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Materialise Receives MFDS License For Medical Use of 3D Software in South Korea

2018-09-14 07:00 1939

MFDS licenses Mimics Medical and ProPlan CMF software to plan surgeries in 3D.

LEUVEN, Belgium, Sept. 14, 2018 /PRNewswire/ -- The South Korean Ministry of Food and Drug Safety (MFDS) has licensed the medical use of 3D planning software Mimics Medical and ProPlan CMF. Mimics Research by Materialise (Nasdaq: MTLS) was already available in South Korea for R&D purposes, but with the license for Mimics Medical, the software can now also help surgeons to simulate and evaluate surgical treatment options before entering the operating room. The MFDS license is another milestone for the medical 3D printing industry: patient-specific solutions are gaining ground across the world thanks to the possibilities offered by high-quality 3D planning software.

The image-processing software Mimics Medical and ProPlan CMF have been designed to help researchers, engineers, and surgeons create accurate 3D models, design medical devices that fit each patient's unique anatomy, and plan procedures preoperatively.

Mimics Medical takes a surgeon seamlessly from scan to virtual surgery, taking away the guesswork. Surgeons can virtually plan a procedure, perform dedicated anatomical analysis and create accurate virtual 3D models that can help them achieve the desired patient outcomes. Before the MFDS clearance, only Mimics Research could be used in South Korea for research and development purposes, such as the design and creation of implants. From now on, the image-based software can also be used for medical applications. Moreover, the software can be implemented as an educative tool to train future surgeons.

The Proplan CMF software is used as a preoperative tool for simulating and evaluating implant placement and surgical treatment options for cranio-maxillofacial surgeries. It allows a surgeon to use an interactive 3D rendering of the CT or MRI images for his presurgical planning.

Global increase of patient-specific solutions

The medical clearance of the 3D planning software by South Korea's MFDS aligns with the global increase of patient-specific solutions and will support the adoption of 3D planning and printing for medical use.  

"Thanks to this medical clearance, our 3D planning software will no longer be limited to R&D purposes. We can now help South Korean surgeons to offer their patients personalized solutions that fit their unique anatomy", says Brigitte de Vet, Vice President Medical of Materialise. "Moreover, the medical clearance of both Mimics Medical and ProPlan CMF serve as a benchmark for the clinical implementation of 3D printing for physicians creating 3D models at the point-of-care."

About Materialise

Materialise brings almost three decades of 3D printing experience to 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. Twitter: @MaterialiseNV

About Materialise Medical

Materialise Medical, which has pioneered many of the leading medical applications of 3D Printing, enables researchers, engineers and clinicians to revolutionize innovative patient-specific care. Materialise Medical's open and flexible platform of software and services, Materialise Mimics, forms the foundation of certified Medical 3D Printing, in clinical as well as research environments, offering virtual planning software tools, 3D-printed anatomical models, and patient-specific surgical guides and implants. For additional information, please visit: materialise.com/medical

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.

Source: Materialise Sdn Bhd
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