CD-R

Goals

• Complete CD-R Pilot Study
• Complete Statement of Work for miniaturization of CD-R (2nd generation device)
• Construct Pivotal Study
• Address and Resolve Reimbursement

CPE

Goals

• Complete with Infotonics the production prototype (12 to 18 months) Complete Clinical Protocol
• Design Pilot Study

Business Development

Goals

• Identify Distribution Partners
• Identify Licensing and Corporate Development Opportunities
• Identify In-Licensing Opportunities

Competitive Spectrum

Potential Competitors:

1. Spectrx, Medispectra, and Spectra Science:
   Spectrx, Medispectra, and Spectra-Science use technology based on either diffuse reflection (light scattering measurements to determine absorbers in tissues) and/or fluorescence spectroscopy in the visible spectral region. The fluorescence technology is in violation of MDSC’s seminal 516 and other patents on Optical Biopsy. The excitation wavelengths used by these companies are not optimal and therefore, their instruments exhibit poorer sensitivity (< 80%) and/or specificity then MDSC technology which excites the tissue at 300 and 340 nm, which gives sensitivity and specificity > 90%. Moreover, MDSC uses light scattering and visible/UV wavelengths in the CDRatiometer.

2. Xillix, Polartechnics (TruScreen) and Lifespex
   Utilizing similar and dissimilar technology that does not exhibit the sensitivity and/or specificity of MDSC

Alternate Imaging Technology:

• Traditional imaging diagnostics (x-ray, CT, MRI, ultrasound, Nuclear, etc.)
• Optical imaging diagnostics (microscopy, light scattering, etc.)

Assessment: Traditional imaging diagnostics are not suited to the interrogation of tissue samples. Optical imaging based on light scattering and absorption does not provide the detail (molecular signature) and information specificity of fluorescence based technology.

Genomic and tracer based diagnostics

• Cell based screening procedures
• Enhancement of traditional screening procedures (e.g. PAP screening and Thinprep)

Assessment: This technology continues to emerge; but the need for lesion localization remains. The use of optical imaging alone versus genomic based screening, plus optical imaging will be based on cost and quality of outcomes. Tracer based diagnostics are synergistic and will likely offer the potential to enhance the effectiveness of optical imaging.

Corporate Competitors:

Fluorescence technology

• Point Interrogation
• 2D/3D Imaging

Light scattering and absorption technology (Diffuse Feflectance)

• Point interrogation
• 2D/3D imaging

Assessment: Focus has been on point interrogation or imaging based on light scattering and absorption versus fluorescence. The technology does not provide the lever of information available from fluorescence based diagnostics.