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Sample Medical Device Presentation
 

Sample Medical Device Presentation

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Medical Device Sample Presentation

Medical Device Sample Presentation

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    Sample Medical Device Presentation Sample Medical Device Presentation Presentation Transcript

    • 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)