Orthofix Medical Inc. OFIX recently announced favorable results from its two-year U.S. Investigational Device Exemption ("IDE") study. This announcement came on the heels of the recent FDA approval of the company’s M6-C artificial cervical disc. The outcome was demonstrated at the International Society for the Advancement of Spine Surgery ("ISASS") annual meeting in Anaheim, California.
The study was a non-randomized, controlled clinical trial, conducted at 23 locations in the United States with an average patient age of 44 years. The primary goal of the study was to assess the safety and efficacy of the M6-C artificial cervical disc in comparison to anterior cervical discectomy and fusion ("ACDF") for the treatment of single level symptomatic cervical radiculopathy with or without cord compression.
Results of the Study
The data highlights that patients who received treatment on the M6-C artificial cervical disc witnessed some major benefits when compared to patients on the ACDF treatment. These benefits were significant reduction in neck and arm pain, improvement in neurological functions, maintenance of natural disc motion and better quality of life. Moreover, the patients using the M6-C cervical disc reported a significant alleviation in pain and much lower dependence on opioid medications in comparison to patients on ACDF treatment. After two years, patients in the ACDF group were found to have seven times higher tendency of opioid use than those in the M6-C disc group.
The clinical study data statistically demonstrated some other key advantages of the M6-C device over the ACDF treatment, viz. improvement of Neck Disability Index, significant reduction in average surgery time, higher satisfaction rate with surgery and lower incidence of adverse events.
Per PS market research, the global artificial disc market is projected to see a CAGR of 18.8% during the 2014-2024 period.
Developments Related to M6-C Cervical Disc
In February 2019, the M6-Cartificial cervical disc received FDA approval for treatment of cervical disc degeneration. This M6-C artificial cervical disc was designed by Spinal Kinetics, a company acquired by Orthofix last April.
The launch of the M6-C artificial cervical disc in the United States has strengthened Orthofix’s spine portfolio. The favorable study results are expected to widen the scope of the device in the United States.
Over the past three months, the Orthofix stock has outperformed the industry it belongs to. The stock has rallied 9.8% compared with the industry’s rise of 8.7%.
Zacks Ranks and Key Picks
Orthofix currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are Stryker Corporation SYK, Penumbra, Inc. PEN and Amedisys, Inc. AMED. Notably, each of these stocks currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker’s long-term earnings growth rate is projected at 10%
Penumbra’s long-term earnings growth rate is estimated at 20.9%.
Amedisys’s long-term earnings growth rate is projected at 19.7%.
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