Medicalcv (MM) (NASDAQ:MDCV)
Historical Stock Chart
From Jun 2019 to Jun 2024
MedicalCV Announces 510(k) Clearance of Its ATRILAZE(TM) Surgical
Ablation System for Use in Surgery
MINNEAPOLIS, Dec. 13 /PRNewswire-FirstCall/ -- MedicalCV, Inc. (OTC:MDCV)
(BULLETIN BOARD: MDCV) , a cardiovascular surgery device manufacturer,
announced today that on December 1, 2004, it received 510(k) clearance from the
U.S. Food and Drug Administration to market its AtriLaze(TM) Surgical Ablation
System for use on cardiac tissue in surgery. The company expects to commence
marketing its AtriLaze System via a direct U.S. sales force in January 2005.
"This 510(k) clearance is just one more milestone achieved by the new
management at MedicalCV," said Marc P. Flores, president and chief executive
officer. "With a repopulation of management, 'right sizing' of the company,
exiting the valve business, obtaining a 510(k) clearance on our AtriLaze
System, and a directed focus into the atrial fibrillation market, we believe we
have taken the necessary steps to reposition MedicalCV."
"This is an exciting time for us to go to market with our AtriLaze System. The
chaotic atrial fibrillation market provides an enormous opportunity for
MedicalCV's management team to step in and truly define the market, which to
date has yet to be accomplished," said Christopher C. Hlozek, vice president,
marketing. "We are committed to bring our AtriLaze Surgical Ablation System and
other innovative technologies to the cardiac market that positively impact
patient outcomes."
About MedicalCV, Inc.
MedicalCV, a cardiothoracic surgery device manufacturer, focuses on the design,
development and commercialization of new, improved and enhanced technologies,
products, methods and techniques to treat cardiovascular disorders and disease,
including products targeting the treatment of atrial fibrillation. MedicalCV
previously developed and marketed mechanical heart valves and its proprietary
pyrolytic carbon processes. The Company's securities are traded on the OTC
Bulletin Board under the symbol "MDCV."
This release contains certain forward-looking statements of expected future
developments, as defined in the Private Securities Litigation Reform Act of
1995. The forward-looking statements in this release refer to our expectations
regarding disposition of our heart valve business, operating improvements,
development of atrial fibrillation product and minimally invasive treatment of
atrial fibrillation. These forward-looking statements reflect management's
expectations and are based on currently available data; however, actual results
are subject to future risks and uncertainties, which could materially affect
actual performance. Risks and uncertainties that could affect such performance
include, but are not limited to, the following: the Company's ability to fund
significant capital needs; market acceptance in the U.S. of the Company's
cardiovascular products; acceptance of minimally invasive techniques for the
reduction of atrial fibrillation through ablation; potential reductions in
pricing by competitors; the costs of licensing and acquiring new products and
technologies; the time and costs involved in obtaining regulatory clearance for
cardiovascular products; competing technological and market developments;
physician acceptance of the Company's cardiovascular products; dependence upon
governmental reimbursements and third party supplies; and the strength of the
market for cardiovascular products. For more detailed information about these
risks and uncertainties, please review the Company's Annual Report on Form 10-
KSB for the fiscal year ended April 30, 2004.
These events and uncertainties are difficult or impossible to predict
accurately and many are beyond the Company's control. The Company assumes no
obligation to publicly release the results of any revisions that may be made to
any forward-looking statements to reflect events or uncertainties after the
date of such statements or to reflect the occurrence of anticipated or
unanticipated events.
DATASOURCE: MedicalCV, Inc.
CONTACT: Christopher C. Hlozek, Vice President, Marketing of MedicalCV,
Inc., +1-651-452-3000
Web site: http://www.medcvinc.com/