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Symphony Medical Inc. Announces Initiation Of Phase II Multi-Center Clinical Trial For Biologic Therapy To Prevent Post-Operative Atrial Fibrillation


7/5/2006 2:43:48 PM

LAGUNA HILLS, Calif., July 5 /PRNewswire/ -- Symphony Medical, Inc., a developer of new non-destructive biologic and biopolymer therapies to treat atrial fibrillation and other cardiac abnormalities, announced today patient enrollment is underway in its Phase II multi-center human clinical trial of a novel, non-destructive therapy designed to prevent sustained post-operative atrial fibrillation (AF). Post-operative AF is the most common complication associated with the approximately 500,000 coronary artery bypass grafting and cardiac valve replacement surgeries performed each year. The financial impact of post-operative AF on hospital resources represents the most important potentially reversible health care expenditure related to cardiothoracic surgery today, with annual costs estimated to exceed $1 billion in the U.S. alone.

The Company's novel post-operative AF procedure, developed in collaboration with clinicians at The Cleveland Clinic Foundation and St. Mary's Hospital and Imperial College School of Medicine in London, employs a non-ablative, non-surgical approach whereby a biopolymer that prevents the development of persistent atrial fibrillation is prophylactically injected into a specific location of a patient's heart prior to the conclusion of an open chest cardiothoracic procedure.

According to numerous published studies, the incidence of post-operative AF is significant and occurs as an unintended consequence of cardiothoracic surgery effecting more than 30 percent of coronary artery bypass patients and up to 60 percent of patients who undergo a combination valve replacement and bypass procedure.

Raymond W. Cohen, Symphony Medical chief executive officer said, "Physicians recognize the acute and long term implications related to post-operative AF including the potential for higher incidences of post-op stroke and the development of chronic atrial fibrillation. Cardiologists are virtually unanimous in their view that a prophylactic approach that prevents post-op AF is highly desirable and, moreover, that the current approach towards post-op AF treatment, which typically involves significant doses of pharmacologics, is, at best, inadequate and ineffective. In addition to the clinical issue, economics are also relevant. Patients who develop post-op AF typically have increased lengths of stay by three or four days which create significant non-reimbursed costs to hospitals."

About Symphony's Technology to Prevent Post-Operative Atrial Fibrillation

The post-operative AF treatment "Kit" includes three proprietary components; a hemostatic sealant derived from human plasma, a disposable two-channel applicator to facilitate delivery of the biopolymer and a disposable hand-held electrical stimulation device used to accurately detect the precise location of the injection. The hemostatic sealant does not include any animal-derived components and is supplied to Symphony under an exclusive licensing arrangement by OMRIX Biopharmaceuticals, Inc. . OMRIX's hemostatic sealant is currently approved in numerous countries including the United States and the European Union.

It is believed that the administration of the biologic material into the Epicardial fat pads achieves temporary modulation of the autonomic nervous system of the heart by blocking the vagal inputs to the heart than can serve as an initiating trigger for atrial fibrillation. There are no known pharmacological, immunological or metabolic interactions that are believed to occur and the Company's pre-clinical studies have demonstrated that the biological material dissipated in less than 30 days after introduction into the heart.

About the Clinical Study

The 40-patient, open label study will take place at multiple sites in Europe including the German Heart Center in Munich, the Dresden University Heart Center, the Leipzig University Heart Center, the Cardiovascular Clinic Bad Neustadt and the Cardiothoracic Surgery Department of the University of Erlangen/Nurenberg. Patients undergoing routine coronary bypass grafting and/or heart valve repair will be enrolled in the study. Endpoints will include safety parameters as well as the incidence of persistent atrial fibrillation and/or atrial fibrillation requiring medical intervention during the first few days following surgery.

An abstract with the results from the Company's initial human clinical trial as well as certain peer-reviewed publications on post-operative AF can be found by visiting www.symphonymed.com and the link below: http://www.symphonymed.com/news-room.php?d=20060517a&type=Abstract

About Symphony Medical, Inc.

Symphony Medical, founded in 2003, is a privately-held, venture-backed development stage company developing proprietary biotherapeutic products and tools to address the unmet clinical needs of millions of patients suffering from cardiac disorders. The Company's products use proprietary biopolymers and cell therapies to treat patients with arrhythmias and other cardiac abnormalities through non-destructive (non-ablative and non-surgical) means. This is achieved, in part, by injecting biologic material directly into specific locations of the heart during either open chest surgery or via a minimally invasive procedure employing a catheter-based cardiac delivery system.

Symphony's initial product, which has advanced from pre-clinical to clinical stage testing, is a prophylactic method of preventing sustained post- operative atrial fibrillation, a common side affect of the approximately 500,000 coronary artery bypass grafting and cardiac valve replacement surgeries performed each year.

In an recent study that underscores the importance of addressing the problem of post-operative atrial fibrillation presented at the 27th Annual Scientific Session of the Heart Rhythm Society, May 17-20, 2006 in Boston, researchers from Brigham and Women's Hospital, Boston, MA and University of Pennsylvania, Philadelphia, PA, examined coronary artery bypass grafting (CABG) patients who did not have any incidence of atrial fibrillation pre-operatively to determine if the development of post-CABG atrial fibrillation predicts a risk for being in atrial fibrillation at long term follow up. The authors concluded that patients who experience new atrial fibrillation post-CABG prior to discharge from the hospital have a high incidence of atrial fibrillation at three years if the atrial fibrillation fails to be successfully converted to normal prior to discharge. In contrast, transient post-CABG atrial fibrillation (whose atrial fibrillation spontaneously converted to normal prior to discharge) is not associated with any increased incidence of atrial fibrillation when compared to patients with no post-CABG atrial fibrillation.

For more information on Symphony Medical please visit our website at www.symphonymed.com.

Contact: Matt Clawson Allen & Caron Inc 949-474-4300 matt@allencaron.com

Symphony Medical, Inc.

CONTACT: Matt Clawson of Allen & Caron Inc, +1-949-474-4300,matt@allencaron.com, for Symphony Medical, Inc.


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