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 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

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)

Getting out

• Dr. Stan Louie, Drug Formulation Expert (USC Pharmacy)• Dr. Giovanni Cucchiaro, Anesthesiologist (CHLA)

• Dr. Diana Hull, Physician (Group Health in Washington state, formerly at Kaiser California)

• Thomas Hsu, Insurance Specialist (Network Medical Management; a California ICA)

• Two chronic pain patients – Pump user and creator of support forum– User of oral narcotics and patches

• Dr. Frances Richmond (Director Regulatory Science Program, USC)

• Richard Hull (formerly at company selling Lapband)

Clinicians

Institutions/patients

Regulatory

Entrepreneurs/Industry

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

Channels (Direct)

• Direct to institutions• Some formularies involved in purchase decisions• Some doctors make purchase decision directly

• Device company/Doctor relationship is key • Heavily influenced by :

• Clinical study results • Regulatory approval• Reimbursement

Hospitals

Pain Clinics

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

Regulatory considerations

PMA 510K

Trial size 100’s of patients 20-100

Costs Up to $100,000 per patient

$10-50 MM $1-10 MM

Time ~ 3-4 yrs + post approval follow-on

~ 2-3 yrs

• PMA approval with grouping of FDA approved drugs.• Clinical trials results used to obtain CMS (Medicare) approval• 510K restricts technology to predicate devices

• Can be more difficult to market against incumbents• European CE mark is easier to attain (safety and performance only)

Take-aways• Channel is direct in this existing market

• Channel for e-health is more complex and evolving• State-to-state regulations can impact incentives

• Can pose problems as electronic records systems vary across the country

Next Steps• Understand costs associated with reaching

doctors/institutions directly• Understand structure of e-health channel• Develop regulatory pathway (timelines and cost profile)

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

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