2. 2
This presentation contains statements of a forward-looking nature which
represent our management's beliefs and assumptions concerning future
events. When used in this presentation, the words “believe,” “expect,” and
similar expressions are intended to identify forward-looking statements,
including statements regarding revenue, distribution agreements and
potential partnerships. Forward-looking statements involve risks,
uncertainties and assumptions, and are based on information currently
available to us. Actual results may differ materially from those expressed in
the forward-looking statements due to many factors, including, without
limitation, those disclosed under “Item 1A. Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2015 and our
quarterly reports on Form 10-Q. We undertake no obligation to update any
forward-looking statements to reflect events or circumstances that may
arise after the date of this presentation.
3. 3
♦ Patented platform technologies using light to provide faster, more
accurate, less costly non-invasive detection and diagnosis of
cancerous tissue
– Replaces physical biopsies with optical biopsies when differentiating
between normal and cancerous tissue
– Only “true” optical biopsy
– Procedure can be performed by nurses
– In vivo, in real time, approximately 1 second
♦ First indication ready for immediate sales in Europe and Middle East
♦ Second indication ready for clinical evaluation
♦ Product exceeds medical society’s accuracy criteria
♦ Technology & Development Risk behind us
♦ Sales, Marketing and Manufacturing Execution
♦ Management team with extensive turnaround and commercial
experience
4. 4
Team Background
Michael Oliver
President & CEO
♦ 30 years of experience in the medical device field spanning management, sales
and marketing
♦ Expertise in commercial operations and product management
♦ Four previous successful turnaround / restarts at Prescription Health Services,
Diatek, Inc., New Image Industries, and “A” Company Orthodontics
♦ MBA, George Washington University; BS, United States Naval Academy
Lowell Giffhorn
Chief Financial
Officer
♦ More than 25 years of senior management experience spanning finance,
operations, strategic planning and turnaround situations
♦ Former CFO of Patriot Scientific & Sym-Tek Systems, Inc.
♦ Raised more than $30MM in public equity
♦ MBA, National University; BS in Accounting, University of Illinois
Hughes
Wielemans
Director,
European Sales
♦ More than 25 years experience in medical device sales and marketing
♦ Experience with direct sales and distributor models
♦ Previous companies: US Surgical, Tyco Healthcare, Covidien
♦ Fluent in English, French, Dutch and German
♦ Economic Sciences Degree from ICHEC, Brussels, and Vierick-Leuven Ghent
Business School
♦ Board with more than 150 years of medical device experience
♦ Internationally renowned Medical Advisors
6. 6
♦ The largest patent portfolio for “optical methods for
identifying cancer and its precursors” provides a
substantial barrier to entry
♦ 38 utility and 7 design patents in US and
approximately 28 active European and Canadian
counterparts
– Optical biopsy apparatus (forceps)
– Scanning technologies (detection)
– Analysis and analytics
– Calibration, alignment, normalizing, etc.
♦ Continue to broaden product offerings through
licensing and acquisition
– Recent IP license from Duke University
8. 8
Platform Technology Adaptable to a Wide Spectrum of Cancers
Annual Procedures US ($Cost*)
Esophagus
1,600,000 ($4.0B)
Colon
8,900,000 ($17B)
Bladder
660,000 ($1.1B)
Oral Cavity
884,000 ($0.9B)
Lung
220,000 ($0.38B)
Stomach
294,000 ($0.6B)
Cervix
1,320,000 ($1.32B)
- Areas of Interest
• US, annual endoscopy monitoring cost
• and Duke (under UCSF support)
9. 9
Lower GI
Colon
Upper GI
Barrett’s
Lower GI
IBD
Urology
Bladder
US & EU Cases/year1 12.2 M 3.9 M 5.4 M 1.2M
Revenue/Case2 $162.00 $550.00 $ 650.00 $1,045.00
Total Addressable
Market (per annum)
$ 2.0 Billion $ 2.15 Billion $3.5 Billion $1.25 Billion
First Revenue 2017 2018 2019 2018
1Statistics from National Cancer Institute data base
2Company Estimates
10. 10
♦ Reduce total cost of colorectal cancer screening
♦ 80% of physical biopsies removed during screening are normal tissue
♦ Pathology savings alone in US for those unnecessary “normal tissue”
biopsies is more than $1 Billion per year**
♦ UK Savings approximately £ 60,000,000 annually
♦ WavSTAT Optical Biopsy System is a valuable tool in realizing savings
Endoscopist* Add WavSTAT*
Sensitivity 56.2% 96.9%
False Negative 43.8% 3.1%
Economic Considerations
WavSTAT Reduces False Negatives
* AMC, Netherlands, 2012
** Kessler WR, Imperiale TF, Klein RW, Wielage RC, Rex DK. A
quantitative assessment of the risks and cost savings of
forgoing histologic examination of diminutive polyps.
Endoscopy. 2011 Aug;43(8):683-91.
11. 11
♦ Growth in screening as population ages
♦ New modalities (DNA, MRI) for preliminary screening
bring more people to colonoscopy
♦ If benign: Diagnose and Ignore
♦ If malignant: Resect and Discard
12. 12
♦ American Society for Gastrointestinal Endoscopy (ASGE)
– Preservation and Incorporation of Valuable endoscopic Innovation
(PIVI)
– Real-Time Endoscopic Assessment of Histology of Diminutive
Colorectal Polyps (2011)
– “…reduce costs and improve patient safety compared to current
paradigm.”
– “…therapeutic threshold that must be met for a technology or device
to become considered appropriate for incorporation into clinical
practice.”
– 90% or greater Negative Predictive Value (NPV)
– “The ASGE encourages and supports the appropriate use of
technologies that meet its established PIVI thresholds.”
♦ WavSTAT NPV is 96% overall, 98% in recto-sigmoid
colon*
Dr. Noor Mohammed, presentation at UEGW, October 2016
Dr. Noor Mohammed, presentation to BSG, June 2016
*Dr. Timo Rath, et. al., Endoscopy, April 2016
*Dr. Timo Rath, presentation at UEGW, October 2015
*Pr. Helmut Neumann, presentation at DDW, May 2015
13. 13
♦ Multi-Center, Prospective Marketing Evaluation
– 8 sites, 7 nations, 800+ patient specimens
– Italy, Germany, France, Sweden, Denmark, Belgium, UK
– Leading authorities in each country
– Early results promising
♦ Replicate results of 96-98% NPV
♦ Capture economic savings at each site
♦ Submit to approval authorities in each country
♦ Coverage determination
♦ Accepted as “Standard of Care”
♦ Completed data collection Q4 2016
14. 14
♦ Nothing new for the clinician to learn
– Designed as a tool to assist
– Procedure does not change
♦ Compatible with existing endoscopes
– Uses working channel of flexible endoscopes
♦ Business Model (Razor/Blade)
– Recurring revenue stream from disposables
– Mobile console leased at nominal charge
– Hospital customers familiar with this model
Output = 1 second
15. 15
♦ Definitive, instant
diagnosis
♦ Non-subjective, no
interpretation
♦ Significantly
reduces costs of
follow-on
procedures
Results
Laser Induced Fluorescence (“LIF”) Technology
Optical fiber transmits
laser light via endoscope
to tissue
Auto-fluorescence collected
by fiber and returned to optical
detector within console for
analysis
OUTPUT
(one second)
}
16. 16
SpectraScience
WavSTAT
Mauna Kea
Technologies
Olympus
Medical
Fujinon
Procedure Type Endoscope Based Probe Based Endoscope
Based
Endoscope
Based
Technology Laser Induced
Fluorescence
Confocal
Microscopy
Narrow Band
Imaging
Confocal
Endomicroscopy
Costs $0 capital cost
~$175 per
procedure
$125K capital cost
$400+ per
procedure
$125-150K
capital
cost
$125-150K
capital
cost
Results Suspect/Not
Suspect
Objective
Interpretive
Subjective
Interpretive
Subjective
Interpretive
Subjective
Lengthens
Procedure?
No Yes Yes Yes
Interval/Specime
n
One Second Three to Ten
Minutes
Three to Ten
Minutes
Three to Ten
Minutes
NPV 96-98% 95% 82% 84%
17. 17
• Increased by 600% since 1975!
• Fastest growing cancer type, with 96% mortality
• Barrett’s esophagus is a precursor to esophageal
cancer:
• U.S. prevalence of 3M+
• 0.3M-0.5M new cases annually
• Predicated on GERD (~40M in U.S.)
• 1.6M+ endoscopy screenings annually US
• Early detection and treatment can result in 90%
cure!
Relevant Statistics
18. 18
3M+ US Barrett’s patients are screened
every 6 months to 2 years
Standard of Care: Random Biopsy Oncoscope: Guided Biopsy
$
$
$
$
$
$
$
19. 19
Kelloff, et al. Nature Vol 7, 508 – 518 (2007)
9 to 13 years
Delivers smarter, targeted biopsies,
requiring fewer of them
Diagnostic Area of
Existing Technologies
Narrow Band Imaging
Fluorescence
Ultrasound
Pill-Cam
20. 20
Feature SpectraScience NinePoint Mauna Kea
Compatible with current
procedure – –
Full tissue depth –
Real-time – –
Automated analysis – –
Dysplasia detection High Limited Manual
Cost $ $$$ $$$
Which is
easiest for
clinician to
interpret &
act upon?
SpectraScience NinePoint Mauna
Kea
21. 21
♦ Market first to EU, then to U.S. managed care
– Germany, UK and France, Middle East
– Distribution agreements in place
– EU markets are single-payer
– Economic savings already determined by NIHR in UK
– Approximately £ 60M annually
– Germany private pay physicians incentivized to use WavSTAT
♦ Europe-based Director of Business Dev.
– Direct sales organization in Germany, UK, France
– Distribution elsewhere
– Discussions regarding China, Korea, Japan
22. 22
√ Distribution agreements across Europe and Middle East
√ Products address large, growing and increasingly cost-
conscious markets
√ Exceed the technology adoption hurdle 96-98% NPV
√ No Technology or Development Risk
√ Proven technology that is faster, more accurate and less
costly
√ Faster for clinician; Answer in 1 second
√ Safer for the patient; Fewer biopsies & polypectomies
√ Less expensive for payers
√ Platform ensures multiple products to drive growth and
diversify distribution
√ Robust portfolio of Intellectual Property
√ Management team with extensive experience
24. 24
♦ Complementary to current endoscopic
standard of care
♦ Can be used wherever endoscopes are used
for diagnosis
♦ Targets biochemical properties of tissue
Laser Induced Fluorescence (“LIF”)
Lower GI (Colon)
Scattering Spectroscopy (“SS”)
Upper GI (Barrett’s Esophagus)
♦ Complementary to current endoscopic
standard of care
♦ Can be used wherever endoscopes are used
for diagnosis
♦ Targets physical properties of tissue
♦ Best technology or combination for optimal clinical result
♦ Multiple potential partners
♦ Multiple distinct channels
♦ Multiple markets
Multi-modal Future