1. InfusSafe LLCInfusSafe LLC
Products that increase the valueProducts that increase the value
and improve the safety ofand improve the safety of
intravenous infusion therapyintravenous infusion therapy

2. The MarketThe Market
 Intravenous infusion therapy is one of the mostIntravenous infusion therapy is one of the most
ubiquitous practices in medicine today.ubiquitous practices in medicine today.
 200-300 million peripheral “IV starts” per year in200-300 million peripheral “IV starts” per year in
the US alone.the US alone.
 Estimated market $6 billion per year.Estimated market $6 billion per year.
 New products that aid nurses in managing IV sitesNew products that aid nurses in managing IV sites
are currently creating a significant market segmentare currently creating a significant market segment
within intravenous infusion therapy.within intravenous infusion therapy.
Examples: Bard StatLockExamples: Bard StatLock®®
I.V.I.V. Catheter StabilizationCatheter Stabilization
Device, Becton Dickenson InstaFlash™Device, Becton Dickenson InstaFlash™

3. Industry Trend DriversIndustry Trend Drivers
 Risk managers, clinicians and administrators are focusedRisk managers, clinicians and administrators are focused
on procedures and products, which can help reduce oron procedures and products, which can help reduce or
eliminate preventative medical errors and/or complications.eliminate preventative medical errors and/or complications.
 Recently, new Medicare regulations are pushing the cost ofRecently, new Medicare regulations are pushing the cost of
many preventable medical errors and complications backmany preventable medical errors and complications back
to the providers.to the providers.
 The healthcare industry has moved towards ‘Pay forThe healthcare industry has moved towards ‘Pay for
Outcomes’ model.Outcomes’ model.
Safety/Value Overall CostSafety/Value Overall Cost
II

4. Infusion Nurses SocietyInfusion Nurses Society
Two qualitative surveys designed andTwo qualitative surveys designed and
sponsored by InfusSafe, regardingsponsored by InfusSafe, regarding
peripheral IV site complications.peripheral IV site complications.
INS Membership, 4200 cliniciansINS Membership, 4200 clinicians
 2006 response rate 17 % (700)2006 response rate 17 % (700)
 2007 response rate 9 % (376)2007 response rate 9 % (376)

5. Ranked IV Site ComplicationsRanked IV Site Complications
Complication Frequency Severity
Infiltration/Extravastation 1 2
Infection 4 1
Occlusions 2 3
Phlebitis 3 4
Infusion Nurses Society Survey 2006 Results

6. # 1 Complication# 1 Complication (peripheral IV(peripheral IV
infiltration)infiltration)
1-Epidermis
2-Interstitial tissue
3-Subcutaneous tissue
4-Admin cannula
5-Vein
5

7. InfiltrationInfiltration (compartment syndrome)(compartment syndrome)

8. Extreme CasesExtreme Cases
Adult Extravasation Neonate
Extravasation
$$$$ in follow-up care and treatments

9. Infiltration RateInfiltration Rate
 Quantitative data is very difficult to findQuantitative data is very difficult to find
 2006 survey results2006 survey results
 > ½ of INS respondents believe the rate to be 5> ½ of INS respondents believe the rate to be 5
– 25 % of all peripheral IVs– 25 % of all peripheral IVs
 70 % of respondents believe the incidence rate70 % of respondents believe the incidence rate
is under reportedis under reported

10. 2007 Survey Results2007 Survey Results
 64 % of respondents believe an IV site64 % of respondents believe an IV site
assessment device would aid in monitoringassessment device would aid in monitoring
and catch infiltration earlyand catch infiltration early
 ~~ 3/4 of respondents would use the3/4 of respondents would use the
InfusSafe ClearSite device on 20 % or moreInfusSafe ClearSite device on 20 % or more
peripheral IVsperipheral IVs

11. InfusSafeInfusSafe SolutionSolution
What we do!What we do!
 Reduce the frequency and severity ofReduce the frequency and severity of
catheter infiltration by facilitating detectioncatheter infiltration by facilitating detection
 Aid in assessment complianceAid in assessment compliance

12. InfusSafeInfusSafe SolutionSolution
How we do it!How we do it!
 Use proprietary technology toUse proprietary technology to replicate andreplicate and
automate the trusted practiceautomate the trusted practice of venousof venous
blood visualization through aspirationblood visualization through aspiration
 Maintain the sterile fluid pathwayMaintain the sterile fluid pathway
 Range of product solutionsRange of product solutions
Single Use
Manual Device
Electronic + Disposable
Automatic Device

13. InfusSafeInfusSafe ClearSiteClearSite
(single patient sterile disposable)(single patient sterile disposable)
Visual
Window
Modeled on a 7 year old
pediatric patient
“Squeeze”

14. Intellectual PropertyIntellectual Property
Current StatusCurrent Status
 US Patent pending since April 2006US Patent pending since April 2006
 Provisional protection to April 2005Provisional protection to April 2005
 Divisional patent application submitted Oct 2011Divisional patent application submitted Oct 2011
 On-going patent discussion with USPTO, 2014On-going patent discussion with USPTO, 2014

15. RegulatoryRegulatory
510(k) Device (product code FPA)510(k) Device (product code FPA)
 Predicates exist…Predicates exist…
 Wyeth TubexWyeth Tubex™™ pre-filled parenteral syringepre-filled parenteral syringe
 Becton Dickinson, InstaFlashBecton Dickinson, InstaFlash™™ cathetercatheter
 ClearSite is a fast and inexpensive first step inClearSite is a fast and inexpensive first step in
our technology commercialization plan.our technology commercialization plan.

16. Other Technology ApplicationsOther Technology Applications
Securing our place on the patient…Securing our place on the patient…
 What else can you do once you haveWhat else can you do once you have
automatically drawn a blood sample in situ?automatically drawn a blood sample in situ?
 Blood glucose levelBlood glucose level
 Blood borne pathogens and pyrogensBlood borne pathogens and pyrogens
 White blood cell countWhite blood cell count
Point of Care Diagnostics, closing the feedback loop betweenPoint of Care Diagnostics, closing the feedback loop between
clinical data and care.clinical data and care. (Included in pending patent)(Included in pending patent)

17. The TeamThe Team
Kevin Durand, Co-Founder:Kevin Durand, Co-Founder: 25 years product development,25 years product development,
executive and senior operations management. Holds 6 patents inexecutive and senior operations management. Holds 6 patents in
medical devices and pharmaceuticals technology.medical devices and pharmaceuticals technology.
Charlie Grinnell, Co-Founder:Charlie Grinnell, Co-Founder: 25 years of experience in research25 years of experience in research
and development and executive level management. Holds 8 patents inand development and executive level management. Holds 8 patents in
medical devices.medical devices.
Darcy Doellmann RN CRNI, Clinical Advisor:Darcy Doellmann RN CRNI, Clinical Advisor: Critical careCritical care
pediatric nurse at Cincinnati Children’s Medical Center and passpediatric nurse at Cincinnati Children’s Medical Center and pass
President of the Association of Vascular Access (AVA)President of the Association of Vascular Access (AVA)

18. InfusSafe In SummaryInfusSafe In Summary
 Increasing the safety and value of one ofIncreasing the safety and value of one of
the most prolific medical practicesthe most prolific medical practices
 Strong revenue in a growing marketStrong revenue in a growing market
 High value proposition to patients, cliniciansHigh value proposition to patients, clinicians
and hospitalsand hospitals
 Proprietary technologyProprietary technology
 510(k) device510(k) device
 Experienced proven teamExperienced proven team

19. ContactContact
 Kevin DurandKevin Durand
978.771.9604978.771.9604
kadurand@yahoo.comkadurand@yahoo.com
 Charlie GrinnellCharlie Grinnell
603.387.9135603.387.9135
cmgrinnell@mac.comcmgrinnell@mac.com