Kelyniam Global, Inc. Achieves FDA Approval for Revolutionary Fusion™ BCP-PEEK Implants

Kelyniam Global, Inc. Achieves FDA Clearance for Fusion™ BCP-PEEK Implant

In a groundbreaking development for medical technology, Kelyniam Global, Inc., based in Canton, Connecticut, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative Fusion™ Cranial and Craniofacial Implants. This approval represents a significant milestone in the field of cranial and craniofacial implants, as it marks the first use of Biphasic Calcium Phosphate (BCP) combined with Polyether Ether Ketone (PEEK) in such applications.

The Fusion™ BCP-PEEK implant is heralded not only for its unique composition but also as the first entirely new implant introduced to the cranial and craniofacial sector in the past eight years. As stated by Desiree Webb, Chief Operating and Revenue Officer at Kelyniam, this achievement underscores the company’s commitment to innovation and advancements in medical technology. The implants are designed to facilitate bone integration, deliver exceptional durability, and ensure a customized fit for patients, thereby reinforcing Kelyniam’s leadership in regenerative solutions.

These revolutionary implants cater to specific neurosurgical needs, particularly critical in treating traumatic injuries, deficiencies resulting from tumor removals, or congenital abnormalities. The efficiency of Kelyniam’s operations is evident; the Fusion™ BCP-PEEK implants can be custom-designed, manufactured, and shipped to medical practitioners within 24-48 hours, ensuring timely intervention for patients requiring urgent care.

Chairman and CEO Ross Bjella highlighted that Kelyniam continues to push the boundaries of neurotechnology, stating that the new implant is a vital extension of their regenerative product line, which includes other advanced products such as their CustomizedBone™ implants.

Kelyniam Global, Inc. prides itself on its capacity for rapid production of bespoke cranial and craniofacial implants utilizing biocompatible materials, aiming to provide high-quality, patient-specific solutions with swift turnaround times. By collaborating with neurosurgeons across the globe, the company is committed to bettering patient outcomes in surgical procedures.

As Kelyniam embarks on this new chapter of innovation, the medical community eagerly anticipates the impact of the Fusion™ BCP-PEEK implants on cranial surgeries and patient recovery. With their focus on enhancing neurosurgical care through regenerative medicine, Kelyniam continues to pave the way for future advancements in the medical field.

For more information about Kelyniam Global, Inc. and their cutting-edge technologies, you can visit their website at www.kelyniam.com.

This landmark achievement in implant technology paves the way for future innovations in surgical care and underscores Kelyniam's commitment to delivering solutions that meet the evolving needs of healthcare professionals and patients alike.