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1
January, 2017
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
♦ 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
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 $30MM in public equity
♦ MBA, National University; BS in Accounting, University of Illinois
Hughes
Wielemans
Director,
European Sales
♦ More than 25 years experience in medical device sales and marketing
♦ Experience with direct sales and distributor models
♦ Previous companies: US Surgical, Tyco Healthcare, Covidien
♦ Fluent in English, French, Dutch and German
♦ Economic Sciences Degree from ICHEC, Brussels, and Vierick-Leuven Ghent
Business School
♦ Board with more than 150 years of medical device experience
♦ Internationally renowned Medical Advisors
5
♦ Laser-Induced Fluorescence Spectroscopy (LIFS)
– Colon
– Bladder
– Brain
– Pancreas
– Barrett’s Esophagus (BE)
♦ Scattering Spectroscopy
– Barrett’s Esophagus (BE)
– Inflammatory Bowel Disease (IBD)
– Cervix
– Skin
– Prostate
6
♦ The largest patent portfolio for “optical methods for
identifying cancer and its precursors” provides a
substantial barrier to entry
♦ 38 utility and 7 design patents in US and
approximately 28 active European and Canadian
counterparts
– Optical biopsy apparatus (forceps)
– Scanning technologies (detection)
– Analysis and analytics
– Calibration, alignment, normalizing, etc.
♦ Continue to broaden product offerings through
licensing and acquisition
– Recent IP license from Duke University
7
DIAGNOSTIC
OPTICAL
FORCEPS
US6847490
US6394964
US6174291
US6129683
US6066102
US5843000
US5762613
SCANNING
ARRAY
US6826422
US6411835
US6104945
US5713364
CONFOCAL
OPTICS
US6760613
US6411838
SPECTRAL
ANALYSIS
APPLICATIONS
US7260248
US7136518
US7127282
US7103401
US6933154
US6427082
US8005527
OBSTRUCTION
US7309867
US7282723
US6818903
NORMALIZATION
US7310547
US6839661
US6768918
US6421553
US6385484
CALIBRATION
US7459696
IMAGING
TEMPORAL
ALIGNMENT
US7406215
US7187810
US6902935
FOCUS
US7469160
a/LCI
US5555277
US7903254
US8537366
US8860945
US9335154
8
Platform Technology Adaptable to a Wide Spectrum of Cancers
Annual Procedures US ($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
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
♦ 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
♦ 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
♦ 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
♦ 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
♦ 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
♦ 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
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
• 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
3M+ US Barrett’s patients are screened
every 6 months to 2 years
Standard of Care: Random Biopsy Oncoscope: Guided Biopsy
$
$
$
$
$
$
$
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
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
♦ 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
√ 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
23
SpectraScience, Inc.
Michael Oliver,
President/CEO
11568 Sorrento Valley Rd, Suite 11
San Diego, CA 92121
Phone: 858-847-0200 ext. 2001
Fax: 858-847-0880
moliver@spectrascience.com
23
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

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SCIE Investor Presentation January 2017

  • 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 $30MM in public equity ♦ MBA, National University; BS in Accounting, University of Illinois Hughes Wielemans Director, European Sales ♦ More than 25 years experience in medical device sales and marketing ♦ Experience with direct sales and distributor models ♦ Previous companies: US Surgical, Tyco Healthcare, Covidien ♦ Fluent in English, French, Dutch and German ♦ Economic Sciences Degree from ICHEC, Brussels, and Vierick-Leuven Ghent Business School ♦ Board with more than 150 years of medical device experience ♦ Internationally renowned Medical Advisors
  • 5. 5 ♦ Laser-Induced Fluorescence Spectroscopy (LIFS) – Colon – Bladder – Brain – Pancreas – Barrett’s Esophagus (BE) ♦ Scattering Spectroscopy – Barrett’s Esophagus (BE) – Inflammatory Bowel Disease (IBD) – Cervix – Skin – Prostate
  • 6. 6 ♦ The largest patent portfolio for “optical methods for identifying cancer and its precursors” provides a substantial barrier to entry ♦ 38 utility and 7 design patents in US and approximately 28 active European and Canadian counterparts – Optical biopsy apparatus (forceps) – Scanning technologies (detection) – Analysis and analytics – Calibration, alignment, normalizing, etc. ♦ Continue to broaden product offerings through licensing and acquisition – Recent IP license from Duke University
  • 8. 8 Platform Technology Adaptable to a Wide Spectrum of Cancers Annual Procedures US ($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
  • 23. 23 SpectraScience, Inc. Michael Oliver, President/CEO 11568 Sorrento Valley Rd, Suite 11 San Diego, CA 92121 Phone: 858-847-0200 ext. 2001 Fax: 858-847-0880 moliver@spectrascience.com 23
  • 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