Navigation Links
Cardiogenesis Corporation Makes Pre-IDE Submission for PHOENIX Combination Delivery System
Date:7/30/2009

IRVINE, Calif., July 30 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (Pink Sheets: CGCP), a market leader in laser transmyocardial revascularization (TMR), today announced that it has submitted a pre-IDE (Investigational Device Exemption) to the Food and Drug Administration to initiate a feasibility trial for its PHOENIX System in patients with refractory angina. The PHOENIX Combination Delivery System combines intramyocardial laser channeling with the delivery of a biologic substance. The PHOENIX received a CE MARK in 2006 and there have been over 50 clinical cases completed to date outside of the U.S.

"The early clinical results achieved with TMR plus biologics suggest the potential of this combination therapy; to not only mitigate the debilitating effects of refractory angina, but potentially to improve cardiac function as well," said Paul McCormick, Executive Chairman. "Animal work by Dr. Patel demonstrated that the pre-treatment of myocardium with TMR enhanced cell viability and uptake when delivered with the Cardiogenesis PHOENIX combination delivery system, compared to cell therapy alone. This submission is an important step towards initiating the feasibility trial in the United States."

The company plans to evaluate the therapeutic effect of delivering Platelet Rich Plasma (PRP) in combination with TMR. PRP is derived from the patient's own circulating blood and is well documented in clinical applications for its angiogenic effect and accelerated wound healing response.

Center for Biologics Evaluation and Research (CBER) is the lead reviewing center for the PHOENIX application. The company expects to meet with CBER during the next 60 days to identify any additional information required to begin the feasibility trial.

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 planned clinical trials, are based on current expectations and beliefs and are subject to numerous risks and uncertainties, which are discussed in the "Risk Factors" section of the company's Annual Report on Form 10-K 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.

http://www.cardiogenesis.com


'/>"/>
SOURCE Cardiogenesis Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Cardiogenesis Corporation to Report Third Quarter 2007 Results on November 14th
2. Cardiogenesis Reports Fourth Quarter and Full Year 2007 Results
3. Cardiogenesis Reports Third Quarter 2008 Results
4. Cardiogenesis Announces Addition of Raymond W. Cohen to Board of Directors
5. Cardiogenesis Corporation to Report First Quarter 2009 Results on May 14th
6. Memry Corporation Announces Preliminary Fiscal Fourth Quarter and 2007 Revenue
7. PeriCor Therapeutics Announces Closing of Licensing Agreement for Acadesine with Schering-Plough Corporation
8. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
9. Drug Royalty Corporation (DRC) Announces Acquisition Regarding PEG-INTRON(R) From Enzon Pharmaceuticals, Inc. (ENZN)
10. BioElectronics Corporation Announces Singapore and Malaysia Sales
11. Avicena Signs Worldwide Exclusive Distribution Agreement with RITA Corporation for its Proprietary Dermaceutical Compounds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/22/2017)... ... June 22, 2017 , ... ... specialists DST Diagnostische Systeme & Technologien GmbH, thereby expanding its product portfolio to ... from hay fever, urticaria, asthma, atopic eczema or a food allergy. Allergies are ...
(Date:6/22/2017)... ... June 22, 2017 , ... The first human cell line HeLa, established ... first data on cross-contamination of human cell lines with HeLa cells were published. Until ... cell culture labs and is associated with dramatic consequences for research. , In ...
(Date:6/20/2017)... (PRWEB) , ... June 20, 2017 , ... Biologist Dawn ... men. While researching her latest book, Men Chase, Women Choose: The Neuroscience of Meeting, ... love has a physiological effect on men. ”The logical next step, in my estimation, ...
(Date:6/20/2017)... NJ (PRWEB) , ... June 20, 2017 , ... Do ... makes the transition from being a trusted supplier in the weighing industry, to extending ... cell extractions, ELISA essays, enzyme reactions, immunoassays, hybridizations and more, allowing for its ...
Breaking Biology Technology:
(Date:4/17/2017)... Florida , April 17, 2017 NXT-ID, ... technology company, announces the filing of its 2016 Annual Report on ... and Exchange Commission. ... on Form 10-K is available in the Investor Relations section of ... as on the SEC,s website at http://www.sec.gov . ...
(Date:4/11/2017)... , Apr. 11, 2017 Research and ... Market 2017-2021" report to their offering. ... The global eye tracking market to grow at a ... report, Global Eye Tracking Market 2017-2021, has been prepared based on ... covers the market landscape and its growth prospects over the coming ...
(Date:4/5/2017)...  The Allen Institute for Cell Science today announces ... portal and dynamic digital window into the human cell. ... application of deep learning to create predictive models of ... a growing suite of powerful tools. The Allen Cell ... publicly available resources created and shared by the Allen ...
Breaking Biology News(10 mins):