3D Systems' VSP Orthopaedics Receives FDA 510(k) Clearance -- Opening the Door to Personalized Treatment of Complex Musculoskeletal Disease

ROCK HILL, S.C., Sept. 26, 2019 /PRNewswire/ -- 3D Systems (NYSE: DDD) announced that the Food and Drug Administration (FDA) has provided 510(k) clearance to its  new VSP Orthopaedics solution -- enabling surgeons to obtain a clear 3D visualization of a patient's anatomy and develop a personalized surgical plan, prior to entering the operating room.  The expansion of 3D Systems' VSP service-based approach into the field of orthopaedic surgery builds on its VSP technology and anatomic modeling leadership – having helped with more than 120,000 unique patient cases in its 25 years of experience.

The new VSP Orthopaedics solution is available exclusively through Onkos Surgical's My3D™ Personalized Solutions Platform and enables surgeons to devise a precise plan for tumor resection that in some cases allows for the preservation of the native joint. Virtual surgical planning of the patient's 3D anatomy, allows the surgeon to essentially perform the surgery digitally before entering the operating room. Following the online planning session between 3D Systems' biomedical engineers and the surgeon, patient-specific models, personalized surgical tools, and instruments are designed and 3D printed for use within the sterile field. In clinical applications where VSP is used today, the solutions have been shown to improve surgical accuracy and outcomes -- saving time in the operating room which benefits both the surgeon and the patient.^1,2,3  3D Systems fully expects that VSP Orthopaedics will deliver the same benefits to Orthopaedic surgeons and patients.

"Throughout the years, the power and innovation of our VSP solutions has been demonstrated through improved patient outcomes in a variety of surgical specialties," said Radhika Krishnan, senior vice president, software & healthcare, 3D Systems. "Our 3D printing technologies combined with the renowned expertise of our biomedical engineers, in collaboration with surgeons, can have a positive impact on a patient's life -- even before they ever enter the operating room. Based on the success we've seen with our personalized healthcare solutions in other surgical specialties, we are confident in the positive impact on patient care this technology will have for the orthopaedic community. The opportunity to leverage our capabilities with Onkos' passion for providing differentiated solutions for oncologists will translate into meaningful innovation for musculoskeletal oncology surgeons and patients."

As a pioneer in the personalized medicine space, 3D Systems established VSP in 2012 as a service-based approach to personalized surgery, combining expertise in medical image processing, surgical planning, design, and 3D printing.

"As an early stage investor in Onkos, 3D Systems understands our passion for developing innovation," said Patrick Treacy, CEO, Onkos Surgical. "The VSP Orthopaedics System, which is available exclusively through our My3D Personalized Solutions platform is a great example of how we're harnessing the power of advanced surgical planning and personalization to create novel solutions that musculoskeletal patients deserve."

For more information, please visit www.3dsystems.com.

Forward-Looking Statements
Certain statements made in this release by or in reference to 3D Systems 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 3D Systems' periodic filings with the U.S. 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 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.

About 3D Systems
More than 30 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading AM solutions company, it empowers manufacturers to create products and business models never before possible through transformed workflows. This is achieved with the Company's best-of-breed digital manufacturing ecosystem - comprised of plastic and metal 3D printers, print materials, on-demand manufacturing services and a portfolio of end-to-end manufacturing software. Each solution is powered by the expertise of the company's application engineers who collaborate with customers to transform manufacturing environments. 3D Systems' solutions address a variety of advanced applications for prototyping through production in markets such as aerospace, automotive, medical, dental and consumer goods. More information on the company is available at www.3dsystems.com.

1. Sink J, Hamlar D, Kademani D, Khariwala SS: Computer-aided stereolithog-raphy for presurgical planning in fibula free tissue reconstruction of the mandible. J Reconstr Microsurg 28:395-404, 2012
2. Patel A, Levine J, Brecht L, Saadeh P, Hirsch DL: Digital technologies in  mandibular pathology and reconstruction. Atlas Oral Maxillofacial Surg Clin N Am 20:95-106, 2012
3. Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW, Christensen AM, Weimer KA, Steed MB: The accuracy of virtual surgical planning in free fibula mandibular reconstruction: comparison of planned and final results. J Oral Maxillofac Surg 68:2824-2832, 2010

SOURCE 3D Systems

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