CLINICAL TRIALS

SUCCESSFUL HUMAN STUDIES

The Company conducted its pre-clinical human studies and successfully proved that CancerScanner™ can differentiate between cancerous and normal tissues of skin cancers (the most difficult type to detect). The studies were conducted on 27 patients with 38 cancerous and pre-cancerous lesions. CancerScanner™ was able to detect 81.5% of the cancerous and 72.7% of the pre-cancerous lesions while using only a single probe:

Example of Human Results

SpectraPath's technology has great potential to be the gold standard in noninvasive diagnosis of carcinomas, such as cervical, breast, skin, esophagus, and colorectal. Currently, the Company's primary focus is to complete clinical trials of its technology in order to get PMA and CE Mark approvals for domestic and European skin cancer markets. After passing initial phases of the clinical trials, SpectraPath is planning to start clinical trials of the technology for diagnosis of cervical cancer on human subjects.

CancerScanner™ also has potential for neurosurgeons to determine the surgical margins for brain lesions in real-time while operating on the patient. Seven ex-vivo experiments have been performed on human brain tissues just after surgery and before pathologic examination. For the confirmation, spectra taken from human normal and cancerous brain tissue have been compared to the pathological examination. All the measurements are consistent to the pathological examinations. Where, slopes of normal tissues are positive and cancerous tissues are negative.

Brain Lesion: Medulloblastoma

Brain Lesion: Sarcoma metastasis, gliosarcoma

SUCCESSFUL ANIMAL STUDIES

SpectraPath built the first prototype (single-probe version) of the CancerScanner system, and conducted efficacy experiments on mice at Rumbaugh-Goodwin Institute. Experimental results revealed that the CancerScanner system could successfully differentiate between cancerous and healthy tissue with a high rate of reliability. Upon successful completion of the experiments, SpectraPath filed permanent U.S. and International patents for the CancerScanner technology. The Company continued its animal studies with Dr. Kumi-Diaka at Florida Atlantic University (FAU) and proved that CancerScanner can differentiate between cancerous and normal tissues of breast, prostate, kidney, and liver on rats.

The graphical depiction of the data (see next page) clearly shows that the CancerScanner easily differentiated cancerous cells from healthy cells (shown as negative correlation).

Experiments on Balb/c mice with EMT-6 breast cancer cells

Kidney Tissues

Prostate culture cells and tissues

Liver Tissues