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Fluid synchrony final NSF I-Corps Presentation

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  • Say the expertise Pump experts and inventors, domain expert
  • Microtechnology enables core advantages in cost, time and therapeutic efficacy
  • Opportunity to innovate in the EHR Future of medicine is in EHR no competitive products that are compatible with HER Is a great opportunity and we need to understand how to capitalize and offer the first an only HER enabled pump New CPT code $2-3MM; Approval not guaranteed ~2-3 years review process (lost sales)
  • What did we learn Is business viable? Pursue beyond class?

Transcript

  • 1. implantable drug infusion pumps with remote physician control We talked to >60 physicians, patients, entrepreneurs, potential OEM partners, and many others
  • 2. Ellis Meng Christian Gutierrez Tuan Hoang Carol Christopher (PI) (EL) (FE) (IM)
  • 3. Our Innovation Fluid Synchrony Targeting 11M Chronic Pain Patients
  • 4. Canvas Version 1 (10/10/11) Physician remote control Chronic pain patients Training Hospitals Unit sales Trade shows Neurosurgeon Oncologist Anesthesiologist Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Group Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs Marketing Costs FS Team
  • 5. Dr. Leong, Director of Stanford Pain Center “ Could save more than 25% on surgery time with a smaller pump” Dr. Kreiger, CHLA Anesthesiology “ We implant pumps for pain and spasticity” Dr. Tran, CHLA Pediatrics “ This could change quality of life for pediatric cancer patients who have been getting by with daily injections” What We Did: Get Out of the Building
    • Many more including:
      • Pain specialists
      • Pain center directors
      • Oncologists
      • Insurance administrator
      • Hospital decision makers
      • Patients
      • Regulatory specialists
  • 6. What We Found: Value Propositions Fluid Synchrony Clinical Care -Easier surgery - 1 incision (vs. 3) - >25% time saving -  complications (30% now) Patient Care -Personalized relief -Dosing flexibility -Easier recovery Pharmacoeconomics -Reduce clinical visits/ Hospitalization -Outpatient/Home care Access multiple markets
  • 7. Canvas Version 1 (10/10/11) Physician remote control Chronic pain patients Training Hospitals Unit sales Trade shows Neurosurgeon Oncologist Anesthesiologist Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Group Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs Marketing Costs FS Team Feature, not VP Broaden Broaden
  • 8. Implantable Pump Markets Implantable Pumps ~ 250k in use WW Spasticity 12 M pts WW 1 M pts US Liver Cancer 300K pts Experimental (PD, AD, neuromodulation) (Biologics/Biosimilars) Chronic Pain $12.6 B (11 M pts US) Only 2 major players Medtronic and J&J
  • 9. What We Found: Opportunity to Expand Product Offering + + Pump Catheter + tools (OEM) External controller
  • 10. Pump + Controller Support Services Bundled Kits Trail and error, multiple visits, can take months What We Found: Patient Care Flow Fluid Synchrony Hospitals (Anesthesiologists Neurosurgeons) Scheduled follow-up Patient Discharged Surgery/Rx/ reprogramming Trial period/ Home setting Partners/ OEMS
  • 11. Pump + Controller Support Services Bundled Kits Electronic Records Actionable feedback to doctors/institutions E-prescription / closing loop - Process shortened to days - Improves outcomes What We Found: Patient Care Flow Fluid Synchrony Electronic Health Records Hospitals (Anesthesiologists Neurosurgeons) Scheduled follow-up Patient Discharged Surgery/Rx/ reprogramming Trial period/ Home setting Partners/ OEMS
  • 12. Pay for coverage Hospital Reimbursement Product purchase Service provided CPT reimbursement Pump $13,305 Surgical Kit $2887 Refill Kit $200 What We Found: Value Chain Fluid Synchrony
  • 13. Regulatory Pathways (Class III) US IDE EU CE US HDE US PMA US HUD EU CE  3 pathways available; balance cost & speed $2-3MM 1-2YR $3-5MM 30 patients 1-2YR $15-22MM 150 patients 2-3YR $2MM 1YR $2-3MM <20 patients 1YR $5-8MM <60 patients 1-2YR $2MM 1YR $2-3MM <20 patients 1YR $6-9MM <60 patients 1-2YR $20-30MM 4-7YR $10-14MM 3-4YR $9-13MM 3-4YR
  • 14. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Groups Foundations OEMs Manufacturing Costs Product Dev Costs FDA/Clinical Trials FS Team Payors/ICA Marketing Costs
    • Personalized relief
    • Efficient patient management
    • Dosing flexibility
    • Simpler surgery
    High-value therapies Pharmacoeconomics pharmacoeconomics Support Trade secrets / know how Electronic records Electronic health record providers Bundled kits CMS (Medicare) Canvas (12/13/11) Chronic Pain v8
  • 15. What we’re doing next
    • Regulatory pathway is critical determinant
    • Preclinical and clinical plan
      • Investigator IDE
      • Scale up for production
      • Perform pivotal studies
    • Determine if EHR is viable revenue stream
    • Funding: ( SBIR , Translational Medicine grants)
  • 16. implantable drug infusion pumps with remote physician control “ the right dose at the right time and place ”
  • 17. EXTRA SLIDES
  • 18. Canvas (10/10/11) Physician remote control Chronic pain patients Training Hospitals Unit sales Trade shows Neurosurgeon Oncologist Anesthesiologist Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Group Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs Marketing Costs FS Team
  • 19. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Group Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs FDA/Clinical Trials Chronic Pain v2 FS Team Payors Marketing Costs Faster relief Efficient patient management Reduce length of hospital stays ? Canvas (10/12/11)
  • 20. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Groups Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs FDA/Clinical Trials Chronic Pain v3 FS Team Payors Marketing Costs Faster relief Efficient patient management and Dosing flexibility Access to high-value therapies and pharmacoeconomics Reduce length of hospital stays and pharmacoeconomics Support Proprietary knowledge Human Resources Canvas (10/18/11)
  • 21. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Groups Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs FDA/Clinical Trials Chronic Pain v4 FS Team Payors/ICA Marketing Costs Faster relief Efficient patient management and Dosing flexibility Access to high-value therapies and pharmacoeconomics pharmacoeconomics Support Proprietary knowledge Human Resources Electronic records Electronic health record providers Bundled kits CMS (Medicare) Canvas (10/25/11)
  • 22. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Groups Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs FDA/Clinical Trials Chronic Pain v5 FS Team Payors/ICA Marketing Costs Faster relief
    • Efficient patient management
    • Dosing flexibility
    • Reliable access to intrathecal space
    Access to high-value therapies and pharmacoeconomics pharmacoeconomics Support Proprietary knowledge Human Resources Electronic records Electronic health record providers Bundled kits CMS (Medicare) Canvas (11/01/11)
  • 23. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Groups Foundations OEMs Wireless Developers Manufacturing Costs Product Dev Costs FDA/Clinical Trials Chronic Pain v6 FS Team Payors/ICA Marketing Costs Faster relief
    • Efficient patient management
    • Dosing flexibility
    • Reliable access to intrathecal space
    Access to high-value therapies and pharmacoeconomics pharmacoeconomics Support Proprietary knowledge Human Resources Electronic records Electronic health record providers Bundled kits CMS (Medicare) Canvas (11/08/11)
  • 24. Patients Training Hospitals Unit sales Trade shows Clinicians Institutions Support Services Pain clinics Clinical data KOLs Formulary Acceptance FDA IP Advocacy Groups Foundations OEMs Manufacturing Costs Product Dev Costs FDA/Clinical Trials FS Team Payors/ICA Marketing Costs
    • Personalized relief
    • Comfort
    • Efficient patient management
    • Dosing flexibility
    • Simpler surgery (placement)
    Access to high-value therapies and pharmacoeconomics pharmacoeconomics Support Proprietary knowledge Human Resources Electronic records Electronic health record providers Bundled kits CMS (Medicare) Canvas (11/15/11) Chronic Pain v7
  • 25. Pump + Controller Support Services Bundled Kits Electronic Records Sourcing for Expanded Product Offering Patients Fluid Synchrony Electronic Health Records OEMS Hospitals (Anesthesiologists Neurosurgeons) Pain Clinic (Anesthesiologists Neurosurgeons)
  • 26. Sourcing for Expanded Product Offering Pump + Controller Support Services Bundled Kits Electronic Records Partner Partner Patients Fluid Synchrony Electronic Health Records OEMS Hospitals (Anesthesiologists Neurosurgeons) Pain Clinic (Anesthesiologists Neurosurgeons)