Orthofix Announces Publication of New Data Supporting Use of PEMF Stimulation in Lumbar Spine Fusion Procedures for Patients at Risk of Pseudarthrosis

Rhea-AI Summary

Orthofix Medical Inc. (NASDAQ:OFIX) announced new data from a study on Pulsed Electromagnetic Field (PEMF) stimulation as a therapy for spinal fusion procedures. The study showed a high rate of successful fusion and significant improvements in pain, function, and quality of life for patients at risk for pseudarthrosis.

Insights

Medical Research Analyst

An analysis of the recent multicenter study on Pulsed Electromagnetic Field (PEMF) stimulation for lumbar spinal fusion procedures presents significant findings for the medical community and potential investors in Orthofix Medical Inc.

The study outcomes indicating high rates of successful fusion and improvements in patient quality of life are particularly relevant for the orthopedics and spine industry. The efficacy of the SpinalStim™ device as an adjunct therapy could lead to increased adoption rates in surgical procedures, potentially boosting the market share and revenue for Orthofix.

Long-term, these findings may influence insurance coverage decisions and healthcare provider protocols, contributing to the standard of care for patients at risk for pseudarthrosis. However, the study's impact on the company's financials will depend on market penetration and the competitive landscape, which includes alternative bone growth stimulation therapies.

It is critical to consider the scalability of such medical devices and the ability of Orthofix to meet potential demand increases. Additionally, regulatory pathways and reimbursement policies will play a significant role in the widespread adoption of this technology.

Healthcare Industry Analyst

The publication of the study in a peer-reviewed journal adds credibility to the clinical value of the SpinalStim™ device. This could potentially lead to an uptick in investor confidence in Orthofix Medical Inc., considering the positive clinical outcomes.

The data underscores the importance of innovation in postoperative care for spine surgery patients, particularly those with complicating risk factors. The ability to demonstrate improved outcomes in a high-risk population is a strong selling point that can be leveraged in marketing and sales strategies, potentially impacting the company's stock performance.

From an industry perspective, the study reinforces the trend towards value-based healthcare, where patient outcomes are increasingly paramount. As Orthofix positions itself as a leader in this space, strategic partnerships and further research may bolster its market position, influencing both short-term and long-term business performance.

Financial Analyst

Investors will scrutinize the cost-effectiveness of the SpinalStim™ device and its impact on Orthofix's operating margins. The ability to offer a noninvasive and cost-effective solution that can be used at home positions the company favorably in terms of operational efficiency and customer satisfaction.

However, it is crucial to analyze the company's current valuation in the context of this new data. The medical device sector is known for high research and development costs and the potential revenue generated from the SpinalStim™ device must be weighed against these expenses.

Furthermore, the degree to which this study can drive market expansion and the potential for international growth should be factored into the financial analysis. The global spine surgery devices market is competitive and Orthofix's ability to capitalize on this data to gain a competitive edge will be of interest to stakeholders.

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the publication of new data from a prospective, multicenter study investigating Pulsed Electromagnetic Field (PEMF) stimulation as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis. Published in the International Journal of Spine Surgery¹, 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.

Image of the Orthofix SpinalStim Bone Growth Therapy device. (Graphic: Business Wire)

“Patients with risk factors such as a prior failed fusion, the need for a multilevel fusion, nicotine use, osteoporosis or diabetes often have a difficult time healing after lumbar fusion surgery,” said lead author Dr. Marc Weinstein, an orthopedic spine surgeon at the Florida Orthopaedic Institute in Tampa, Florida. “These risk factors contribute to complications and pseudarthrosis, which can prolong pain and ultimately reduce quality of life. This data reinforces the use of PEMF stimulation after lumbar fusion surgery to improve outcomes regardless of the patients’ risk factors.”

The prospective study conducted at 10 centers across the U.S. analyzed a total of 142 patients with one or more risk factors for pseudarthrosis. Participants were assigned in-home use of the SpinalStim bone growth therapy device for six months following surgery. Fusion was determined by radiographic imaging at 12 months. Successful fusion for patients with one, two or three or more risk factors was 88.5 percent, 87.5 percent and 82.3 percent respectively. Patient reported outcomes that measure disability, function, pain, quality of life, and overall well-being were also evaluated with significant improvements noted when compared to baseline.

“The SpinalStim bone growth therapy device provides a noninvasive and cost-effective means to augment spinal fusion procedures that enables the patient to continue their healing at home,” said Kevin Kenny, President, Orthofix Global Spine. “This new data is important as it adds to the body of evidence supporting the use of PEMF for high-risk patients who face challenges with bone fusion healing.”

About the SpinalStim Bone Growth Therapy Device

The SpinalStim device is the only bone growth stimulation therapy system that is FDA-approved as both an adjunct treatment for lumbar spinal fusion and as a nonsurgical treatment for spinal pseudarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site² and has an overall success rate of 92 percent³ in treating spinal fusion surgery patients. Use of the SpinalStim device is supported by the North American Spine Society’s coverage recommendation⁴.

1. Weinstein MA, Beaumont A, Campbell P, Hassanzadeh H, Patel V, Vokshoor A, Wind J, Radcliff K, Aleem I, Coric D. Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis. Int J Spine Surg. 2023 Oct 26:8549. doi: 10.14444/8549. Epub ahead of print. PMID: 37884337.
2. Zborowski M, Androjna C, Waldorff EI, Midura RJ. Comparison of therapeutic magnetic stimulation with electric stimulation of spinal column vertebrae. IEEE Transactions on Magnetics, Vol. 51, No. 12, December 2105, 5001009. Erratum in IEEE Transactions on Magnetics, Vol. 53, No. 2, February 2017, 9700101.
3. PMA P850007/S6. February 1990.
4. Spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx.

About Orthofix

Orthofix 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, where it conducts general business, product development, medical education and manufacturing, 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. To learn more, visit Orthofix.com.

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, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231221037852/en/

Media Relations

Denise Landry

DeniseLandry@orthofix.com

214.937.2529

Investor Relations

Louisa Smith, Gilmartin Group

IR@orthofix.com

Source: Orthofix Medical Inc.

FAQ

What did Orthofix Medical Inc. (NASDAQ:OFIX) announce?

Orthofix Medical Inc. (NASDAQ:OFIX) announced new data from a study on Pulsed Electromagnetic Field (PEMF) stimulation as a therapy for spinal fusion procedures.

What were the results of the study?

The study showed a high rate of successful fusion and significant improvements in pain, function, and quality of life for patients at risk for pseudarthrosis.

Who conducted the study?

The study was conducted at 10 centers across the U.S.

What were the patient reported outcomes that were evaluated?

The patient reported outcomes that were evaluated included disability, function, pain, quality of life, and overall well-being.

What did Kevin Kenny, President of Orthofix Global Spine, say about the new data?

Kevin Kenny stated that the new data adds to the body of evidence supporting the use of PEMF for high-risk patients who face challenges with bone fusion healing.