TranS1 Inc. Announces Tentative Settlement With Office of Inspector General
27 Diciembre 2012 - 3:01PM
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.
Forward-Looking Statements
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.
CONTACT: TranS1 Inc.
Investors:
Joe Slattery, Executive Vice President and
Chief Financial Officer
910-332-1700
Westwicke Partners
Mark Klausner
443-213-0501
trans1@westwicke.com
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