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Kelyniam Global Files 510k for Custom Craniofacial Implants & Closes Financings


6/20/2012 7:56:43 AM

CANTON, Conn., June 20, 2012 (GLOBE NEWSWIRE) -- Kelyniam Global, Inc. (KLYG), a medical device company focused on the design and manufacturing of custom cranial implants, has filed a 510(k) application with the Food and Drug Administration (FDA) for clearance to market a custom craniofacial implant product made from the Invibio PEEK Optima material. The application has been received and is currently in the FDA approval process 510(k) (FDA# K121755).

Financings

Kelyniam has secured a line-of-credit from Westfield Bank (MA). The company recently closed this financing which will give the flexibility to facilitate the custom cranial business as well as expand in other markets and products.

Kelyniam has also closed on an aid package with the State of Connecticut Department of Economic Development. The aid package is designed to assist the company with asset purchases and hiring local skilled workers in support for an expansion plan laid out by management.

"Kelyniam is pleased to have filed this new application for clearance of its custom craniofacial implant, and look forward to the FDA's review of the application," said Tennyson Anthony, President/ CEO of Kelyniam. Mr. Anthony went on to say "Management has worked tirelessly this year to put the company on a greater financial footing. 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. We are excited to have the support of a quality financial institution such as Westfield Bank. Shareholders should find great comfort that both financings are non-dilutive."

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.

The Kelyniam Global Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13366

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.


Read at BioSpace.com


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