Orthofix Highlights New Products and Announces Presentation of Data Supporting the Adjunct Use of Bone Growth Therapy for Lumbar Spine Fusion at North American Spine Society Annual Meeting

Rhea-AI Summary

Orthofix Medical Inc. (NASDAQ:OFIX) announced new data supporting the use of their SpinalStim™ bone growth therapy device for increasing fusion rates in lumbar spine fusion surgery. The study, to be presented at the North American Spine Society (NASS) Annual Meeting, showed high fusion success rates and significant improvements in patient outcomes despite risk factors for pseudarthrosis.

At NASS, Orthofix is also showcasing new products including:

• The full market launch of OsteoStrand™ Plus C, a 100% bone-derived graft with improved packability
• The launch of M6-C™ Single-Use, Disposable Instrumentation sets for cervical disc arthroplasty

Orthofix is sponsoring educational events on the 7D FLASH™ Navigation System and optimizing fusion techniques. Attendees can visit booth #3017 to learn more about Orthofix's spine solutions.

Positive

• New data shows high fusion success rates with SpinalStim™ bone growth therapy device
• Full market launch of OsteoStrand™ Plus C, a 100% bone-derived graft with improved packability
• Introduction of M6-C™ Single-Use, Disposable Instrumentation sets for cervical disc arthroplasty
• Sponsoring educational events to promote their products and techniques

Negative

• None.

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced the presentation of new data supporting the use of Orthofix’s proprietary Pulsed Electromagnetic Field (PEMF) stimulation to increase fusion rates as an adjunct to lumbar spine fusion surgery. Patients treated with the SpinalStim^™ bone growth therapy device demonstrated a high rate of successful fusion with significant improvements in pain, function and quality of life, despite having risk factors for pseudarthrosis.

The abstract will be presented by Dr. Marc Weinstein, an orthopedic spine surgeon at the Florida Orthopaedic Institute in Tampa, Florida, at the North American Spine Society (NASS) Annual Meeting in Chicago, IL, on September 25, during the Research and Innovation Showcase in the McCormick Place West Lobby of the McCormick Convention Center.

During the NASS annual meeting, Orthofix is also highlighting a variety of new products including the full market launch of OsteoStrand^™ Plus C. A 100% bone-derived graft, OsteoStrand Plus C is comprised of Demineralized Bone Matrix (DBM) fibers and Accell^™ Bone Matrix, a dispersed form of DBM that provides immediate release of growth factors upon implantation and increases the concentration of growth factors in the product, and cancellous chips. Used as a bone graft material in fusion applications, the OsteoStrand Plus C features improved graft packability relative to non-chip containing options – for a denser fill and to ensure minimal graft displacement. Additionally, Orthofix is announcing the launch of the M6-C^™ Single-Use, Disposable Instrumentation sets, the first FDA-cleared, single-use, disposable instruments designed specifically for cervical disc arthroplasty.

Orthofix Sponsored Events

Orthofix will be sponsoring opportunities to learn more about the 7D FLASH^™ Navigation System through an educational dinner with Dr. Jason McGowan and Dr. Amir Vokshoor. Additionally, the company is offering an educational dinner for surgeons to learn more about optimizing fusion through identifying the right combination of interbody surface technology, data-driven biologics, and bone growth therapies with Dr. Raymond Hah and Dr. James Bruffey.

Those attending NASS can learn more about these events and Orthofix’s portfolio of spine solutions by visiting booth #3017.

About Orthofix

Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, we deliver exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics and enabling technologies, including the 7D FLASH™ Navigation System. To learn more, visit Orthofix.com and follow Orthofix on LinkedIn.

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, 2023, which was filed with the Securities and Exchange Commission (SEC) on March 5, 2024, as well as any subsequent Quarterly Report on Form 10-Q or Current Report on Form 8-K filed with the SEC. The Company’s public filings with the SEC 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240923211580/en/

Media Relations

Denise Landry

DeniseLandry@Orthofix.com

214.937.2529



Investor Relations

Julie Dewey

JulieDewey@Orthofix.com

209.613.6945

Source: Orthofix Medical Inc.

FAQ

What new data is Orthofix (OFIX) presenting at the NASS Annual Meeting?

Orthofix is presenting data supporting the use of their SpinalStim™ bone growth therapy device for increasing fusion rates in lumbar spine fusion surgery. The study showed high fusion success rates and significant improvements in patient outcomes despite risk factors for pseudarthrosis.

What new products is Orthofix (OFIX) launching at the NASS Annual Meeting?

Orthofix is launching the full market release of OsteoStrand™ Plus C, a 100% bone-derived graft, and the M6-C™ Single-Use, Disposable Instrumentation sets for cervical disc arthroplasty.

What educational events is Orthofix (OFIX) sponsoring at the NASS Annual Meeting?

Orthofix is sponsoring educational events on the 7D FLASH™ Navigation System and optimizing fusion techniques through identifying the right combination of interbody surface technology, data-driven biologics, and bone growth therapies.

Where can attendees find Orthofix (OFIX) at the NASS Annual Meeting?

Attendees can visit Orthofix at booth #3017 to learn more about their portfolio of spine solutions.