Announcement • Nov 14
Kelyniam Global, Inc. Secures Exclusive U.S. License for Evonik's Vestakeep Fusion Biomaterial in Cranial Implants Kelyniam Global, Inc. announced it has secured an exclusive U.S. license from Evonik Industries AG to market VESTAKEEP® Fusion, a bi-calcium phosphate-infused PEEK material, for cranial, craniofacial, and maxillofacial implants. This agreement grants Kelyniam two years of exclusivity with the option for renewal upon mutual agreement. The license enhances Kelyniam's regenerative product lineup by incorporating VESTAKEEP® Fusion's osteoconductive properties, that promote human bone growth and integration. Distributed through Modern Plastics, a trusted long-term supplier of PEEK materials, this partnership leverages a proven relationship to ensure reliable access and supports Kelyniam's growth in advanced neurosurgical solutions. This strategic move adds significant value for shareholders by expanding Kelyniam's regenerative medicine portfolio alongside established regenerative options like Finceramica's CustomizedBone (hydroxyapatite) and Osteopore's polycaprolactone products, positioning the company to meet increasing demand for innovative, patient-focused cranial reconstruction. Announcement • Sep 18
Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™? BCP-PEEK Implant Kelyniam Global, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fusion™? Cranial and Craniofacial Implants. These implants are crafted from a unique combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), marking a advancement in implant technology. This 510(k) clearance marks the first time the FDA has approved this material for use in cranial and craniofacial implants, representing a significant milestone in implant technology. The Fusion™? BCP-PEEK implant is the first totally new implant launched in the cranial and craniof facial market in 8 years. Designed for custom applications, the Fusion™? BCP- PEEK material meets critical neurosurgery needs where precise, patient-specific solutions are essential for treating traumatic injuries, defects from tumor resections, or congenital anomalies. As with Kelyniam's PEEK implants, Fusion™? BCP-pEEK custom implants can be designed, manufactured and shipped to surgeons within 24-48 hours, ensuring timely care for patients in need. Announcement • Apr 03
Kelyniam Global Announces NEOS Surgery Cranial LOOP™ Fixation System Receives 510(k) Clearance from the FDA for use with Finceramica's CustomizedBone™ Hydroxyapatite Cranial Implant Kelyniam Global announced 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. 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. 
