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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
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
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
Week 1: Business Model Canvas 
Team #16, I-Corps @ NIH, Chevy Chase, MD 
Tech Features 
Collage of “Customers”
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
GooB ― first experience 
Team #16, I-Corps @ NIH, Chevy Chase, MD
GooB ― solution 
Well … just walk in to the hospital! 
Team #16, I-Corps @ NIH, Chevy Chase, MD
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
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
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
Reality 3: Customers need market growth! Partnership is unavoidable! 
Team #16, I-Corps @ NIH, Chevy Chase, MD 
Texas
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
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
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
Our Journey LaunchPad Business Model Canvas: Week 1 
Team #16, I-Corps @ NIH, Chevy Chase, MD
Our Journey LaunchPad Business Model Canvas: Week 3 
Team #16, I-Corps @ NIH, Chevy Chase, MD
Our Journey LaunchPad Business Model Canvas: Week 6 
Team #16, I-Corps @ NIH, Chevy Chase, MD
Our Journey LaunchPad Business Model Canvas: Week 8 
Team #16, I-Corps @ NIH, Chevy Chase, MD
Our Journey LaunchPad Business Model Canvas: Week 10 
Team #16, I-Corps @ NIH, Chevy Chase, MD
$ 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
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
APPENDIX 
Team #16, I-Corps @ NIH, Chevy Chase, MD
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
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
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
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
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
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
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
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
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
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
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
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
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 = $18M
Evolution of Business Model Canvas 
Team #16, I-Corps @ NIH, Chevy Chase, MD 
R$: 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
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

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Tomo Wavelabs I-Corps@NIH 121014

  • 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