Columbia Life Systems, Inc., Philadelphia region, presents the novel, adaptive and dynamic technology of the SmartBlender.
Currently in clinical trial at Cooper University Hospital, Camden, NJ, the SmartBlender approach may redefine the standards of respiratory care management globally.
Join in with leading neonatologists' excitement about this new technology
The SmartBlender:
Making babies healthier...one breath at a time.
4. 189
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”
5. 190
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
6. 191
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
7. 192
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
8. 193
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
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™
12. 197
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
15. 200
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
16. 201
Adult ICU
SmartBlender™ Market
NICU
Post
ICU
Extubate
Pediatric
Recovery
Adult
ER
&
Transport
SICKLE
COPD
CELL
17. 202
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
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 ++
20. 205
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
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
23. 208
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
24. 209
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
25. 210
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
27. 212
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
28. 213
Augustine Legido MD, PhD, MBA
Chief of Neurology
St. Christopher‟s Hospital for Children
Philadelphia, PA
30. 215
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
31. 216
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
32. 217
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
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
36. 221
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