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NEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use
NEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use.
About this update from Kelyniam Global, Inc.
[{"type":"text","content":"\n\n\n\nNEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nNEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use\nPR Newswire\nCANTON, Conn., April 2, 2024\n\n\n\nCANTON, Conn., April 2, 2024 /PRNewswire/ -- Kelyniam Global (OTC:KLYG) and Fin-ceramica, Faenza S.p.a., makers of custom cranial implants, announced today that the NEOS Surgery Cranial LOOP™ fixation system has received 510(k) clearance from the FDA for use with Finceramica's CustomizedBone™ hydroxyapatite cranial implant.\n\n \n \n \n \n \n \n\n \nThe Cranial LOOP™ family of cranial fixation devices is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps after craniotomies. With more than 10 years of market experience, Cranial LOOP™ is being used in public and private hospitals in 25 countries worldwide. Cranial LOOP™ was first cleared by the FDA in 2010.  The most recent 510k clearance is for use specifically with Finceramica's CustomizedBone™ hydroxyapatite cranial implant. \nRoss Bjella, Kelyniam's CEO, said, \"This approval will further boost Kelyniam's sales momentum which started in Q4 last year. Alongside the low infection rate and pediatric indication, the rapid fixation provided by the Cranial LOOP™ system is now an added benefit for neurosurgeons choosing CustomizedBone™ for their patients.\"\nSince 2004 over 9000 CustomizedBone™ hydroxyapatite implants have been sutured in place. Hydroxyapatite, similar to human bone, facilitates seamless osteo-integration into patients' skulls. CustomizedBone™ is internationally recognized for its reduced infection risk and is indicated for use in children as young as 7 years old. \nThe NEOS Surgery Cranial LOOP™ system offers rapid implant fixation in under two minutes using just three devices. Crafted from PEEK (poly ether ether ketone), it ensures radiolucency for artifact-free imaging (CT and MRI) during post...