thera soundtechnologies lessonslearned-final
TRANSCRIPT
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TherasoundTechnologiesTx
Bladder ProstateBPH
Target ID Deployment
BPH
Precise TX Post TX
Costs: 4 Billion/yr; Surgeries: 250,000/yr
*
* TTRG, Rad. Onc, UCSF & Radiology, Stanford
Lessons Learned Presentation – Dec. 10, 2013
Lean Launch Pad for Life Sciences
Interviews: 70
Catheter-based Therapeutic Ultrasound for Minimally Invasive BPH Treatments
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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
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Business Model Canvas
• Canvas evolved through customer and mentor interactions, research
• Key lessons learned about
– Value proposition
– Partnership interactions
– Revenue and market potential
Week 1 Week 10
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Evolution of Value Proposition
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.
What We Thought
“... existing TURP, bleeding complications are rare.”
“... most patients have to
stay overnight.”
“GreenLight laser has
definitely made TURP safer for patients.”
What We Learned
Address limitations of
Gold Standard (TURP)
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Adapting VP through Customer Discovery
“Both TURP and laser not office based.”
“Patients ask for minimally invasive procedure…
Reimbursement is better.”
“cannot accommodate more patients”
“Complete ablation ...
not possible with TUMT.”
• Outpatient urology clinics
• Medicare/CMS
• Patients
An outpatient or in-office BPH surgical
treatment with clinical outcomes
comparable to in-patient procedures,
without a need for general anesthesia.
Value Propositions Customers
Limitations: Gold Standard Competing Tech.
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Identifying Partnerships
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.
What We Thought
“... hire FDA consultant.”
“SBIR get 100K for the firstand then 1.5M for second phase.”
“... urologists who are not
only interested in doing
research but are also willing
to speak about your products.”
What We Learned
Limited to
R&D, Sales
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Partnership Flows
TheraSound
UCSF KOLs & PIs
SuppliersRegulatory
consultants
FDA
Funding
agencies
$200/catheter
Clinical
trial : $6M
510K : $20 K
• UCSF – IP license and R&D
support
• Urologists – KOLs and PIs for
trials, and product champions
• Vendors supplying key
materials
• Regulatory consultants
Key PartnersQB3
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Determining Revenue Streams
Sale of capital equipment ($5000/item) ,
disposable treatment catheters ($1500/item)
to urologists/ surgeons.
Revenue Streams
Sale of capital equipment ($15000/item) ,
disposable treatment catheters ($500/item) to
urologists/ surgeons.
Revenue Streams
“… companies charge, but I would assume it would be more in the range
of $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+ - $1050”
What We Thought What We Learned
Manufacturing, R&D
cost based pricing
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Market Opportunity
What We Thought
Based on patient reimbursement,
but not necessarily revenue
What We Learned
“Medication taken in a chronic manner.”
“Capture 20% medical management patients”
Annual
Market
Estimate
Minimally
Invasive
surgeries
Medical
management
market
Revenue ($M) 265 2650
Viable but Crowded Market
“…250,000 surgeries/year. Only 2% patients”
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Investment Readiness Level
Reimbursement/other revenue
Effective team
Attractive solution & ID of MVP
Unit economics Validated
Cash to 1st inflection point
Plausible exit
Compelling clinical need + large mkt
IP freedom to operate, ability to block
Regulatory path certainty & difficulty
IRL 5 Milestone 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-in-
human trials
(n=15)
6 - 8
months
1.5 M
Next Steps
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
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Acknowledgements
• Teaching team
– Allan May, George Taylor, Dan Manian
• Mentor
– John Ryan
• Domain experts, customers
• LLP Peers
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APPENDIX
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Week 1
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Week 3
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Week 5
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Week 6
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Week 8
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Week 10