Vitruvian week 10 presentation
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This document summarizes research on preventing hernias. It includes: 1) A clinical trial of a tissue sealant product called MYOSEAL that showed it significantly reduced hernia rates in rats compared to saline or other treatments. 2) Interviews with surgeons, medical insurers, and a key opinion leader who said that with strong clinical data, most surgeons would adopt a hernia prevention method. However, some surgeons denied the extent of the hernia problem. 3) A business model canvas and timeline laying out the pre-clinical and clinical trial plans for MYOSEAL over 3 years with a total projected cost of $8.4 million. It identifies risks and options to de-
Vitruvian week 10 presentation
- 1. Vitruvian Preventing Hernias Before They Happen December 10, 2013 Mentor: Julie Cherrington Team: Cindy Chang, PhD Hobart W. Harris, MD, MPH David M. Young, MD Customer Interviews : 74
- 2. Preventing hernias before they happen.
- 3. Preventing hernias before they happen.
- 4. Preventing hernias before they happen.
- 6. Preventing hernias before they happen.
- 7. Preventing hernias before they happen. Hernia (%) 100 80 60 40 20 0 saline tissue sealant low dose MYOSEAL high dose MYOSEAL Treatment Group Pre-Clinical Data in Rats
- 9. Preventing hernias before they happen.
- 11. Interviews President of Paradigm Medical Consultants: Medical insurers do want to keep cost down but they have limited ability to force doctors to perform a treatment that prevents a hernia.
- 12. Interviews Quotes from Surgeons My patients don’t develop hernias after my operations. The 10% incidence quoted in the literature just means that another surgeon must have a 20% incidence. At the VA, I don’t think we understand the extent of the problem because the hernias occur outside the usual follow up period. Often my patients are seen and fixed by another surgeon. I don’t even know it.
- 14. Interviews Quote from Key Opinion Leader With strong clinical data, I think most surgeons would adopt hernia prevention. No one wants to be left behind on new and better treatments. After all, surgeons want to do the best for their patients.
- 20. Myoseal Finance & Operations Timeline Program Pre-clinical Formulation, toxicology & IND enabling studies 2014 1Q 2Q 2015 3Q 4Q 1Q 2Q 3Q 2016 4Q 1Q 2Q 3Q Prod. Optim. ($100,000) Applicator ($ 800,000) Toxicology ($ 500,000) Phase 1/2 study over 2.5 years ($ 4 M) Clinical Trials Human Resource $ 200,000 $ 300,000 $ 600,000 $ 600,000 G&A + IP $ 100,000 $ 200,000 $ 500,000 $ 500,000 Running Total $ 1.7 M $3M $ 5.7 M $ 8.4 M 4Q
- 22. De-risk the Technology Change to another indication with the same product Alter the product composition
- 24. Therapeutic Investment Readiness Level Plausible exit Cash to exit Unit economics Validated Reimbursement Regulatory Intellectual Property Attractive solution & ID of MVP Compelling clinical need + large mkt Effective team?
Editor's Notes
- #2: Our company is Vitruvian and we are developing a product to prevent incisional hernias. Introduce the whole team…
- #3: I am the Chief of General Surgery at UCSF, trained to operate in the abdomen. What people rarely know is that each time they have an abdominal surgery there is a good chance that the opening made during the operation will not heal completely, resulting in an area of weakness or a bulge…
- #4: Consequently, I spend hundreds of hours each year fixing incisional hernias.
- #5: The only thing worse for my patients undergoing surgery is the need for another surgery to correct this new problem.
- #6: And, I am constantly bombarded with new surgical techniques…and materials to repair this common problem. Then, several years ago I had an idea…
- #7: …for a simple and easy way to prevent these hernias before they form. In essence, the perfect solution was prevention.
- #8: At the beginning of the class, after 3 years of research and over 300 rats, I thought our compelling data would literally…
- #9: …pave the path to product development. In fact, for years I had carefully guarded the data fearing that…
- #10: …if any of the several companies in the hernia repair space learned of our idea it might get stolen. Getting out of the building has taught us that data alone, no matter how compelling, is insufficient to commercialize a product. Compelling data is great, but it must be paired with a compelling business team and development plan.
- #11: As a practicing plastic surgeon who has to help Hobart fix many of these patient, I felt that I knew the customer and it was me. Our team was confident that everyone recognized the size and importance of this problem. Yet, after conducting dozens of customer interviews
- #12: We interviewed hospital administrators, insurance companies and accountable care organizations. We discovered that no one really understood the extent of the problem
- #13: We interviewed our fellow surgeons and were surprised to discover how many did not recognize the extent of the problem.
- #14: …we discovered that no one really owns this problem, not even some surgeons.
- #15: But surgeons who have to fix these problems really did understand the problem and all embraced any prevention methods.
- #16: Initially we thought that companies would embrace the idea that prevention was a critical part of their business. But we found the majority were not interested in such a new market because the timeline for development was too long and too costly.
- #17: Through the Lean Launch Pad course we came to understand our unique position as a new rather than an established market.
- #18: But through more extensive interviews, we found key opinion leaders understood the problem we are addressing and embraced the idea.We also found companies witha longer time horizon of the market who are eagerto partner if some early stage data could be developed.
- #19: We knew we had the opportunity to enter a multi-billion dollar market. The total US market for patients undergoing abdominal surgery is estimated at $2.5 Billion. available market represents all patient who have abdominal surgery at risk for developing an incisional hernia. Define what these markets represent
- #20: Initially we were excited to “swing for the fences” on our very first at bat. However, dozens of interviews with various potential industry partners and consultants has tempered our enthusiasm and prompted a love for the pivot. We are trying to create value in a step wise fashion rather than swinging for the fences. WE want to create more value with less time and less capital.
- #21: We now have a far greater appreciation for the complexities inherent to product formulation, engineering an applicator, toxicology studies, pre-IND applications, and clinical trials, not to mention…
- #22: ...the time and expertise required to “hit a Grand Slam.”
- #24: Currently, we are exploring strategies to de-risk our product by using our technology to treat clinical problems with more immediate returns. We plan to build incremental value in our company while keeping our goals on the larger market of preventing incisional hernias.