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

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

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

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)

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.

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

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

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

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”

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

Acknowledgements

• Teaching team

– Allan May, George Taylor, Dan Manian

• Mentor

– John Ryan

• Domain experts, customers

• LLP Peers

APPENDIX

Week 1

Week 3

Week 5

Week 6

Week 8

Week 10