Thera soundtechnologies lessonslearned-final


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Thera soundtechnologies lessonslearned-final

  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
  13. Week 1
  14. Week 3
  15. Week 5
  16. Week 6
  17. Week 8
  18. Week 10