February 28, 2015 1:06 AM ET

Healthcare Equipment and Supplies

Company Overview of ACell, Inc.

Company Overview

ACell, Inc. engages in the development and commercialization of extracellular matrix devices to repair and remodel damaged tissues and organs in a range of surgical procedures for the U.S. and international patents. It offers MatriStem technology, a non-crosslinked, resorbable, and acellular material; MatriStem Wound Care Matrix, a wound care device with regenerative medicine technology; MatriStem Plastic Surgery Matrix, a plastic surgery and wound care device; and MatriStem Hernia Matrix, a general surgery device. The company was incorporated in 1999 and is headquartered in Columbia, Maryland. It has a manufacturing facility in Lafayette, Indiana.

6640 Eli Whitney Drive

Columbia, MD 21046

United States

Founded in 1999

Phone:

410-715-1700

Fax:

410-715-4511

Key Executives for ACell, Inc.

Chief Executive Officer, Director, Chairman of Nominating & Corporate Governance Committee and Member of Audit Committee
President
Chief Financial Officer
Age: 66
Vice President of Operations
Senior Vice President and General Counsel
Age: 57
Compensation as of Fiscal Year 2014.

ACell, Inc. Key Developments

ACell, Inc. Appoints Thomas Gilbert as a Chief Science Officer

ACell, Inc. announced that it has appointed Thomas Gilbert as a Chief Science Officer. Dr. Gilbert has served as Vice President, Research and Development at ACell since 2012. In his new position, Dr. Gilbert will add oversight of Clinical Research programs to his Research and Development responsibilities, with the goal of building a unified product development strategy from initial concept to post-market clinical evaluation. Dr. Gilbert previously served as Assistant Professor of Surgery, Cardiothoracic Surgery and Bioengineering at the University of Pittsburgh and was a faculty member of the McGowan Institute for Regenerative Medicine.

ACell, Inc. Announces Management Changes

ACell, Inc. announced that it has appointed James A. D’Orta, MD, as Chief Executive Officer. He has served as a member of the company's Board of Directors since 2013, and as Chairman of the Board’s Corporate Governance, Nominating, and Compliance Committee. Dr. D’Orta is a seasoned business executive, entrepreneur, and physician with a history of strategically developing health care companies. He recently served as the Chairman and CEO of Consumer Health Services, Inc. Dr. D’Orta succeeds James R. DeFrancesco, who served as Chief Executive Officer since the company’s founding in 2002. Mr. DeFrancesco remains a director on the company's Board.

ACell, Inc. Announces First Patient in A U.S. Phase IV Clinical Trial

ACell, Inc. announced enrollment of the first patient in a U.S. Phase IV clinical trial evaluating the safety and long-term effectiveness of the company’s MatriStem Pelvic Floor Matrix device as compared to native tissue repair for the treatment of pelvic organ prolapse. The prospective, non-randomized trial will measure post-operative pelvic pain, quality of life and long-term need for retreatment. More than 300,000 cases of pelvic organ prolapse are treated surgically in the United States each year, and it is estimated that 20% of women will undergo some form of pelvic surgery in their lifetime. The study is part of the company’s commitment to conducting postmarket surveillance for MatriStem Pelvic Floor Matrix in response to the 522 Order issued to all manufacturers of transvaginal pelvic meshes by the United States Food and Drug Administration in January 2012. Collaborations between the American Urogynecologic Society and other industry sponsors led to the development and implementation of the American Urogynecologic Society's Pelvic Floor Disorders Registry. The multi-center, prospective, non-randomized trial will enroll 162 subjects at qualified sites across the United States. The first patient was enrolled at Princeton Urogynecology under Heather van Raalte, M.D., a fellowship trained and board certified urogynecologist specializing in the treatment of female pelvic floor disorders. The objective of the trial is to show that treatment with MatriStem Pelvic Floor Matrix is at least as safe and effective as treatment with native tissue repair, as assessed through anatomic and subjective assessments over a 36-month follow up period. MatriStem devices have received multiple 510(k) clearances from the FDA. MatriStem Pelvic Floor Matrix is specifically intended for implantation to reinforce soft tissue where weakness exists in gynecological anatomy including vaginal prolapse repair, reconstruction of the pelvic floor and pubourethral support. The company offers the next generation of regenerative medicine through the development and commercialization of unique extracellular matrix products to repair and remodel damaged tissues in a broad range of applications. Its patented MatriStem ECM medical devices facilitate constructive remodeling by the body, and are available in particle and sheet forms for the management and reinforcement of wounds and various surgical procedures.

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