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FDA Clears Next-Generation SURGIMAP 2.0 Software, First Pre-Operative Planning Platform for Personalized Spinal ImplantsNEW YORK --(Business Wire)-- NEMARIS, Inc. today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation SURGIMAP 2.0 platform, the preeminent software used to preoperatively plan spine surgery which now offers advanced tools based upon algorithms and the most recent scientific data on the parameters necessary to determine and restore optimal spinal alignment for each patient. The latest release of SURGIMAP 2.0 features case and image sharing across users facilitated through cloud services as well as multiplatform functionality among PC and Mac operating systems. SURGIMAP 2.0 is used by over 2,000 surgeons worldwide. The software was developed by a group of surgeons, engineers, business leaders, software experts and programmers in order to address the physician need for a user-friendly clinical imaging tool dedicated to spine. "We are proud to reach this FDA approval milestone as our new platform offers the market's first pre-operative planning software for custom spinal implants," said Virginie Lafage, PhD, Co-founder of NEMARIS Inc. "We created this software to provide surgeons with a clinical tool to plan, measure and review their results based upon the most current clinical data and algorithms. Our new 2.0 generation software allows for specific cases and images to be shared between surgeons, furthering the education and expertise of the collective group to improve patient outcomes." SURGIMAP 2.0 includes the UNiD™ plug in, jointly developed with one of the company's strategic partners, MEDICREA, (Alternext Paris: FR0004178572-ALMED), a company that specializes in the development of innovative surgical technologies for the treatment of spinal pathologies. The UNiD™ plug in is embedded into the SURGIMAP 2.0 software interface, and provides surgeons a quick and efficient option for planning and ordering the UNiD™ rods, the world's first patient-specific spinal osteosynthesis rods, currently available in Europe. MEDICREA's UNiD™ rod tool eliminates the need to manually ontour the rods in the operating room, providing surgeons with a patient specific rod prior to surgery, thus optimizing clinical outcomes and reducing the amount of time patients spend in the operating room. Once the surgery planning is complete, the order is transferred to MEDICREA's UNiD™ Lab, which processes the request and industrially produces and labels the rod specifically for each patient. "MEDICREA's collaboration with NEMARIS Inc. is an important step forward and brings spine surgery to a new era of personalized medicine, by combining SURGIMAP 2.0 innovative software platform for pre-operative planning with our rod customization and pedicle screw selection hardware solution," said Denys Sournac, Chairman and CEO of MEDICREA. "Importantly, this FDA approval of SURGIMAP 2.0 software represents a significant step in the regulatory process towards UNiD™ Rods implants clearance in the United States. Our partnership with NEMARIS has already produced tremendous results in Europe with very positive feedback from surgeons and we look forward to our patient-specific PASS®LP rods becoming available in the U.S. in the near future." ABOUT NEMARIS (www.surgimapspine.com) NEMARIS Inc (NYC, NY), is the editor of SURGIMAP software. The company was founded in 2008 and has since grown into a team of 20. The company reached profitability in the third quarter of 2014 and expects continued growth in 2015 with the global expansion of healthcare IT. SURGIMAP development was initiated by a group of surgeons, engineers, business leaders, software experts and programmers after they realized that most imaging tools were not user-friendly and not made for the spine specialist. Hence they started with measurement tools, added a DICOM image viewer, a database, and made this all portable so it runs on a USB key, off a mobile device or directly on the web. The SURGIMAP software is free and serves more than 2000 spine surgeon users worldwide. ABOUT MEDICREA (www.medicrea.com) MEDICREA is specialized in the design, development, manufacture and distribution of orthopedic implants dedicated to spinal surgery. In a $10 billion market, MEDICREA is a very dynamic small to medium-sized business of 140 employees - including 40 people with MEDICREA USA based in New York City - with unique innovation capabilities. The company enjoys an excellent and ever-improving reputation and develops unique relationships with some of the most visionary and creative spine surgeons in France, the UK, and the USA. Products developed and patented by MEDICREA provide neurosurgeons and orthopedic surgeons specialized in the spine with new and less-invasive surgical solutions that are faster and easier to implement than traditional techniques. The Group's headquarters are based near Lyon, France, and it also has a manufacturing facility for surgical instruments and implants located in La Rochelle as well as three distribution subsidiaries in the USA, the UK and France. MEDICREA has become a pioneer and global leader in the manufacturing of patient-specific implants, providing the world's first pre-contoured osteosynthesis rod (UNiD™ rod) utilized in spinal surgery in September 2013 followed by the first ever made-to-measure anterior lumbar interbody device (UNiD™ ALIF cage) created by 3-D printer in May 2014.
MEDICREA is listed on ALTERNEXT Paris |
