ST. PAUL, Minn., Jan. 11 /PRNewswire-FirstCall/ -- Synovis Life Technologies, Inc. , has received clearance by the U.S. Food and Drug Administration (FDA) for an additional important indication for its Veritas(R) Collagen Matrix. Veritas has been shown to minimize internal tissue attachment, a common and painful post-surgical complication. Veritas is an implantable, biomedical material that provides a scaffold into which the body’s own tissue can grow, effectively remodeling the implant to the host tissue.
The FDA granted the additional indication after Synovis completed research in 2006 which examined adhesion formation and the tenacity of adhesions post surgery, and demonstrated that Veritas implants had minimal tissue attachment. Synovis received the original FDA 510(k) marketing clearance for Veritas in 2000. Additionally, Synovis holds a U.S. patent for the process to manufacture Veritas and was just issued another U.S. patent for “a method and composition for preventing surgical adhesions.”
“Receiving this additional indication from the FDA for Veritas is significant news for Synovis, and supports our strategy to maximize the applications for Veritas in many areas of soft tissue repair,” said Richard Kramp, president and chief executive officer of Synovis Life Technologies. “Our versatile, remodelable Veritas is currently used in various applications, from gastric bypass and thoracic surgeries to pelvic floor reconstruction. We are excited about these and additional market opportunities for this product, and we are directing R&D resources to develop new applications. Veritas will be a top priority for Synovis in 2007 and beyond.”
The newly issued patent covers a method and composition for preventing adhesions related to surgery. More specifically, the tissue surfaces proximal to the repair are separated by a biomaterial provided in the form of a non- crosslinked, decellularized and purified mammalian tissue (e.g., bovine pericardium). The biomaterial effectively inhibits fibrosis, scar formation and surgical adhesions, while also serving as a scaffold for recellularization of the repaired tissue site.
About Veritas
Veritas Collagen Matrix exhibits true remodelability as well as exceptional strength and suture retention. Its structure provides a scaffold, which is incorporated by cells from a body’s healing surface; essentially becoming the tissue it is repairing. Veritas is a biological material derived from bovine pericardium (a sac-shaped tissue surrounding the heart), which exhibits great suppleness and durability. As it is being placed in the human body, it handles and conforms like the patient’s own tissue facilitating the surgical procedure and enabling normal healing.
About Synovis Life Technologies
Synovis Life Technologies, Inc., based in St. Paul, Minn., is a diversified medical device company engaged in developing, manufacturing and bringing to market medical devices for the surgical and interventional treatment of disease. For additional information on Synovis Life Technologies and its businesses, visit the company’s Web site at http://www.synovislife.com .
Forward-looking statements contained in this press release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The statements can be identified by words such as “should,” “could,” “may,” “will,” “expect,” “believe,” “anticipate,” “estimate,” “continue,” or other similar expressions. Certain important factors that could cause results to differ materially from those anticipated by the forward-looking statements made herein include the timing of product introductions, outcomes of clinical and market trials as well as regulatory submissions, the number of certain surgical procedures performed, the ability to identify, acquire and successfully integrate suitable acquisition candidates, the cost and outcome of intellectual property litigation, and the level and timing of orders from contract manufacturing customers, as well as the other factors found in the company’s Annual Report on Form 10-K for the year ended October 31, 2005.
Synovis Life Technologies, Inc.
CONTACT: Nancy A. Johnson, +1-612-455-1745, or Marian Briggs,+1-612-455-1742, both for Padilla Speer Beardsley Inc.; or Richard Kramp,President and CEO, or Brett Reynolds, CFO, both of Synovis LifeTechnologies, +1-651-796-7300
Web site: http://www.synovislife.com/
