., Dec. 15, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc. (Nasdaq: SRGA), a worldwide medical expertise firm targeted on elevating the usual of care by driving the evolution of digital surgical procedure, at this time introduced a key milestone for its not too long ago launched posterior fixation platform – the Cortera™ Spinal Fixation System.
Surgalign obtained FDA 510(okay) in August 2022 and Cortera and was launched in a restricted market launch shortly thereafter. In somewhat over three months, the Firm has efficiently penetrated goal markets and at this time introduced the completion of the 100th case using this new flagship pedicle screw system. Throughout this preliminary market launch, Surgalign’s purpose has been to gather medical and design suggestions on the system from a variety of spine surgeons, representing the consumer wants and preferences of the broader market. Efforts are actually underway to safe further merchandise and the Firm intends to ramp up commercialization within the first half of 2023 because it seems to be to develop its market share within the estimated $2.2B US posterior fixation market.
“My early expertise using the Cortera system has been extremely promising,” stated Dr. Sergey Neckrysh, Chief of Backbone Surgical procedure at UI Health in Chicago, Illinois. “The primary technology of the system boasts a better high quality than many screw methods which have been available on the market for years. I deal with a spread of sufferers presenting with fundamental degenerative pathologies to advanced deformities and revision wants, and I’ve discovered the Cortera system to be a sturdy and dependable surgical resolution that permits me to offer best-in-class care to my sufferers.”
The Cortera system was designed primarily based on suggestions from among the most skilled and educated surgeons and engineers on the planet and at its core, 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. As beforehand communicated, the Firm intends to develop further implants and devices so as to add to the Cortera System over the subsequent 3-4 years and can be working to combine Cortera with its HOLO Portal™ surgical steerage system.
Terry Wealthy, President and Chief Government Officer of Surgalign acknowledged, “Cortera represents the primary organically developed product at Surgalign and we imagine holds nice promise for our Firm and our prospects. Market reception has been very robust to this point and we look ahead to shifting into the subsequent part of our industrial launch in 2023, whereas persevering with to drive innovation within the system.”
About Surgalign Holdings, Inc. Surgalign Holdings, Inc. is a worldwide 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 actually attainable for his or her sufferers. Surgalign is targeted on growing options that predictably ship superior medical and financial outcomes. Surgalign markets merchandise all through the US and in roughly 50 international locations worldwide via an increasing community of prime unbiased distributors. Surgalign is headquartered in Deerfield, IL, with industrial, innovation and design facilities in San Diego, CA, Warsaw and Poznan, Poland, and Wurmlingen, Germany. Study extra at www.surgalign.com and join on LinkedIn and Twitter.
Ahead Wanting Statements This press launch accommodates forward-looking statements together with, with out limitation, statements relating the meant use of proceeds from the registered direct providing. These forward-looking statements are primarily based on administration’s present expectations, estimates and projections about our trade, our administration’s beliefs and sure assumptions made by our administration. Phrases comparable to “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such phrases and comparable expressions are meant to establish such forward-looking statements. Components that would trigger precise outcomes to vary materially from these forward-looking statements embrace: i) the Firm’s entry to enough working money circulate, commerce credit score, borrowed funds and fairness capital to fund its operations and pay its obligations as they develop into due, and the phrases on which exterior financing could also be obtainable, together with the impression of hostile developments or disruption within the international credit score and fairness markets; (ii) dangers regarding current or potential litigation or regulatory actions; (iii) the identification of management deficiencies, together with materials weaknesses in inner management over monetary reporting; (iv) common worldwide financial situations and associated uncertainties; (v) the continued impression of the COVID-19 and the Firm’s makes an attempt at mitigation, notably in worldwide markets served by the Firm; (vi) the failure by the Firm to establish, develop and efficiently implement its strategic initiatives, notably with respect to its digital surgical procedure technique ; (vii) the reliability of our provide chain; (viii) our capability to satisfy obligations, together with buy minimums, underneath our vendor and different agreements; (ix) whether or not or when the demand for procedures involving our merchandise will enhance; (x) our monetary place and outcomes, whole income, product income, gross margin, and operations; (xi) failure to appreciate, or sudden prices in looking for to appreciate, the anticipated advantages of the Holo Surgical Inc. (“Holo Surgical”) and Inteneural Networks Inc. (“INN”) acquisitions, together with the failure of Holo Surgical’s and INN’s services to be satisfactorily developed or obtain relevant regulatory approvals or on account of the failure to commercialize and distribute its merchandise; (xii) the failure to successfully combine Holo Surgical’s and INN’s operations with these of the Firm, together with: retention of key personnel; the impact on relationships with prospects, suppliers, and different third events; and the diversion of administration time and a spotlight to the combination; (xiii) the variety of shares and amount of money that will likely be required in reference to any post-closing milestone funds, together with on account of modifications within the buying and selling worth of the Firm’s frequent inventory and their impact on the amount of money wanted by the Firm to fund any post-closing milestone funds in reference to the acquisitions; (xiv) the continuation of latest high quality points with respect to our international provide chain and (xv) the impact and timing of modifications in legal guidelines or in governmental laws. These components ought to be thought-about rigorously, and undue reliance shouldn’t be positioned on the forward-looking statements. Every forward-looking assertion on this communication speaks solely as of the date of the actual assertion.
These forward-looking statements are usually not ensures of future efficiency and are topic to varied dangers and uncertainties, together with market and different situations and the dangers recognized in Surgalign’s most up-to-date Annual Report on Kind 10-Ok and different filings with the SEC. Our precise outcomes might differ materially from the anticipated outcomes mirrored in these forward-looking statements. Copies of Surgalign’s SEC filings could also be obtained with out cost by visiting Surgalign’s web site at www.surgalign.com or the SEC’s web site at www.sec.gov. We undertake no obligation to replace these forward-looking statements besides as could also be required by legislation.