CABG Medical Suspends Enrollment in Clinical Trial and Schedules Conference Call for Today
28 Novembre 2005 - 12:00PM
PR Newswire (US)
MINNEAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- CABG Medical, Inc.
(NASDAQ:CABG) today announced it has suspended enrollment in its
international clinical trial of the Holly Graft(TM) System (HGS). A
total of eight patients have been treated with an anti-coagulant
regimen of aspirin and warfarin and two of the grafts were
determined to have occluded prior to the patient's discharge from
the hospital. The Company previously announced that the first
enrollment arm, consisting of 36 patients implanted with the HGS
and treated with an anti-platelet regimen of aspirin and
clopidogrel failed to meet the standards necessary to obtain
regulatory approval. The company will host a conference call today
to discuss these results. (Logo:
http://www.newscom.com/cgi-bin/prnh/20050114/CGF013LOGO ) "The
incorporation of warfarin into the treatment regimen of HGS
patients has not prevented occlusions in the limited set of
patients treated with this regimen. The results are disappointing
and at this time do not warrant further evaluation in clinical
trials," commented Manny Villafana, the Company's Chairman and
Chief Executive Officer. Mr. Villafana added, "It appears the
majority of the failures are due to graft occlusions rather than
restenosis, and we will aggressively seek the cause of these
failures. We are in the process of reviewing all of our clinical
and preclinical data to determine whether any modifications can be
made to the HGS which would reduce the occurrence of occlusion to a
level necessary to meet standards required to obtain regulatory
approvals. Such modifications may take up to twelve to eighteen
months to implement and test preclinically." Conference Call Today
CABG Medical will host a conference call and web cast today,
November 28, 2005 at 11:00 a.m. Eastern Standard Time, to discuss
the latest results of its clinical trial. The dial in number for
the conference call is 1-888-208-1812. A live web cast of the call
can be accessed at http://www.cabgmedical.com/ by clicking on the
investor relations icon. An archive of the web cast will be
available on the company's website for at least 30 days following.
About CABG Medical CABG Medical, Inc. is a medical technology
company developing technologies and therapies to improve the
treatment of coronary heart disease by advancing conventional
bypass surgery. Safe Harbor This Press Release contains
forward-looking statements that may include statements regarding
intent, belief or current expectations of the Company and its
management and they are subject to certain risks set forth below.
Such forward-looking statements include the Company's statement
regarding the possibility of making modifications to the HGS which
would reduce the occurrence of occlusion to a level necessary to
obtain regulatory approvals. There is no assurance that we will be
able to develop such modifications or if modifications are
eventually developed that we will be successful in reducing the
occurrence of occlusion to an acceptable level. Prior to embarking
on such a project, the CABG Board of Directors will have to
determine the feasibility of the project, taking into account the
cost, time, requirement of new animal testing and human clinical
trials, and likelihood of success of the project. For a discussion
of these and other risks and uncertainties that could affect the
Company's activities and results, please refer to the Company's
filings with the Securities and Exchange Commission.
http://www.newscom.com/cgi-bin/prnh/20050114/CGF013LOGO DATASOURCE:
CABG Medical, Inc. CONTACT: Manny Villafana, Chairman & CEO, or
John L. Babitt, President & CFO, both of CABG Medical, Inc.,
+1-763-258-8005, Fax: +1-763-258-8008 Web site:
http://www.cabgmedical.com/
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