Orthofix Expands Solutions for Minimally Invasive Spine Procedures with the Full Commercial Launch of Two Access Retractor Systems

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch of two access retractor systems to aid surgeons during minimally invasive spine (MIS) procedures. The Lattus^™ Lateral Access System and the Fathom^™ Pedicle-Based Retractor System expand the Company’s offering of access solutions to address the estimated $1.8 billion MIS surgery market.

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(Shown left to right) Image of the Fathom Pedicle-Based Retractor System and the Lattus Lateral Access System for minimally invasive spine procedures. (Photo: Business Wire)

The Lattus Lateral Access System is designed for ease of use and versatility. The novel, independent blade retraction strength, with “down-and-out” splay feature, provides access to challenging anatomy. With a full suite of instrumentation that facilitates use of the Company’s innovative WaveForm^® L and Regatta^® NanoMetalene^® interbody devices, the Lattus retractor system optimizes the lateral procedure.

“The Lattus Lateral Access System addresses five important areas of lateral spine surgery: access to the spine, preparation or removal of the disc, interbody placement, plate fixation, and easy integration with intraoperative monitoring through an advanced interface,” said Dr. James Lynch, a spinal neurosurgeon and president of the Swift Institute in Reno, NV. “This improved lateral portfolio optimizes each procedural element, from access to fusion, so that I can efficiently and effectively treat each patient’s unique spinal condition.”

Orthofix has also initiated the full commercial launch of the Fathom Pedicle-Based Retractor System. With three points of active telescoping blade fixation, the Fathom Retractor allows the surgeon to control the precise length of each blade and dial in a customized lateral to medial tilt, providing a rigid construct to address each patient’s specific anatomy. Fathom also enables a reproducible surgical workflow, enhances visualization with minimal soft tissue disruption, and complements the complete TLIF procedural solutions offered by the Company.

“Fathom is the first and only pedicle-based retractor to offer continuously telescoping cranial/caudal blades and active control to shorten or extend the length of the medial blade in situ,” stated Dr. Justin Kubeck, orthopedic spine surgeon at Monmouth Medical Center in Long Branch, NJ. “With its offering of modular components, the Fathom Retractor affords me the ability to perform a minimally invasive TLIF surgery with retractor placement customized to each patient unlike anything else currently on the market.”

“We are pleased to offer two truly market differentiating access systems,” said Kevin Kenny, President of Orthofix Global Spine. “The Lattus Lateral Access System paired with our innovative WaveForm^® 3D printed interbodies integrate seamlessly into our lateral access procedural solution. Likewise, the Fathom Pedicle-Based Retractor System integrates with our Mariner^® MIS pedicle screw system and the 7D FLASH^™ enabling technology platform to meet surgeon’s needs and greatly expands our ability to provide full procedural solutions in the OR.”

About Orthofix

The newly merged Orthofix-SeaSpine organization is 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 São Paulo, Brazil.

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 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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