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.