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Medical Customer & Revenue Plan
The Unmet Needs
Safety Under MR Imaging
◦ “Standard of Care” to Measure Core Temperature in MRI
  Especially for Neonatal Cases and Sedated Adults
◦ Thermistors & TCs Generally Cannot Be Used
◦ Available Reusable FO Technology Measures Only Skin
  Temperature and Suffers from Poor Reliability

RF Therapies for Oncology and Cardiology
◦ Need to Measure Tissue Temperature During RF Procedure
◦ TCs Cannot Measure Deep Tissue Temperature in Cardiac
  Therapy
◦ TCs Are Prone to Electronic Noise in Oncology Therapies
Benefits of FO Sensors
To Physicians
◦ Greatly Improve Control of Therapy By Providing the Physician
  with the Temperature Profile at Critical Locations
◦ For AF, Enable Improved Procedure Control by Measuring
  Temperature in Deep Tissue

To
T OEM M  Manufacturers
                f
◦ Expand Utility of RF Therapeutic Equipment (esp. for AF) and
  Thus Expand Market Penetration
         p
◦ Reduce Liability Risk and Risk of Redoing Procedure
◦ For Oncology Therapy, Specifically Address Concerns from FDA
7
7+M MR Scans Qualify for
       Sca s Qua y o
Temp Monitoring
      Immediate need for
                                          Qualified adult Adult scan qualified for
                           Neo-natal
      temp sensing
                                                          temp monitoring but
                                              scan
                           500,000
                                                          p
                                                          probably not p
                                                                  y    performed
                                           4,977,000
                                           4 977 000



                                                      Performed at      Adult scan qualified
                                                                        for temp monitoring
                                                       Physician's
                                                       Ph i i '
                                                                        and performed at
                                                         Choice         physician’s choice
                                                        2,133,000

Non-Qualifiying
    Q      yg
 16,590,000                            Market Size = $100M ~ $150M/yr
                                                        Source: Benchmark MRI Report 2004



…But Vast Majority of Installed Base of Patient Monitoring
  B t V t M j it f I t ll d B         f P ti t M it i
Systems Cannot Measure Temp
Opportunity in Patient Monitoring
                                      Forecast figures for opportunity in MR monitoring
                             70,000                                                       1,200
                                             Nb of Adult MR probes
                                             Nb of Neonatal probes
Quarterly volume of probes


                             60,000
                                                                                          1,000
                                             Installed base of instruments

                                                                                                  Penetrate 2.1M
                             50,000                                                               adult MR scans
                 o




                                                                                          800     qualified and at
                                                                                                  physician’s choice
                             40,000
                                        Build a new installed
                                                                                          600
                                        base at 700 – 800
                                        instruments per year
                             30,000
                             30 000
        y




                                                                                                  Neonatal
                                                                                          400
                                                                                                  consumption at
                             20,000
                                                                                                  rate of 100
                                                                                                  probes/yr per MR
                                                                                          200     machine
                             10,000


                                 0                                                        0
                                      Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08

                               In 2009, Opportunity is 250+k Probes/yr at $30 ea.
Opportunity
                                  $8,000
                                           J&J Biosense Webster
                                           Boston Scientific
                                  $7,000
                   ntial ($000)




                                  $6,000
                                                                                              Short-term
                                                                                              opportunity
                                  $5,000
                                  $5 000
        evenue Poten




                                                        $6.0M (requires
                                                        $6 0M (      i
                                                                                              is small,
                                                        collaborative
                                                        development with J&J
                                  $4,000                                                      and large
                                                        and BSX)
                                                                                              opportunity
                                  $3,000
                                  $3 000
Annual Re




                                                                                              is 3
                                                                                              i 3+ years
                                                                                              out
                                  $2,000

                                  $1,000
                                  $1 000
                                                                  $0.8M
                                    $-
                                                 RF Oncology                   Cardiac

                                                                               Potential in
                                                     Potential
                                                                               3+ Yrs
                                                     Within 2 Yrs
Revenue
                            $3,500,000
                                          Total RF Oncology Revenue
                                          Total Adult MR revenue
                            $3,000,000
                                          Total Neonatal revenue

                            $2,500,000
                      00)
 Potentia Revenues ($00




                            $2,000,000


                            $1,500,000
        al




                            $1,000,000


                             $500,000
                             $500 000


                                   $0
                                         Q1   Q2   Q3   Q4    Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4
                                         07   07   07   07    08   08   08   08   09   09   09   09
Disposable Probe Cost –
   Current Cost
RPC Connector Assembly: $6.05
                                                    Phosphor A
                                                    Ph   h Assembly: $0 8
                                                                bl $0.85
            Fiber: $1.20




     Sheath: $0.50


                                                                Test & Assembly
                                                                Labor: $6.65

                                                     Packaging & Sterilization: $0.50

                     Total Direct Cost yielded at 50%: $31.00
            Trusting our probe when you are sedated: Priceless
Disposable Probe Cost – Future
   Cost    $1.00
SC
RPC connector assembly: $6.05

                                                       phosphor assembly: $0.85
           fiber: $1.20




   sheath: $0.50
                                                                      On-going evaluation
                                                                      of outsourcing to Asia
                                                                                 $1.50
                                                                                 $1 50
                                                         test & assembly labor: $6.65
                                                         packaging & sterilization: $0.50
                                                  80%
                   total direct cost yielded at 50%: $31.00
                              EEPROM Smart Probe +$2.00
                                                   $8.80
                                        New Cost
Products and Timeline
        Key Product Specs for Patient Monitoring:
         ◦    Single-Use (Cost < $10 Per Probe)
         ◦    Accuracy (< 0.2 °C)
                         (      C)
         ◦    Calibration-Free
         ◦    Qualified for Esophageal or Rectal Use
                                                                         Complete engineering
MRI Core Body Temp Solution
                                         Mar-06 Apr-06 May-06 Jun-06 Jul-06 Aug-06 Sep-06 Oct-06 Nov-06 Dec-06 Jan-07 Feb-07
Feasibility & Probe Development             Ongoing
Spec Agreement & Contract                              15-May
System Development
Probe Test Fixture Development
                                                                                                       Complete 510(k)
Send Integration Details to Customer                          15-Jun
Internal V&V
                                        Spec Freeze
Ship V&V System to Customer                                                                1-Oct
510(k) Qualification
Customer Intergration/Validation
Identify CDRH-Registered CMs
Manufacturing Transfer/Pilot
Customer Training / Marketing Support
                                                   Initiate Pilot Line in Asia


  •       Product Specs for RF Oncology and Timeline to Be Defined and
          Validated
Reimbursement

Monitoring:
◦ Temperature monitors are under a capped system, so direct
  strategy not applicable

RF Ablation:
◦ J i t participation in activities with OEM’ t i
  Joint    ti i ti i       ti iti    ith OEM’s to impact
                                                       t
  payment, opening new market opportunities, (ie. clinical
  studies)

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Sample Medical Device Presentation

  • 1. Medical Customer & Revenue Plan
  • 2. The Unmet Needs Safety Under MR Imaging ◦ “Standard of Care” to Measure Core Temperature in MRI Especially for Neonatal Cases and Sedated Adults ◦ Thermistors & TCs Generally Cannot Be Used ◦ Available Reusable FO Technology Measures Only Skin Temperature and Suffers from Poor Reliability RF Therapies for Oncology and Cardiology ◦ Need to Measure Tissue Temperature During RF Procedure ◦ TCs Cannot Measure Deep Tissue Temperature in Cardiac Therapy ◦ TCs Are Prone to Electronic Noise in Oncology Therapies
  • 3. Benefits of FO Sensors To Physicians ◦ Greatly Improve Control of Therapy By Providing the Physician with the Temperature Profile at Critical Locations ◦ For AF, Enable Improved Procedure Control by Measuring Temperature in Deep Tissue To T OEM M Manufacturers f ◦ Expand Utility of RF Therapeutic Equipment (esp. for AF) and Thus Expand Market Penetration p ◦ Reduce Liability Risk and Risk of Redoing Procedure ◦ For Oncology Therapy, Specifically Address Concerns from FDA
  • 4. 7 7+M MR Scans Qualify for Sca s Qua y o Temp Monitoring Immediate need for Qualified adult Adult scan qualified for Neo-natal temp sensing temp monitoring but scan 500,000 p probably not p y performed 4,977,000 4 977 000 Performed at Adult scan qualified for temp monitoring Physician's Ph i i ' and performed at Choice physician’s choice 2,133,000 Non-Qualifiying Q yg 16,590,000 Market Size = $100M ~ $150M/yr Source: Benchmark MRI Report 2004 …But Vast Majority of Installed Base of Patient Monitoring B t V t M j it f I t ll d B f P ti t M it i Systems Cannot Measure Temp
  • 5. Opportunity in Patient Monitoring Forecast figures for opportunity in MR monitoring 70,000 1,200 Nb of Adult MR probes Nb of Neonatal probes Quarterly volume of probes 60,000 1,000 Installed base of instruments Penetrate 2.1M 50,000 adult MR scans o 800 qualified and at physician’s choice 40,000 Build a new installed 600 base at 700 – 800 instruments per year 30,000 30 000 y Neonatal 400 consumption at 20,000 rate of 100 probes/yr per MR 200 machine 10,000 0 0 Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08 In 2009, Opportunity is 250+k Probes/yr at $30 ea.
  • 6. Opportunity $8,000 J&J Biosense Webster Boston Scientific $7,000 ntial ($000) $6,000 Short-term opportunity $5,000 $5 000 evenue Poten $6.0M (requires $6 0M ( i is small, collaborative development with J&J $4,000 and large and BSX) opportunity $3,000 $3 000 Annual Re is 3 i 3+ years out $2,000 $1,000 $1 000 $0.8M $- RF Oncology Cardiac Potential in Potential 3+ Yrs Within 2 Yrs
  • 7. Revenue $3,500,000 Total RF Oncology Revenue Total Adult MR revenue $3,000,000 Total Neonatal revenue $2,500,000 00) Potentia Revenues ($00 $2,000,000 $1,500,000 al $1,000,000 $500,000 $500 000 $0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 07 07 07 07 08 08 08 08 09 09 09 09
  • 8. Disposable Probe Cost – Current Cost RPC Connector Assembly: $6.05 Phosphor A Ph h Assembly: $0 8 bl $0.85 Fiber: $1.20 Sheath: $0.50 Test & Assembly Labor: $6.65 Packaging & Sterilization: $0.50 Total Direct Cost yielded at 50%: $31.00 Trusting our probe when you are sedated: Priceless
  • 9. Disposable Probe Cost – Future Cost $1.00 SC RPC connector assembly: $6.05 phosphor assembly: $0.85 fiber: $1.20 sheath: $0.50 On-going evaluation of outsourcing to Asia $1.50 $1 50 test & assembly labor: $6.65 packaging & sterilization: $0.50 80% total direct cost yielded at 50%: $31.00 EEPROM Smart Probe +$2.00 $8.80 New Cost
  • 10. Products and Timeline Key Product Specs for Patient Monitoring: ◦ Single-Use (Cost < $10 Per Probe) ◦ Accuracy (< 0.2 °C) ( C) ◦ Calibration-Free ◦ Qualified for Esophageal or Rectal Use Complete engineering MRI Core Body Temp Solution Mar-06 Apr-06 May-06 Jun-06 Jul-06 Aug-06 Sep-06 Oct-06 Nov-06 Dec-06 Jan-07 Feb-07 Feasibility & Probe Development Ongoing Spec Agreement & Contract 15-May System Development Probe Test Fixture Development Complete 510(k) Send Integration Details to Customer 15-Jun Internal V&V Spec Freeze Ship V&V System to Customer 1-Oct 510(k) Qualification Customer Intergration/Validation Identify CDRH-Registered CMs Manufacturing Transfer/Pilot Customer Training / Marketing Support Initiate Pilot Line in Asia • Product Specs for RF Oncology and Timeline to Be Defined and Validated
  • 11. Reimbursement Monitoring: ◦ Temperature monitors are under a capped system, so direct strategy not applicable RF Ablation: ◦ J i t participation in activities with OEM’ t i Joint ti i ti i ti iti ith OEM’s to impact t payment, opening new market opportunities, (ie. clinical studies)