Kelyniam Receives 510k approval for Custom Craniofacial Implants

Kelyniam Global, Inc. (OTC: KLYG), today announced that the U.S. Food and Drug Administration (FDA) has granted the company authorization to market Custom Craniofacial Implants made from PEEK OPTIMA material.

The approval allows Kelyniam to expand its customer base and pursue ENT doctors, plastic surgeons, Facial/Cranial surgeons, military hospitals and government agencies. Patients with maxiofacial defects resulting from trauma or oncologic resection may now benefit from a superior-fitting PEEK implant made by Kelyniam. The company anticipates sales to begin in the 4th quarter of 2012.

“We seek to replicate the success and market penetration experienced in the custom cranial market” said President Tennyson Anthony. “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.”

Kelyniam Global will participate in the Congress of Neurological Surgeons Annual Meeting October 8th-10th in Chicago.

The company anticipates releasing Q2 financials in the coming weeks.



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