Orthofix Announces First Cases and Full Commercial Launch of the 7D FLASH Navigation System Percutaneous Module 2.0 for Minimally Invasive Surgery

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch and successful completion of the first cases in the U.S. with the 7D FLASH^™ Navigation System Percutaneous Module 2.0. The Percutaneous Module 2.0 provides new planning features and increased functionality for the 7D FLASH Navigation System, allowing Orthofix to further serve the Minimally Invasive Surgery (MIS) spine market, estimated at approximately $1.8 billion in the U.S.¹

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Image of the 7D FLASH™ Navigation System with the Percutaneous Module 2.0 for minimally invasive surgeries. The system uses visible light to create a three-dimensional image for surgical navigation in seconds, enabling faster and more efficient spinal procedures. (Photo: Business Wire)

“The 7D FLASH Navigation System provides a truly unique offering for both open and MIS procedures enabling us to perform navigated spinal fusion procedures without compromising safety, speed and efficiency,” said Dr. Michael Hisey, an orthopedic surgeon at Texas Back Institute in Dallas, Texas. “The planning features of the Percutaneous Module 2.0 help optimize my navigation workflow and allow me to minimize surgical incisions during MIS procedures.”

The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in seconds, enabling faster and more efficient spinal procedures. The only image-guidance system that utilizes novel and proprietary camera-based technology, coupled with machine-vision algorithms, the 7D FLASH Navigation System eliminates many of the long-standing frustrations with other surgical navigation platforms. The speed, accuracy, and efficiency of machine-vision technology is intended to provide significant economic value and lower radiation exposure for staff and patients during open procedures.

“We are excited to complete our first cases using the Percutaneous Module 2.0,” said Dr. Beau Standish, President of Global Enabling Technologies at Orthofix. "This launch expands the clinical functionality and utility of the 7D FLASH Navigation System by providing surgeons with a fully integrated procedural solution for MIS, including implant planning and an expanded offering of navigated tools. This new application addresses the important MIS spine navigation market and further positions the 7D FLASH Navigation System to be the navigation choice for a wide range of institutions from teaching hospitals to ambulatory surgery centers.”

To learn more about the 7D FLASH Navigation System, please visit SeaSpine.com or 7DSurgical.com.

^1. Source iData Research Inc. 2022.

About Orthofix

On January 5, 2023, Orthofix and SeaSpine merged to form a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Its products are distributed in approximately 68 countries worldwide.

The Company is headquartered in Lewisville, Texas and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined Company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and Sao Paulo, Brazil. A new name for the combined entity will be announced at a future date; the Company will continue to operate as Orthofix until said announcement.

Forward-Looking Statements

This news release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other comparable terminology. Orthofix cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6, 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Orthofix does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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