MediCor Ltd. Announces Plans to Seek IDE Approval for High-Consistency Silicone-Filled Breast Implants
September 22 2005 - 5:07PM
PR Newswire (US)
LAS VEGAS, Sept. 22 /PRNewswire-FirstCall/ -- MediCor Ltd.
(OTC:MDCR) (BULLETIN BOARD: MDCR) announced today that it plans to
file for an Investigational Device Exemption (IDE) with the U.S.
Food and Drug Administration (FDA) in the first quarter of 2006 for
high-consistency silicone-filled breast implants. IDE approval is
the precursor to the Company beginning clinical trials and filing
for Premarket Approval (PMA) to market silicone-filled implants in
the U.S. MediCor is the world's third leading manufacturer and
distributor of breast implants. The Company markets silicone and
saline-filled breast implants in more than 70 countries and has an
approximate 30% non-U.S. global market share. The Company is
currently conducting U.S. clinical trials for both a pre-filled
saline and an inflatable saline-filled breast implant, and expects
to file for PMA approval of the inflatable saline implant by
year-end 2005, and the pre-filled saline implant in 2006. "Given
the recent positive developments with respect to silicone breast
implants in the U.S., we believe the time is right for MediCor to
introduce its advanced high-consistency silicone-filled implants to
the U.S. market," said Jim J. McGhan, MediCor's Chief Operating
Officer. "Our plan to apply for an Investigational Device Exemption
and begin clinical trials represents yet another significant
milestone for MediCor as we continue to grow our business and
develop the world's highest quality products for the aesthetic,
plastic and reconstructive surgery markets." MediCor was founded by
Chairman of the Board Donald K. McGhan, the pioneer of the modern
day breast implant industry. The Company acquires, develops,
manufactures and markets products for medical specialties in
aesthetic, plastic and reconstructive surgery and dermatology
markets. Products include surgically implantable prostheses for
aesthetic, plastic and reconstructive surgery and scar management
products. Its products are sold worldwide to hospitals, surgery
centers and physicians through various distributors and direct
sales personnel. MediCor's strategy is to be the leading integrator
of selected international medical device markets, technologies and
corporations. To achieve this strategy, MediCor intends to build
upon and expand its business lines, primarily in the aesthetic,
plastic and reconstructive surgery and dermatology markets. MediCor
intends to accomplish this growth through the expansion of existing
product lines and offerings and through the acquisition of
companies and other assets, including intellectual property rights
or distribution rights. This release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements are based upon the current
beliefs and expectations of MediCor's management and are subject to
significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements. The following
factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the ability to
timely complete and satisfy all regulatory requirements, the
ability to obtain governmental approvals following our submissions;
the risk of new and changing regulations. Additional factors that
could cause MediCor's results to differ materially from those
described in the forward-looking statements can be found in the
Annual Report on Form 10-KSB for the year ended June 30, 2004, and
subsequent Quarterly Reports on Form 10-QSB of MediCor filed with
the Securities and Exchange Commission and available at the
Securities and Exchange Commission's Internet site
(http://www.sec.gov/). Contact: Marc S. Sperberg U.S. 702-932-4560,
x308 Mark Collinson 310-231-8600, x117 DATASOURCE: MediCor Ltd.
CONTACT: Marc S. Sperberg, +1-702-932-4560 x308, or Mark Collinson,
+1-310-231-8600, x117, both for MediCor Ltd.
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