Healthcare Industry News:  PEEK 

Devices Neurosurgery FDA

 News Release - April 20, 2011

Kelyniam Receives FDA 510(k) Clearance to Market Cranial Implants

NEW BRITAIN, CT--(Healthcare Sales & Marketing Network), an emerging medical device manufacturer, today announced that it has received clearance from the U.S. Food and Drug Administration to begin marketing its Patient Specific Custom Cranial Implants.

The Kelyniam Custom Skull Implants (CSI) are designed and manufactured for each individual patient to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects. Streamlined CAD/CAM design and manufacturing techniques will enable Kelyniam to deliver patient specific implants to surgeons in as little as 24 hours from the receipt of an order, unlike similar products on the market that require 4-5 weeks for delivery. The ability to provide custom implants quickly and accurately will reduce the time between trauma and implantation and provide surgeons additional treatment options.

Kelyniam began the development of these new medical devices in the second quarter of 2009. In less than 2 years, the company has perfected a process to quickly and accurately deliver high tolerance, patient specific custom skull implants using PEEK-OPTIMAŽ. The regulatory expertise gained during the submission process will be applied to future Kelyniam products.

"Receiving the 510K clearance has validated our strategy of applying advanced engineering techniques to specific segments of the medical device market. We are pleased to have reached this milestone," said James Ketner, Kelyniam's President & CEO. "The approval of Kelyniam's Custom Skull Implants allows us to provide our customers unsurpassed service and the most advanced Patient Specific Implants available. Entering the multi-billion dollar trauma fixation market with a high quality custom implant will position Kelyniam as a service oriented leader in the custom device segment."

Kelyniam will now focus on the sales, manufacturing, and customer support of Kelyniam's Custom Skull Implants. The company plans to develop and in-license additional medical devices for surgical markets. The products will be marketed through independent sales representatives with strong relationships in their respective territories.

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 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.

Source: Kelyniam Global

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