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FDA Clears NEOS Cranial LOOP™ for Utilization with CustomizedBone™

Tuesday, April 02, 2024

Kelyniam Global (OTC:KLYG) and Finceramica, Faenza S.p.a., renowned for their custom cranial implants, have jointly announced today that the NEOS Surgery Cranial LOOP™ fixation system has been granted FDA 510(k) clearance for use with Finceramica's CustomizedBone™ hydroxyapatite cranial implant. The Cranial LOOP™ family of fixation devices, crafted from PEEK-OPTIMA™, a biocompatible polymer, effectively secures bone flaps following craniotomies. With a decade-long track record in the market, this latest clearance specifically validates its compatibility with Finceramica's CustomizedBone™ implant.

This milestone is expected to bolster Kelyniam's sales, alongside its already established low infection rate and pediatric indication. The rapid fixation provided by the Cranial LOOP™ system is now an added advantage for neurosurgeons preferring CustomizedBone™. CustomizedBone™ hydroxyapatite implants, designed to mimic human bone, seamlessly integrate into patients' skulls, previously affixed with sutures.

The NEOS Surgery Cranial LOOP™ system offers swift implant fixation in under two minutes, using just three devices. Crafted from PEEK, it ensures radiolucency for artifact-free imaging (CT and MRI) during post-operative monitoring, and in terms of cost, it remains competitive with traditional plate and screw systems. Kelyniam holds exclusive distribution rights for CustomizedBone™ implants with the NEOS Cranial LOOP™ in the U.S.






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