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BioSciCon, Inc.

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Insufficient Accuracy - ( 15% false negatives) Leads to unacceptable death rates. ... Mailing specimen to cytopathology laboratory ... – PowerPoint PPT presentation

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Title: BioSciCon, Inc.


1
BioSciCon, Inc.
  • BioSciCon has developed and manufactures a
    patented biomarker-based technology, the MarkPap
    System, for the early detection and screening of
    cervical cancer which is more accurate, less
    costly and less invasive than current Pap test
    technologies.

2
The Problem
  • Existing Pap Test Technology
  • Insufficient Accuracy - (gt15 false negatives)
    Leads to unacceptable death rates.
  • Invasive - Requires a doctor visit which leads to
    fewer women being tested.
  • Costly Increasing insurance costs in US and
    prohibitively expensive in developing countries.
  • Slow - Takes weeks to obtain results.

3
The Solution
  • BioSciCons MarkPap is the solution
  • More Accurate - (lt5 false negatives).
  • Less Invasive - May be self-administered,
    leading to increased use by women.
  • Less Costly - Priced gt25 less than conventional
    Pap tests.
  • Timely - Results within hours vs. weeks.

4
MarkPap Technology
  • CAP-PAP Test
  • (US patent, 2000).
  • CAP-PAP Test Kit
  • (US patent pending).
  • International Application (PCT 2004).

Chemical sensitive biomarker flags abnormal
cells for early detection.
5
MarkPap Products
  • MarkPap Kit Assembly of reagents, instructions
    and controls
  • Kit Accessories Cytopreservative solution
  • Available for research only in the US (before
    FDA approval). International sale under local
    regulations.
  • MarkPap Test service, assay

6
Regulatory Process
  • Non-Regulatory, NIH Clinical Study Completed
  • Supported by NIH, SBIR Phase-1, Phase-2 Grants.
  • Total Subjects 2,000
  • Total Specimens 4,000
  • Controls Pap Smear and ThinPrep Pap
  • Performance Safe and more efficient than the
    controls (up to 50).
  • FDA One Year Clinical Trial Required

7
BioSciCon Founders Team
  • President - Nenad Markovic, M.D., Ph.D.
  • Developed a National Cancer Comprehensive
    Center, university hospital director.
  • Director - Olivera Markovic, M.D., Ph.D.
  • Developed, directed research and clinical
    laboratories.
  • Clinical Laboratory Managers
  • 20 Ob/Gy, pathologists and GPs in U.S. (MD, DC,
    CA, NY) and abroad (India, SCG).
  • Business Management Team TBN

8
Market Opportunity - US
100 million women at risk 50 million Pap tests
per year
  • Per Test Breakdown
  • Price 9
  • Manufacturing 3
  • Mktg. Distribution 1
  • Expected Margin 5
  • 25 below nearest competitor

We expect to capture 5 of market in 1 year of
sale, leading to 60 in 5 yrs.
2.5m tests/yr. 12.5m/yr. profit
9
Market Opportunity - WORLD
1.7 billion women at risk
  • Dev. Countries
  • 18m total tests/yr
  • 1/test expected margin
  • 5 of market in 2 yrs. leading to 60 in 5 yrs.
  • EU
  • 42m total tests/yr.
  • 5/test expected margin
  • 5 of market in 2 yrs of sale, leading to 40 in
    5 yrs.

2.1m tests/yr. 10.5m/yr. profit
MarkPap Self MarkPap Digital
10
Funding Exit Strategy
  • Invested Value 6 Million
  • Funding Sought 3 Million
  • FDA PreMarket Approval (PMA).
  • Initial Funding sought 1.6 Million.
  • Exit Strategy
  • Acquisition by a large pharmaceutical or medical
    device company Confidential conversations
    currently ongoing.

11
Todays Story
  • Serious health problem
  • Possible solution
  • Technology available
  • Company that has developed this technology
  1. Needs to bring tech. to market
  2. Market opportunity and hurdles
  3. Why we are here Funding Exit strategy
  4. Invitation

12
MarkPap Self Digital
  • BioSciCons New Products in 2005

13
MarkPap Self
  • Collecting cervico-vaginal fluids on swabs
  • Smearing onto microscopic slide, or rinsing into
    MarkPap Solution
  • Mailing specimen to cytopathology laboratory
  • MarkPap test for specimen staining and
    interpretation

14
MarkPap Self
15
MarkPap Digital - 1
  • MarkPap slide examined under a microscope
  • Search for cervical acid phosphatase in control
    cells accept/reject the slide
  • Search for cervical acid phosphatase in
    epithelial-like cells
  • Capture images (x20 magnification) of areas with
    CAP positive epithelial cells by a digital camera

16
MarkPap Digital - 2
  • Transfer images of CAP positive epithelial cells
    to Image analysis system via Internet
  • Automatically eliminate of debris
  • Automatically select of cells with biomarker
    (microscopic images)
  • Transfer selected images to human observer for
    screening
  • Validate screening with QC of normal and abnormal
    images

17
MarkPap Digital
18
BioSciCon, Inc. 14905 Forest Landing
Circle Rockville, MD 20850 Tel (301)
610-9130 Fax (301) 610-7662 Web site
www.bioscicon.com
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