fluid synchrony lecture 8 resources
TRANSCRIPT
implantable drug infusion pumps
with remote physician control
for at home care
“the right dose at the right time and place”
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Christian Gutierrez (EL), Ellis Meng (PI), Carol Christopher (IM), Tuan Hoang (FE)
Value PropositionsValue Propositions
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Fluid SynchronyFluid Synchrony
Clinical Care-Easier surgery-Fewer complications-High value therapy
Patient Care-Personalized relief-Dosing flexibility-Easier recovery
Pharmacoeconomics-Reduce clinical visits/ Hospitalization-Outpatient/Home care
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
Chronic Pain v6 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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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
Income Statement (US Sales; $MM)
0 0 0 0 0
0
8 (1.0)(2.0)(0.8) (0.2)
(3.5)
(3.5)
IncomePatientsPumpBundled kitSupportEHR
Subtotal:
ExpenseHead CountFDA/TrialsProduct R&DManufacturingMarketing
Subtotal:
Net
0 0 0 0 0
0
20 (4.0) (2.0) (1.0) (0.5)
(7.5)
(7.5)
0 0 0 0 0
0
25 (9.0) (2.0) (1.5) (1.0)
(13.5)
(13.5)
1,250 16.6
2.5
3.8 0.0
21.0
40 (2.0) (3.0) (6.0) (2.0)
(13.0)
8.0
12,500166.3
25.0
74.3
0.0
265.6
60 (12.0) (8.0)
(65.0) (9.0)
(94.0)
171.6
Key Financial Assumptions
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• Over 250 pumps total WW today, 40K implanted/yr in US; (60K pumps/yr implanted in US by 2021
• 2% market penetration by first sale (yr 6)• 20% by yr10 (including off-label use) (Entry into EU markets)
• Marketing performed during Clinical trials Phase 2 & 3, so customers aware After PMA approval sales can ramp quickly
Patients
Product flow/Channel
Fluid SynchronyElectronic
Health Records
Partners/
OEMS
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
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Patients
Product flow/Channel
Fluid SynchronyElectronic
Health Records
Partners/
OEMS
Hospitals
(Anesthesiologists
Neurosurgeons)
Pain Clinic
(Anesthesiologists
Neurosurgeons)
Pump + Controller
Support Services
Bundled Kits
Electronic Records
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PartnerPartner
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Why partner on Surgical Kits?
• OEM partners provide complete kits to doctors• Products are complementary and additional revenue stream.• Risks:
• Lack of oversight over functional components to pump therapy ie. catheters and tunnelers.• Exclusive partnership possible here
Why partner with EHR providers?
Multiple platforms exist with same goal – easier integration of medical records and data from 3rd party devices.
• Platforms looking for greater interoperability (software)• Compatibility with newest high value therapies is attractive• Risks:
• Negotiations over access to data• Dependency on success of partner in fragmented market• Would not want exclusive agreement here
OEM Partners
OEM Partners
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OEM Hardware Suppliers:
Micropump and patient controller – FludSynchrony
Bundled Surgical and Refill Kits• Medtronic, • Codman (J&J)• Abbot• other smaller manufacturers
OEM Software
Subset of systems that support remote patient monitoring.Some are for specific sectors ex cardiac, or multiparameter.
• Siemens Medical• GE HealthCare• Abbott• MedApps (recent 501k approval)• St. Jude• Medtronic
Getting out
• Dr. Prodip Bose/Floyd Thompson, TBI/spasticity experts, U Florida/VA
• Dr. Michael Leong, Anesthesiologist, Stanford
• Dr. Paul Wacnik, Researcher, Medtronic• Multiple managers, Charles River• Wireless telemetry (Hardware/software)
– Philips– Millar– Ripple– Noldus
• Dr. Sarah Richardson-Burns, Co-founder Biotectix & Director R&D
Clinicians
Partners
Entrepreneurs
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Take-aways • Current pumps do not meet needs of spasticity – intermittent dosing is
needed as reported in recent research/clinical data• Intrathecal baclofen for spasticity requires accuracy and tight dose
titration• Many conditions may lead to spasticity; many patients • Fragmented e-health market will require careful partner selection
Next Steps • Continue to talk to and follow up with potential partners• Figure out how to best integrate EHR• Evaluate IDE process
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• Hardware kit:
• Refill kits
• Software add-on services• Remote control software • Electronic record service
Product offering
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+ +Pump Catheter + tools
(OEM)External
controller
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Intrathecal catheter
Intrathecal pump
Catheter complication Patients affected (%)
Dislodgement/migration 6.1
Fracture/break 5.1
Kink/occlusion 4.0Cut/puncture 3.0
Disconnected from pump 0.7Leak 0.4
Disconnect 0.3
Misplacement 0.3
Unknown 0.1
Tip fibrosis 0.1
Distal segment in cerebrospinal fluid
0.1
Table 2Catheter complications from three Meditronic sponsored clinical studies (http://www.medtronic.com/)
Complications from 3 Medtronic clinical trials(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2080496/)