Cardiogenesis Announces Preliminary Results Combining TMR + Platelet Rich Plasma (PRP)
18 Juni 2008 - 12:00PM
PR Newswire (US)
IRVINE, Calif., June 18 /PRNewswire-FirstCall/ -- Cardiogenesis
Corporation (Pink Sheets: CGCP), a leading developer of surgical
products for cardiac revascularization today announced an upcoming
scientific presentation that describes the use of combining
transmyocardial revascularization (TMR) with platelet rich plasma
(PRP). The presentation titled "Intramyocardial Injection of
Autologous Platelet Rich Plasma combined with Transmyocardial
Revascularization" will be presented by Kurt E. Wehberg, MD of
Peninsula Regional Medical Center (Salisbury, Maryland) at the 34th
annual meeting of the Western Thoracic Surgical Association on June
28, 2008 in Kona, Hawaii. The abstract of the presentation is
available at
http://www.westernthoracic.org/Abstracts/2008/BC8.html. Dr. Wehberg
will be presenting on a group of 25 consecutive patients treated
with the Cardiogenesis holmium: YAG Laser TMR System. Eleven
patients in the series received a combination therapy of TMR with
an intramyocardial injection of autologous PRP, which is a
concentration of platelets, white blood cells and circulating stem
cells from the patients' own peripheral blood. At six months, a
blinded angina assessment demonstrated: -- Both groups achieved
significant angina relief. -- The TMR + PRP group had a lower
average angina score (0.4 vs 1.7, p=0.07) than the TMR alone group,
and were more likely to be angina free (71% vs 23%, p=0.04). --
Ejection fraction (EF) improved in the TMR + PRP group (+9.0% vs.
-2.0%, p=0.07) compared to the TMR group. The authors conclude,
"These preliminary results suggest that combining intramyocardial
injection of PRP with TMR may be more efficacious at relieving
angina and improving myocardial function than TMR alone." Richard
Lanigan, President of Cardiogenesis, noted, "The results that Dr.
Wehberg will present not only reinforce the clinical utility of
TMR, but also suggests that our TMR system can enhance the
effectiveness of a biologic agent." Lanigan added, "Dr. Wehberg
utilized the FDA approved Cardiogenesis TMR System along with
readily available PRP as combination therapy in his series with
favorable results. Earlier this month, at the 10th annual meeting
of the International Society of Minimally Invasive Cardiothoracic
Surgeons (ISMICS) meeting in Boston, Dr. Guillermo Reyes (La
Princesa University Hospital, Madrid) reported on the use of the
Company's PHOENIX System that enables a combination TMR and
biologics delivery in a single handpiece. Dr. Reyes reported the
combination of TMR with bone marrow derived stem cells had
demonstrated an improvement in angina class and reduction in the
use of nitrates for the treated patients. These two reports
demonstrate the clinical potential for TMR to enhance the effect of
biologic substances through their precise delivery into the
stimulated tissue border zone around the holmium: YAG TMR channels.
Our focus is to build on this early work and provide clinicians
with effective tools to treat the large patient population
suffering from refractory angina by means of TMR and TMR plus
biologics." 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
technologies and the effect of such technologies 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 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; 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/
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