Profile: TranS1 Inc. (TSON.O)

TranS1 Inc. (TranS1), incorporated in May 2000, is a medical device company. The Company is focused on designing, developing and marketing products that implement its minimally invasive surgical approach to treat degenerative disc disease and instability affecting the lower lumbar region of the spine. Using the TranS1 pre-sacral approach, a surgeon can access discs in the lower lumbar region of the spine through a 1.5 centimeters incision adjacent to the tailbone and can perform an entire fusion procedure through a small tube that provides direct access to the degenerative disc. TranS1 developed its TranS1 pre-sacral approach to allow spine surgeons to access and treat degenerative lumbar discs without compromising important surrounding soft tissue. This approach enables fusion procedures to be performed with low complication rates, short procedure times, low blood loss, short hospital stays, fast recovery times and reduced pain. TranS1 markets two single-level fusion products, the AxiaLIF and the AxiaLIF 360° and a two-level fusion product, the AxiaLIF 2L.

As of December 31, 2008, over 5,500 fusion procedures had been performed globally using the Company’s AxiaLIF products. At December 31, 2008, TranS1 sold its AxiaLIF products in the United States and through 16 independent distributors internationally. The Company also has two additional products under development that implement its pre-sacral approach: Percutaneous Nucleus Replacement (PNR), and Partial Disc Replacement (PDR), devices. The Company commenced a pilot clinical trial outside the United States for its PNR product in the second quarter of 2008. The Company’s products include surgical instruments for creating a reproducible access route to the L4/L5/S1 vertebrae, fusion implants, as well as supplemental stabilization products.

AxiaLIF Lumbar Fusion Implants

The Company’s AxiaLIF implant is a threaded titanium rod, called 3D Axial Rod that comes in varying lengths to enable one-level L5/S1 fusions and two-level L4/L5/S1 fusions. As it is implanted, its thread design separates the vertebrae to restore disc height. The increased disc height relieves pressure on the nerve, while its 3D Axial Rod provides immediate rigid fixation.

AxiaLIF 360° Implants

The Company’s AxiaLIF 360° implants consist of its 3D Axial Rod plus its titanium facet screws for supplemental posterior fixation. The two AxiaLIF 360° facet screws are implanted through a single 1.5 centimeter incision in the patient’s back using its delivery system.

TranS1 Access and Disc Preparation Instruments

The Company’s pre-sacral approach requires the use of a sterile set of surgical instruments that are used to create a reproducible working channel and to prepare the disc and vertebrae for its implant. The instrumentation contained in the set includes stainless steel navigation tools and access cannulae to create the working channel, as well as nitinol cutters and brushes to cut and remove the degenerated disc material and prepare the disc space for its implant.

Percutaneous Nucleus Replacement

The Company’s PNR implant incorporates a soft polymer that facilitates normal range of motion and restores disc height to simulate the performance of a healthy disc. This design is intended for patients suffering from earlier stage disc degeneration prior to requiring disc replacement or fusion. By utilizing the Company’s pre-sacral approach, the PNR implant enables surgeons to replace the disc nucleus while preserving other native anatomy that provides stabilization, such as the annulus.

Partial Disc Replacement

The Company’s PDR implant is its PNR implant with the addition of a cobalt chrome rod incorporating a ball-and-socket design intended to provide additional stability while preserving normal range of motion. This design is intended for patients suffering from mid-stage disc degeneration, or PNR patients whose disease has progressed but does not require fusion. The PDR implantation procedure is identical to that of the PNR, with the addition of the insertion of the cobalt chrome rod. If the patient already has a PNR, converting to its PDR only requires the insertion of the cobalt chrome rod through the existing PNR implant.

TranS1 competes with Medtronic Sofamor Danek, Johnson & Johnson DePuy Spine, Stryker, NuVasive, Zimmer Spine, Synthes, Orthofix International, Globus Medical and Alphatec Spine.