Columbia, MD— (June 11, 2019) ACell, Inc. today announced that it has reached final settlement agreements with the United States Attorney’s Office for the District of Maryland and three states to resolve all civil and criminal allegations relating to the sales and marketing of the Company’s products.
ACell has agreed to plead guilty to one misdemeanor count of failure to report a medical device removal in 2012. ACell has also entered into a separate civil False Claims Act settlement that resolves DOJ civil claims and state claims. Under the agreements, ACell will pay a total amount of $15 million, over the course of five years, to the Department of Justice and the states. ACell has also entered into a Corporate Integrity Agreement with the Office of Inspector General for a term of five years. ACell cooperated fully with the government in the process that led to the agreement. The Company will continue to work collaboratively with its regulators. Except to the extent admitted in ACell’s guilty plea, ACell does not admit liability or wrongdoing.
The activities DOJ investigated occurred many years ago, when ACell was headed by a different management team.
ACell is committed to putting patients first in all that it does. ACell remains committed to the highest
standards of compliance, quality, integrity and ethics. ACell has had, and will continue to have, a comprehensive compliance program and internal controls to ensure that the Company complies with applicable laws and regulations.
“We look forward to putting this matter behind us,” said Patrick McBrayer, ACell’s President and CEO. “We are focused on moving forward with positive momentum and growth as we pursue our mission of creating high-quality, innovative solutions to transform standards of medical care and improve the quality of life for every patient for whom our products are used.”
About ACell, Inc.
ACell, Inc. is a leading regenerative medicine company focused on the development, manufacturing, and commercialization of medical devices for wound management and surgical soft tissue repair. ACell is committed to becoming and remaining an innovative leader in regenerative medical technology, offering superior healing options for doctors and patients. ACell is a privately held company and operates manufacturing facilities in Columbia, MD and Lafayette, IN. For more information about ACell please visit www.acell.com