Kelyniam Receives 501k approval for Custom Craniofacial Implants
27 September 2012 - 11:41PM
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 and government agencies. Patients with maxiofacial
defects resulting from trauma or oncologic resection will now have
the option of having 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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