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FDA Approves Merit Medical's HiQuality Clinical Trial Protocol for the Treatment of Primary Liver Cancer

First large-scale multi-site U.S. study comparing doxorubicin-eluting QuadraSphere™ Microspheres to conventional chemoembolization
/ Source: GlobeNewswire

First large-scale multi-site U.S. study comparing doxorubicin-eluting
QuadraSphere™ Microspheres to conventional chemoembolization

Interventional radiologists from U.S., Europe, South America
participating in liver cancer study

SOUTH JORDAN, Utah, Nov. 29, 2010 (GLOBE NEWSWIRE) -- The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s (Nasdaq:MMSI) phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.  The FDA action will result in the first phase 3 study in the U.S. comparing drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma. Currently in the U.S. there is no FDA-approved embolic for the treatment of liver cancer.

QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations.  The identical product marketed in Europe as HepaSphere Microspheres has been CE-marked in the European Union since 2007 for embolization of HCC and hepatic metastases, with or without delivery of doxorubicin.  

"I am extremely pleased with the efforts of our BioSphere Regulatory and Medical Affairs Department headed by Dr. Melodie R. Domurad, PhD," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "We are very excited about the initiation of this important study."

Merit Medical is a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy.  It has recently added the BioSphere microsphere products to its line of tumor treatment options.

The phase 3 study is a prospective, randomized, blinded and controlled investigation of HepaSphere/QuadraSphere Microspheres for delivery of doxorubicin for the treatment of hepatocellular cancer. Known as the HiQuality Study (HepaSphere/QuadraSphere in Liver Cancer Treatment), the primary endpoint of the clinical trial is survival.  Secondary endpoints include tumor response by mRECIST criteria, safety, resource utilization such as length of hospitalization, and adverse events.  The study will enroll 500 patients and be conducted in approximately 20 clinical sites in the U.S., Europe, and South America. 

Dr. Riccardo Lencioni, who developed the guidelines for image acquisition and interpretation for the trial stated, "This study meets the highest standards for clinical research in hepatocellular carcinoma, as recommended in Design and Endpoints of Clinical Trials in Hepatocellular Carcinoma, guidelines for clinical research in HCC by an expert panel convened by the American Association for the Study of Liver Disease, and published in the Journal of the National Cancer Institute. The design of the investigation is rigorous, and has been extensively reviewed by the FDA."

Dr. Lencioni, M.D., Associate Professor of Radiology at the University of Pisa in Italy and Director of the Division of Diagnostic Imaging and Intervention at the Department of Hepatology and Liver Transplantation at the Pisa University Hospital, will be overseeing the central imaging review and evaluation of tumor response.  Professor Lencioni is Chairman of the Membership Committee and a member of the Executive Committee of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and Chairman of the Programme Committee of the European Conference on Interventional Oncology (ECIO).  He is also a member of the Steering Committee of the World Conference on Interventional Oncology (WCIO).  Professor Lencioni has been one of the founders of the International Liver Cancer Association (ILCA), and is a member of the Governing Board.  Professor Lencioni has received more than 40 international awards; authored 134 articles or editorials; and is the editor of seven books.  Professor Lencioni has served on the editorial board of Cardiovascular andInterventional Radiology, Investigative Radiology, European Radiology, Journal of Hepatology, Journal of Interventional Oncology, and La Radiologia Medica.

Michael Soulen, M.D. from the University of Pennsylvania Medical Center and Professor of Radiology specializing in Interventional Radiology, will direct the study as principal investigator. Active in the Society of Interventional Radiology (SIR), Dr. Soulen has served on the Executive Council, chaired the 1999 Annual Scientific Meeting, and acted as Director of Research Education for the SIR Foundation.  He also serves on committees of the Radiological Society of North America (RSNA) and the American College of Radiology (ACR).  Dr. Soulen chairs the steering committee of the World Conference of Interventional Oncology (WCIO).  He is also an editorial board member and/or reviewer for numerous publications, including the Journal of Vascular and Interventional Radiology.  He has published nearly100 peer-reviewed articles and more than 50 editorials, chapters and invited manuscripts.

About Liver Cancer

Liver cancer is the third leading cause of cancer deaths worldwide.  The sharp rise in hepatitis C infections, alcohol consumption and obesity are reported as key contributing factors to the increase in liver cirrhosis and liver cancer. Liver transplantation or tumor resection is considered potentially a curative treatment; however, only about 25 percent of liver cancers are diagnosed when they can be treated surgically.                   

Surgical removal is not possible for more than two-thirds of primary liver cancer patients and 90 percent of patients with secondary liver cancer. According to the U.S. National Cancer Institute (NCI), no currently exists for liver cancer when tumors cannot be surgically removed and liver transplantation is not a viable option. However, both the NCI and the Society of Interventional Radiologists (SIR) report that transarterial chemoembolization (TACE) has shown promising results. 

hqTACE - Merit Advances Chemoembolization

Drug-eluting embolization treats hepatocellular carcinoma through the dual action of delivering chemotherapy into the tumors while also cutting off the blood supply that supports them.  QuadraSphere adds two benefits to embolization therapy.  First, by ionically binding the doxorubicin throughout the microspheres and eluting it into the cancer in a sustained manner, more drug can be delivered into the tumor, with less escaping into peripheral circulation.  Complementary to the targeted delivery, QuadraSphere Microspheres have a unique formulation that makes them highly compressible and conformable, so they mold to the vessel lumen, creating both excellent contact with the vessel walls for delivery of chemotherapy and very efficient occlusion of the vessels feeding the tumor.  Initial clinical results have demonstrated improved safety and reduced adverse events compared to treatment by conventional chemoembolization.

About Conventional Transarterial Chemoembolization (cTACE)

Conventional transarterial chemoembolization (cTACE) is a two-stage process involving the injection of chemotherapeutic drugs, typically emulsified with iodized oil, directly into the blood vessels that feed a tumor.  The drug is followed by the delivery of an embolic agent used as a plug to block the tumor's blood supply and temporarily retain the cytotoxic drugs in place. However, the occlusion is limited in area and some of the chemotherapy still escapes into circulation, which leads to adverse effects.

About Merit

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 130 individuals. Merit employs approximately 2,170 people worldwide with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Copenhagen, Denmark; and Rockland, Massachusetts.

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Statements contained in this release which are not purely historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2009. Such risks and uncertainties include risks relating to Merit's recent acquisition of BioSphere (including, without limitation, the risk that the operations of the two companies will not be integrated successfully; and the risk that Merit may be unable to successfully develop, commercialize and market new products and technology which Merit acquired through the acquisition); uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; possible infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; downturn of the national economy and the corresponding effect on Merit's revenues, collections and supplier relations; potential termination of supplier relationships, or failure of suppliers to perform; product recalls and product liability claims; delays in obtaining regulatory approvals, or the failure to maintain such approvals; Merit's inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future acquisitions, including without limitation the Endotek acquisition; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's products obsolete; market acceptance of new products; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; volatility of the market price of Merit's common stock; foreign currency fluctuations; changes in key personnel; work stoppage or transportation risks; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; impact of force majeure events on Merit's business, including severe weather conditions; failure to comply with applicable environmental laws; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2009 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

CONTACT: Merit Medical Systems, Inc. Anne-Marie Wright, Vice President, Corporate Communications (801) 208-4167 Fax: (801) 253-1688