3D Systems’ Solution Enables World’s First Facial Implant Manufacturing at Point-of-Care

Rhea-AI Summary

3D Systems (NYSE: DDD) has achieved a significant milestone in medical technology by enabling the world's first Medical Device Regulation (MDR)-compliant 3D-printed PEEK facial implant at the point-of-care. The breakthrough was accomplished in collaboration with the University Hospital Basel, Switzerland, where surgeons successfully implanted the device on March 18, 2025.

The implant was produced using VESTAKEEP® i4 3DF PEEK on 3D Systems' EXT 220 MED printer, which features cleanroom-based architecture and simplified post-processing workflows. Since its launch in August 2023, the EXT 220 MED has been used in over 80 successful cranial implant surgeries at partner hospitals.

The 3D-printed maxillofacial implant market is projected to grow from over $2 billion in 2024 to more than $4 billion by 2034. 3D Systems has already worked with surgeons to plan more than 150,000 patient-specific cases and manufacture over two million implants and instruments for 100+ CE-marked and FDA-cleared devices.

Positive

• First-mover advantage in MDR-compliant 3D-printed PEEK facial implants
• Strong market growth potential with maxillofacial implant market expected to double by 2034
• Proven track record with 80+ successful cranial implant surgeries since August 2023
• Extensive portfolio of 100+ CE-marked and FDA-cleared devices

Negative

• None.

Insights

Medical Technology Analyst

3D Systems' announcement represents a significant technological milestone in patient-specific medical device manufacturing. The successful production and implantation of the world's first MDR-compliant 3D-printed PEEK facial implant at University Hospital Basel demonstrates meaningful clinical validation of their point-of-care manufacturing approach.

The rapid adoption of their EXT 220 MED printer—already used in over 80 successful cranial surgeries since its August 2023 launch—indicates strong market traction and clinical acceptance. This expansion into facial implants broadens their addressable market within the maxillofacial reconstruction sector, which is projected to grow from $2 billion in 2024 to $4 billion by 2034.

From a competitive standpoint, 3D Systems' cleanroom-based printer architecture and simplified post-processing workflows create meaningful differentiation by enabling efficient on-site production of custom implants. This directly addresses the limitations of standard medical devices while potentially improving outcomes, increasing efficiency, and lowering costs—three critical healthcare objectives.

The company's established track record in personalized healthcare solutions (150,000+ patient-specific cases planned and 2+ million implants manufactured) provides the credibility and regulatory expertise necessary to navigate this complex market. This point-of-care manufacturing model represents a paradigm shift in implant production, moving from centralized manufacturing to distributed, hospital-based production that can significantly compress time-to-treatment.

• First 3D-printed PEEK facial implant manufactured at the point-of-care using 3D Systems’ EXT 220 MED
• Point-of-care collaboration between surgeons, engineers, and technology enables tailored solutions to address complex patient needs
• 3D Systems’ solutions accelerating additive manufacturing use in maxillofacial reconstruction — total market anticipated to reach more than $4 billion by end of 2034
  

ROCK HILL, S.C., April 08, 2025 (GLOBE NEWSWIRE) -- Today, 3D Systems (NYSE: DDD) announced that in collaboration with the University Hospital Basel (Switzerland) the Company’s unique point-of-care additive manufacturing solution has been used to design and produce the world’s first Medical Device Regulation (MDR)-compliant 3D-printed PEEK facial implant. Prof. Florian Thieringer and Dr. Neha Sharma, together with their team of biomedical engineers, successfully designed and manufactured a custom device to address a patient’s unique need using 3D Systems technology and product manufacturing expertise. They used this implant as part of a successful surgery completed at the hospital on March 18, 2025. Production of the first MDR-compliant facial implant was completed using VESTAKEEP^® i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED. The cleanroom-based architecture of the printer and simplified post-processing workflows enable the efficient production of patient-specific medical devices directly at the hospital.

“Our goal is always to provide the best possible care for our patients,” said Prof. Thieringer. “Being directly involved in both the design and manufacturing of patient-specific implants — right here in our hospital — allows us to tailor treatments precisely to individual needs, respond faster, and improve surgical outcomes. The ability to produce implants on demand represents a new era in personalized care.”

For more than a decade, surgeons have used VSP^® surgical planning solutions that combine best-in-class digital workflows with the industry’s broadest additive manufacturing portfolio of printers and materials to deliver comprehensive patient-matched solutions. Bringing together surgeons, engineers, and technology in the clinical setting allows for the immediate development of patient-specific treatments, overcoming the limitations of standard medical devices. As a result, healthcare providers are improving outcomes^1,2, increasing efficiency³, and lowering the cost of care⁴. 

“The rapid adoption of the EXT 220 MED by leading healthcare institutions combined with our expanding applications pipeline, underscores the transformative power of 3D printing in clinical settings,” said Stefan Leonhardt, Ph.D., director, medical devices, 3D Systems. “We are proud to collaborate with the pioneering clinicians at University Hospital Basel and other leading hospitals worldwide to expand the applications that can be addressed with additive manufacturing. Since its launch in August 2023, our innovative solution has already been utilized in more than 80 successful cranial implant surgeries at partner hospitals, demonstrating its swift integration and real-world effectiveness in delivering personalized patient care. The successful use of the EXT 220 MED for maxillofacial implants showcases our commitment to ongoing innovation that delivers personalized healthcare solutions for new applications.”

It is anticipated that the use of 3D-printed facial implants will accelerate based on the availability of advanced technologies. According to Market Research Future⁵, the 3D-printed maxillofacial implant market size was estimated at more than $2 billion in 2024 and is anticipated to more than double to over $4 billion by the end of 2034. Additive manufacturing is disrupting this sector by enabling a more cost-effective, efficient solution. As a pioneer in personalized healthcare solutions, 3D Systems has worked with surgeons for over a decade to plan more than 150,000 patient-specific cases and additively manufacture more than two million implants and instruments for 100+ CE-marked and FDA-cleared devices from its world-class, FDA-registered, ISO 13485-certified facilities in Littleton, Colorado, and Leuven, Belgium. For more information, please visit the Company’s website.

Forward-Looking Statements
Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as “believes,” “belief,” “expects,” “may,” “will,” “estimates,” “intends,” “anticipates” or “plans” or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings “Forward-Looking Statements” and “Risk Factors” in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise, except as required by law.

About 3D Systems
More than 35 years ago, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the company is available at www.3dsystems.com.

Investor Contact:   investor.relations@3dsystems.com 
Media Contact:      press@3dsystems.com

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¹ Ballard DH, Trace AP, Ali S, et al. Clinical Applications of 3D Printing: Primer for Radiologists. Acad Radiol 2018;25(1):52–65. 
² Chepelev L, Wake N, Ryan J, et al. Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios. 3D Print Med 2018;4(1):11. 
³ Morgan C, Khatri C, Hanna SA, Ashrafian H, Sarraf KM. Use of three-dimensional printing in preoperative planning in orthopaedic trauma surgery: A systematic review and meta-analysis. World J Orthop 2020;11(1):57– 67.
⁴ Ballard DH, Mills P, Duszak R Jr, Weisman JA, Rybicki FJ, Woodard PK. Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides. Acad Radiol. 2020 Aug;27(8):1103-1113.
⁵ Market Research Future, 3D Printed Maxillofacial Implant Market Research Report By Application (Craniomaxillofacial Reconstruction, Dental Implants, Orthognathic Surgery, Trauma Reconstruction), By Material (Titanium, POM, Polyether Ether Ketone, Glass Ceramics), By Technology (Stereolithography, Selective Laser Sintering, Fused Deposition Modeling, Computer-Aided Design), By End Use (Hospitals, Dental Clinics, Ambulatory Surgical Centers) and By Regional (North America, Europe, South America, Asia-Pacific, Middle East and Africa) - Forecast to 2034 (March 2025).

FAQ

What is the market potential for 3D-printed maxillofacial implants by 2034?

The market is expected to grow from $2 billion in 2024 to over $4 billion by 2034, according to Market Research Future.

How many successful cranial implant surgeries has DDD's EXT 220 MED been used in?

Since its August 2023 launch, the EXT 220 MED has been used in more than 80 successful cranial implant surgeries at partner hospitals.

When was the first 3D-printed PEEK facial implant surgery performed using DDD's technology?

The first surgery was performed on March 18, 2025, at the University Hospital Basel, Switzerland.

How many patient-specific cases has DDD planned with surgeons?

3D Systems has planned more than 150,000 patient-specific cases and manufactured over two million implants and instruments.