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
outcomes1,2, 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 StatementsCertain 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
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).
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