WILMINGTON, N.C., April 28, 2008 (PRIME NEWSWIRE) -- TranS1 Inc. (Nasdaq:TSON), a medical device company focused on designing, developing and marketing products that implement its proprietary minimally invasive surgical approach to treat degenerative disc disease affecting the lower lumbar region of the spine, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AxiaLIF 2L(tm), two level percutaneous lumbar fusion system, in the United States. The AxiaLIF 2L(tm) is designed to treat degenerative disc disease at both the L5-S1 and L4-L5 lumbar discs through a single, one and a half inch incision.
"The AxiaLIF 2L(tm) enables spine surgeons to perform, for the first time ever, a multi-level lumbar fusion with no disruption of functional, supportive soft tissue structures," stated Rick Randall, President and CEO of TranS1. "From a business perspective, the AxiaLIF 2L(tm) significantly expands the patient population eligible for TranS1's novel, least invasive treatments for low back pain and increases the potential product revenue TranS1 can realize from each surgical procedure."
Mr. Randall added, "Our early clinical experience with the AxiaLIF 2L(tm) outside of the U.S. reveals the same positive patient outcomes experienced with our AxiaLIF single level product: early release from the hospital, rapid return to normal lifestyle activities and dramatic long-term reduction of disabling leg and back pain. Additionally, the two-level product has demonstrated the same favorable safety profile as our single-level product."
The Company will discuss plans for the domestic commercial release of the AxiaLIF 2L(tm) on its previously scheduled earnings call scheduled on Thursday, May 1, 2008 at 4:30 PM EST. To listen to this conference call on your telephone, please dial 877-397-0300 for domestic callers and 719-325-4897 for international callers approximately ten minutes prior to the start time. The call will be concurrently webcast. To access the live audio broadcast or the subsequent archived recording, visit the TranS1 Web site at www.trans1.com under the investor relations section.
About TranS1 Inc.
TranS1 is a medical device company focused on designing, developing and marketing products that implement its proprietary minimally invasive surgical approach to treat degenerative disc disease affecting the lower lumbar region of the spine. TranS1 currently markets two single-level fusion products -- the AxiaLIF(r) and the AxiaLIF 360(tm) in the U.S. and Europe. In addition, the company currently markets a two-level fusion product -- the AxiaLIF 2L(tm) in Europe. 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 forward-looking statements, including, without limitation, Mr. Randall's statement regarding the growth of the sales and marketing team, the accuracy of which is 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, 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 the Registration Statement on Form S-1.