Synovis Life Technologies Receives Approval to Manufacture and Ship Recently Acquired Orthopedic and Wound Care Products.
ST. PAUL, Minn. -- Synovis Life Technologies, Inc. (Nasdaq: SYNO) is pleased to report that its Synovis Orthopedic and Woundcare, Inc. (OWC) subsidiary in Irvine, Calif., has successfully completed its California Department of Public Health inspection, allowing OWC to manufacture and sell the OrthADAPT([R]) Bioimplant and Unite([R]) Biomatrix soft tissue repair products, which are used in orthopedic and wound care applications. Synovis acquired the assets of OWC in July 2009 from Pegasus Biologics.
"We anticipated this approval, and it is very good news that we can now begin to manufacture OrthADAPT and Unite products. We have already started to ship Synovis-labeled OWC products," said Richard W. Kramp, Synovis Life Technologies president and chief executive officer. "As previously reported, we have hired 25 experienced employees covering production, regulatory and clinical affairs, quality, marketing and customer service. We have also started hiring eight direct sales representatives for our OWC products, and we expect to complete this hiring in the first quarter of fiscal 2010. We are also looking to contract with independent representatives to complete our coverage of the United States and to begin seeking qualified distributors for European Union countries.
"Many physicians are already familiar with OrthADAPT and Unite products, and we are pleased to again make these proven, clinically advantageous products available to them," Kramp continued. "Our investment in OWC fits our long-term growth strategy of acquiring approved products that expand our presence in the growing soft tissue repair market. Synovis increased its available market potential by almost one billion dollars with this acquisition, thus almost doubling the size of the markets where we have approved products to sell."
The OrthADAPT and Unite products have received both U.S. and European regulatory clearances. The platform technologies for these products utilize flexible cross linking, which preserves the native handling characteristics and flexibility of the tissue, and processes to sterilize biological tissue without the use of high temperature, gamma radiation or harsh chemicals.
Synovis is manufacturing two commercialized equine pericardial-based products at OWC:
* The OrthADAPT([R]) Bioimplant, a scaffold developed with patented technologies for orthopedic surgical applications, including rotator cuff and Achilles tendon repair, where there is a clinical need to reinforce the repair.
* The Unite([R]) Biomatrix, a wound dressing that provides a new treatment alternative for chronic wounds, such as diabetic foot ulcers and pressure ulcers, which are worldwide healthcare concerns.
Physicians treated approximately 10,000 patients with Pegasus' equine pericardial products in various orthopedic and complex wound applications from March 2006 to May 2009.
About Synovis Life Technologies Synovis Life Technologies, Inc., based in St. Paul, Minn., is a diversified medical device company that develops, manufactures and markets medical devices for the surgical treatment of disease. The company's products include implantable biomaterials for soft tissue repair, devices for microsurgery and surgical tools - all designed to reduce risks and/or facilitate critical surgeries, improve patient outcomes and reduce healthcare costs. For additional information on Synovis Life Technologies and its products, visit the company's Web site at 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, the ability of the expanding direct sales force to grow revenues, outcomes of clinical and marketing trials as well as regulatory submissions, the number of certain surgical procedures performed, the ability to identify, acquire and successfully integrate suitable acquisition candidates, such as Pegasus Biologics, the cost and outcome of intellectual property litigation, any operational or financial impact of the current global economic downturn, current market conditions affecting its investments and any claims for indemnification related to the sale of the interventional business, as well as the other factors found in the company's reports to the Securities and Exchange Commission, including our Annual Report on Form 10-K, as amended by Form 10-K/A (Amendment No. 1) for the year ended October 31, 2008.
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|Date:||Oct 7, 2009|
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