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Kelyniam wins FDA clearance for custom craniofacial implants

Kelyniam Global has gained US marketing authorization rights for its custom craniofacial implants made from PEEK OPTIMA material, designed to treat patients with maxiofacial defects resulting from trauma or oncologic resection.

With the US Food and Drug Administration’s (FDA) 510(k) approval, the company will provide access of craniofacial implant to its customer base and ENT doctors, plastic surgeons, Facial/Cranial surgeons, military and government agencies.

The company anticipates sales to begin in the 4th quarter of 2012.

Kelyniam Global president Tennyson Anthony said the company seeks to replicate the success and market penetration experienced in the custom cranial market.

"The company has sold custom cranial implants in about 25 states this year and can quickly plug this new product offering into medical centers in those states," Anthony added.