DEERFIELD, Ill., Dec. 15, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc. (Nasdaq: SRGA), a global medical technology company focused on elevating the standard of care by driving the evolution of digital surgery, today announced a key milestone for its recently introduced posterior fixation platform – the Cortera™ Spinal Fixation System.
Surgalign received FDA 510(k) in August 2022 and Cortera and was introduced in a limited market release shortly thereafter. In a little over three months, the Company has successfully penetrated target markets and today announced the completion of the 100th case utilizing this new flagship pedicle screw system. During this initial market release, Surgalign’s goal has been to collect clinical and design feedback on the system from a wide range of spine surgeons, representing the user needs and preferences of the broader market. Efforts are now underway to secure additional products and the Company intends to ramp up commercialization in the first half of 2023 as it looks to grow its market share in the estimated $2.2B US posterior fixation market.
“My early experience utilizing the Cortera system has been incredibly promising,” said Dr. Sergey Neckrysh, Chief of Spine Surgery at UI Health in Chicago, Illinois. “The first generation of the system boasts a higher quality than many screw systems that have been on the market for years. I treat a range of patients presenting with basic degenerative pathologies to complex deformities and revision needs, and I have found the Cortera system to be a robust and reliable surgical solution that allows me to provide best-in-class care to my patients.”
The Cortera system was designed based on feedback from some of the most experienced and knowledgeable surgeons and engineers in the world and at its core, is a 5.5/6.0mm rod pedicle screw system, that has both open and MIS modules. The system boasts a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism. As previously communicated, the Company intends to develop additional implants and instruments to add to the Cortera System over the next 3-4 years and is also working to integrate Cortera with its HOLO Portal™ surgical guidance system.
Terry Rich, President and Chief Executive Officer of Surgalign stated, “Cortera represents the first organically developed product at Surgalign and we believe holds great promise for our Company and our customers. Market reception has been very strong to date and we look forward to moving into the next phase of our commercial launch in 2023, while continuing to drive innovation in the system.”
About Surgalign Holdings, Inc.
Surgalign Holdings, Inc. is a global medical technology company committed to the promise of digital health to drive transformation across the surgical landscape. Uniquely aligned and resourced to advance the standard of care, the company is building technologies physicians and other health providers will look to for what is truly possible for their patients. Surgalign is focused on developing solutions that predictably deliver superior clinical and economic outcomes. Surgalign markets products throughout the United States and in approximately 50 countries worldwide through an expanding network of top independent distributors. Surgalign is headquartered in Deerfield, IL, with commercial, innovation and design centers in San Diego, CA, Warsaw and Poznan, Poland, and Wurmlingen, Germany. Learn more at www.surgalign.com and connect on LinkedIn and Twitter.
Forward Looking Statements
This press release contains forward-looking statements including, without limitation, statements relating the intended use of proceeds from the registered direct offering. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. Factors that could cause actual results to differ materially from those forward-looking statements include: i) the Company’s access to adequate operating cash flow, trade credit, borrowed funds and equity capital to fund its operations and pay its obligations as they become due, and the terms on which external financing may be available, including the impact of adverse trends or disruption in the global credit and equity markets; (ii) risks relating to existing or potential litigation or regulatory actions; (iii) the identification of control deficiencies, including material weaknesses in internal control over financial reporting; (iv) general worldwide economic conditions and related uncertainties; (v) the continued impact of the COVID-19 and the Company’s attempts at mitigation, particularly in international markets served by the Company; (vi) the failure by the Company to identify, develop and successfully implement its strategic initiatives, particularly with respect to its digital surgery strategy ; (vii) the reliability of our supply chain; (viii) our ability to meet obligations, including purchase minimums, under our vendor and other agreements; (ix) whether or when the demand for procedures involving our products will increase; (x) our financial position and results, total revenue, product revenue, gross margin, and operations; (xi) failure to realize, or unexpected costs in seeking to realize, the expected benefits of the Holo Surgical Inc. (“Holo Surgical”) and Inteneural Networks Inc. (“INN”) acquisitions, including the failure of Holo Surgical’s and INN’s products and services to be satisfactorily developed or achieve applicable regulatory approvals or as a result of the failure to commercialize and distribute its products; (xii) the failure to effectively integrate Holo Surgical’s and INN’s operations with those of the Company, including: retention of key personnel; the effect on relationships with customers, suppliers, and other third parties; and the diversion of management time and attention to the integration; (xiii) the number of shares and amount of cash that will be required in connection with any post-closing milestone payments, including as a result of changes in the trading price of the Company’s common stock and their effect on the amount of cash needed by the Company to fund any post-closing milestone payments in connection with the acquisitions; (xiv) the continuation of recent quality issues with respect to our global supply chain and (xv) the effect and timing of changes in laws or in governmental regulations. These factors should be considered carefully, and undue reliance should not be placed on the forward-looking statements. Each forward-looking statement in this communication speaks only as of the date of the particular statement.
These forward-looking statements are not guarantees of future performance and are subject to various risks and uncertainties, including market and other conditions and the risks identified in Surgalign’s most recent Annual Report on Form 10-K and other filings with the SEC. Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of Surgalign’s SEC filings may be obtained without charge by visiting Surgalign’s website at www.surgalign.com or the SEC’s website at www.sec.gov. We undertake no obligation to update these forward-looking statements except as may be required by law.