RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced today that the company received approval to CE mark Fortiva™ Porcine Dermis and will begin distribution throughout Europe. Fortiva received 510(k) clearance from the U.S. Food and Drug and Administration (FDA) in March 2013 and was launched in the U.S. in July 2013. The implant is manufactured at RTI’s Neunkirchen, Germany facility.
“Fortiva raises the bar in patient care and we are very pleased that it will now be available in Europe,” said Stefan Seuferling, managing director of RTI Surgical Europe. “Since its introduction in the U.S., we have seen the positive response from surgeons, and we are looking forward to offering this implant to surgeons here in Europe.”
Fortiva porcine dermis is a non-crosslinked acellular porcine dermal matrix intended for use as a soft tissue path to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. The implant is indicated for use in repairing hernias and/or body wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome. Fortiva porcine dermis is ready-to-use, requiring no rehydration or rinsing. Fortiva also aids in efficiency in the OR, with a temperature indicator for quick indication of proper storage, rounded corners for ease of suturing and consistent thickness. The implant is available in a broad array of sizes, including 35x35 cm, which represents the largest biologics graft available today.
Fortiva is sterilized through RTI’s Tutoplast® Tissue Sterilization Process, a validated chemical sterilization process that thoroughly penetrates tissue, removing antigenicity and inactivating pathogens. Terminal sterilization using low dose gamma irradiation achieves a sterility assurance level (SAL) of 10 -6.About RTI Surgical Inc. RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to advancing science, safety and innovation, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit http://www.rtix.com/. Forward Looking Statement This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). In addition, these statements are subject to risks associated with the Pioneer’s financial condition, business and operations and the integration of Pioneer’s business with ours. Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.
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