Orthofix Announces Full Market Launch of Opus Mg Set – a Magnesium-based Settable Bone Void Filler for Orthopedic Procedures

Rhea-AI Summary

Orthofix Medical Inc (NASDAQ:OFIX) has launched the Opus^™ Mg Set, a synthetic magnesium-based osteoconductive scaffold designed for orthopedic procedures. This innovative product aids in filling non-structural bony voids, enhancing the natural bone-healing process. The Opus Mg Set is available in moldable and injectable forms, providing immediate compressive strength and significant bone remodeling, with preclinical studies indicating over 80% bone remodeling in 26 weeks. This launch reflects Orthofix’s commitment to advancing biologic solutions in orthopedic care.

Positive

• Market launch of Opus Mg Set osteoconductive scaffold enhances product portfolio.
• Demonstrated over 80% bone remodeling in preclinical studies, indicating effectiveness.
• Immediate compressive strength at surgical sites supports quicker patient recovery.

Negative

• Surgeon adoption risk may impact sales and market penetration.
• Future studies may indicate less favorable patient outcomes than expected.
• Potential competition could hinder market share and product success.
• Insurance reimbursement uncertainties could affect product accessibility.

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the full market launch of the Opus^™ Mg Set osteoconductive scaffold, a synthetic magnesium-based bone void filler for orthopedic procedures.

Image of the Orthofix Opus Mg Set in injectable form. (Photo: Business Wire)

Opus Mg Set provides a procedure-specific solution for orthopedic fracture care and trauma applications by filling non-structural bony voids or gaps during surgery. Available in both a moldable and injectable form, Opus Mg Set provides immediate compressive strength at the surgical site post-implantation. When injected or placed into bony voids or gaps, Opus Mg Set forms a supportive scaffold to help facilitate the natural bone-healing process.

“We are pleased to add the Opus Mg Set osteoconductive scaffold to our comprehensive portfolio of biologic solutions,” said Orthofix President and CEO Jon Serbousek. “Opus Mg Set is yet another example of our commitment to innovative biologic solutions that will meet the needs of our valued surgeon customers and their patients.”

Opus Mg Set is a synthetic magnesium-based solution. The magnesium phosphate crystallizes to give thixotropic properties and high compressive strength. Additionally, magnesium is important in bone healing as it supports proliferation of osteogenic cells, enhances new bone formation, and stimulates proteins for bone regeneration. Preclinical studies on Opus Mg Set have shown greater than 80-percent bone remodeling in 26 weeks.

For those attending the American Orthopaedic Foot & Ankle Society annual meeting in Charlotte, N.C., please visit the Orthofix booth #414 to learn more about the Opus Mg Set osteoconductive scaffold.

About Orthofix

Orthofix Medical Inc. is a global medical device 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’ lives. 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 surgeons may be slow to adopt the Opus Mg Set osteoconductive scaffold; the risk that future patient studies or clinical experience and data may indicate that treatment with the Opus Mg Set osteoconductive scaffold 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/20210921005189/en/

Alexa Huerta

Investor Relations

Tel 214 937 3190

alexahuerta@orthofix.com

Denise Landry

Media Relations

Tel 214 937 2529

deniselandry@orthofix.com

Source: Orthofix Medical Inc.

FAQ

What is the Opus Mg Set launched by Orthofix?

The Opus Mg Set is a synthetic magnesium-based osteoconductive scaffold designed for orthopedic procedures, specifically for filling non-structural bony voids.

When was the Opus Mg Set launched?

The Opus Mg Set was launched as part of a full market launch announced in September 2021.

How effective is the Opus Mg Set based on preclinical studies?

Preclinical studies have shown that the Opus Mg Set achieved greater than 80% bone remodeling in 26 weeks.

What are the risks related to the adoption of Opus Mg Set?

Risks include slow adoption by surgeons, potential unfavorable outcomes in future studies, and competition from superior products.

What stock symbol is associated with Orthofix?

The stock symbol for Orthofix Medical Inc is OFIX.