PETACH TIKVA, Israel, May 4, 2015 (GLOBE NEWSWIRE) -- Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biopharmaceutical company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that Lewis Gryziewicz has joined Macrocure as Vice President, Regulatory Affairs, effective May 1, 2015.
Prior to joining Macrocure, Dr. Gryziewicz spent 16 years at Allergan, 10 years at Johnson & Johnson and 3 years at Bristol-Myers Squib. At Allergan, Dr. Gryziewicz held senior-level positions within Regulatory Affairs, most recently as Global Regulatory Liaison for Ophthalmology, where he was responsible for the submission and approval of global marketing applications, liaising with global regulatory agencies, and regulatory strategy, which led to product approvals, including US and European Union approvals of Ozurdex® and Combigan® and approval in the US and Japan for Alphagan® P and Lumigan®, among others. During his tenure at Johnson & Johnson, Dr. Gryziewicz also held positions in Regulatory Affairs and was responsible for the approval of the acne indication for Ortho Tri-Cyclen® and the removal of the black box warning for Renova®.
"Lewis is an accomplished leader with a long-standing track record of achievement in regulatory affairs at large, global and reputable companies. He has been directly responsible for numerous landmark product approvals in ophthalmology, women's health and aesthetics. Specifically, he has vast experience in establishing development strategies and achieving marketing approvals for pharmaceutical and biological products in the US, Europe and Japan," stated Nissim Mashiach, President and Chief Executive Officer of Macrocure. "As we approach the completion of our pivotal, Phase III clinical trials in DFU and VLU and the subsequent BLA filing for CureXcell, Lewis will be an invaluable contributor to Macrocure in the execution of our regulatory strategy, including the preparation of the filing and the interface with the FDA," concluded Mr. Mashiach.
Dr. Gryziewicz holds a PharmD from the University of Colorado, a BS in Pharmacy from the Philadelphia College of Pharmacy and Science, and an MBA from Fairleigh Dickinson University.
About Macrocure Ltd.
Founded in 2008, 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. 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.
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