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Orthofix (OFIX) Reaches Milestone for M6-C Disc Implants
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Orthofix Medical Inc. (OFIX - Free Report) attained a milestone with more than 60,000 M6-C artificial cervical discs being implanted around the world. TheM6-C disc is a next-generation artificial disc, which is intended to mimic a native disc’s natural movements. It has been developed to replace an intervertebral disc damaged by cervical disc degeneration as an alternative to cervical fusion.
The M6-C disc received FDA’s authorization in 2019. It was first approved for distribution under the CE Mark in the European Union and other international geographies.
Per management, with more than 60,000 devices implanted worldwide, the M6-C disc is continuing to establish a market-leading position globally.
More About M6-C Disc
The M6-C disc is made up of an artificial visco-elastic nucleus and fiber annulus. Its unique design absorbs shock at the implanted level and offers a controlled range of motion as the spine bends and translates in several planes like a natural disc. The M6-C disc is known to be the only device with these features available in the United States.
Image Source: Zacks Investment Research
In August 2021, Orthofix reported the first patient implant in a FDA clinical study, comparing the M6-C disc to anterior cervical discectomy and fusion (ACDF). The study conducted under a U.S. Investigational Device Exemption is assessing the safety and effectiveness of the M6-C disc compared to ACDF for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7, with or without spinal cord compression.
Industry Prospects
Per a report published in Global Market Insights, the artificial disc market is expected to witness more than 18.6% CAGR by 2026. Factors driving the market include several product and technological innovations like multi-level disc replacement, rising incidence of degenerative disc diseases, long-term cost benefits, owing to reduced re-operation rate for disc replacement, and the growing propensity for minimal incision surgery.
Further, the growing awareness regarding the benefits of the disc-replacement procedure over spinal fusion surgeries is expected to fuel market growth.
Given the substantial market prospects, Orthofix’s recent milestone with the M6-C disc implants seems strategic.
Notable Developments
Orthofix has been engaging in a number of significant developments in September 2021.
The company launched the Opus Mg Set osteoconductive scaffold, a synthetic magnesium-based bone void filler utilized in orthopedic procedures. The Opus Mg Set adds to the company’s comprehensive portfolio of biologic solutions. By filling non-structural bony voids or gaps during surgery, the Opus Mg Set offers a procedure-specific solution for orthopedic fracture care and trauma applications.
The company announced that the Fitbone intramedullary lengthening system implant for limb lengthening of the femur and tibia bones has been placed in the first U.S. pediatric patient. The Fitbone system is the only FDA-approved intramedullary limb lengthening solution for pediatric and adult use. It is available in sizes of 9mm, 11mm and 13mm, to address the specific needs of patients. The Fitbone system is compatible with the OrthoNext digital platform at present.
Share Price Performance
The stock has outperformed its industry over the past year. It has rallied 26.2% compared to the industry’s growth of 18.3%.
Zacks Rank and Other Key Picks
Currently, Orthofix carries a Zacks Rank #2 (Buy).
Image: Bigstock
Orthofix (OFIX) Reaches Milestone for M6-C Disc Implants
Orthofix Medical Inc. (OFIX - Free Report) attained a milestone with more than 60,000 M6-C artificial cervical discs being implanted around the world. TheM6-C disc is a next-generation artificial disc, which is intended to mimic a native disc’s natural movements. It has been developed to replace an intervertebral disc damaged by cervical disc degeneration as an alternative to cervical fusion.
The M6-C disc received FDA’s authorization in 2019. It was first approved for distribution under the CE Mark in the European Union and other international geographies.
Per management, with more than 60,000 devices implanted worldwide, the M6-C disc is continuing to establish a market-leading position globally.
More About M6-C Disc
The M6-C disc is made up of an artificial visco-elastic nucleus and fiber annulus. Its unique design absorbs shock at the implanted level and offers a controlled range of motion as the spine bends and translates in several planes like a natural disc. The M6-C disc is known to be the only device with these features available in the United States.
In August 2021, Orthofix reported the first patient implant in a FDA clinical study, comparing the M6-C disc to anterior cervical discectomy and fusion (ACDF). The study conducted under a U.S. Investigational Device Exemption is assessing the safety and effectiveness of the M6-C disc compared to ACDF for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7, with or without spinal cord compression.
Industry Prospects
Per a report published in Global Market Insights, the artificial disc market is expected to witness more than 18.6% CAGR by 2026. Factors driving the market include several product and technological innovations like multi-level disc replacement, rising incidence of degenerative disc diseases, long-term cost benefits, owing to reduced re-operation rate for disc replacement, and the growing propensity for minimal incision surgery.
Further, the growing awareness regarding the benefits of the disc-replacement procedure over spinal fusion surgeries is expected to fuel market growth.
Given the substantial market prospects, Orthofix’s recent milestone with the M6-C disc implants seems strategic.
Notable Developments
Orthofix has been engaging in a number of significant developments in September 2021.
The company launched the Opus Mg Set osteoconductive scaffold, a synthetic magnesium-based bone void filler utilized in orthopedic procedures. The Opus Mg Set adds to the company’s comprehensive portfolio of biologic solutions. By filling non-structural bony voids or gaps during surgery, the Opus Mg Set offers a procedure-specific solution for orthopedic fracture care and trauma applications.
The company announced that the Fitbone intramedullary lengthening system implant for limb lengthening of the femur and tibia bones has been placed in the first U.S. pediatric patient. The Fitbone system is the only FDA-approved intramedullary limb lengthening solution for pediatric and adult use. It is available in sizes of 9mm, 11mm and 13mm, to address the specific needs of patients. The Fitbone system is compatible with the OrthoNext digital platform at present.
Share Price Performance
The stock has outperformed its industry over the past year. It has rallied 26.2% compared to the industry’s growth of 18.3%.
Zacks Rank and Other Key Picks
Currently, Orthofix carries a Zacks Rank #2 (Buy).
A few other top-ranked stocks from the Medical-Instruments industry are Semler Scientific Inc. , Alcon Inc. (ALC - Free Report) and IDEXX Laboratories, Inc. (IDXX - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Semler Scientific has a long-term earnings growth rate of 25%.
Alcon has a long-term earnings growth rate of 17.7%.
IDEXX has a long-term earnings growth rate of 19.9%.