Orthofix Announces U.S. Launch and First Patient Implant of 3D-Printed FORZA Titanium PLIF Spacer System with Nanovate Technology

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the U.S. launch and first patient implant of the FORZA^™ Ti PLIF Spacer System. Developed to enhance Posterior Lumbar Interbody Fusion (PLIF) procedures, the 3D-printed FORZA Ti Spacer with Nanovate^™ Technology is a titanium lumbar interbody device featuring an optimized design, porosity and surface that allows bone to grow into and through the spacer.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210629005280/en/

Image of the FORZA™ Ti Spacer System for PLIF procedures. (Graphic: Business Wire)

“Posterior lumbar interbody fusion involves inserting an interbody device between the vertebrae during a spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs,” said Dr. Joel Siegal, a neurosurgeon at St. Vincent Charity Medical Center in Cleveland, Ohio, who performed the first implant procedure. “Being able to maximize bone ingrowth is critical to the success of the fusion process. The large opening for packing bone grafting materials and the 3D-printed titanium endplates of the FORZA Ti Spacer are well designed to aid in our goal of maximizing bone ingrowth to aid fusion.”

Features of the FORZA Ti PLIF Spacer System include:

• Large open graft window for packing bone-grafting material
• Bulleted nose to assist with distraction
• 3D-printed porous titanium with macro, micro, and nanoscale surface features
• Nanoscale surface that has been shown to increase proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells in vitro*
• Functional gradient porous structure with 80-percent porosity at the midline of the implant which allows for increased fluoroscopic visualization
• Endplates with 400 micron pores and 50-percent porosity designed to help facilitate bone ingrowth**
• Endplates consisting of interconnected gyroid structures analogous in form to trabecular bone which provide an open porous environment

The FORZA Ti PLIF Spacer System with Nanovate Technology is available in the U.S. through a targeted commercial release.

“The FORZA Ti PLIF Spacer System, featuring Orthofix’s unique Nanovate Technology, is one of several new 3D-printed titanium products we have launched recently and highlights our commitment to delivering innovative solutions to the market,” said Orthofix President of Global Spine Kevin Kenny. “The FORZA Ti system is also ideal for use with our flagship Trinity ELITE^™ allograft with viable cells that supplies the essential components for new bone formation.”

The FORZA Ti PLIF Spacer System is one of many products that feature Orthofix’s Nanovate Technology including the recently launched FORZA TI TLIF Spacer System, CONSTRUX Mini Ti Spacer System, CONSTRUX Mini PTC Spacer System, Pillar^™ SA PTC Spacer System, and the FORZA^™ PTC Spacer System.

*As suggested in an in vivo ovine lumbar spinal fusion model
**In vitro performance may not be representative of clinical performance

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic products are distributed in more than 60 countries via the Company’s sales representatives and distributors. For more information, please visit www.Orthofix.com.

Forward-Looking Statements

This communication contains 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, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. 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,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2020 (the “2020 Form 10-K”). In addition to the risks described there, factors that could cause or contribute to such differences may include, but are not limited to: the risk that FDA approvals may be delayed or not be obtained; the risk that surgeons may be slow to adopt the FORZA Ti Spacer System; the risk that future patient studies or clinical experience and data may indicate that treatment with the FORZA Ti Spacer System does not improve patient outcomes as much as previously believed, or otherwise call into question the benefits of its use to patients, hospitals and surgeons; the risk that the product may not perform as intended and may therefore not achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; the risk that insurance payers may decline to reimburse healthcare providers for the use of our products.

This list of risks, uncertainties and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210629005280/en/