Transcript Presentation Format - Florida Institute of Technology

NON-INVASIVE EARLY SKIN
CANCER DIAGNOSTIC SYSTEM
PULSE IMAGING, Inc.
Company Overview
A World Without Skin Biopsies
11/12/08
Problem

What if there is a skin cancer diagnostic
technique that is painless, more accurate, less
expensive, and quick?
– Early cancer detection critical
– Current testing can be time-consuming,
expensive, and uncomfortable
– Currently dermatologists do multiple
biopsies to detect a single case of
melanoma
– Lack of accurate instruments
Background
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Short Pulse Laser Based Optical Tomography
System
– world’s first fully software-controlled, desktopsize
– ultra-short pulse laser system providing high
spatial and temporal resolution
– displays soft tissue contrast at cellular level
Preliminary proof of concept demonstrated in
animal model
Provisional Patent (April 2006); Full patent filed
(March 2007)
Solution

Non-invasive Real-time Cancer Diagnostics
– Less expensive
– Eliminate unnecessary costly biopsies
– Comfortable
– Transportable compared to other imaging
techniques
– High sensitivity, specificity, and resolution
– Fast image turnaround for patients
– Reduce the probability of missing lesions
especially in the margins compared to biopsies
Resources and Capabilities
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Leverages existing Florida Tech’s human
capital and infrastructure
Development partnership with Raydiance Inc.
Intellectual Property and Business
Transactional capabilities through FIT Tech
Transfer Office
Design and prototyping capabilities
Volume
Production
Concept Platform
Developer Platform
Production Version
Paradigm Shifts
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Discovery at university
Preliminary technology development
completed
Design factors leading to several generation
systems
Clinical trials for next generation system
Regulatory approval from FDA
Manufacture and ship systems to customers
Market and Competition

Market size and Growth rate
– More than 10 million skin biopsies are performed
annually in US - by far the most common biopsy
– Medical imaging market worth about $15B in 2006;
app. 50% of the revenues garnered by the core
modalities MRI, CT, x-ray, ultrasound
– App. double digit market growth over the next five
years
– Medical expenditure for melanoma is $2.5B

Competitive Technologies
– Biopsy vs Imaging Diagnostics such as MRI
– Optical Coherence Tomography (OCT)
Competition
time
cost
Optical
Biopsy MRI
CT
PET
Tomography
15 mins
4-14 45-60 45-60 75-90
days mins mins mins
$
$$
$$$
$$
$$$
safety
Excellent
Poor
Good
Poor
Fair
resolu
tion
size
Very Good
Good
Excellent
Good
Very Very Good
Good Good
Poor Fair
Fair
Sales and Distribution
• Research Institutes
• Research Hospital
• Radiologists
Target Distribution
Partners or Customers
Shands Healthcare
Orlando Regional Healthcare
Kaiser Permanente
• PULSE IMAGING sales in year 5
Mayo Clinic
• 200 systems
• $300,000 per unit
Sloan Kettering
• 40% per year growth
Management Team
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CEO - TBA
Dr. Kunal Mitra - CTO; Responsible for overall
product design and development
Robert Merrill - Florida Tech Tech Transfer
Office
Ari Schuler - Raydiance Inc. (A DFJ Company);
Commercialization partner
Dr. Carolyn Fausnaugh - Florida Tech School of
Business; Responsible for market research
Dr. Grace – Florida Tech Biology Department;
Responsible for animal studies
Regulatory Consultant - TBA
Financial Forecast
2009
2010
Revenue $ 1.75
million
$ 8.5
million
Margin
Profit
Head
count
2011
2012
2013
$16.5
million
-$500k $ 2.875 $6.5
million million
-$50k $287k $975k
$32
million
$ 13
million
$2.6
million
18
$60
million
3
6
9
$24
million
$6
million
30
Use of Proceeds

Funding
– Initial investment - $1 million
– First year (2009)

Uses:
– Prototype development for animal studies
– Regulatory data development cost
– Completion of clinical trials through partnership
– Working investment capital
Summary
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“A World Without Skin Biopsies”
Conducting animal studies for safety and efficacy
Product development partnership in place
Patent application filed (2007)
Need for initial investment of $1 million
Kunal Mitra, Ph.D.
Professor
Mechanical and Aerospace Engineering Department
Director- Biomedical Engineering Program
Florida Institute of Technology
Phone: (321) 674 7131
Email: [email protected]