1. Tx
Therasound
Technologies
Catheter-based Therapeutic Ultrasound for Minimally Invasive BPH Treatments
Costs: 4 Billion/yr; Surgeries: 250,000/yr
*
BPH
Target ID
Bladder
Prostate
BPH
Deployment
Precise TX
Post TX
Lessons Learned Presentation – Dec. 10, 2013
Lean Launch Pad for Life Sciences
Interviews: 70
* TTRG, Rad. Onc, UCSF & Radiology, Stanford

2. Team Therasound
Anupam Agarwal, MD, MPH
•
•
Therapeutic Area Director, Cardiovascular &
Respiratory at Gilead Sciences
Expertise: Regulatory and Safety Analysis
Shilpi Mahajan, PhD, CAPM
•
•
Post Doctoral Scholar at University of California,
San Francisco working on GPCRs
Expertise: Cancer Biology
Vasant A. Salgaonkar, PhD
•
•
Specialist, Radiation Oncology, University of
California, San Francisco
Expertise: Medical device development

3. Business Model Canvas
Week 1
Week 10
• Canvas evolved through customer and mentor interactions, research
• Key lessons learned about
– Value proposition
– Partnership interactions
– Revenue and market potential

4. Evolution of Value Proposition
What We Thought
Compared
with
current
BPH
therapies, our device may reduce:
1. Procedural complications
2. Procedure time
3. Cost
4. Length of hospital stay
Our device may increase patients’
accessibility to BPH therapies and may
be cost-effective due to the above
factors.
Address limitations of
Gold Standard (TURP)
What We Learned
TURP, bleeding
complications are rare.”
“... existing
“... most patients have to
stay
overnight.”
“GreenLight
laser has
definitely made TURP
for patients.”
safer

5. Adapting VP through Customer Discovery
Limitations: Gold Standard
“Both TURP and laser
office
not
based.”
“cannot accommodate more
patients”
Value Propositions
An outpatient or in-office BPH surgical
treatment with clinical outcomes
comparable to in-patient procedures,
without a need for general anesthesia.
Competing Tech.
“Patients ask for minimally
invasive procedure…
Reimbursement
“Complete
not
possible
is
better.”
ablation ...
with TUMT.”
Customers
• Outpatient urology clinics
• Medicare/CMS
• Patients

6. Identifying Partnerships
What We Thought
1. Key
partners:
Urologists
specializing in prostrate surgery
2. Key suppliers: Transurethral
ultrasound device manufacturer
3. Key resources acquiring from
the partners: Knowledge of
competing BPH therapies as a
source of market research.
Additionally, access to clinical
proliferation
of
our
device/procedure.
4. Key activity the partners
perform: Clinical use of the
device.
Limited to
R&D, Sales
What We Learned
“...
only
urologists
who are not
interested in doing
research but are also willing
to
speak
about your products.”
“SBIR get 100K for the first
and then 1.5M for second phase.”
“... hire
FDA consultant.”

7. Partnership Flows
UCSF
KOLs & PIs
Key Partners
QB3
Funding
agencies
Clinical
trial : $6M
TheraSound
• UCSF – IP license and R&D
support
• Urologists – KOLs and PIs for
trials, and product champions
510K : $20 K
$200/catheter
Regulatory
consultants
FDA
Suppliers
• Vendors supplying key
materials
• Regulatory consultants

8. Determining Revenue Streams
What We Thought
What We Learned
“… companies charge, but I would
assume it would be more in the range
of
Revenue Streams
Sale of capital equipment ($15000/item) ,
disposable treatment catheters ($500/item) to
urologists/ surgeons.
$1,000 to $2,500.”
“... Generator sale price is
$4,999 and Scope sale price is
$2,500.
Kits per order as follows: 1-5 $1300, 6-12 - $1150, 13+ - $1050”
Revenue Streams
Sale of capital equipment ($5000/item) ,
Manufacturing, R&D
cost based pricing
disposable treatment catheters ($1500/item)
to urologists/ surgeons.

9. Market Opportunity
What We Learned
What We Thought
“…250,000 surgeries/year.
Only 2% patients”
“Medication taken in a
Based on patient reimbursement,
but not necessarily revenue
Viable but Crowded Market
Annual
Market
Estimate
Minimally
Invasive
surgeries
Medical
management
market
Revenue ($M)
265
2650
“Capture
20%
chronic
manner.”
medical management patients”

10. Investment Readiness Level
Plausible exit
IRL 5
Cash to 1st inflection point
Unit economics Validated
Reimbursement/other revenue
Feasibility of targeted prostate treatment
demonstrated in animal studies [MVP]
Our solution is very different and less
complex than rectal HIFU
“Predicates” for soft tissue coagulation
Next Steps
Milestone
Regulatory path certainty & difficulty
IP freedom to operate, ability to block
Attractive solution & ID of MVP
Compelling clinical need + large mkt
Effective team
Timeline
Funding
Product Dev.
for clinical
integration
6–8
months
200 – 300 K
Animal study,
IRB approval,
510K
submission
12 – 15
months
200 – 300 K
First-inhuman trials
(n=15)
6-8
months
1.5 M

11. Acknowledgements
• Teaching team
– Allan May, George Taylor, Dan Manian
• Mentor
– John Ryan
• Domain experts, customers
• LLP Peers

12. APPENDIX

13. Week 1

14. Week 3

15. Week 5

16. Week 6

17. Week 8

18. Week 10