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Globus Medical (GMED) Gets FDA Nod for ExcelsiusFlex, ACTIFY 3D
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Globus Medical, Inc. (GMED - Free Report) recently announced that its ExcelsiusFlex with Total Knee Arthroplasty (“TKA”) application has received 510(k) clearance from the Food and Drug Administration (“FDA”). The ACTIFY 3D Total Knee System has also received 510(k) clearance.
With the addition of ExcelsiusFlex and ACTIFY 3D, the company aims to introduce next-generation robotic technology, along with the next generation of implant technology, to the orthopedic market.
About ExcelsiusFlex
ExcelsiusFlex is engineered to assist surgeons in primary TKA procedures for robotically guided resections based on implant placement planning. Streamlined user software is designed to enable efficient procedures.
This new robotic navigation platform is set to expand the Excelsius ecosystem.
About ACTIFY 3D
The ACTIFY 3D Total Knee System is a contemporary total knee solution designed to pair cementless reconstruction with operative efficiency and anatomic fit. ACTIFY 3D is engineered, either through manual or robotic-assisted workflows, to combine strength and a porous lattice interface conducive to cementless fixation. The system provides a comprehensive suite of implants and instruments to address individual surgeon preferences and varying anatomy in a diverse patient population.
ACTIFY 3D will be paired with the ExcelsiusFlex platform.
More on the News
The TKA implant systems that are compatible with ExcelsiusFlex are GENflex2 and ACTIFY Total Knee System.
ExcelsiusFlex, when used in conjunction with ExcelsiusHub, is intended for precisely located anatomical structures and spatial positioning and orientation of a tool holder. Itis to be used by surgeons for navigating and/or guiding compatible surgical instruments.
ACTIFY Total Knee System and ACTIFY 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Image Source: Zacks Investment Research
Followed by the latest FDA clearances, Globus Medical is ramping up the production of Excelsiusflex and ACIFY 3D, and preparing for their commercial release.
Industry Prospects
Per a Skyquest report, the global Knee Replacement market was valued at $10.34 billion in 2022 and is poised to grow from $10.93 billion in 2023 to $16.99 billion by 2031, at a CAGR of 5.67%. The aging population and increased desire for less invasive surgical procedures are primary factors likely to fuel the market growth rate. Additionally, an increase in the frequency of bone-related ailments, accidents and obesity, and the convenience of modern designs are also responsible for driving the market’s expansion.
Looking at the market growth, the Latest FDA clearance turns out to be in favor of Globus Medical.
Robust Prospects in Musculoskeletal Arm
Globus Medical is gaining market share in the musculoskeletal solutions space, banking on the strong performance of its implantable devices, biologics, accessories and unique surgical instruments used in an expansive range of orthopedic procedures.
At the beginning of this fiscal year, the company launched several new products, such as the DuraPro and VERZA power tool systems, the Reline 3D system for complex spinal deformity, the ANTHEM Distal Radius system with additional plating options and the ADIRA Aflex Plate system.
Price Performance
In the past year, shares of GMED have risen 16.7% compared with the industry’s 0.5% growth.
Zacks Rank and Other Key Picks
Globus Medical currently sports a Zacks Rank #1 (Strong Buy).
Hims & Hers Heath’s shares have surged 141.3% in the past year. Estimates for the company’s earnings have moved north 11.1% to 20 cents per share for 2024 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
The Zacks Consensus Estimate for Veracyte’s 2024 loss per share has remained constant at 5 cents in the past 30 days. Shares of the company have lost 8.1% year to date against the industry’s 6.1% growth.
VCYT’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 59.65%. In the last reported quarter, it delivered an earnings surprise of 89.47%.
Estimates for Haemonetics’ 2024 EPS have increased 2.4% to $4.57 in the past 60 days. Year to date, shares of HAE have risen 5.7% against the industry’s 3.2% decline.
In the last reported quarter, HAE delivered an earnings surprise of 2.27%. The company has a trailing four-quarter average earnings surprise of 13.24%.
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Globus Medical (GMED) Gets FDA Nod for ExcelsiusFlex, ACTIFY 3D
Globus Medical, Inc. (GMED - Free Report) recently announced that its ExcelsiusFlex with Total Knee Arthroplasty (“TKA”) application has received 510(k) clearance from the Food and Drug Administration (“FDA”). The ACTIFY 3D Total Knee System has also received 510(k) clearance.
With the addition of ExcelsiusFlex and ACTIFY 3D, the company aims to introduce next-generation robotic technology, along with the next generation of implant technology, to the orthopedic market.
About ExcelsiusFlex
ExcelsiusFlex is engineered to assist surgeons in primary TKA procedures for robotically guided resections based on implant placement planning. Streamlined user software is designed to enable efficient procedures.
This new robotic navigation platform is set to expand the Excelsius ecosystem.
About ACTIFY 3D
The ACTIFY 3D Total Knee System is a contemporary total knee solution designed to pair cementless reconstruction with operative efficiency and anatomic fit. ACTIFY 3D is engineered, either through manual or robotic-assisted workflows, to combine strength and a porous lattice interface conducive to cementless fixation. The system provides a comprehensive suite of implants and instruments to address individual surgeon preferences and varying anatomy in a diverse patient population.
ACTIFY 3D will be paired with the ExcelsiusFlex platform.
More on the News
The TKA implant systems that are compatible with ExcelsiusFlex are GENflex2 and ACTIFY Total Knee System.
ExcelsiusFlex, when used in conjunction with ExcelsiusHub, is intended for precisely located anatomical structures and spatial positioning and orientation of a tool holder. Itis to be used by surgeons for navigating and/or guiding compatible surgical instruments.
ACTIFY Total Knee System and ACTIFY 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Image Source: Zacks Investment Research
Followed by the latest FDA clearances, Globus Medical is ramping up the production of Excelsiusflex and ACIFY 3D, and preparing for their commercial release.
Industry Prospects
Per a Skyquest report, the global Knee Replacement market was valued at $10.34 billion in 2022 and is poised to grow from $10.93 billion in 2023 to $16.99 billion by 2031, at a CAGR of 5.67%. The aging population and increased desire for less invasive surgical procedures are primary factors likely to fuel the market growth rate. Additionally, an increase in the frequency of bone-related ailments, accidents and obesity, and the convenience of modern designs are also responsible for driving the market’s expansion.
Looking at the market growth, the Latest FDA clearance turns out to be in favor of Globus Medical.
Robust Prospects in Musculoskeletal Arm
Globus Medical is gaining market share in the musculoskeletal solutions space, banking on the strong performance of its implantable devices, biologics, accessories and unique surgical instruments used in an expansive range of orthopedic procedures.
At the beginning of this fiscal year, the company launched several new products, such as the DuraPro and VERZA power tool systems, the Reline 3D system for complex spinal deformity, the ANTHEM Distal Radius system with additional plating options and the ADIRA Aflex Plate system.
Price Performance
In the past year, shares of GMED have risen 16.7% compared with the industry’s 0.5% growth.
Zacks Rank and Other Key Picks
Globus Medical currently sports a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks in the broader medical space are Hims & Hers Health, Inc. (HIMS - Free Report) , Veracyte (VCYT - Free Report) and Haemonetics (HAE - Free Report) . While Hims & Hers Health and Veracyte currently sport a Zacks Rank #1 each, Haemonetics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Hims & Hers Heath’s shares have surged 141.3% in the past year. Estimates for the company’s earnings have moved north 11.1% to 20 cents per share for 2024 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
The Zacks Consensus Estimate for Veracyte’s 2024 loss per share has remained constant at 5 cents in the past 30 days. Shares of the company have lost 8.1% year to date against the industry’s 6.1% growth.
VCYT’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 59.65%. In the last reported quarter, it delivered an earnings surprise of 89.47%.
Estimates for Haemonetics’ 2024 EPS have increased 2.4% to $4.57 in the past 60 days. Year to date, shares of HAE have risen 5.7% against the industry’s 3.2% decline.
In the last reported quarter, HAE delivered an earnings surprise of 2.27%. The company has a trailing four-quarter average earnings surprise of 13.24%.