Kelyniam files craniofacial implant 510(k) application with FDA

Kelyniam Global has registered craniofacial implant's 510(k) application with the US Food and Drug Administration (FDA).

Craniofacial implant, made of Invibio PEEK Optima material, is designed for the treatment of patients with congenital deformities or major head injuries.

The company closed the financing with Westfield Bank and State of Connecticut Department of Economic Development for cranial business expansion.

Kelyniam Global president and CEO Tennyson Anthony said the company looks forward to the FDA’s review of craniofacial implant’s application.

"Management has worked tirelessly this year to put the company on a greater financial footing," Anthony added.

"We are ecstatic both institutions are confident in the technology behind the manufacture of Kelyniam Custom Skull Implants and the execution of our business plan."