December 25, 2014 11:12 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 and Director
Age: 65
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. 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.

ACell Launches New MatriStem Multilayer Wound Matrix Device

ACell, Inc. launched the new MatriStem(R) Multilayer Wound Matrix device for deep, hard-to-heal, full-thickness wounds. The one-to-one (1:1) mesh design of MatriStem Multilayer Wound Matrix is built to accommodate moderate to heavy wound exudate and provides effective contouring functionality in wound application. MatriStem products are medical devices that maintain and support a healing environment through constructive remodeling. Comprised of naturally-occurring urinary bladder matrix (UBM), MatriStem maintains an intact epithelial basement membrane which is hypothesized to facilitate the body's natural healing potential. The MatriStem Multilayer Wound Matrix device is easy to prepare, apply and fixate and requires no special handling or storage requirements. MatriStem Multilayer Wound Matrix is appropriate for both acute and chronic wounds. MatriStem devices have received multiple 510(k) clearances from the FDA and are indicated for wound management including for pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds and trauma wounds, and the reinforcement of soft tissue where weakness exists in urological, gynecological and gastroenterological anatomy.

ACell Expands MatriStem Pelvic Floor Matrix Product Portfolio with Addition of Four Device Sizes

ACell, Inc. announced that it has expanded the MatriStem(R) Pelvic Floor Matrix product portfolio with the addition of four device sizes. The addition of four new sizes to the portfolio offers a broad range of viable solutions for physicians treating patients in need of pelvic floor repair. MatriStem Pelvic Floor Matrix is a naturally-occurring, non-synthetic scaffold that provides a unique balance of strength and pliability for use in repair of anterior, posterior and apical defects. Comprised of proprietary Urinary Bladder Matrix (UBM), MatriStem Pelvic Floor Matrix is intended for implantation to reinforce soft tissue where weakness exists in urological and gynecological anatomy including vaginal prolapse repair, reconstruction of pelvic floor, and pubourethral support. On the market since 2010, MatriStem Pelvic Floor Matrix is currently available in 9x9x12cm (trapezoid) size, with four new sizes being added to the product line: 5x5cm, 4x12cm, 7x10cm and 10x15cm. The full line of products in five sizes was made available on January 10, 2014.

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