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3D Systems' (DDD) Cranial Implant Solution Receives FDA Nod
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3D Systems (DDD - Free Report) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative 3D-printed, patient-specific cranial implant solution, the VSP PEEK Cranial Implant.
VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), and a pre-defined production process.
The VSP PEEK Cranial Implant integrates cutting-edge additive manufacturing techniques with advanced materials, offering several advantages over traditional methods. These implants leverage 3D printing technology and can be tailored precisely to individual patients, leading to improved outcomes and reduced costs.
The VSP PEEK Cranial Implant stands out as the first FDA-cleared additively manufactured PEEK implant for cranioplasty procedures. The solution utilizes up to 85% less material compared to conventionally manufactured implants, resulting in substantial savings, especially considering the high cost of implantable PEEK material.
PEEK, renowned for its exceptional mechanical properties mirroring human bone, offers outstanding biocompatibility, resistance to bodily fluids and stability across temperatures, making it an ideal choice for medical devices. Its radiolucency ensures minimal interference in medical imaging, facilitating clearer evaluations of surgical sites and implant integrity.
The FDA clearance not only expands 3D Systems’ PEEK product portfolio but also paves the way for a comprehensive range of advanced medical solutions. With extensive experience in developing patient-specific implants, 3D Systems is poised to accelerate the development process, offering expedited pathways for its partners and customers to bring innovative products to market.
Anticipated growth in the cranial implants market, driven by technological advancements like 3D printing, underscores the significance of this FDA clearance. According to a report by Acumen Research and Consulting in February 2023, the cranial implants market size in 2021 was roughly $1.2 billion and is anticipated to approach $2.1 billion by 2030.
3D Systems Benefits From Robust Portfolio
Additive manufacturing is gaining traction among larger industries seeking economically viable solutions. 3D Systems’ wide range of solutions includes orthopedic and dental implants for human beings to key components for aerospace, automotive, and many other industrial markets. Increased printer size, speed and reliability are helping 3D Systems offer mass customization of components that is attracting large industrial as well as healthcare companies.
3D Systems expects the additive manufacturing industry to witness a CAGR of more than 20% over the next five to seven years, hitting $80 billion during this timeframe. This opportunity bodes well for DDD, given its portfolio strength and high investments in research & development.
In the fourth quarter of 2023, 3D Systems delivered nine new products, five new materials, three printer upgrades and one key accessory. It recently shipped its first MJP300W jetting system and completed validation of testing on its SLS300 machine. DDD remains involved in the development of 40 new products that are anticipated to be available for release by the end of 2024.
However, uncertain macroeconomic conditions that are keeping customer budgets under pressure and have hurt capital expenditure spending are a concern in the near term. Increasing competition, particularly from new entrants in China in the hardware side of the business, has been a headwind.
These factors have hurt performance year to date, with shares declining 44.4%, underperforming the Zacks Computer & Technology sector’s return of 11.1%.
Image: Bigstock
3D Systems' (DDD) Cranial Implant Solution Receives FDA Nod
3D Systems (DDD - Free Report) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative 3D-printed, patient-specific cranial implant solution, the VSP PEEK Cranial Implant.
VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), and a pre-defined production process.
The VSP PEEK Cranial Implant integrates cutting-edge additive manufacturing techniques with advanced materials, offering several advantages over traditional methods. These implants leverage 3D printing technology and can be tailored precisely to individual patients, leading to improved outcomes and reduced costs.
The VSP PEEK Cranial Implant stands out as the first FDA-cleared additively manufactured PEEK implant for cranioplasty procedures. The solution utilizes up to 85% less material compared to conventionally manufactured implants, resulting in substantial savings, especially considering the high cost of implantable PEEK material.
PEEK, renowned for its exceptional mechanical properties mirroring human bone, offers outstanding biocompatibility, resistance to bodily fluids and stability across temperatures, making it an ideal choice for medical devices. Its radiolucency ensures minimal interference in medical imaging, facilitating clearer evaluations of surgical sites and implant integrity.
3D Systems Corporation Price and Consensus
3D Systems Corporation price-consensus-chart | 3D Systems Corporation Quote
The FDA clearance not only expands 3D Systems’ PEEK product portfolio but also paves the way for a comprehensive range of advanced medical solutions. With extensive experience in developing patient-specific implants, 3D Systems is poised to accelerate the development process, offering expedited pathways for its partners and customers to bring innovative products to market.
Anticipated growth in the cranial implants market, driven by technological advancements like 3D printing, underscores the significance of this FDA clearance. According to a report by Acumen Research and Consulting in February 2023, the cranial implants market size in 2021 was roughly $1.2 billion and is anticipated to approach $2.1 billion by 2030.
3D Systems Benefits From Robust Portfolio
Additive manufacturing is gaining traction among larger industries seeking economically viable solutions. 3D Systems’ wide range of solutions includes orthopedic and dental implants for human beings to key components for aerospace, automotive, and many other industrial markets. Increased printer size, speed and reliability are helping 3D Systems offer mass customization of components that is attracting large industrial as well as healthcare companies.
3D Systems expects the additive manufacturing industry to witness a CAGR of more than 20% over the next five to seven years, hitting $80 billion during this timeframe. This opportunity bodes well for DDD, given its portfolio strength and high investments in research & development.
In the fourth quarter of 2023, 3D Systems delivered nine new products, five new materials, three printer upgrades and one key accessory. It recently shipped its first MJP300W jetting system and completed validation of testing on its SLS300 machine. DDD remains involved in the development of 40 new products that are anticipated to be available for release by the end of 2024.
However, uncertain macroeconomic conditions that are keeping customer budgets under pressure and have hurt capital expenditure spending are a concern in the near term. Increasing competition, particularly from new entrants in China in the hardware side of the business, has been a headwind.
These factors have hurt performance year to date, with shares declining 44.4%, underperforming the Zacks Computer & Technology sector’s return of 11.1%.
Zacks Rank & Stocks to Consider
3D Systems currently has a Zacks Rank #4 (Sell).
NVIDIA (NVDA - Free Report) , Veeva Systems (VEEV - Free Report) and Synopsys (SNPS - Free Report) are some better-ranked stocks in the broader Zacks Computer and Technology sector, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Year to date, shares of NVDA, VEEV and SNPS have gained 73.1%, 4.7% and 5.5%, respectively.
Long-term earnings growth rates for NVIDIA, Veeva Systems and Synopsys are currently pegged at 30.93%, 24.09% and 17.51%, respectively.