Cardiogenesis Announces Presentation of its PHOENIX(R) Combination TMR Plus Stem Cell Delivery System at the International Socie
04 June 2009 - 9:30PM
PR Newswire (US)
IRVINE, Calif., June 4 /PRNewswire-FirstCall/ -- Cardiogenesis
Corporation (Pink Sheets: CGCP) the market leader in laser
transmyocardial revascularization (TMR) for the treatment of
chronic cardiac ischemia, announces that Dr. Naresh Trehan of New
Delhi will be presenting his clinical results of combining laser
TMR and stem cells to treat regions of myocardium that could not be
revascularized by conventional methods. Eight patients treated with
the PHOENIX System completed 1 year follow up: -- Seven patients
had concomitant coronary bypass grafting, one patient stand alone
therapy. -- There was no operative or hospital mortality. One year
survival was 100%. -- Compared to baseline, patients had NYHA Class
improvement (Mean 3.5+/-0.5 to 1.33+/- 0.5, p= 0.001), and improved
six minute walk test: 250+/- 112.1 seconds to 360+/-10 seconds,
p=0.01. -- MRI showed improved perfusion in the regions of
myocardium treated by the PHOENIX System The PHOENIX combination
delivery system is CE Mark approved and has been used in over 50
procedures at cardiac centers outside the U.S. It is not currently
FDA approved. The abstract "One Year Follow up of Combined
Autologous Bone Marrow Derived Progenitor Cell Therapy and
Transmyocardial Laser Revascularization for Diffuse Nongraftable
Coronary Artery Disease" can be located at:
http://www.ismics.org/abstracts/2009/10.html. "These results add to
the growing body of evidence that TMR has a positive impact on the
intramyocardial delivery of biologics, such as stem cells. The
PHOENIX System is designed to create transmural laser channels and
with its three integrated injector needles, deliver the biologic
into the surrounding tissue," said Richard Lanigan, President of
Cardiogenesis. "These results, along with a paper recently
published in the European Journal of Cardiothoracic Surgery, "Bone
Marrow Laser Revascularisation for Treating Refractory Angina Due
to Diffuse Coronary Heart Disease", reinforce the company's
regulatory strategy of submitting an IDE for its PHOENIX System in
the upcoming months." About Cardiogenesis Corporation Cardiogenesis
is a medical device company specializing in the therapies for the
treatment of chronic cardiac ischemia. 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, 2008 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. Cardiogenesis Corporation, +1-949-420-1800
http://www.cardiogenesis.com/ 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/
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