COLUMBIA LIFE SYSTEMS, INC, Philadelphia region, introduces it novel, dynamic and adaptive technology. Find out why leading neonatalogists are so excited about this new technology, now in clinical trial at Cooper University Hospital. The SmartBlender, redefining standards in respiratory care management and taking the 'current 1950's medicine into the 21st century'. The SmartBlender: Making babies healthier...one breath at a time.

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Columbia Life Systems, Inc.
SmartBlender™

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Columbia Life Systems, Inc.
Redefining the standards of respiratory care

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Making babies healthier…
one breath at a time.

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Dr. Jay Greenspan, Chief of Neonatology
Thomas Jefferson University Hospital
Philadelphia, PA
June 2007
“We (currently) have 1950’s
medicine in the 21st century”
“It’s a little embarrassing that we
don’t have a mechanized way”

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The SmartBlender™
An adaptive controlled oxygen blender utilizing
novel, „smart‟ technology
• Delivers continuous supplemental oxygen to
newborn babies/patients in respiratory distress
 Maintains baby‟s blood-oxygen level, as
assessed by a pulse oximeter, at a set range
specified by a physician, continuously.
Components:
 Pulse Oximeter
 Oxygen Blender
 Computer: Software/Algorithms

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SmartBlender™ Technology:
Adaptive, Dynamic, Continuous, Accurate
NICU
PATIENT
Newborn
baby
Blood saturation assessed
Proper mix of oxygen by pulse oximetry
dispensed by blender
Computer
Data
samples oxygen level
interpreted/manipulated
every 10 seconds
by computer algorithm

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SmartBlender™ Value Proposition
The SB promotes automatic, adaptive and consistent maintenance
of blood saturation which will reduce or eliminate development of
acute and chronic health problems due to unregulated oxygen
therapy.
• Pneumonia, bronchio-pulmonary displasia, retinopathy are just a
few of the conditions that can result from inhalation of excessive
oxygen amounts.
• Clinical study at Pennsylvania Hospital, Philadelphia, PA has
indicated: the weaning of patients from oxygen sooner, which may
reduce patient length of stay in NICU.
• Reduction in patient stay affects hospitals‟ bottom line, therefore
reducing costs, increasing profitability
• Neonatologists believe: SB promotes better lung health

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CLS: The right combination
Management believes the four most important advantages
of the SmartBlender™:
Clinical and therapeutic effectiveness
Strong receptivity from physicians
Clear path to product reimbursement
Reduced cost of treatment

9. Columbia Life Systems, Inc.:
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The journey: concept to
clinical trial

10. The process
195
1985 Concept 1999Mallinckrodt/Tyco
Phospho-Energetics
Ohmeda/Hill-Rom
1987 SmartBlender™
2000 Hill-Rom/Air-Shields
patent
Tri-Virix International
Otsuka Electronics
2003Draeger Medical
1992 Ventilator patent
2007Respironics
1998 Varian
NC Biotechnology SmartBlender™
additional patents
Dr. Robert Black
2009Clinical trial at Cooper
University Hospital
and beyond!

11. Competitive position: 196
Intellectual Property
First patent (#4,886,116) filed 1985
2nd and 3rd patents pending (38 claims)
 Solenoid system for oxygen control
 Display and User Interface
 Methods (CPAP, long-term therapy, Heliox, sleep
apnea, weaning, newborn, adult)
 Alarm features
 Apnea control
“Adaptive Controller for Automatic Ventilators” (patent
#5,388,575) filed 1992 -SmartTap™

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Market: competitive landscape
Fixed concentration oxygen blenders, adjusted
manually, are the industry standard
Four companies control lion‟s share of market
No adaptive smart technology blenders are
available in the hospital space
Bottom line: No competition at this time
globally
CLS: preparing for market entry

13. Pediatric and Adult 198
SmartBlender™ Market Applications
NICU
Post
ICU
Extubate
Pediatric
Adult
Recovery
ER
&
Transport
SICKLE
COPD
CELL

14. Pediatric NICU 199
SmartBlender™ Market
NICU
Post
ICU
Extubate
Pediatric
Adult
Recovery
ER
&
Transport
SICKLE
COPD
CELL

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INFANT Potential: Primary NICU
market niche
• Price Range/device: $6,000 - $8,000
• Average price/device: $7,000.00
NICU size
• Adoption over 7 years: 75 %
• # of devices per year:
19,000 beds 2714
US
• Annual revenue potential: $ 19M
• TOTAL MARKET POTENTIAL: $133M
1 unit/bed

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Adult ICU
SmartBlender™ Market
NICU
Post
ICU
Extubate
Pediatric
Recovery
Adult
ER
&
Transport
SICKLE
COPD
CELL

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ADULT Potential: Primary (US) ICU
market niche
• Price Range/device: $6,000 - $8,000
• Average price/device:
ICU $7,000.00
size
• Adoption over 7 years: 30%
• # of devices per year: 2915
68,000 beds
US
• Annual revenue potential: $ 20M
• TOTAL MARKET POTENTIAL: $143M
1 unit/bed

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SmartBlender™ Market Applications
ADDITIONAL AREAS
NICU
Post
ICU
Extubate
Pediatric
Recovery
Adult
ER
&
Transport
SICKLE
COPD
CELL

19. SB Market Revenue Projections: 204
Total Market US: $ 276M
 NICU & ICU
$ 63M
Additional market NICU WW:
9000 units @ 75% adoption
Additional Market Areas:
TBD*
ER, Post extubated, Transport, Recovery,
COPD, Sickle Cell
Total Market Size: $339M ++

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SmartTap™Ventilator market
“Adaptive Controller for Automatic Ventilators”
(patent #5,388,575) filed 1992
Integration of SB „smart‟ technology into
active, mechanical ventilation (i.e. for
intubation)
 Worldwide market size is double the combined
infant NICU and adult ICU markets: 100,000 +
units
 Priced similarly to SmartBlender™
SmartTap™Projected revenue: $700M

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Moving forward
to the
Marketplace

22. Pathways to the Marketplace
A. B.
Clinical trial concurrent Clinical trial
with product re-design concurrent with
product re-design
Submission of 510(k)
Submission of 510(k)
FDA clearance
FDA clearance
Sale of CLS
Manufacturing of SB
for sales to US
luminary hospitals
Sale of CLS

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Regulatory: 510(k) pathway process
to FDA clearance
1. IRB: Investigational Review Board approval 1.9.09
Cooper University Hospital, Camden, NJ
Utilization of Predicate device code approved via 510(k): MITI OptiSat
2. Clinical Trial: comprised of 40-60 patients at CUH
for 90 days, commencing March 2009
3. 510(k) Application:submission for FDA clearance
utilizing trial data
4. FDA clearance time frame: within 60 days of application
submission

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SmartBlender™ Re-design Objectives
1.Replace computer board
2. Reduce weight and size by 50%
3. Improve industrial design: aesthetic and
ergonomic modifications
4.Reduce manufacturing cost from $1,800/unit to
$860/unit
5.Submit enhanced design with trial data for FDA
clearance

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Health and Market Information
US infant mortality increasing: ranked 180/222 countries - 42nd
in the world with 6.30 deaths/thousand*
World infant mortality: 49.4 deaths/thousand*
42.64 deaths/thousand according to
CIA World Fact Book
Number of premature births continues to rise: IVF procedures
and multiple births are on the rise
Number of NICU beds continues to grow
National healthcare initiative: lower cost of treatment and
increase standard of care *according to United Nations

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Market Receptivity:
What are they saying?*
 “concept is superb …great for RNs”
 “makes sense … would keep baby‟s SATs in
medically desired range”
 “may improve outcomes … important to our practice
…purchase would be a high priority”
 “we are not titrating O2 very well … could shorten
hospital stay”
 “we‟re currently using 1950s medicine in the 21st
century”
* excerpts from doctors and clinicians

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Market Pricing: What would they pay?
Dr. L $7K
Dr. LB $6-7K
Dr. B No opinion
Dr. EB $7-8K
Dr. W $5-6K
MEAN: $7, 000

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Augustine Legido MD, PhD, MBA
Chief of Neurology
St. Christopher‟s Hospital for Children
Philadelphia, PA

29. Columbia Life Systems: 214
down to
business

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Who we are
Corporate Medical Advisors
John Taube
Vinod Bhutani, MD
President and Founder
Professor, Stanford University
Brad Coleman Medical Center
Software
Jay Greenspan, MD
Larry Pope Department Chair, Newborn
Pediatrics, Thomas Jefferson
Engineering University Hospital
Lois Smart
Pasquale Casale, MD
Regulatory Pediatric urology, Children‟s Hospital
of Philadelphia (CHOP)
Linda D. Rocca
Marketing

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CLS, Inc. Pre-money valuation
• Valuation of $1.5M
• Sale of $25K blocks
• Liabilities of $320K
• $1M investment gains 40% of CLS
• Management has made significant cash and
human capital investment of $750K in getting
the product poised for the final push to market

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Use of proceeds
Project manager, 18 months $135K
Re-design $180K
Safety Testing $ 25K
Clinical Trial $ 25K
Regulatory Consulting $ 45K
Legal and Accounting $ 30K
Product Launch: device manufacturing $500K
Marketing/business development $ 60K
TOTAL: $1,000,000

33. The End Game: Pathway to the 218
marketplace
A. B.
Clinical trial
Clinical trial concurrent concurrent with
with product re-design product re-design
Submission of 510(k) Submission of 510(k)
FDA clearance FDA clearance
EXIT: Sale of CLS Manufacturing of SB
for sales to US
luminary hospitals
EXIT:Sale of CLS

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The Endgame:
Early Exit
…Sell to whom?

35. Why invest in Columbia
220
Life Systems, Inc.?
Business
• Novel Intellectual property
• Cutting edge technology: smart technology does not
exist in the marketplace today - NO
COMPETITION
• Significant market pull from doctors and clinicians
• Better medicine: may improve lung health in long run
which reduces healthcare costs
• Reduces hospital expenditures: pilot studies reveal
the weaning of patients off oxygen sooner, saving
hospitals hard dollars in NICU costs
• Early exit strategy: quick return on investment
• Below market valuation
• Excellent projected ROI based on expected valuation

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Why invest in Columbia
Life Systems, Inc.?
Medicine
• Leads respiratory care management into the 21st century
• Significant therapeutic receptivity from doctors and
clinicians
• May increase respiratory health for patients in NICU/ICU:
optimizes manner to dispense oxygen based on
patient physiological demand
• Better medicine: may improve lung health in long run
• Pilot studies show weaning patients off of oxygen sooner;
may expedite release from hospital/NICU earlier

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Columbia Life Systems SmartBlender™
Making babies healthier
one breath at a time.

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