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.
The 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.
Ross 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.”
Since 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.
The 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-operative monitoring. Cost-wise, Cranial LOOP™ is comparable to traditional plate and screw systems. Kelyniam exclusively distributes CustomizedBone™ implants with the NEOS Cranial LOOP™ in the U.S.
