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For Surgeons U.S. AxiaLIF^® Fusion Registry

AxiaLIF^® Animation

Clinical Experience

U.S. AxiaLIF^® Fusion Registry

Prior to its marketing in the U.S., the AxiaLIF^® System was subjected to significant preclinical testing, and was the subject of a relatively small clinical trial outside the U.S. The device became available for distribution in the U.S. in December 2004.

As part of its distribution plan, TranS1^® initiated a U.S. based, post marketing clinical trial to add additional outcome information to the existing database. The post-marketing trial is prospective, approved by participating IRBs,* and was initiated in July 2005. It will include four primary investigators, three of whom have already been enrolled. The study will include approximately 50 subjects, and early results are positive. Detail will be made available as the study progresses.

* The study is exempt from the IDE regulation because the investigation involves a use which is consistent with the existing labeled indication.

Clinical Update
Preliminary Report of AxiaLIF Registry Study Results: 8/17/06
Principal Investigator: William Tobler, MD

Clinical Site: Mayfield Clinic & Spine Institute Between July 2005 and January 2006

Dr. William Tobler consented 28 patients for the AxiaLIF registry study enrolling 26 (two did not choose to participate due to health insurance coverage issues).

The summary statistics of the subject population are similarly distributed across gender as shown below. The overall mean age of all subjects is 42 years, Body Mass Index (BMI) of 30 (19-46). The predominant diagnosis is degenerative disc disease at L5-S1.

Summary Statistics (by Gender):

Gender	Mean Ages and Ranges (years)	BMI (Body Mass Index)	Diagnoses
15 Men	44 (34-68)	28 (21-36)	12 DDD, 2 Spondylolisthesis (Grades 1-2)
11 Women	39 (19-54)	32 (19-46)	11 DDD

The mean preoperative Visual Analogue Score (VAS) was 67 mm with a mean preoperative Oswestry Disability Index (ODI) of 36%. By the three month followup visit the mean VAS was 41 mm with a mean ODI of 36%. At six months the VAS and ODI continued to decrease to 35mm and 34%, respectively.

The investigator reports that of 23 subjects that have six-month CTs, 21 are fused and 2 are in stages of fusion, e.g., developing bone. After 24 months of follow-up, investigator reports 23 0f 24 patients are fused. Nineteen subjects reported 54 adverse events none of which were serious but none were related to the AxiaLIF device.

Fusion Progression, Patient A.: