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TMCNet:  CorMatrix Completes Enrollment of Patients in RESTORE, First-In-Human Study with CorMatrix for Improvement of Myocardial Function

[July 01, 2014]

CorMatrix Completes Enrollment of Patients in RESTORE, First-In-Human Study with CorMatrix for Improvement of Myocardial Function

WARSAW, Poland --(Business Wire)--

CorMatrix Cardiovascular Inc. of Roswell, Georgia and the Central Clinical Hospital of the Ministry of Interior in Warsaw (Centralny Szpital Kliniczny MSW) of Warsaw, Poland announced the successful enrollment and treatment of 5 patients in the first ever study evaluating the CorMatrix ECM delivered trans-epicardially for the improvement of myocardial function in patients at risk or suffering from congestive heart failure (CHF).

The RESTORE Study is being conducted at the Central Clinical Hospital of the Ministry of Interior in Warsaw, Poland under the direction of Study Investigator Dr. Piotr Suwalski, Chief of the Department of Cardiac Surgery. The objective of this study is to evaluate the safety of the CorMatrix ECM delivered trans-epicardially with a proprietary delivery system to patients with left ventricular ejection fraction (LVEF) 25 to 40% during coronary artery bypass grafting (CABG). The endpoints of the study include device related safety and improvement in global ventricular function. Echocardiograph and MRI data will be evaluated by Yale Cardiovascular Research under the direction of Dr. Alexandra Lansky. Patients will be followed for 18 months, with interim assessments being conducted at 6 months and 12 months post treatment.

Heart failure (HF) or congestive heart failure (CHF) represents one of the largest unsolved medical problems today, with more than five million patients in the U.S. alone, and this number is expected to double over the next ten years. In 2012, the direct and indirect cost of HF in the U.S. was estimated to be $31 billion. Globally, the incidence of HF is increasing with over one million new cases diagnosed annually. Current treatment options for HF are limited to pharmacological therapy, cardiac resynchronization therapy, mechanical circulatory support devices, and heart transplant. In advanced HF, transplant offers the best opportunity for long-term survival, but is restricted to select patients and the number of available donor organs is limited and cannot meet the growing demand. These circumstances have promoted mechanical circulatory support devices as a treatment option aimed at restoring cardiac output. Left ventricular assist devices (LVAD), which mechanically unload blood volume from the failing left ventricle into the aorta, have become a standard therapeutic option for bridging to transplantation or for permanent use in patients not eligible for heart transplantation with end-stage HF. Recently the Bridge-to-transplantation (BTT) trial/ADVANCE and ADVANCE CAP by Slaughter and Aaronson and another publication from Starling (News - Alert) reveal BTT outcomes are equivalent to heart transplant at 1 and 2 years. Additionally, a paper by Kirklin shows that Destination Therapy (DT) outcomes at 2 years are also equal to transplant).

CorMatrix has developed an extracellular matrix device and an intra-myocardial delivery device that enables efficient implantation of the CorMatrix ECM directly into damaged cardiac tissue. Intra-myocardial delivery of the CorMatrix to mechanically stabilize, repair and recover infarcted regions of the heart could provide myocardial recovery for these heart failure patients. The CorMatrix ECM is an implantable material derived from porcine small intestine submucosa (SIS) that has een shown to provide a biologically and mechanically favorable scaffold for cell incorporation, differentiation, and proliferation. The proprietary delivery system enables targeted implantation and uniform distribution of the CorMatrix ECM to the ischemic regions of the myocardium to maximize recovery.


Dr. Suwalski commented that "it is very exciting to take part in a study like the RESTORE Study that has the potential to provide data in support of what would be the first time the potential of a patient's own stem cells were harnessed for the treatment or prevention of congestive heart failure by restoring a natural matrix with the regenerative power of the heart. The CorMatrix ECM treatments and the delivery system provided safe and easy application of the CorMatrix ECM to the patients."

Dr. Mark Slaughter, director of the Heart Transplant and Mechanical Assist Device program at Jewish Hospital & St. Mary's HealthCare, as well as Chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville added, "this First in Human study follows pre-clinical work that we've conducted at the University of Louisville demonstrating that CorMatrix ECM may provide a favorable environment to enhance myocardial regeneration and promote sustained myocardial recovery. The RESTORE Study will further clarify this question and set the bar for future CHF technologies."

"CorMatrix has been pursuing a viable treatment/prevention for CHF since our Company was founded. Studies using isolated stem cell treatments to correct CHF have not resulted in relevant clinical benefits. Harnessing the power of our body's own supply of stem cells, CorMatrix provides a natural environment, allowing these cells to repair damaged tissue structures. We are excited to be advancing the development of this application of the CorMatrix technology to improve patient lives," commented David Camp, CorMatrix Cardiovascular Chief Executive Officer.

Background of Extracellular Matrix (ECM) Biomaterial

The decellularized matrix material serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM material is gradually replaced as the patient's own cells reinforces and rebuilds the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. The safety of extracellular matrices has been well established in a number of different clinical applications and more than 500 published papers. Since 1999, an estimated two million patients worldwide have received an extracellular matrix implant.

About CorMatrix

CorMatrix® Cardiovascular, Inc. was founded in 2001 as a privately held medical device company dedicated to developing and delivering innovative biomaterial devices that harness the body's own innate ability to repair damaged cardiovascular tissues. Headquartered in Atlanta, Georgia, the Company is currently researching, developing and commercializing a platform technology known as CorMatrix ECM® for a variety of cardiovascular indications, and has U.S. clearance and European approval (with a CE Mark) for its ECM® technology as an implant for pericardial closure, cardiac tissue repair, as well as clearance for carotid repair. With significant patent protection, CorMatrix is poised to successfully expand its current line of products. For more information, visit www.cormatrix.com.

About Central Clinical Hospital Warsaw

Founded October 8, 1951, the Central Clinical Hospital of the Ministry of Interior located at 137 Woloska Str, 02 - 507 Warsaw, Poland, is a leading medical center not only in Warsaw but also in Poland. The confirmation of this is the ever-increasing number of patients who want to be treated here. In the 50 years of its activity, the Central Clinical Hospital has admitted more than 5 million patients, including providing medical care to members of the government, parliament, and diplomats. The Department of Cardiac Surgery (registered in September 1998 as the third heart transplant center in Poland), bypass surgery has become almost a routine operation after a heart attack. The number of operations performed in the Department of Cardiac Surgery increased 3 times, thanks to the most modern Postoperative Intensive Care Unit in the country, which was opened in 2000. The wheel of history has made a full 360-degree turn, with today, like 60 years ago, the Central Clinical Hospital of the Ministry of Interior being a modern diagnostic and treatment center, friendly for patients and their families.

Safe Harbor Statement

This report includes forward-looking statements covered by the Private Securities Litigation Reform Act of 1995. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results for fiscal year 2014 and beyond could differ materially from the Company's current expectations. Forward-looking statements are identified by words such as "anticipates," "projects," "expects," "plans," "intends," "believes," "estimates," "targets," and other similar expressions that indicate trends and future events.

Factors that could cause the Company's results to differ materially from those expressed in forward-looking statements include, without limitation, variation in demand and acceptance of the Company's products and services, the frequency, magnitude and timing of raw-material-price changes, acceptance by FDA or other regulatory agencies, general business and economic conditions beyond the Company's control, the consequences of competitive factors in the marketplace including the ability to attract and retain customers, results of continuous improvement and other cost-containment strategies, and the Company's success in attracting and retaining key personnel. The Company undertakes no obligation to revise or update forward-looking statements as a result of new information, since these statements may no longer be accurate or timely.


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