LYON, France & NEW YORK–(BUSINESS WIRE)–MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which completes its UNiD® ASI platform technology.
UNiD® IB3D Patient-Matched interbody cages are 3D-printed titanium implants which allow customization of the cage dimensions, features and endplate morphology. It is the first time that this level of customization is commercially available on the spinal device market.
These cages are specifically defined to precisely match the optimal patient’s surgical and anatomical requirements, determined by the UNiD® LAB engineers during the pre-op planning phase. Through 3D reconstruction of the spine, the engineers map out the exact anatomy of each vertebrae endplates. They then design the ideal cage to restore proper height and angulation but also to offer an optimized surface contact between the implant and the vertebrae endplates in order to improve stability of the instrumented segment and reduce subsidence.
With this new FDA clearance, MEDICREA® offers a solution that does not only meet standard clinical needs, but also provide surgeons with a solution that was not available to them before. UNiD® IB3D Patient-Matched interbody cages allow the surgeon to accommodate geometrical inconsistencies (such as an asymmetric anatomy) of endplates and vertebral bodies, thus improving surgical and clinical outcomes.
UNiD® IB3D Patient-Matched interbody cages designed through the UNiD® ASI pre-operative surgical planning tool provide surgeons with accurate patient-specific implantable devices and help streamlining implant inventory in the operating room.
Denys Sournac, Chief Executive Office and founder of MEDICREA®, to conclude: “Until now, the only FDA-cleared patient-matched implants were limited to cranioplasty implants. These are mainly aesthetic and do not bear any weight. UNiD® IB3D Patient-Matched interbody cages are the first patient-matched implants FDA-cleared for load bearing applications, specifically designed for spine surgery. MEDICREA®’s recent FDA-clearance reinforces its leading position in changing the spine industry by offering an alternative option for these very specific cases that did not have a personalized solution until now.”
Through the lens of predictive medicine, MEDICREA® leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.
Operating in a $10 billion marketplace, MEDICREA® is a Small and Medium sized Enterprise (SME) with 180 employees worldwide, which includes 40 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and internal production of 3D- printed titanium patient-specific implants.
For further information, please visit: medicrea.com.
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MEDICREA® is listed on
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