implantable drug infusion pumps

with remote physician control

for at home care

“the right dose at the right time and place”

1

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 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)

2

3

Implantable pump markets

Implantable Pumps

~ 250k in use WW

• Hardware kit:

• Refill kits

• Software add-on services• Remote control software • Electronic record service

Product offering

4

+ +Pump Catheter + tools

(OEM)External

controller

Payment flows

5

Fluid Synchrony

Pay for coverage

Hospital reimbursement

Product purchase

Service provided

6

Pricing for Outpatient Facilities(2011 Medicare Reimbursement)

PumpBundled KitSupportEHR

Patient UsePump(Replace/Revise)

Refill events

LTV

$13,305 $13,305 $2,887 $450 $400 $50 ??? ???

20 yrs 20 yrs 2 pump 2 pump 150 150

$47,265

Existing CPTFull Cost Fluid Synchrony

New CPT (30% Premium)Full Cost Fluid Synchrony

$17,297 $17,297

$59,240

New CPT application cost

$2-3MM; Approval not guaranteed~2-3 years review process (lost sales)

Income Statement ($MM)

0 0 0 0 0

0

8 (1.0)(1.5)(0.8) (0.2)

(3.5)

(3.5)

IncomePatientsPumpBundled kitSupportEHR

Subtotal:

ExpenseHead CountFDA/TrialsProduct R&DManufactureMarketing

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

30 (9.0) (2.0) (1.0) (0.5)

(12.5)

(12.5)

100 1.3

0.4

0.1 0.0

1.8

50 (1.5) (1.0) (1.5) (1.0)

(5.0)

(3.2)

100013.3

4.5

1.0 0.0

18.8

70 (1.0) (1.0) (2.0) (1.0)

(5.0)

13.8

Getting out

• Dr. Terry Sanger, Pediatric Movement Disorders, CHLA• Dr. Hung Tran, Pediatric Oncologist, CHLA• Dr. Leslie Saxon, Directon USC Body Computing

• Diana Ferman – Physician assistant, USC Neurology• Dr. George Tolomiczenko, Direct of health technologies

USC. • Dr. Shinyi Yi Wu, Healthcare operations, USC

• Dr. Mark Jamieson – Medical Device Regulatory strategist

• Dr. Justin Boland Co-founder Looxcie

Clinicians

Institutions/patients

Regulatory

Entrepreneurs

8

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

term access to intrathecal space (for several indications)• Same pump and procedures are applied to multiple indications (pain,

spasticity, cancer)• E-health record market is a highly fragmented market with high growth

(partnership opportunities)• ~ 30% failure rate in first year – infection (refill), catheter issues, huge

issues

Next Steps • Continue investigations into other indications• Figure out how to best integrate EHR• Pathway to IDE

9

10

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

11

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

12

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 regulationsDays13

14

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/)