Orthofix Announces FDA Clearance and First Patient Implant of the 3D-Printed FORZA Titanium TLIF Spacer System with Nanovate Technology

Rhea-AI Summary

Orthofix Medical (NASDAQ: OFIX) has received FDA 510(k) clearance and successfully implanted its FORZA™ Ti TLIF Spacer System, designed for Transforaminal Lumbar Interbody Fusion. This 3D-printed titanium implant incorporates Nanovate™ Technology to promote bone growth during spinal fusion. Key features include optimized porosity and a large graft window. Orthofix aims to address current surgeon needs and enhance patient outcomes with this innovative system, building on the recent launch of its cervical interbody product. The product rollout will target specific commercial channels.

Positive

• FDA 510(k) clearance received for FORZA Ti TLIF Spacer System.
• First patient implant successfully completed.
• Advanced 3D-printed titanium implant improves bone growth capabilities.
• Nanovate Technology enhances biological effects for better osteogenesis.
• Recent product initiative follows the launch of the cervical interbody CONSTRUX Mini Ti Spacer System.

Negative

• Potential slow adoption by surgeons may hinder market penetration.
• Future studies may not support the anticipated patient outcomes.
• Risk of competition introducing superior products affecting market success.
• Insurance payers might decline reimbursement for the FORZA Ti Spacer System.

Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and extremities focus, today announced the U.S. Food and Drug Administration 510(k) clearance and first patient implant of the FORZA^™ Ti TLIF Spacer System. Developed to help optimize Transforaminal Lumbar Interbody Fusion (TLIF) procedures, the FORZA Ti Spacer with Nanovate^™ Technology is a titanium 3D-printed interbody featuring an optimized design, porosity and surface that allows bone to grow into and through the spacer. Interbody implants are spacers that surgeons insert between the vertebrae during spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs.

Image of the 3D-printed FORZA Ti Spacer System for TLIF procedures. (Photo: Business Wire)

“The 3D-printed surface technology, titanium material, and implant design all play a role in the bone growth process during fusion,” said Gary Rosenberg, D.O., an orthopedic spine surgeon operating at Orange County Global Medical Center in Santa Ana, CA who performed the first patient implant procedure. “The intuitive instrumentation allows for easy insertion, and the optimized porosity and surface features support our goal of fostering bone growth in order to aid with the patient’s fusion.”

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

“Following quickly behind the recent launch of our new cervical interbody, the CONSTRUX^™ Mini Ti Spacer System, we are excited to introduce our newest 3D-printed titanium lumbar interbody system,” said Orthofix President of Global Spine Kevin Kenny. “The result of our intense focus on bringing solutions to market to meet the current needs of surgeons, the FORZA Ti TLIF Spacer System with our innovative Nanovate Technology will be a key differentiator for surgeons. It will provide access to advanced fusion technology backed by studies that support the proven biological effects of nanoscale features applied to interbody devices.”

The FORZA Ti TLIF Spacer System features include:

• 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*
• Endplates with 400 micron pores and 50-percent porosity designed to help facilitate bone ingrowth**
• Functional gradient porous structure with 80-percent porosity at the midline of the implant which allows for increased fluoroscopic visualization
• Large open graft window for packing bone-grafting material
• Bulleted nose to assist with distraction
• Straightforward instrumentation for easy implantation

Featuring Orthofix’s unique Nanovate Technology, the FORZA Ti TLIF Spacer System is one of many products with nanotechnology FDA clearance including the recently launched CONSTRUX Mini Ti Spacer System, CONSTRUX Mini PTC Spacer System, the Pillar^™ SA PTC Spacer System, and the FORZA^™ PTC Spacer System. When compared to solid PEEK devices, the 3D-printed endplates of implants show a significant increase in growth factors involved in osteogenesis and osteoblast maturation resulting in a more favorable osteogenic environment for bone ingrowth.

*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 and biologics company with a spine and extremities focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in more than 70 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 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/20210422005292/en/

FAQ

What is the FORZA Ti TLIF Spacer System by Orthofix?

The FORZA Ti TLIF Spacer System is a 3D-printed titanium interbody device designed to enhance Transforaminal Lumbar Interbody Fusion surgeries by promoting bone growth.

When did Orthofix receive FDA clearance for the FORZA Ti TLIF Spacer System?

Orthofix received FDA 510(k) clearance for the FORZA Ti TLIF Spacer System in April 2021.

What technology does the FORZA Ti TLIF Spacer System utilize?

The FORZA Ti TLIF Spacer System incorporates Nanovate Technology, which enhances biological effects for improved bone ingrowth.

What are the key features of the FORZA Ti TLIF Spacer System?

Key features include 3D-printed porous titanium, optimized porosity for bone ingrowth, and straightforward instrumentation for easy implantation.

What challenges could affect the success of the FORZA Ti TLIF Spacer System?

Challenges include potential slow adoption by surgeons, lack of supportive clinical data, competitive pressures, and possible reimbursement issues from insurance payers.