Orthofix (OFIX) Releases New Data for Spinal Fusion Procedures

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Orthofix Medical Inc. OFIX recently released favorable data on Pulsed Electromagnetic Field (PEMF) stimulation. This prospective, multicenter study, published in the International Journal of Spine Surgery, sheds light on the efficacy of Orthofix's SpinalStim bone growth therapy device as an adjunct therapy for lumbar spinal fusion procedures, particularly in patients at risk of pseudarthrosis.

This is a significant step forward in terms of the company’s efforts to expand its global spine business.

Study Details

The study, conducted across 10 U.S. centers and involving 142 patients with one or more risk factors for pseudarthrosis, revealed a success rate of 88.5%, 87.5%, and 82.3% for patients with one, two, or three or more risk factors, respectively. Dr. Marc Weinstein, the lead author, emphasized the challenges faced by patients with risk factors, such as prior failed fusion, multilevel fusion, nicotine use, osteoporosis or diabetes. The SpinalStim device, however, is claimed to significantly improve outcomes in terms of pain relief, function and overall quality of life.

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Strategic Significance

The SpinalStim bone growth therapy device is the only FDA-approved system for both lumbar spinal fusion adjunct treatment and nonsurgical spinal pseudarthrosis treatment. The device, utilizing PEMF technology, is offering 360 degrees of treatment coverage around the fusion site, achieving 92% success rate in treating spinal fusion surgery patients.

According to Orthofix, this data highlights the noninvasive and cost-effective nature of SpinalStim, enabling patients to continue their healing in the comfort of their homes.

The evidence provided by this study has reinforced the use of PEMF stimulation for high-risk patients undergoing lumbar fusion surgery. The SpinalStim bone growth therapy device is expected to enhance spinal fusion outcomes, strengthening Orthofix’s in the spine implant space.

Market Prospects

Going by a Grand View Research report, the global spinal implants and devices market, valued at $12.8 billion in 2022, is set to witness a 5.2% CAGR from 2023 to 2030. Driven by the surge in spinal cord injuries worldwide, the market's growth stems from factors like spine degeneration, fractures and abnormalities. Increasing cases of spinal disorders, fractures and injuries, coupled with a demand for advanced medical technology, contribute to the market's trajectory. The rising elderly population and obesity-related vertebral column disorders further propel the need for spinal surgery, ensuring sustained market expansion. With preventable causes like falls and accidents contributing to a significant number of spinal cord injuries globally, the market's prospects remain robust, addressing the pressing healthcare needs of a growing population.

Share Price Performance

Shares of OFIX have declined 28.5% over the past year against the industry’s 5.6% growth.

Zacks Rank and Other Key Picks

Orthofix currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the broader medical space are Insulet PODD, Haemonetics HAE and DexCom DXCM. Insulet sports a Zacks Rank #1 (Strong Buy), while Haemonetics and DexCom each presently carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Insulet’s 2023 earnings per share have moved up from $1.90 to $1.91 in the past 30 days. Shares of the company have lost 26% in the past year compared with the industry’s decline of 2.6%.

PODD’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 105.1%. In the last reported quarter, it delivered an average earnings surprise of 77.4%.

Haemonetics’ stock has risen 12.3% in the past year. Earnings estimates for Haemonetics have increased from $3.86 per share to $3.89 per share for 2023 and from $4.11 per share to $4.15 per share for 2024 in the past 30 days.

HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.

Estimates for DexCom’s 2023 earnings per share have increased from $1.43 to $1.44 in the past 30 days. Shares of the company have increased 11.2% in the past year compared with the industry’s growth of 2.1%.

DXCM’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 36.4%. In the last reported quarter, it delivered an average earnings surprise of 47.1%.

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