Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite

Introductory Workflow, Mimics Enlight Mitral provides support for
transcatheter mitral valve replacements

CHICAGO–(BUSINESS WIRE)–$MTLS #3Dprinting–TVT2019 – Structural Heart Summit — Materialise (NASDAQ:MTLS), a
global 3D printing software and solutions company, has received FDA
clearance for its Mimics Enlight cardiovascular planning software suite.
The first release will support clinicians planning complex transcatheter
mitral valve replacement (TMVR) procedures.

Mimics Enlight is based on the strengths of Materialise’s Mimics
Innovation Suite, which has helped clinicians produce patient-specific
3D models for more than 20 years. Created in collaboration with Henry
Ford Health System in Detroit with Dr. Dee Dee Wang, MD, FACC, Director
of Structural Heart Imaging, and leveraging the Henry Ford Innovation
Institute’s patented workflow, Mimics Enlight is intended to support
patient selection and planning for structural heart and vascular
therapy. The software is the first of its kind to include consistent
methods of taking critical measurements. This enables clinicians to
reliably plan and screen patients for cardiovascular procedures. The
TMVR workflow provides a streamlined, easy-to-use clinical workflow for
planning complex procedures to correct mitral regurgitation, a disease
affecting nearly one in 10 people age 75 and older.

“We believe in the power of our mission to create a better and healthier
world,” said Bryan Crutchfield, vice president and general manager of
Materialise North America. “We work very closely with teams at our
partner hospitals and medical device companies to identify areas where
3D planning and printing can improve their ability to plan procedures.
With the FDA clearance of Mimics Enlight, we are expanding the 3D
toolkit for cardiologists working to treat patients with complex
cardiovascular issues, starting with mitral valve replacement.”

Each mitral valve replacement differs due to a patient’s unique anatomy,
making procedural planning crucial to the successful implantation of
TMVR devices. Accurate measurements during planning are vital for
predicting patients’ risk for left ventricle outflow track (LVOT)
obstruction, a complication resulting in obstruction of blood flow out
of the left ventricle to the rest of the body.

“Materialise has a wealth of medical technology and experience built
throughout two decades of development and implementation of the Mimics
Innovation Suite,” said Brigitte de Vet-Veithen, vice president of
Materialise Medical. “That expertise in delivering patient-specific
solutions serves as the foundation for Mimics Enlight Mitral’s ability
to consistently view and measure each patient’s complex mitral valve
anatomy. Using a 3D model created in Mimics Enlight Mitral improves
physicians’ ability to understand and plan procedures before entering
the cath lab and gives them the reliable measurements critical to
successful implantation of TMVR devices in highly diseased hearts.”

Leveraging Materialise’s expertise in creating accurate patient-specific
3D anatomical models, Mimics Enlight Mitral gives clinicians accurate 3D
models for consistency in taking measurements like Neo-LVOT to screen
patients for TMVR therapy, plan procedures and determine the appropriate
size and positioning of TMVR devices.

Materialise, a leader in software solutions and 3D printing services in
the medical and industrial markets, helps medical professionals improve
procedural planning and communications through innovative 3D solutions.
With Mimics Enlight, clinicians and hospitals will be able to scale
their 3D modeling solutions for cardiovascular procedures, knowing they
are working with a trusted partner in the medical device field.

Learn more about the Mimics Enlight Software from the Materialise
medical team at the Transcatheter Valve Therapies TVT2019 – Structural
Heart Summit in Chicago June 13-15, 2019.

About Materialise
Materialise incorporates nearly three
decades of 3D printing experience into a range of software solutions and
3D printing services, which together form the backbone of the 3D
printing industry. Materialise’s open and flexible solutions enable
players in a wide variety of industries, including healthcare,
automotive, aerospace, art and design, and consumer goods, to build
innovative 3D printing applications that aim to make the world a better
and healthier place. Headquartered in Belgium, with branches worldwide,
Materialise combines the largest group of software developers in the
industry with one of the largest 3D printing facilities in the world.
For additional information, please visit: www.materialise.com.

Cautionary Statement on Forward-Looking Statements
Some of
the statements in this press release are “forward-looking” and are made
pursuant to the safe harbor provision of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements include
statements relating to, among other things, our planned
commercialization efforts and regulatory approvals of our technologies
as well as the success thereof and our research and development
projects. These forward-looking statements are based upon the
expectations of management under current assumptions at the time of this
press release. We caution you that forward-looking statements are not
guarantees of future performance and involve known and unknown risks,
uncertainties and other factors that are in some cases beyond our
control that may cause our actual results to differ materially from our
expectations. We are providing this information as of the date of this
press release and do not undertake any obligation to update any
forward-looking statements contained in this presentation as a result of
new information, future events or otherwise, unless we have obligations
under the federal securities laws to update and disclose material
developments related to previously disclosed information.

Contacts

Press contacts:
Virginia Goble
Materialise
Phone:
734.259.6445
Mobile : 248.921.5500
Email: [email protected]
Twitter:
@MaterialiseNV
Visit:
www.materialise.com

Dan Horn
Franco
Phone: 313.567.5008
Mobile: 313.410.3992
Email:
[email protected]

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