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RTI SurgicalTM Receives Letter From FDA on map3(R) Cellular Allogeneic Bone Graft

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RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, received a letter from the Food and Drug Administration (FDA) regarding the company’s map3(R) cellular allogeneic bone graft. The letter addresses some technical aspects of the processing of the map3 allograft, as well as language included in the map3 website.

The company has submitted an initial response to the FDA letter, and is preparing a comprehensive package of data to address the Agency’s comments and provide clarifying information regarding the technical components of the implant processing. We believe we understand the basis for questions and points raised by FDA in the letter and at this time, we feel confident that in developing map3 and processing of map3, we properly considered the relevant regulatory questions. Additionally, the company has removed the website pending thorough review and revisions as needed.

“We will work diligently to fully address any concerns or questions the FDA has,” said Brian K. Hutchison, president and CEO of RTI. “We have carefully considered the regulatory pathway of this important implant from the beginning of development, and we continue to be confident in the science behind our map3 allograft.”

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, 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

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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 anticipated financial results, 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). 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 or the SEC’s website at

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