Kelyniam Files 510k for Custom Craniofacial Implants & Closes Financings
June 20 2012 - 9:35AM
Kelyniam Global, Inc. (OTC: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.
CONTACT: Michael Hamblett
Director of Investor Relations
Kelyniam Global Inc.
97 River Road
Canton, CT 06019
(800) 280-8192 Ext 3
kelyniam.com
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