WILMINGTON, N.C., Dec. 27, 2012 (GLOBE NEWSWIRE) -- TranS1 Inc. (Nasdaq:TSON), a medical device company focused on designing, developing and marketing products to treat degenerative conditions of the spine affecting the lower lumbar region, today announced that it had reached a tentative agreement in principle with the U.S. Department of Justice related to the subpoena issued in October 2011. On December 24, 2012, the Company and the staff of the Department of Justice tentatively agreed to settle its federal investigation for $6 million, subject to completion and approval of written settlement agreements with the Department of Justice and the HHS-OIG, which are expected to be finalized in the first few months of 2013. The Company admits no wrongdoing as part of the settlement.
"TranS1 has cooperated fully with this investigation and the proposed settlement is consistent with our efforts to instill a culture of compliance throughout the Company," stated Ken Reali, TranS1's President and CEO. "We believe that resolving this issue and reducing the related financial uncertainty is in the best interests of the Company and its shareholders."
About TranS1 Inc.
TranS1 is a medical device company focused on designing, developing and marketing products to treat degenerative conditions of the spine affecting the lower lumbar region. TranS1 currently markets the AxiaLIF® family of products for single and multilevel lumbar fusion, the VEOTM lateral access and interbody fusion system, and the VectreTM posterior fixation system for lumbar fixation supplemental to AxiaLIF fusion. TranS1 was founded in May 2000 and is headquartered in Wilmington, North Carolina. For more information, visit www.trans1.com.
This press release includes statements relating to our efforts to gain favorable coverage decisions for our products that are based on our current beliefs and assumptions. These statements constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the pace of adoption of our product technology by spine surgeons, the outcome of coverage and reimbursement decisions by the government and third party payors, the success of our continuing product development efforts, the effect on our business of existing and new regulatory requirements, uncertainty surrounding the outcome of the matters relating to the subpoena issued to the Company by the OIG, stockholder class action lawsuits, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with TranS1's business, please review the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2011. You are cautioned not to place undue reliance on these forward looking statements, which are based on TranS1's expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
Joe Slattery, Executive Vice President and
Chief Financial Officer