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Orthofix's (OFIX) SpinalStim Demonstrates Improved Fusion Rates

Orthofix Medical Inc. OFIX recently announced the publication of retrospective data that assessed the fusion rates in patients receiving three-and four-level lumbar arthrodesis surgery who were treated adjunctively with the SpinalStim bone growth therapy device.

The SpinalStim device is an FDA authorized bone growth stimulator that is used as an adjunct for lumbar spinal fusion procedures and as an alternative for treating failed spinal fusion surgery. The device is known to emit 360 degrees of Pulsed Electromagnetic Field Stimulation (PEMF) treatment around the fusion site, covering up to five vertebral levels.

Results from the study show impressive fusion rate across all patient types, including those potentially at high risk of fusion failure, reconfirming the benefit PEMF therapy can offer following multi-level lumbar fusion surgery.

The recent findings backing the SpinalStim device is expected to bolster Orthofix’s Bone Growth Therapies arm.

More in the Study

The study collected data from 55 patients diagnosed with lumbar degenerative disease, spinal stenosis, and/or spondylolistheses who underwent three- or four-level arthrodesis surgery followed by PEMF treatment with the SpinalStim device.

The results published in The International Journal of Spine Surgery confirmed that the efficacy of PEMF stimulation with the SpinalStim device in three- and four-level fusion surgery patients was similar to the results observed in the original Orthofix IDE clinical study conducted in patients with one- and two-level lumbar procedures.

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It showed an overall 92.7% fusion rate at 12-month follow-up in patients regardless of risk factors such as diabetes, obesity, tobacco use, advanced age and osteoporosis that are often linked to higher rates of nonunion or bone healing complications.

Industry Prospects

Per a report published in MarketsandMarkets, the global bone growth stimulator market is expected to see CAGR of 5.4% by 2022. Factors fueling market growth include growing patient preference for non-invasive and minimally-invasive surgical treatments; surge in target patient population; procedural benefits such as reduced hospital stay, fewer risks for complications and infections; and clinical evidence supporting the efficacy of bone growth stimulation products in the effective and rapid bone regeneration.

Given the market prospects, the retrospective data backing Orthofix’s SpinalStim device bears strategic significance.

Notable Developments

In June 2021, Orthofix announced the U.S. launch and first patient implant of the FORZA Ti PLIF Spacer System. The FORZA Ti Spacer is a titanium lumbar interbody device featuring Orthofix’s unique Nanovate Technology. It is developed to enhance Posterior Lumbar Interbody Fusion procedures.

In May 2021, Orthofix announced the U.S. and European full market launch of OSCAR PRO Ultrasonic Arthroplasty Revision System. The product is a fourth-generation iteration of Orthofix’s successful OSCAR product family. It aids the removal of bone cement during complex joint revision surgeries.

In the same month, Orthofix expanded its pediatric offerings with the FDA’s 510(k) clearance of the OrthoNext digital platform, which is the only software tool in the market that offers deformity analysis and preoperative planning for pediatric orthopedic procedures. The OrthoNext digital platform is developed specifically for use with the JuniOrtho Plating System.  

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 23.5% compared to the industry’s 17.5% growth.

Zacks Rank and Key Picks

Currently, Orthofix carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space include Apollo Medical Holdings, Inc. AMEH, Envista Holdings Corporation NVST and Teleflex Incorporated TFX.

Apollo Medical, which carries a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 20%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Envista Holdings, which carries a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.4%.

Teleflex, sporting a Zacks Rank #2, has a long-term earnings growth rate of 11%.

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