Biomedical Designs
Introduces
SmartCathXtraTM
Providing
• Catheter Placement Assistance
• Catheter Tip Monitoring
• Key Vital Sign Monitoring
January 2012
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Clinician’s Pain
Problem
Solution
Inconsistent Catheter Placement
Rapid and Sure Placement
Assistance
Catheter Migration
Location Tip Monitoring
Lack of Integrated Vital Sign Monitoring
Technologies
Integrated Technologies for Vital
Sign Monitoring
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Integrated Technologies
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Endotracheal Tubes and Clinical Issues
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ET's positioned too high in the trachea leads to inadequate respiration, potential brain damage,
cardiac arrest and death. Placed too far down in the trachea the tube enters the main stem bronchus
(airway pipe which leads to one of the two lungs).
ET migration can lead to acute respiratory distress (ARDS).
Tube clogging - lung secretions or other substances block the tube, tube kinks or patient bites on tube
excessively.
Unplanned extubations - the tube comes out of patient's trachea. Occurs in 10% adult ICU patients.
Over 25% of ‘out of hospital intubations’ were reportedly misplaced, with 66% being misplaced into
the esophagus.
17% placement errors within the ER setting according to data released by the CDC in 2004.
Esophageal Intubation - tube is accidentally placed in the esophagus (food pipe) instead of trachea.
Tracheal cuff overinflation leading to tracheal stenosis; 55% to 62% incidence of cuff overinflation
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Nasogastric Tubes Used for Enteral or Nutritional
Feeding
 Approximately 1,254,000 NG tubes are used for enteral
feeding with the following clinical issues noted:
1. Lung placements – 3.2% - 40,000
2. Lung punctures – 1.2% - 15,000
3. Pulmonary Injuries – between 3,600 and 8,800
4. Deaths per year – 6,000
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Nasogastric Tubes used for other Clinical
Procedures
Approximately 7.5 million additional NG tubes are used in the
United States to:
1. decompress the stomach after abdominal surgery
2. To remove a poison or toxic substance from the stomach
to obtain an aspirate from the stomach for analysis
Clinical issues associated with these procedures include:
 Puncture of esophagus  Lung injuries -
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Societal Impact and Consequences of Endotracheal
Tubes (ET) and Nasogastric Tubes (NGT) Lack of
Integrated Monitoring
 ET- 300,000 annual cases of ventilator acquired
pneumonia - $40,000 per incident =
 NGT - 65,000 annual cases of aspirated
pneumonia - $28,000 -$40,000 per incident =
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Societal Impact and Consequences of ETT
and NGT Lack of Integrated Monitoring - II
 >$100 million annual Lawsuits from misplaced or migrating
nasogastric or endotracheal tube that led to either severe
injury or death.
 The “gold standard” x-ray to confirm NGT placement providing a “ momentary snap shot” - Costs $62.5 million
annually. ET x-ray –Annual cost $600 million.
 Unknown cost associated with NG tube placement and
migration errors.
 Unknown cost associated with ET misplacements and
BI O MEDICAL DESIGNS
unrecognized migrations.
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The Solution: A Smart Catheter System
Nasogastric tubes ( NGT)
Endotracheal tubes (ET)
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SmartCathXtra Technology
Key Components
Base Unit - Multiple
Integrated Technologies
Encapsulated RFID &
Sensors for NGT or ET tip
Reader to send key health parameters
to the Base unit for interpretation
and display.
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Emerging Markets
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SmartCathExtraTM
Key Product Features of System
•Provides multiple parameters in “real time” for accurate
placement assistance of catheters – pH, air pressure differentials,
sound recordation through electronic stethoscope.
•Provides multiple parameters in “real time” for continuous
catheter tip location monitoring – pH/temperature, air pressure
differentials, sound recordation through electronic stethoscope.
•Provides integrated “real time” vital sign monitoring - for
detection of complications - pH, core temperature, pulse
oximetry to assess oxygen levels in patients, Co2-“side stream”
for lungs, electronic stethoscope to monitor
respiratory/pulmonary function.
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Biomedical Designs Developmental Timelines
Conforming to FDA and Industry Requirements
Stages of
Development
Process:
Catheter
Controller
FDA
Clinical Testing
Deliverable
SmartCathXtra
Disposable
units
SmartCathXtra
Controller with
RFID
Development
FDA regulatory
process during
development
cycle
Patient Testing
300 Patients
Cost
$250k
$1.1M
$75k
$1.6M
10 months
Conducted
during
SmartCathXtra
development
12 months
Timing
Provider
10 months
3 independent
sites
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ROI Assumptions
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Projected SmartCathXtra Sales
NGT Application Projected Sales
$70
Sales Revenue (000,000)
$60
$50
$40
$30
$20
$10
$0
1
2
3
4
5
Year
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Projected SmartCathXtra Sales
ET Total Projected Sales
$120
Sales Revenue (000,000)
$100
$80
$60
$40
$20
$0
1
2
3
Year
4
5
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Proforma Income
1
2
3
4
5
$ 59,264
$ 101,377
$137,249
$ 173,121
$
$
$
$
$
1,163
13,085
14,248
2,617
11,631
$ 2,617
$ 20,358
$ 22,975
$ 4,072
$ 18,903
$ 4,072
$ 27,631
$ 31,702
$ 5,526
$ 26,176
$
5,526
$ 34,903
$ 40,430
$
6,981
$ 33,449
24,982
$ 47,634
$ 82,473
$111,073
$ 139,672
$
7,408
$ 14,816
$ 25,344
$ 34,312
$
43,280
$
17,574
$ 32,818
$ 57,129
$ 76,760
$
96,392
$
5,272
$
9,845
$ 17,139
$ 23,028
$
28,918
$
12,302
$ 22,972
$ 39,990
$ 53,732
$
67,474
Years
REVENUE
Gross Sales
$
29,632
Cost of Sales
Beginning Inventory
Cost of Goods purchased / manufactured
Total Goods Available
Less Ending Inventory
Total Cost of Goods Sold
$
$
$
$
$
5,813
5,813
1,163
4,650
$
Gross Profit (Loss)
Selling and Administrataive Expenses
Net Income Before Taxes
Taxes
Net Income
* Post market introduction (all numbers in $000)
Net Present Value Calculation
Discount rate
Investment ($000)
0.05
2,500
NPV= $ 161,671
BI O MEDICAL DESIGNS
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Biomedical Designs Key Personnel

Suzanne Biddiscombe, B.A., M.A., CEO – 20 years in sales, marketing and
pharmaceutical sales. Responsible for the day to day operations of Biomedical
Designs, specifically sales and marketing.
•
David Decker – CFO; V.P. of Personnel Communications. A highly successful
entrepreneur in multiple fields. Provided capital to develop the two prototype
controller units that comprise the SmartCathXtra System.
•
Dr. Jimmie Spraker, Jr. CSO; PhD, EE – Co-inventor of technology. 25 years
experience in hardware and software development and engineering. Jimmie’s
entire 30 year career has been dedicated to the advancement of the
biotechnology field.
BI O MEDICAL DESIGNS
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Biomedical Designs Key Personnel

Philip Rowe - 30 years experience in science. Co-Inventor of Technology.
Holds multiple degrees including one in nuclear medicine. Philip has invented
numerous technologies and has received one patent to date.

C. William King – BSEE, MBA , CEO and President of Essential Research,
Inc., A high tech entrepreneur with experience in four startups since 1998.
Bringing more than 50 new products to the market with a cumulative value
>$250 million, including >12 new products requiring 510 k approval.

Kimberly Chafee –

Dr. Sandra Perez-Spraker, MD, RN. Worked for over 10 years in ICU’s and
ER’s abroad. Consulted during the development on issues germane to ICU’s
and Surgical Units for Adult and Pediatric Patients.
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Intellectual Property Status
All Patent Filings* are Pending:
Filing Date
 Nasogastric Placement and Monitoring System
 Medical Device Placement and Monitoring Device
Utilizing Radio Frequency Identification (CIP) July
May 2007
2009
* All filings have been published
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Capital Required
 Biomedical Designs, LLC has raised and
invested $650K to date
 Clinical Testing and FDA approval are the next
significant inflection points
 Amount: $3,700,000 to complete
 Structure: Membership interests based upon
percentage.
 Timing: 1st quarter 2012
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Exit Strategy
Biomedical Designs, LLC is a catheter development
oriented company, with these key objectives:
 Be a research oriented company advancing numerous
proprietary catheter technologies to engage designed electronics.
 Within 24 months complete technology, testing and FDA
approval.
 Within 30 months return the principal of investments plus
percentage on sale of technology.
 Create liquidity through sale of completed technology to tube
manufacturer, medical device manufacturer, or recognized
industry leader in respiratory care or equivalent.
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Contact Information
Suzanne M. Biddiscombe, CEO
Phone: 678-794-5657
e-mail: Suzanne4sure@yahoo.com
Please Review Video Demonstration
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