Onco-LIFE™ Clinical Results

RESULTS OF THE MULTI-CENTER LUNG CANCER CLINICAL TRIAL

Per lesion sensitivity analysis Early Stage Cancer

Per patient sensitivity analysis Early Stage Cancer

An international multi-center clinical trial was conducted to evaluate the safety and effectiveness of Onco-LIFE™. The results of this lung cancer clinical trial demonstrated a 325% per-lesion improvement in the detection of early lung cancer (moderate-severe dysplasia and carcinoma in situ) and a 250% per-patient improvement compared to white light alone. The study results including invasive lung cancer demonstrated a 50% per-lesion improvement and a 33% per-patient improvement compared to white light alone. (Summary of Safety and Effectiveness, Onco-LIFE™ P950042/S003: www.fda.gov/cdrh/pdf/p950042s003.html)

Clinical Investigators

Dr. Stephen Lam, British Columbia Cancer Agency, Vancouver, Canada

Dr. Eric Edell, Mayo Clinic, Rochester, MN

Dr. Harvey Pass, Karmanos Cancer Institute/Harper Hospital, Detroit, MI

Dr. Tim Kennedy, HealthONE Presbyterian/St. Luke’s Medical Center, Denver, CO

Dr. York Miller, Denver Veterans’ Affairs Medical Center, Denver, CO

Dr. Greg Loewen, Roswell Park Cancer Institute, Buffalo, NY

Dr. Tom Sutedja, Vrije University Medical Center, Amsterdam, the Netherlands

Reference Pathologist

Dr. Adi Gazdar, University of Texas Southwestern Medical Center, Dallas, TX