WILMINGTON, N.C., March 21, 2011 (GLOBE NEWSWIRE) — TranS1 Inc. (Nasdaq:TSON), a medical device company focused on designing, developing and marketing products that implement its proprietary approach to treat degenerative conditions of the spine affecting the lower lumbar region, today announced that two noteworthy clinical papers have been accepted for publication in peer-reviewed journals. In addition, TranS1 updated its revenue guidance for the first quarter of 2011.
Clinical Publication Update
TranS1 recently received notification that two clinical papers highlighting the efficacy and safety of its AxiaLIF spinal fusion procedure have been approved for publication. The first paper reviews efficacy data from a four site, 156 patient study with two-year follow up and demonstrates a 94% fusion rate. This paper has been accepted for publication in SPINE. The second paper is a 9,152 patient retrospective safety study that shows a 1.3% complication rate. This paper has been accepted for publication in the SAS Journal.
“The publication of significant clinical data supporting the use of our AxiaLIF approach is critical to our reimbursement strategy,” commented Ken Reali, President and Chief Executive Officer of TranS1 Inc. “We believe that these papers will be important as we pursue additional payor coverage decisions for our Category 3 CPT code and seek to gain society support for the graduation of the current Category 3 code to a Category 1 code.”
For the first quarter ending March 31, 2011, the company expects total revenues in the range of $4.8 – $5.2 million. Previously, the company had expected revenues to be in the range of $5.0 – $6.0 million.
“Our sales for the quarter will be at the low end of our previously anticipated range as our business continues to be adversely affected by general spine market conditions and ongoing AxiaLIF physician reimbursement pressures,” commented Ken Reali, President and Chief Executive Officer of TranS1 Inc.
About TranS1 Inc.
TranS1 is a medical device company focused on designing, developing and marketing products that implement its proprietary approach 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 and the Vectre and Avatar posterior fixation systems. TranS1 was founded in May 2000 and is headquartered in Wilmington, North Carolina. For more information, visit www.trans1.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, the accuracy of which are necessarily subject to risks and uncertainties. These risks and uncertainties include, among other things, risks associated with the adoption of a new technology by spine surgeons, product development efforts, regulatory requirements, maintenance and prosecution of adequate intellectual property protection and other economic and competitive factors. These forward looking statements are based on the company’s expectations as of the date of this press release and the company undertakes no obligation to update information provided in this press release. For a discussion of 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, 2010.