Kelyniam Receives FDA 510(k) Clearance to Market Cranial Implants
April 20 2011 - 4:00PM
Marketwired
Kelyniam Global, Inc. (PINKSHEETS: KLYG), 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-OPTIMA®. 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 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.
Embedded Video Available
Embedded Video Available:
http://www2.marketwire.com/mw/frame_mw?attachid=1584701
Contact: Kelyniam Global, Inc. www.kelyniam.com 1-800-280-8192
Email Contact
Kelyniam Global (PK) (USOTC:KLYG)
Historical Stock Chart
From Jul 2024 to Aug 2024
Kelyniam Global (PK) (USOTC:KLYG)
Historical Stock Chart
From Aug 2023 to Aug 2024