Rvex Engr245 2021 Lessons Learned
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Rvex Engr245 2021 Lessons Learned
- 2. Ileana Pirozzi (L) DESIGNER/HACKER Max Denning (L) PICKER Ali Kight (L) HACKER/DESIGNER Davide Zanchi (L) HUSTLER Andre Esteva Mentor RVEX TEAM WEEK 1 WEEK 10 82 interviews Biomimetic Sleeve Platform Technology
- 3. 250,000 people in the United States are waiting for heart transplants, but fewer than 5000 of them will receive a donor heart.
- 4. 250,000 people in the United States are waiting for heart transplants, but fewer than 5000 of them will receive a donor heart. Left Ventricular Assist Devices (LVADs) could change their lives... … with the help of RVEX
- 5. The Left Ventricular Assist Device (LVAD) is an artificial pump implanted in the left ventricle to replace or support the function of a failing heart.
- 6. Right Heart Failure (RHF) occurs in 30-40% of LVAD implantations Extremely unpredictable High mortality and morbidity burden Inefficient, Invasive, High risk therapies
- 7. We created a novel technology, now what? RVEX MVP Benchtop set-up
- 8. BUSINESS MODEL CANVAS Key customers Manufacturers Physicians Providers Payors Preclinical/ Clinical Trials Regulatory Manufacturing Quality control Training Value: Minimize incidence of RHF post LVAD implantation Promote increased utilization of LVADs to support the 250k waiting patients Decrease cost for stakeholders by obviating need for reoperations MedTech Abbott Medtronic Edwards Thoratec Surgeons Product Research & Development ($100k) Manufacturing Costs ($100/unit) Price: Effect size * QALYs ($150k/QALY) ~ $5,000 per unit Direct Sales Hospitals IP Expertise Testing Facilities Manufacturing FDA/Regulatory 4 B2B: Clinical development, licensing, regulatory 5 6 7 8 9 B2B: Device manufacturers B2C: Clinicians 3 Manufacturing Carbon 3D FluidForm 3D B2C: Training, sales Beneficiaries Primary beneficiary is the patient. Extended beneficiary are the families and caregivers Licensing/M&A MedTech Giant Organizations key partners key activities cost structures key resources value proposition 1 customer relationships customer segments channels revenue streams 2 Value/Clinical Strategy: Promote increased utilization of LVADs to support the 250k waiting patients Activities: What are our regulatory, reimbursement, strategies?
- 9. Is the LVAD market big enough for this product to be financially viable as a venture? W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 Efficacy in LVAD patient population Size of LVAD- adjunct markets
- 10. Initial Hypothesis: our technology, alongside existing trends, will enable expansion of the LVAD market Reduce adverse events Increase adoption Expand market RVEX as LVAD - Adjunct W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
- 11. Critical Insight: LVAD adoption and market are not guaranteed to expand with technological innovation The limiting reagent for LVAD utilization is the cardiologist - they are not referring patients because there is a lack of education around the technology. W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 “
- 12. Pivotal Insight: Our technology can be useful beyond LVADs Why focus solely on LVADs? You have a technology that can help and doesn’t hurt - it can be adopted and used as a “safety net” to help the right ventricle after many other procedures W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 “
- 13. Critical Pivot: RVEX as a platform technology W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 5000 500,000
- 14. Updated Clinical Strategy: Going after Right Heart Failure, one beat at a time Phase 1: “Foot in the door” Right-Heart Failure Device Strategy: LVAD-adjunct ❏ Smaller patient population ❏ Severely ill patients 2021 - 2023 2022 - 2027 Phase 2: Product Expansion Right-Heart Failure Device Strategy: Procedure-adjunct ❏ Larger patient population ❏ Moderately ill patients W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
- 15. Funding: RVEX secures non-dilutive funding from Coulter Foundation!!! Medical Device Translational Grant Supports collection of pre-clinical data W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
- 16. R&D: RVEX preclinical safety studies in small animals demonstrate fast, safe implantation W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
- 17. Partnerships: Additive manufacturing leader to support product development W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
- 18. MedTech Activities: key learnings from regulatory and reimbursement Regulatory Class III device (PMA pathway) Our technology qualifies for FDA Breakthrough designation Outlined clinical endpoints and effect size W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 Reimbursement Qualified for existing DRG codes Breakthrough designation provides 4 years of automatic CMS coverage
- 19. The Future: Incubate Technology at Stanford W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 Potential new partners / funding sources Existing partners / funding sources Research & Development
- 20. Appendix
- 21. FDA Key customers Hospitals Surgeons (VAD) Medical device companies Experimental data Reimbursement Regulatory / FDA Manufacturing Quality control IP Strategy Education Value: Reduce complications post cardiac surgery “Foot in the door” LVAD - adjunct Value: MedTech Abbott Medtronic Product Research & Development ($100k) Manufacturing Costs ($100/unit) Price: Effect size * QALYs ($150k/QALY) ~ $20,000 per unit Reimbursement calculations Direct Sales Hospitals Indirect Sales Distributors IP Expertise Testing Facilities Manufacturing MedTech Incubators Stanford OTL 5 6 7 8 9 B2B: Device manufacturers B2C: Clinicians 3 BUSINESS MODEL CANVAS Manufacturin g Carbon 3D FluidForm 3D Surgeons Beneficiaries Primary beneficiary is the patient. Extended beneficiary are the families and caregivers Licensing/M&A MedTech Giant Organizations key partners key activities cost structures key resources value proposition 1 customer relationships customer segments channels revenue streams 2 Advocates Surgeons Cardiologists 4 Regulatory FDA/EMA Regulatory consultants Insurance companies
- 22. Fundraising & Clinical Development Plan Q1 Q2 Q3 Q4 2021 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Cash reserves 5M 10 M 20M 30 M Seed $5M Series A $15M Clinical Milestones Design Milestones Pre-submission meetings FDA $20 000 Proof of Concept Benchtop Testing Analyze Results Partnerships with manufacturer s Regulatory/ IP Milestones IDE Submission and Approval $150 000 Clinical Phase Ia (First-in-Humans, Pilot 1) $4M Clinical Phase Ib (Pilot 2) $10M Pre-Clinical Phase I & II $100,000 Iterative Design Refinemen t Device Refinement Human - ready device Pre-Seed (Non-dilutive) $300,000 Device Refinement $150 000 2025 Q1 Q2 Q3 Q4 Series B $60M Device Refinement Breakthrough Designation $50 000 CMS 4- year coverage Provisional IP filed Issued IP PMA Submission and Approval $300 000 Clinical Phase II (Pivotal) $48M Pre-submission meetings FDA $100 000
- 23. What’s our story? (Brainstorm slide) 1. From academia to patients is a black box 2. LLP → Black box uncovered 3. Initial hypothesis → LVAD Market will expand with technological innovation (trends analysis) a. Thus, LVAD market remains limited / doesn’t justify company formation 4. From device to platform a. Technological basis, KOL, clinical due diligence b. Input from KOLs, financial analysis c. Will address indications in the future d. First focus on a narrow population 5. Overview of regulatory / reimbursement / health economics learnings a. PMA w Breakthrough, DRG codes, CMS reimbursement, collect data for future adjustments to reimbursement, IP strategy (broad, encompassing of various indications, etc) 6. Next steps a. LVAD is still foot-in-the-door i. Inflection point is clinical data 1. Best way to get good clinical data is to pick the right initial population (enrichment strategy) - identify population you’re most likely to have good outcomes for a. Gated approach. If fails → fails quickly and saves money b. Benefit from being incubated in University environment until efficacy data in large animals i. Advice from incubators, investors, etc.