Cardiogenesis Announces Preliminary Clinical Results With the PHOENIX System Combining TMR + Stem Cells
12 Junio 2008 - 5:00AM
PR Newswire (US)
IRVINE, Calif., June 12 /PRNewswire-FirstCall/ -- Cardiogenesis
Corporation (Pink Sheets: CGCP), a leading developer of surgical
products for cardiac revascularization, today announced a
scientific presentation that describes the use of the PHOENIX
delivery system combining transmyocardial revascularization (TMR)
with autologous bone marrow derived stem cells. The presentation
titled "Transmyocardial Revascularization Combined with
Concentrated Autologous Stem Cells," is to be presented by
Guillermo Reyes, M.D. of La Princesa Hospital (Madrid, Spain) at
the 10th annual meeting of the International Society of Minimally
Invasive Cardiothoracic Surgeons (ISMICS) on June 12, 2008 in
Boston. The abstract of the presentation is available at
http://www.ismics.org/abstracts/2008/MP5.html. Dr. Reyes reports on
the use of the PHOENIX system, a Holmium YAG Laser TMR and biologic
combination delivery system manufactured by Cardiogenesis. Dr.
Reyes is presenting on a series of 9 patients with diffuse coronary
artery disease and medically refractory class III/IV angina that
were treated by the application of TMR in combination with bone
marrow derived stem cells in targeted ischemic heart muscle. At an
average follow up of 6 months: -- All patients experienced at least
a two class reduction in angina; -- 7 patients were angina free; --
Sublingual nitrate use pre procedure was 37 per patient per month
compared to 4 per month at follow up (p=0.03); -- and there were no
perioperative adverse events including no arrhythmias. The
hypothesis for the study is an enhanced cell uptake and angiogenic
effect when delivering concentrated bone marrow derived stem cells
to the stimulated tissue border zone surrounding the TMR channels
at the time of surgery. "These initial clinical results utilizing
the PHOENIX delivery system are very promising," stated Richard
Lanigan, President of Cardiogenesis, "and they build upon the
growing body of evidence that our Holmium YAG TMR system has a
favorable impact on cell retention and survival in cardiac tissue
as described by Dr. Amit Patel in a recent animal study published
in Cell Transplantation. Our corporate focus is to build on this
early work and provide clinicians effective tools to treat the
large patient population suffering from refractory angina, be it as
sole therapy or concomitant with coronary bypass." The PHOENIX
combination delivery system was CE Mark approved in November of
2006. It has been used in over 40 procedures at cardiac centers
outside the U.S. It is not currently FDA approved. The Company
intends to utilize the clinical experience outside the U.S. to
support its clinical and regulatory strategy in the U.S. About
Cardiogenesis Corporation Cardiogenesis is a medical device company
specializing in the treatment of cardiovascular disease and is a
leader in devices that stimulate cardiac angiogenesis. The
company's market leading Holmium:YAG laser system and disposable
fiber-optic accessories are used to perform a FDA-cleared surgical
procedure known as Transmyocardial Revascularization (TMR) to treat
patients suffering from angina. Surgical products and accessories
for the Cardiogenesis TMR procedure, which are marketed in the U.S.
and around the world, have been shown to reduce angina and improve
the quality of life in patients with coronary artery disease. For
more information on the company and its products, please visit the
Cardiogenesis company website at http://www.cardiogenesis.com/ or
the direct to patient website at http://www.heartofnewlife.com/.
With the exception of historical information, the statements set
forth above include forward-looking statements. Any forward-looking
statements in this news release related to the possible
effectiveness of the company's PHOENIX delivery system or other
technologies and the effect of such system or technology on the
company's sales, profitability, the adoption of its technology and
products and FDA clearances are based on current expectations and
beliefs and are subject to numerous risks and uncertainties, many
of which are outside the company's control, that could cause actual
results to differ materially. Factors that could affect the
accuracy of these forward-looking statements include, but are not
limited to: any inability by the company to sustain profitable
operations or obtain additional financing on favorable terms if and
when needed; any failure to obtain required regulatory approvals;
failure of the medical community to expand its acceptance of TMR or
PMC procedures; possible adverse governmental rulings or
regulations, including any FDA regulations or rulings; the
company's ability to comply with international and domestic
regulatory requirements; possible adverse Medicare or other
third-party reimbursement policies or adverse changes in those
policies; any inability by the company to ship product on a timely
basis; the company's ability to manage its growth; adverse economic
developments that could adversely affect the market for our
products or our ability to raise needed financing; actions by our
competitors; restrictions contained in our convertible debt
obligations requiring the issuance of shares rather than repayment
in cash; and the company's ability to protect its intellectual
property. Other factors that could cause Cardiogenesis' actual
results to differ materially are discussed in the "Risk Factors"
section of the company's Annual Report on Form 10-KSB for the year
ended December 31, 2007 and the company's other recent SEC filings.
The company disclaims any obligation to update any forward-looking
statements as a result of developments occurring after the date of
this press release. DATASOURCE: Cardiogenesis Corporation CONTACT:
William R. Abbott, Senior Vice President and Chief Financial
Officer of Cardiogenesis Corporation, +1-949-420-1800 Web site:
http://www.cardiogenesis.com/ http://www.heartofnewlife.com/
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