UPDATE: RTI Surgical Announces Received Letter from FDA Related to map3 Cellular Allogeneic Bone Graft
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® 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.”
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