implantable drug infusion pumps

with remote physician control

for chronic pain patients at home

“the right dose at the right time and place”

Christian Gutierrez (EL), Ellis Meng (PI), Carol Christopher (IM), Tuan Hoang (FE)

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)

Current Pumps

Channel Incentives

Hospitals

Pain Clinics

Private Hospitals, specialty clinics

HMO, ACO, Non-profit, University Hospitals

All Institutions

VP

High Value Therapies

Pharmacoeconomics

Dosing flexibility

Efficient patientmanagement

Demand Creation

Budget ~ $300 k/year

Regulatory Pathway (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

Take-aways • New VP: Simpler more reliable surgery (smaller size), volume, stable long

term access to intrathecal space (for several indications)• Mini-Pivot – Opportunity to target multiple indications. Doctors use

intrathecal pumps for multiple conditions (not just pain)• Some institutions specialize in high volume of implants

Next Steps • Talk to high-volume specialty centers• Evaluate steps to file IDE application• Investigate additional indications for intrathecal space• New addressable markets?

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)

Getting out

• Dr. Mark Kreiger, Pediatric Neurosurgeon, CHLA• Dr. Terry Sanger, Pediatric Movement Disorders, CHLA• Dr. Hung Tran, Pediatric Oncologist, CHLA• Dr. Steven Richeimer, Head of USC pain center

• Medtronic pump user – Pump user and creator of support forum

Clinicians

Institutions/patients

In motion • Dr. Mark Jamieson – Medical Device Regulatory

strategist• Dr. Jamie Henderson (Stanford, Spasticity)• Miller Children’s Hospital• Oakland Children’s Hospital (Oakland)

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

Patient Care Flow (Now)

Fluid Synchrony

Hospitals

(Anesthesiologists

Neurosurgeons)

Pain Clinic

(Anesthesiologists

Neurosurgeons)Scheduled follow-up

Patient Discharged

Surgery/Rx/

reprogramming

Trial period/ Home setting

Weeks/monthsKey factors: Reimbursement , state regulations

Pump + Controller

Support Services

Bundled Kits

Partners/

OEMS

Patient Care Flow (Proposed)

Fluid SynchronyElectronic

Health Records

Hospitals

(Anesthesiologists

Neurosurgeons)

Pain Clinic

(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

Key factors: Reimbursement , state regulationsDays