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Macrocure (MCUR) Completes Enrollment In Pivotal Phase 3 Clinical Trial Of Curexcell In Diabetic Foot Ulcers



9/2/2014 10:30:21 AM

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PETACH TIKVA, Israel, Sept. 2, 2014 (GLOBE NEWSWIRE) -- Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that it has completed enrollment in its pivotal, double-blind, Phase III clinical trial of CureXcell in Diabetic Foot Ulcers ("DFUs"). A total of 280 patients at 25 participating sites have been enrolled and randomized.

CureXcell is currently in two pivotal, Phase III clinical trials for the treatment of chronic, hard-to-heal wounds below the knee. The first clinical trial is a multicenter, randomized, double-blind, parallel group, sham-controlled study of CureXcell in DFUs. The Company expects to announce study results in the second half of 2015. The Company's second pivotal, Phase III clinical trial is studying CureXcell in Venous Leg Ulcers ("VLUs"). The VLU study initiated patient enrollment in May 2014. Interim data in the VLU study is expected in the second half of 2015 with the study expected to conclude in the second half of 2016.

"The rate at which we were able to enroll patients in the DFU trial allowed us to meet our previously disclosed milestone and demonstrates our commitment to execution. We are eager to extend our resources, with the same level of focus, to the VLU trial. If successful, the DFU clinical trial will be one of two pivotal trials to support our Biologics License Application for CureXcell, which we believe has the potential to change how chronic, hard-to-heal wounds are treated," stated Nissim Mashiach, President and Chief Executive Officer of Macrocure.

About Macrocure Ltd.

Macrocure Ltd. is a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, such as DFUs and VLUs. The Company's novel approach is to treat and close chronic and other hard-to-heal wounds by injecting the human body's own wound healing and regenerative components directly into the wound itself.

About CureXcell

Macrocure's lead product candidate, CureXcell, is a unique combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure. CureXcell addresses each phase of healing in the impaired wound, including the production of growth factors and other biochemical factors involved in fibroblast activation, cell migration and extracellular matrix production, stimulating the body's natural healing process. CureXcell is currently in two pivotal, Phase III, double-blind clinical trials targeting a broad indication for the treatment of all types of wounds below the knee. For more information, please visit: www.macrocure.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecasts, commercial results, clinical trials and regulatory authorizations. Forward-looking statements are based on Macrocure's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in regulatory approval process or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and Macrocure undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

CONTACT: Francesca DeMartino Investor Relations & Corporate Communications +1 (310) 739-6476 francesca@macrocure.com

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