MAGLA - Magna-Lab Receives FDA Clearance for Cardiac View Probe
SYOSSET, N.Y., May 23, 2001 (BUSINESS WIRE) -- Magna-Lab Inc. (OTCBB: MAGLA)
today announced that its Cardiac View Probe has been cleared for marketing and
distribution in the United States by the U.S. Food and Drug Administration
("FDA").
Cardiac View Probe(TM) is a transesophageal receiving coil designed to operate
in conjunction with a magnetic resonance imaging ("MRI") system to
non-invasively aid in the production of high resolution MRI images of the aortic
arch, the descending aorta and the coronary vessels of the heart to advance the
definitive diagnosis of Coronary Artery Disease ("CAD").
John R. Geisel, Chief Executive Officer of Magna-Lab, commented, "This is a very
significant milestone in the Company's history. We can now move forward with the
post clearance marketing work that will introduce the Cardiac View Probe to the
physician marketplace. We recently had our first meeting of the Clinical Focus
Group organized by Eminent Research Systems, Inc., so this development is very
timely."
Cardiac View Probe is a transesophageal MRI disposable receiver coil. The device
is inserted into the patient's esophagus, placing it directly behind the heart,
where in conjunction with MRI it produces high quality images of the heart.
As previously reported, Magna-Lab has also submitted to the FDA 510(k)
Notification for clearance to market its Cardiac View Surface Coil(TM) for use
in MRI and is awaiting a response to that Notification. It is intended that when
the Cardiac View Probe is utilized in conjunction with the Cardiac View Surface
Coil, the two products would surround the heart allowing the generation of
additional imaging information.
Dr. Lawrence A. Minkoff, Ph.D., President and Chief Scientific Officer of
Magna-Lab, said, "We believe that our Cardiac View Probe product represents an
important leap forward in diagnosing a disease that afflicts more than 12
million Americans and is the nation's leading cause of death. The Cardiac View
Probe is designed to produce high quality images of the heart and coronary
vessels to aid in the detection of CAD."
Daniel M. Mulvena, Chairman of Magna-Lab, stated, "Cardiac View results from
years of research by Magna-Lab under the scientific leadership of Dr. Minkoff. I
am very excited about the future of Magna-Lab as we enter this new phase of the
Company's corporate development. Our efforts are also supported by a strong
financial position at our February 28, 2001 fiscal year-end, highlighted by cash
and equivalents of $5.8 million and working capital of approximately $5.2
million."
Magna-Lab Inc. is the developer of products that are designed to help make MRI
technology more effective for the detection and diagnosis of Coronary Artery
Disease. The products are non-invasive or minimally invasive disposable medical
devices intended to permit the imaging of the major vessels of the heart.
Certain statements in this press release constitute "forward-looking statements"
within the meaning of the private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or achievements of
the Company, or industry results, to be materially different from any future
results, performance, or achievements expressed or implied by such
forward-looking statements. Such factors include, among others, the following:
delays in product proprietary rights; competition; material costs and
availability; changes in business strategy or development plans; quality of
management; availability, terms and deployment of capital; business abilities
and judgment of personnel; availability of qualified personnel; changes in, or
the failure to comply with, government regulations as well as other matters
discussed in the Company's filings with the Securities and exchange Commission.
CONTACT: Magna-Lab, Inc.
John R. Geisel, CEO,
978/887-0055
or
The Equity Group Inc.
Devin Sullivan, SVP,
212/836 9608
dsullivan@equityny.com |
