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

CANTON, Conn., Sept. 18, 2025 /PRNewswire/ -- Kelyniam Global, Inc. (Kelyniam), a leading provider of custom cranial and craniofacial implant solutions, announced today 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 groundbreaking 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 craniofacial market in 8 years.

"Kelyniam's achievement as the first company in the U.S. to gain FDA clearance for Fusion^™ BCP-PEEK implants highlights our innovative spirit and dedication to advancing medical device technology," said Desiree Webb, Chief Operating and Revenue Officer. "Kelyniam's Fusion^™ BCP-PEEK implants are designed to encourage bone integration while providing exceptional durability and personalized fit, reinforcing our leadership in regenerative implant solutions."

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.

Ross Bjella, Chairman and CEO, added, "Kelyniam continues to deliver cutting-edge technology to neurosurgeons. This unique implant is an important part of our regenerative product line, which includes our CustomizedBone^™ (hydroxyapatite) implant from Finceramica, SpA, and the Osteopore range of products."

About Kelyniam Global, Inc. Kelyniam Global, Inc. specializes in rapidly producing custom cranial and craniofacial implants using biocompatible materials. By partnering with neurosurgeons worldwide, the company delivers high-quality, patient-specific solutions with a quick turnaround time. Dedicated to innovation in regenerative medicine, Kelyniam continues to enhance neurosurgical care. For more information, visit www.kelyniam.com .

Forward-Looking Statements This press release contains forward-looking statements under Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements involve risks and uncertainties that may cause actual results to differ from projections. Investors should not place undue reliance on these forward-looking statements.

SOURCE Kelyniam Global Inc