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

Picture of the 7D FLASH™ Navigation System with the Percutaneous Module 2.0 for minimally invasive surgical procedures. The system makes use of seen mild to create a three-dimensional picture for surgical navigation in seconds, enabling sooner and extra environment friendly spinal procedures.

LEWISVILLE, Texas, August 28, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a number one world spine and orthopedics firm, at present introduced the total industrial launch and profitable completion of the primary instances within the U.S. with the 7D FLASH^™ Navigation System Percutaneous Module 2.0. The Percutaneous Module 2.0 offers new planning options and elevated performance for the 7D FLASH Navigation System, permitting Orthofix to additional serve the Minimally Invasive Surgical procedure (MIS) spine market, estimated at roughly $1.8 billion within the U.S.¹

“The 7D FLASH Navigation System offers a very distinctive providing for each open and MIS procedures enabling us to carry out navigated spinal fusion procedures with out compromising security, velocity and effectivity,” mentioned Dr. Michael Hisey, an orthopedic surgeon at Texas Again Institute in Dallas, Texas. “The planning options of the Percutaneous Module 2.0 assist optimize my navigation workflow and permit me to attenuate surgical incisions throughout MIS procedures.”

The 7D FLASH Navigation System makes use of seen mild to create a three-dimensional picture for surgical navigation in seconds, enabling sooner and extra environment friendly spinal procedures. The one image-guidance system that makes use of novel and proprietary camera-based know-how, coupled with machine-vision algorithms, the 7D FLASH Navigation System eliminates lots of the long-standing frustrations with different surgical navigation platforms. The velocity, accuracy, and effectivity of machine-vision know-how is meant to supply vital financial worth and decrease radiation publicity for employees and sufferers throughout open procedures.

“We’re excited to finish our first instances utilizing the Percutaneous Module 2.0,” mentioned Dr. Beau Standish, President of World Enabling Applied sciences at Orthofix. “This launch expands the medical performance and utility of the 7D FLASH Navigation System by offering surgeons with a totally built-in procedural answer for MIS, together with implant planning and an expanded providing of navigated instruments. This new software addresses the vital MIS spine navigation market and additional positions the 7D FLASH Navigation System to be the navigation selection for a variety of establishments from instructing hospitals to ambulatory surgical procedure facilities.”

To study extra in regards to the 7D FLASH Navigation System, please go to SeaSpine.com or 7DSurgical.com.

^1.Supply iData Analysis Inc. 2022.

About Orthofix

On January 5, 2023, Orthofix and SeaSpine merged to type a number one world spine and orthopedics firm with a complete portfolio of biologics, progressive spinal {hardware}, bone progress therapies, specialised orthopedic options, and a number one surgical navigation system. Its merchandise are distributed in roughly 68 international locations worldwide.

The Firm is headquartered in Lewisville, Texas and has main workplaces in Carlsbad, CA, with a give attention to spine and biologics product innovation and surgeon schooling, and Verona, Italy, with an emphasis on product innovation, manufacturing, and medical schooling for orthopedics. The mixed Firm’s world R&D, industrial and manufacturing footprint additionally consists of services and workplaces in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Department, MS, Maidenhead, UK, Munich, Germany, Paris, France and Sao Paulo, Brazil. A brand new title for the mixed entity can be introduced at a future date; the Firm will proceed to function as Orthofix till mentioned announcement.

Ahead-Trying Statements

This information launch could embody forward-looking statements inside the which means of Part 21E of the Securities Trade Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended. In some instances, you may establish forward-looking statements by terminology corresponding to “could,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “tasks,” “intends,” “predicts,” “potential,” “proceed” or different comparable terminology. Orthofix cautions you that statements included on this information launch that aren’t an outline of historic information are forward-looking statements which can be primarily based on the Firm’s present expectations and assumptions. Every forward-looking assertion contained on this information launch is topic to dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such assertion. Relevant dangers and uncertainties embody, amongst others: the flexibility of newly launched merchandise to carry out as designed and meant and to fulfill the wants of surgeons and sufferers, together with because of the shortage of sturdy medical validation; and the dangers recognized below the heading “Threat Components” in Orthofix Medical Inc.’s Annual Report on Kind 10-Ok for the fiscal 12 months ended December 31, 2022, which was filed with the Securities and Trade Fee (SEC) on March 6, 2023. The Firm’s public filings with the Securities and Trade Fee can be found at www.sec.gov. You’re cautioned to not place undue reliance on forward-looking statements, which communicate solely as of the date when made. Orthofix doesn’t intend to revise or replace any forward-looking assertion set forth on this information launch to mirror occasions or circumstances arising after the date hereof, besides as could also be required by legislation.