The document discusses a new technology for guiding cryoablation of prostate cancer using optoacoustic tomography (OAT) to provide high resolution temperature monitoring and visualization of the ice ball, aiming to reduce rectal damage, impotence, and cancer recurrence. It provides estimates of the total available market, served available market, and target market for the technology, projecting sales of 600 units for $84 million. Customer interviews conducted during an I-Corps program helped shift the business model from direct sales to physicians to partnerships with cryoablation providers.

1. OAT guided cryoablation of prostate cancer – new standard for minimal rectal damage, impotence and cancer recurrence
Original Opportunity Estimates
$140,000 – estimated price/unit of the technology Total Available Market: Total number of urological hospitals in U.S – 2,000 (1,570 ranked by U.S. News) $280 million Served Available Market: 1,200 clinics served by cryoablation providers $168 million Target Market: Focused cryoablation, est. half – 600 clinics $84 million
Team #16, I-Corps @ NIH, Chevy Chase, MD
NIH I-Corps™ Team #16

2. Sergey Ermilov (C-level Exec) VP Research and Development
Peter Brecht (Industry Exp) Director, Business Development
Elena Petrova (PI)
Scientist
Customer interviews: 126 Instructor engagements: 43
Week 1
Week 10
Team 16
Team #16, I-Corps @ NIH, Chevy Chase, MD
Fast
Faster

3. Original idea
$140,000 x 600 = $84,000,000
600 units: High-resolution T-maps Enhanced contrast of ice ball
urologist
TomoWave, Inc.
37oC
Physiological temperature
-7oC
Freezing
-6oC
Flipped OA signal
-1oC
T0 – zero OA signal
Temperature
Team #16, I-Corps @ NIH, Chevy Chase, MD
DIRECT SALE TO PHYSICIANS

4. Week 1: Business Model Canvas
Team #16, I-Corps @ NIH, Chevy Chase, MD
Tech Features
Collage of “Customers”

5. And next we … GooB
Urologic surgeons
Hospital specialists
Thermal therapy scientists
Patient support groups
Got out of the Building!
Team #16, I-Corps @ NIH, Chevy Chase, MD

6. GooB ― first experience
Team #16, I-Corps @ NIH, Chevy Chase, MD

7. GooB ― solution
Well … just walk in to the hospital!
Team #16, I-Corps @ NIH, Chevy Chase, MD

8. Reality 1: We are doctors! And we need better treatment control and … better money!
1 C accuracy
1 mm spatial resolution
1 frame per second
Team #16, I-Corps @ NIH, Chevy Chase, MD
Doctor’s Pains Doctor’s Gain

9. Reality 2: … and, by the way, we do not buy your equipment!. Mobile service instead!
Selling
Leasing
Team #16, I-Corps @ NIH, Chevy Chase, MD
Buyer

10. Customer archetypes
o 50-75 years old man diagnosed with a localized prostate cancer
o Pays in full or splits costs with medical insurance
o Values excellent cancer control, fast recovery & min complications
o 30-60 years old
o Practices cryoablation or just from residency
o Mostly rents equipment and buys consumables
o Values patient’s satisfaction, fast learning & payment comparable to office dollars
TomoWave
Cryoablation business
Patient
Urologist
Decision Maker
User, Influencer
Buyer
o Stressed by competition and defiant surgeons
o CEO, Director of Marketing, CTO
o Buys/licenses monitoring technology or OEM
o Values larger servable market & competitive advantage
Proposer: academic urologist experimenting with novel prostate cancer treatment techniques
Saboteur: prostatectomy guru and radiologist
Team #16, I-Corps @ NIH, Chevy Chase, MD

11. Reality 3: Customers need market growth! Partnership is unavoidable!
Team #16, I-Corps @ NIH, Chevy Chase, MD
Texas

12. Cryoablation of prostate cancer: Cash flow
Team #16, I-Corps @ NIH, Chevy Chase, MD
Clinical
Technology
Ultrasound OEM
Patient
Cryoablation manufacturer- provider
OAT OEM (TWL)
Private Insurance
Urologist
Product/Service
Payment
Medicare
Outpatient facility
Cancer treatment
& post-treatment activities
$1k, annual payments
Self-payment per procedure
Self-payment
per procedure
$786 per procedure
$800-1k per procedure
Federal tax
$5.5k
per procedure
Lease equipment, sell consumables

13. Market Size
Team #16, I-Corps @ NIH, Chevy Chase, MD
$5,500 – price of a single cryoablation procedure
Based on HealthTronics pricing
12,000 – current number of annual prostate cryoablation treatments in US
Based on HealthTronics estimates
230,000 – number of new prostate cancer cases in US in 2014
http://seer.cancer.gov/statfacts/html/prost.html
Total Available Market:
100% market dominance. Fixed price. 50-50 split of the revenue growth
$600 million
Served Available Market:
Double current prostate cryoablation market. Fixed price. 50-50 split of the revenue growth
$66 million
Target Market:
Double prostate cryoablation market for a single major player. Fixed price. 50-50 split of the revenue growth
$33 million

14. Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
Week 9
Week 10
NIH I-Corps™ lessons learned
Cryo- provider
•Better Control
•Easy Learning
Urologist
•Better Control
•Easy Learning
Cryo- provider
•OEM
•License
•Tech sale
Cryo- provider
•Partners
•Market Growth
Urologist
•Technical Specs
Urologist
•Better Control
•Easy Learning
•Reimbursement
Team #16, I-Corps @ NIH, Chevy Chase, MD

15. Our Journey LaunchPad Business Model Canvas: Week 1
Team #16, I-Corps @ NIH, Chevy Chase, MD

16. Our Journey LaunchPad Business Model Canvas: Week 3
Team #16, I-Corps @ NIH, Chevy Chase, MD

17. Our Journey LaunchPad Business Model Canvas: Week 6
Team #16, I-Corps @ NIH, Chevy Chase, MD

18. Our Journey LaunchPad Business Model Canvas: Week 8
Team #16, I-Corps @ NIH, Chevy Chase, MD

19. Our Journey LaunchPad Business Model Canvas: Week 10
Team #16, I-Corps @ NIH, Chevy Chase, MD

20. $ 60M = double of
annual revenue
Urologist
2 Leasing
No complications
No cancer
2  Happy patient
w/o cancer
Technology
License
OEM
Cryoequipment provider
Next? … To be continued!
TomoWave Laboratories, Inc.
Team #16, I-Corps @ NIH, Chevy Chase, MD

21. Final Notes
Team #16, I-Corps @ NIH, Chevy Chase, MD
With respect to submitting an SBIR/STTR Phase II application, we are making the following decision (PICK ONE):
•Go with a significant pivot: The feasibility data generated in the Phase I grant provide the appropriate technical foundation for a Phase II application, BUT we are targeting very different customer segments than we had originally anticipated
Start
Current
Investment Readiness Level (IRL)
Prior to NIH I-Corps™ – 1
Current – 5

22. APPENDIX
Team #16, I-Corps @ NIH, Chevy Chase, MD

23. Slide A1: Story Telling
The World: market/Opportunity – how it operates
Characters: Customers/Value Proposition/Product-Market-Fit, pick few examples to illustrate
Narrative arc – lessons learned how? Enthusiasm, despair, learning, then insight!
Show images and demo to illustrate learning
Editing – does each slide advance the characters and plot?
Team #16, I-Corps @ NIH, Chevy Chase, MD

24. Slide A2: Theater
Point audience at what they need to see!
Self-explanatory
Use analogies
Tell a story that others can repeat
Use common audience appropriate language
Team #16, I-Corps @ NIH, Chevy Chase, MD

25. Team #16, I-Corps @ NIH, Chevy Chase, MD
OAT guided cryoablation of prostate cancer – new standard for minimal rectal damage, impotence and cancer recurrence
Interviews: 123
Sergey Ermilov (C-level Exec)
Peter Brecht (Industry Exp)
Elena Petrova (PI)
Team # 16
OA-US module
to visualize ice ball with high contrast and monitor temperature near rectal wall
Joseph F. Harryhill, “Cryoablation for Salvage Treatment of Prostate Cancer,” Web: Univ. of Pennsylvania Health System, March 23, 2011

26. Original Market Estimates
Team #16, I-Corps @ NIH, Chevy Chase, MD
$140,000 – estimated price/unit of the technology
Source: Estimate is based on known price for some of the components(laser, ultrasound probe, DAQ) and company’s price policy for similar system for small animal imaging
Total Available Market:
Total number of urological hospitals in U.S – 2,000 (1,570 ranked by U.S. News)
Source: http://health.usnews.com/best-hospitals/rankings/urology
$280 million
Served Available Market:
Healthtronics, Inc. - major provider of prostate cryoablation – 600 clinics
http://www.healthtronics.com/
GalilMedical, Inc. – another, est. about the same 600 clinics
http://www.galilmedical.com/
$168 million
Target Market:
Focused cryoablation, est. half – 600 clinics
$84 million

27. Customer archetypes
Team #16, I-Corps @ NIH, Chevy Chase, MD
o 50-75 years old man diagnosed with a localized prostate cancer
o Pays in full or splits costs with medical insurance
o Values excellent cancer control, fast recovery & min complications
o 30-60 years old
o Practices cryoablation or just from residency
o Mostly rents equipment and buys consumables
o Values patient’s satisfaction, fast learning & payment comparable to office dollars
TomoWave
Cryoablation business
Patient
Urologist
Decision Maker
Influencer
Buyer
o Stressed by competition and defiant surgeons
o CEO, Director of Marketing, CTO
o Buys/licenses monitoring technology or OEM
o Values larger servable market & competitive advantage
Proposer: academic urologist experimenting with novel prostate cancer treatment techniques
Saboteur: prostatectomy guru and radiologist

28. Customer relationships funnel
Team #16, I-Corps @ NIH, Chevy Chase, MD
New monitoring algorithms
New US co-registration
($100k)
Journal publications
In person communication
Co-development
Joint journal articles
Software updates
Hardware & probe upgrades
Awareness
Interest
Consideration
Purchase
TV & media promotion Free trials of new technology Up-Selling features Cross-Selling new technology with consumables Referral deal on consumables
($1M)  Joint clinical studies Presentations & Demo at conferences & med schools Focus groups Existing social media groups Free educational trainings Free trial lease
Joint journal articles
Low cost lease Free software updates Free on-site trainings Free tech support Dedicated social media group (active recruiting)
Relay success stories to general public through TV & social media
($10k)
Clinical brochures
Paid links from cancer educational websites
Clinical brochures
Referral by physicians
Paid links from cancer educational websites
Get
Grow
Keep
Unbundle
Up-Sell
Cross-Sell
Referrals

29. The channel economics (approximate numbers)
Team #16, I-Corps @ NIH, Chevy Chase, MD
Cost of Goods
$60K
Direct sales to physicians
R&D, Selling Cost, Gen & Admin $80K
-5%
Profit $78K
List Price $230K
Our revenue $218K
Cost of Goods
$60K
Indirect sales to cryoproviders
R&D, Selling Cost, Gen & Admin $70K
-5%
Pro- fit $55K
List Price $230K
Our revenue $185K
Reseller 15%
COGS
OEM to cryomanufacturer
SGA
-5%
Pro- fit
List Price $380K
Our revenue $220K
Reseller
License? Sell technology?
Direct leasing to physicians
-5%
Profit $1.5K
List Price $9K
Our revenue $8.5K
COGS/20
$3K
SGA/20 $4K
Indirect leasing to cryoproviders
-5%
List Price $9K
Our revenue $7.2K
Pro- fit $0.7K
Resell 15%
COGS/20
$3K
SGA/20 $3.5K

30. Key Activities and Resources
Team #16, I-Corps @ NIH, Chevy Chase, MD
Freedom to operate
Quality data
Regulatory approval
Final product
Sales
• Internal financing
• Patent lawyer
•SBIR/SBA
•Internal financing
•R&D facility, equipment
•R&D personnel
•SBIR/SBA
•Investment
•R&D facility and equipment
•R&D personnel
•Mentors, advisors
•Investment
•Assembly facility
•Laser, optical, US, electronic parts
•Trade secrets, patents, licenses
• Engineers, tech- nicians, quality control
•Mentor, advisors
Finance
Physical
Intellectual
Human
Purpose
Activity
Resource
•Investment
•Internal financing
•Marketing personnel
•Sales personnel
•Customer service
•Mentors, advisors
5 steps to our success
•Clinical trials
•Negotiation of reimburse- ment
•Manufacturing
•Licensing
•Marketing
•Sales/Leasing
•Education
•TechSupport
•Blocking patents on OA imaging
•Ultrasound license
•R&D
•Clinical studies

31. Key Resources: IP
Team #16, I-Corps @ NIH, Chevy Chase, MD
Field
IP solution
Ice ball
IP
OA technology
Thermal monitoring
Ultrasound imaging
Cryoablation
Block- ing patent
Trade secrets
Blocking patent / licensing
Blocking patent / licensing
Partners
Partners
Service directly to urologists
Licensing
Open platform
Development
Electronics
Soft- ware
Probes

32. Original Revenue Models
Team #16, I-Corps @ NIH, Chevy Chase, MD
CMP
TWL
Urologist
Sale
Cash
Leasing
Cash
Reimbursement
Licensing
TWL – TomoWave Labs
CMP – Cryoablation Manufacturer & Provider
Sales
Leasing
CMP
TWL
Urologist
Licensing
License Fee
Leasing
Cash
Reimbursement
Leasing
Cash
CMP
TWL
Urologist
Leasing
Cash
Reimbursement

33. Cryoablation of prostate cancer: Cash flow
Team #16, I-Corps @ NIH, Chevy Chase, MD
Clinical
Technology
Ultrasound OEM
Patient
Cryoablation manufacturer- provider
OAT OEM (TWL)
Private Insurance
Urologist
Product/Service
Payment
Medicare
Outpatient facility
Cancer treatment
& post-treatment activities
$1k, annual payments
Self-payment per procedure
Self-payment per procedure
$786 per procedure
$800-1k per procedure
Federal tax
$5.5k per procedure
Lease equipment, sell consumables

34. Market Size
Team #16, I-Corps @ NIH, Chevy Chase, MD
$60,000 – estimated price/unit of the technology Source: Estimate is based on direct costs + 100% margin. $17k – 805 nm Q-switched OEM laser, $7k proprietary modified OEM ultrasound, $6k – proprietary OAUS probe, $0k – proprietary software. Total Available Market: Total number of urological hospitals in U.S – 2,000 (1,570 ranked by U.S. News) Source: http://health.usnews.com/best-hospitals/rankings/urology 1 unit per hospital – 2,000 units $120 million Served Available Market: Current share of cryoablation in prostate cancer ~ 1% Dominating revenue model (>90%) – mobile service Need 50% less units – 1,000 units $60 million Target Market: Bipolar U.S. market of cryoablation providers: HealthTronics www.healthtronics.com 50% market – 200 units GalilMedical www.galilmedical.com 50% market – 200 units Total number of in-field units – 400, Market growth – 600 units $36 million

35. Finance and operation timeline
Team #16, I-Corps @ NIH, Chevy Chase, MD
OEM to CMP 2 (300 units)
R&D,
Preclin. studies
R&D, Clinical studies
(30 patients, 3 units), GMP
Exclusive OEM to CMP 1 (20 units)
Spending
Profit
Time
OEM to CMP 1 (300 units)
6 months
24 months
42 months
Co-development with CMP 1
18 months
$200k
$1M
20 x $30k = $600k
600 x $30k = $18M

36. Evolution of Business Model Canvas
Team #16, I-Corps @ NIH, Chevy Chase, MD
R$: Now only direct sales revenue stream remains CS: Direct sales to one of two major cryoablation manufacturers and providers C: Direct sales via OEM or acquisition KA: Quality control will be required for in-house assembly of OAT units and probes. KA: Requirements for clinical studies were updated to reflect time frame, available funds, and planned business development

37. Key Activities and Resources/Partners
Team #16, I-Corps @ NIH, Chevy Chase, MD
Partner
Activity
Resource
•Clinical trials
•Negotiation of reimbursement
•Manufacturing
•Licensing
•Marketing
•Sales/Leasing
•Education
•TechSupport
•Patents on OA imaging
•Ultrasound license
•R&D
•Clinical studies
Cryoablation provider
Clinicians
Ultrasound machine producer
•R&D personnel
•R&D facility, equipment
•Consultants
•Marketing personnel
•Sales personnel
•Investment
•SBIR/SBA
•Assembly facility
•Laser, electronics and parts
Trade secrets, patents, licenses
•Engineers, technicians
•Quality control
Customer service