TranS1 Inc. Receives FDA 510(k) Clearance for the AxiaLIF 2L, Two Level Percutaneous Lumbar Fusion System
Wilmington, N.C., Apr 28, 2008 - 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.
