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)

Competitive Edge

2

Fluid SynchronyFluid Synchrony

Value PropositionsValue Propositions

3

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)

4

5

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

7

• 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

8

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

9

PartnerPartner

10

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

11

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

12

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

13

14

• Hardware kit:

• Refill kits

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

Product offering

15

+ +Pump Catheter + tools

(OEM)External

controller

16

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/)