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Kelyniam Global Receives FDA 510(k) Approval for Custom Craniofacial Implants


10/15/2012 7:40:25 AM

Canton, CT, Oct. 15, 2012 (GLOBE NEWSWIRE) -- Kelyniam Global, Inc. (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.

About Kelyniam Global, Incorporated

Kelyniam Global Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.

Please visit our website at www.kelyniam.com for more information.

Forward-Looking Statements

Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.



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