This document discusses opportunities for medical temperature monitoring products in MRI, RF therapies for oncology and cardiology, and outlines plans and timelines. It notes an unmet need to measure core body temperature during MRI and tissue temperature during RF procedures. Benefits of fiber optic temperature sensors are described for physicians to improve therapy control and for OEM manufacturers to expand markets and reduce liability. Large potential markets are identified in MRI monitoring and longer-term in cardiac RF therapies. Product specifications, costs, and development timelines are provided for an MRI temperature monitoring solution.
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
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)