fluid synchrony final presentation
TRANSCRIPT
implantable drug infusion pumpswith remote physician control
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We talked to >60 physicians, patients, entrepreneurs, potential OEM partners, and many others
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Ellis Meng Christian Gutierrez Tuan Hoang Carol Christopher (PI) (EL) (FE) (IM)
Our Innovation
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Fluid SynchronyFluid Synchrony
Targeting 11M Chronic Pain Patients
Physician remote control
Chronic pain patients
Training
Hospitals
Unit sales
Trade shows
Neurosurgeon
Oncologist
Anesthesiologist
Support Services
Pain clinics
Clinical dataKOLsFormulary Acceptance
FDA
IP
Advocacy Group
Foundations
OEMs
Wireless Developers
Manufacturing Costs
Product Dev Costs
Marketing Costs
FS Team
Canvas Version 1 (10/10/11)
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Dr. Leong, Director of Stanford Pain Center“Could save more than 25% on surgery time with asmaller 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 patientswho have been getting by with daily injections”
What We Did: Get Out of the Building
Many more including:Pain specialistsPain center directorsOncologistsInsurance administratorHospital decision makersPatientsRegulatory specialists
What We Found: Value Propositions
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Fluid SynchronyFluid 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
Physician remote control
Chronic pain patients
Training
Hospitals
Unit sales
Trade shows
Neurosurgeon
Oncologist
Anesthesiologist
Support Services
Pain clinics
Clinical dataKOLsFormulary Acceptance
FDA
IP
Advocacy Group
Foundations
OEMs
Wireless Developers
Manufacturing Costs
Product Dev Costs
Marketing Costs
FS Team
Canvas Version 1 (10/10/11)
Feature,not VP
Broaden
Broaden
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Implantable Pump Markets
Implantable Pumps
~ 250k in use WW
Spasticity12 M pts WW1 M pts US
LiverCancer300K pts
Experimental (PD, AD, neuromodulation) (Biologics/Biosimilars)
Chronic Pain$12.6 B(11 M pts US)
Only 2 major players Medtronic and J&J
What We Found: Opportunity to Expand Product Offering
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+ +Pump Catheter + tools
(OEM)External
controller
Fluid Synchrony
Hospitals
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Scheduled follow-up
Patient Discharged
Surgery/Rx/
reprogramming
Trial period/ Home setting
Partners/
OEMS
Trail and error, multiple visits, can take months
What We Found: Patient Care Flow
Fluid SynchronyElectronic
Health Records
Hospitals
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
Scheduled follow-up
Patient Discharged
Surgery/Rx/
reprogramming
Trial period/ Home setting
Partners/
OEMS
Actionable feedbackto doctors/institutions
E-prescription / closing loop
- Process shortened to days - Improves outcomes
What We Found: Patient Care Flow
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Fluid Synchrony
Pay for coverage
Hospital Reimbursement
Product purchase
Service provided
CPT reimbursementPump $13,305Surgical Kit $2887Refill Kit $200
What We Found: Value Chain
Regulatory Pathways (Class III)
$2-3MM
1-2YR
$3-5MM
30 patients
1-2YR
US IDE
EU CE
$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
US HDE
US PMA
US HUD
EU CE
$20-30MM
4-7YR
$10-14MM
3-4YR
$9-13MM
3-4YR
3 pathways available; balance cost & speed
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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)
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Canvas (12/13/11)Chronic Pain v8
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)
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implantable drug infusion pumps
with remote physician control
“the right dose at the right time and place”
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EXTRA SLIDES
Physician remote control
Chronic pain patients
Training
Hospitals
Unit sales
Trade shows
Neurosurgeon
Oncologist
Anesthesiologist
Support Services
Pain clinics
Clinical dataKOLs Formulary Acceptance
FDA
IP
Advocacy Group
Foundations
OEMs
Wireless Developers
Manufacturing Costs
Product Dev Costs
Marketing Costs
FS Team
Canvas (10/10/11)
Patients
Training
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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)
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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 andpharmacoeconomics
Support
Proprietary knowledge
Human Resources
Canvas (10/18/11)
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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)
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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)
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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)
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Canvas (11/08/11)
PatientsTraining
Hospitals
Unit sales
Trade shows
Clinicians
Institutions
Support Services
Pain clinics
Clinical dataKOLs 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)
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Canvas (11/15/11)Chronic Pain v7
Patients
Fluid SynchronyElectronic
Health Records
OEMS
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
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Sourcing for Expanded Product Offering
Patients
Sourcing for Expanded Product Offering
Fluid SynchronyElectronic
Health Records
OEMS
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
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PartnerPartner