1 bi o medical designs provides smart catheter solutions january 2012
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BiBi oo medical Designsmedical DesignsProvides Provides
Smart Catheter SolutionsSmart Catheter Solutions
January 2012
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Clinician’s PainClinician’s Pain
ProblemProblem SolutionSolutionIncorrect Catheter Placement Rapid and Sure Placement
Catheter Migration Location Monitoring
No Preliminary Diagnostics Integrated Diagnostic MicroSensors
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Societal Impact and Consequences of Endotracheal Societal Impact and Consequences of Endotracheal Tubes (ETT) and Nasogastric Tubes (NGT) Tubes (ETT) and Nasogastric Tubes (NGT)
Misplacement and Lack of MonitoringMisplacement and Lack of Monitoring
ETT- 350,000 annual cases of Ventilator Acquired Pneumonia - Cost $3.0 billion.
NGT - 65,000 annual cases of aspirated pneumonia (following abdominal surgery) - Cost $2.0 billion.
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Societal Impact and Consequences of ETT Societal Impact and Consequences of ETT and NGT Misplacement and Lack of and NGT Misplacement and Lack of
Monitoring - IIMonitoring - II
>$100 million annual Lawsuits from misplaced or migrating NGT or ETT that lead to either severe injury or death.
The “gold standard” x-ray to confirm NGT placement - That provides only a “ momentary snap shot” - Cost $62.5 million annually.
ETT x-ray “momentary snap shots” - Annual cost $600 million.
Misinterpretation of x-rays taken is another issue with an unknown cost.
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The Solution: SmartCathThe Solution: SmartCath
Nasogastric tubes ( NGT)
Endotracheal tubes (ETT)
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NG-ET Optimizer TechnologyNG-ET Optimizer Technology
Base unit with DisplayBase unit with Display
Encapsulated RFID & Encapsulated RFID &
Sensors for NGT or ETT tip Sensors for NGT or ETT tip
A Reader to send key health parametersA Reader to send key health parameters
to the Base unit for interpretation to the Base unit for interpretation
and display.and display.
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SmartCath SystemSmartCath SystemReplaces multiple ineffective Replaces multiple ineffective
position techniques, provides ongoing monitoring and display of position techniques, provides ongoing monitoring and display of key health parameterskey health parameters
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Biomedical Designs Developmental Timelines Biomedical Designs Developmental Timelines Conforming to FDA and Industry RequirementsConforming to FDA and Industry Requirements
Stages of Stages of Development Development
Process:Process:
Catheter Catheter developmentdevelopment
ElectronicElectronic
UnitUnit
DevelopmentDevelopment
Regulatory Regulatory submissionsubmission
Proof of Proof of concept for concept for
IndustryIndustry
DeliverableDeliverable
Sensorized Sensorized Nasogastric , Nasogastric , Endotracheal Endotracheal
CathetersCatheters
Catheter Catheter integration integration
developmentdevelopment
FDA regulatory FDA regulatory process during process during development development
cyclecycle
Design Design production of production of catheters and catheters and
systems/systems/
conduct clinical conduct clinical testingtesting
Cost Cost $450k$450k $950k$950k $30$30 $1.9$1.9
TimingTiming
9 months9 months
(in conjunction (in conjunction with electronic with electronic
system system development)development)
9 months ( in 9 months ( in conjunction conjunction
with catheter with catheter development)development)
Conducted Conducted during catheter during catheter
system system developmentdevelopment
12 months12 months
ProviderProvider Bit- MedTech Bit- MedTech Bit-MedTechBit-MedTech AlquestAlquest Hospital Hospital Surgical units Surgical units
and ICU’sand ICU’s
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Projected NGT SalesProjected NGT Sales
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Projected ETT SalesProjected ETT Sales
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Biomedical Designs Key PersonnelBiomedical Designs Key Personnel
Suzanne BiddiscombeSuzanne Biddiscombe, B.A., M.A., CEO – 20 years in sales and marketing. , B.A., M.A., CEO – 20 years in sales and marketing. Responsible for the day to day operations of Biomedical Designs, specifically Responsible for the day to day operations of Biomedical Designs, specifically research, business plan development, marketing and sales.research, business plan development, marketing and sales.
• David Decker David Decker – CFO; President of Personnel Communications. A highly – CFO; President of Personnel Communications. A highly successful entrepreneur in multiple fields. Provided capital to develop the two successful entrepreneur in multiple fields. Provided capital to develop the two prototype base units that comprise the SmartCath System.prototype base units that comprise the SmartCath System.
• Dr. Jimmie Spraker, Jr. CSO; Dr. Jimmie Spraker, Jr. CSO; PhD, EE – Co-inventor of technology. 25 years PhD, EE – Co-inventor of technology. 25 years experience in hardware and software development and engineering. Jimmie’s experience in hardware and software development and engineering. Jimmie’s entire 30 year career has been dedicated to the advancement of the entire 30 year career has been dedicated to the advancement of the biotechnology field.biotechnology field.
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Biomedical Designs Key PersonnelBiomedical Designs Key Personnel
Kim Chaffee- B.S. E.M.T – Director of Smith’s Medical North American Division of Kim Chaffee- B.S. E.M.T – Director of Smith’s Medical North American Division of Anesthesiology . Kim has been with Smith’s Medical for 15 years and has extensive Anesthesiology . Kim has been with Smith’s Medical for 15 years and has extensive knowledge of the respiratory care arena within the hospital environment. She knowledge of the respiratory care arena within the hospital environment. She oversees Smith’s Respiratory marketing team within the United States.oversees Smith’s Respiratory marketing team within the United States.
C. William King C. William King – BSEE, MBA , CEO and President of Essential Research, Inc., A – BSEE, MBA , CEO and President of Essential Research, Inc., A high tech entrepreneur with experience in four startups since 1998. Bringing more 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 than 50 new products to the market with a cumulative value >$250 million, including >12 new products requiring 510 k approval.>12 new products requiring 510 k approval.
Patty Kelly Patty Kelly – A registered nurse with over 25 years of experience working in Hospital – A registered nurse with over 25 years of experience working in Hospital ICU’s. Consulted during the development of the two prototype units.ICU’s. Consulted during the development of the two prototype units.
Dr. Sandra Perez-SprakerDr. Sandra Perez-Spraker, MD, RN. Worked for over 10 years in ICU’s and ER’s. , MD, RN. Worked for over 10 years in ICU’s and ER’s. Consulted during the development of two prototype units.Consulted during the development of two prototype units.
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Intellectual Property StatusIntellectual Property Status
All Patent Filings are Pending: Filing Date Nasogastric Placement and Monitoring System May 2007 Medical Device Placement and Monitoring Device Utilizing Radio Frequency Identification July 2009
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Capital RequiredCapital Required
Biomedical Designs, LLC has raised and invested $500K to date
Clinical Testing and FDA approval are the next significant inflection points
Amount: $4,500,000 to complete Structure: Percentage of return based upon
Investment Timing: Spring 2012
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Exit StrategyExit StrategyBiomedical 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 InformationContact Information
Suzanne M. Biddiscombe, CEOSuzanne M. Biddiscombe, CEO Phone: 678-794-5657Phone: 678-794-5657 e-mail: [email protected]: [email protected] website: www.biomedicaldesigns.comwebsite: www.biomedicaldesigns.com Video Demonstration available
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