- Chicago-based Dimension Inx, a regenerative therapeutics
company, has now had its innovative CMFlex material implanted in
multiple patients
- CMFlex is an off-the-shelf, customizable bone graft material
indicated for maxillofacial, mandibular, and dental bone
defects
- The first 3D printed regenerative bone graft product cleared by
the FDA, CMFlex has now been used in two patient jaw surgeries, an
upper and lower, and several dental socket preservation cases
- CMFlex eliminates the need for doctors to invasively harvest
bone from another area of a patient's body and shape it into a
desired anatomy for a bone graft
- Dimension Inx developed and manufactures CMFlex on the Desktop
Health 3D-Bioplotter Manufacturing Series model
- The 3D-Bioplotter has now been used for separate in-patient
applications in Germany and the United States, as bioprinting
applications in development for years begin advancing to the first
in-patient applications
- A video showcasing the work done by Dimension Inx on the
3D-Bioplotter is now available at TeamDM.com/CMFlex
Desktop Health – the trusted production-grade medical 3D
printing brand of Desktop Metal, Inc. (NYSE: DM) – today announced
the first patients have been treated with CMFlex™, an off-the-shelf
3D printed synthetic bone graft product developed and manufactured
by Chicago-based Dimension Inx on the 3D-Bioplotter®.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20231129556039/en/
CMFlex™ was co-invented by Dimension Inx
co-founders, Dr. Ramille Shah, CSO, Head of R&D, (pictured
right) and Dr. Adam Jakus, CTO, Head of Technology Strategy,
(pictured left). The duo have been developing the material and
product since 2009 on the Desktop Health 3D-Bioplotter®. (Photo:
Business Wire)
Founded in 2017, Dimension Inx is a regenerative therapeutics
company that designs, develops, and manufactures therapeutic
products to restore tissue and organ function. The company owns
four Desktop Health 3D-Bioplotters – two used for R&D and two
used for manufacturing their commercial CMFlex product.
Dimension Inx received FDA clearance of CMFlex in December of
2022. CMFlex is currently available to a limited number of key
surgeons with a broader release to follow later in 2024.
The first jaw cases were performed by Dr. Derek Steinbacher,
Director of West River Surgery Center (Guilford, CT ), Former
Professor Plastic surgery and Chief of Oral and Maxillofacial
surgery at Yale New Haven Health, and Dr. Brian Farrell, DDS, MD,
of the Carolinas Center for Oral & Facial Surgery (Charlotte,
NC). Procedures performed included a mandibular angle augmentation
(surgery of the lower jaw) and maxillary segmental osteotomy
(surgery of the upper jaw).
CMFlex has also been used in dental socket preservation
surgeries for future dental implant placement by Dr. Robert Bosack,
DDS, Oral, Maxillofacial & Dental Implant Surgery (Orland Park,
IL).
“These first cases are not only indicative of a new generation
of biomaterials, but also highlight our technology platform’s
unique capability to rapidly create biomaterials that direct cell
behavior to restore tissue and organ function. It is a proud moment
for us to be able to demonstrate the value of therapeutics derived
from integrating novel biomaterial design and 3D-printing
approaches,” said Dr. Adam Jakus, CTO, Head of Technology Strategy,
and Dimension Inx co-founder.
Dr. Ramille Shah, CSO, Head of R&D, and co-founder of
Dimension Inx, added, "We’re excited by the interest we’ve already
received from surgeons who recognize the importance of a
ready-to-use solution with great handling characteristics and the
ability to cut and shape the graft to match the defect site.”
About CMFlex
CMFlex is comprised primarily of hydroxyapatite, a naturally
occurring mineral found in bone, combined with biodegradable
polylactide-co-glycolide (PLG) polymer. Both materials have an
extensive history demonstrating biocompatibility and clinical
utility. Dimension Inx combines these base materials into a
proprietary, microstructurally porous composite material,
Hyperelastic Bone®, as first published in Science Translational
Medicine in 2016.
This unique, easily deployable bone repair material is then 3D
printed into CMFlex. which has an engineered architecture with
nano, micro, and macro-level features designed to promote natural
bone regeneration after implantation, without the need for an
invasive autograft.
The resulting product is one that surgeons can size for each
patient and is uniquely capable of absorbing fluid, which enables
it to control bleeding during surgery while assisting the bone
remodeling process once implanted.
“After many years of research and development, we’re proud to
see the first bioprinting applications move into clinical use with
patients,” said Ric Fulop, Founder and CEO of Desktop Metal. “We
are especially proud that our 3D-Bioplotter platform is accurate,
reliable, and robust enough to take customer inventions all the way
from R&D to commercial manufacturing on the same platform.”
The 3D-Bioplotter is a sophisticated extrusion-based 3D printer
that processes liquids, melts, pastes, gels, or other materials,
including cells, through a needle tip on a Swiss-made, 3-axis
gantry system with high accuracy and repeatability, along with
tight controls for temperature, sterility, and design.
3D-Bioplotter offers eight printheads with the widest range of
temperatures in bioprinting – from 2°C to 500°C (35.6°F to 932°F) –
enabling complex, multi-material medical parts.
3D-Bioplotter is also the world’s most cited and researched
bioprinter in peer-reviewed scientific and medical journals, with
more than 2,490 citations and more than 640 research papers
directly produced with the system. To learn more, visit
TeamDM.com/3DBioplotter.
About Desktop Metal
Desktop Metal (NYSE:DM) is driving Additive Manufacturing 2.0, a
new era of on-demand, digital mass production of industrial,
medical, and consumer products. Our innovative 3D printers,
materials, and software deliver the speed, cost, and part quality
required for this transformation. We’re the original inventors and
world leaders of the 3D printing methods we believe will empower
this shift, binder jetting and digital light processing. Today, our
systems print metal, polymer, sand and other ceramics, as well as
foam and recycled wood. Manufacturers use our technology worldwide
to save time and money, reduce waste, increase flexibility, and
produce designs that solve the world’s toughest problems and enable
once-impossible innovations. Learn more about Desktop Metal and our
#TeamDM brands at www.desktopmetal.com.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. Forward-looking
statements generally are identified by the words “believe,”
“project,” “expect,” “anticipate,” “estimate,” “intend,”
“strategy,” “future,” “opportunity,” “plan,” “may,” “should,”
“will,” “would,” “will be,” “will continue,” “will likely result,”
and similar expressions. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties. Many factors could
cause actual future events to differ materially from the
forward-looking statements in this document, including but not
limited to the risks and uncertainties set forth in Desktop Metal,
Inc.'s filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and Desktop Metal, Inc. assumes no obligation and does
not intend to update or revise these forward-looking statements,
whether as a result of new information, future events, or
otherwise.
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Investor Relations: (857) 504-1084 DesktopMetalIR@icrinc.com
Media Relations: Sarah Webster sarahwebster@desktopmetal.com
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