Transcript www.spectrascience.com

Company Presentation
www.spectrascience.com
Forward looking statements
This presentation may contain predictions, estimates
and other forward-looking statements. Our use of
the words “estimate”, “project” and similar
expressions is intended to identify these statements.
These statements represent our current judgment
on what the future holds. While we believe them to
be reasonable, these statements are subject to risks
and uncertainties that could cause actual results to
differ materially as a result of certain factors,
including those set forth in the Company’s 10KSB
and 10QSB filings with the Securities and Exchange
Commission.
Proceedings Today
• Formal resolutions
• CEO’s address
• Q&A
Transforming the business
• Moving from R&D to commercialization
• Recent funding provides capital to deepen
sales and marketing, expand operations
and increase inventory
• Taking proactive stance toward the public
markets
Highlights
•
•
•
•
•
•
•
•
•
•
LUMA acquisition
EU certification
Established initial distribution in EU
Initial WavSTAT® sale in EU
Closed financing of $5.5M
Upgraded WavSTAT with new technology
Re-started Barrett’s study
Expanded sales force
Sought further FDA approvals
Strengthened Board
Innovation
Creating a Leading Cancer Detection Company
• 85% of all cancers begin in the epithelial layer
• FDA approved for detecting colon/cervical cancer;
– approval for esophageal cancer expected in 2008 (PMA supplement)
– Sales in EU before FDA approval.
– FDA approved for detecting pre-cervical cancer
• Instantaneous detection (decreases procedure time)
• Treatment possible at point-of-care (decreases number of
visits)
Gastrointestinal/Tissue Penetration
Disease originates at the lowest level of the epithelial tissue
_
20-30 Cell Layers Deep
WavSTAT
Fluorescence Excitation at 337nm_
Laser Florescence
Endoscopy/Colonoscopy (Today’s Gold Standard)_
Limited to White Light Visualization
TISSUE
The Solution
WavSTAT® Optical Biopsy Device and Forceps
Diagnostic: WavSTAT optical biopsy
console generates and sends Laser light
through optical fiber, reads reflected light
and makes cancer determination.
Therapeutic: forceps
deployed through
scope center channel biopsies AND removes
tissue in same
procedure
What is an Optical Biopsy?
• Pre-cancer cells reflect light differently vs. normal
cells. The difference is what we detect.
• WavSTAT display gives instant absolute answer:
– GREEN = normal
– RED = suspect
• Determine margin (edge) of disease
• Can remove tissue immediately with forceps
WavSTAT Advantages
Fast, accurate early detection and ability to treat/biopsy in situ
• Reduced procedure time
• Reduced cost of care
• Additional MD revenue
• Improved patient outcomes
– Patient goes home with peace of mind - no waiting for
pathology
– If positive – sent directly to surveillance or oncologist
– Esophageal* - low pain versus present method
*
Investigational
Esophageal Cancer
• 2 million screenings per year
• Growing 5X faster than other cancers
• Particularly high incidence in Asia
• Very difficult to visualize and diagnose
• Over 90% mortality rate
Esophageal Cancer
Stages of Disease Progression
GERD* (“Heart-burn”)
Weekly occurrence in 60M Americans;
daily in 20M
Barrett’s esophagus
10% of patients with chronic
heartburn
Low-grade dysplasia
WavSTAT
begins
detecting
here **
*Gastroesophageal reflux disease
** Investigational
20% of Barrett’s patients
High-grade dysplasia
3% of LGD patients
progress to HGD
Esophageal cancer
17% of
HGD pts
Esophageal Cancer
Limitations of current diagnostic procedure
• Random physical biopsy in four quadrants
• Up 2cm…do it again…; Up 2cm…do it again. Could be
as many as 16-20 vs. as low as none optically
• Hope specialist biopsies correct spot and hope
pathologist accurately interprets what might be
cancerous
Colon Cancer
• Second most common cancer diagnosed in US
• 149,000 diagnosed and 55,000 deaths annually
• All persons over 50 at risk
• Expected to increase 20% over next 10 years
• 92% of patients “cured” if cancer detected early
Cervical cancer
• Second most common malignancy in women
world-wide
• A National study showed 200,000 women are
sent home by their physicians each year with
pre-cancer – and don’t know it!
• Abnormal Pap test requires colposcopy
• Colposcopy is subjective – depends on training
• LUMA is objective, accurate, a permanent record
and directs the biopsy target
LUMA Cervical Imaging
System
®
LUMA
Colposcopist/LUMA view cervix
LUMA Control Panel
Obstetrics & Gynecology Ad
Obstetrics & Gynecology Ad
Sales/Marketing Strategy
• Direct sales force to sell to physicians and
group practices
• Start with thought-leaders and expand
from there
• Work with Patient Advocacy Groups
• Begin integration with Managed Care
Networks
Intellectual Property
• Exclusive rights to sixty issued and pending
U.S. and international patents
• All patents cover various aspects of the
WavSTAT & LUMA Systems, methods for
tissue diagnosis and our disposables
• New non-endoscopic patent filed
• Exclusive licensee of an additional patent from
Massachusetts General Hospital
Board of Directors
•
•
•
•
•
•
•
Jim Hitchin
Mark McWilliams
Rand Mulford
John Pappajohn
Stan Pappelbaum
Tommy Thompson
Chet Sievert
– (Steve Watson)
Investment Highlights
• Robust Recurring Revenue Model
– Company intends to sell or charge on a per use basis for diagnostic
testing
– Disposable/reusable optical probe/forceps offer a second major
revenue stream
– Company will have compelling cost-effectiveness data to push for
additional CPT codes
• Strong Management/Board Team
– Extensive experience in Operations, Research & Development,
Sales & Marketing, Engineering, Regulatory and Business
Development
– Experience establishing O.E.M. arrangements and building comarketing partnerships
– Extensive experience in medical device industry
Investment Highlights
•
•
•
Large Market Opportunity
–
Esophagus >2M annual procedures in US; $850M US/EU diagnostic potential + $250$650M for disposable/reusable for esophagus alone – multi-billion markets for other
areas of cancer
–
Asian market much higher potential
–
Opportunity for rapid growth given no competition in definitive in situ diagnostics
Clinically-Proven Non-Invasive Technology Platform
–
Successful and statistically significant (96%) studies in hundreds of patients for colon
cancer
–
Significant successful study for esophagus completed (95%)
–
Published reports show >26% more pre-cancers found in cervix
–
Extensive new uses possible – lung, oral, prostate, urinary/bladder, etc.
Strong Intellectual Property Position
–
60 patents issued or pending- cover BOTH WavSTAT and LUMA Systems and
Probe/Forceps
–
Patent license with Mass General
Going Forward
• We have laid the foundation for transition to a
full operating company
• Finish Barrett’s study & file with FDA
• Begin selling Barrett’s in the EU
• Selling LUMA partnering program
• Complete colon study in managed care
• Begin and complete lung study
www.spectrascience.com