profusa’s non-dilutive funding journey - freemind group · training optimization fatigue...

PROFUSA’S NON-DILUTIVE FUNDING JOURNEYTISSUE-INTEGRATING SENSORS

[email protected]

Founder & CTO

Jan 2018

mailto:[email protected]

PROFUSA’S MISSION

IS TO MAKE

OUR BODY’S CHEMISTRY

EASILY ACCESSIBLE

TO IMPROVE HEALTH AND WELLNESS

FOR ALL

2CONFIDENTIAL

3

• Micro hydrogel sensor – 500

micron diameter; 5 mm length

• Soft, flexible, tissue-like

properties

• Fluorescence sensing chemistry

• Hypodermic needle placement

• Non-invasive optical signal

• Clinical-grade data

• > 4 year longevity in humans

INTRODUCING THE PROFUSA SENSOR

Mul -analytesensor1. Glucose2. Oxygen

3. Lactate4. Pyurvate

5. Crea ninte6. Urea7. pH

1

2

34

5

6

7

ReferencepeakMulti-analyte Sensor1) O2

2) glucose

3) lactate

4) potassium

5) sodium

6) chloride

7) calcium

8) pH

9) CO2/bicarbonate

10) urea

11) creatinine

WIRELESS PATCH READER TO PHONE TO CLOUD

WirelessBLE

Analyltics

Decision

making to

improve

outcomes

EXAMPLE - EXERCISE PHYSIOLOGY APPLICATIONSHEALTHY VOLUNTEER 004 EXERCISE – SQ TRICEP SENSOR – RAW DATA

6

Right Upper Arm_WL1 Lifetime (usec) Global Comments

16 16:10 16:20 16:30

Hours

140

160

180

200

ReversePush-up

Relax Relax Relax Relax Relax Relax

Time

Lifetime

Right Upper Arm_WL1 Lifetime (usec) Global Comments

16 16:10 16:20 16:30

Hours

140

160

180

200

Holding body up Holding body up Holding body upKickback

Holding body upKickback

EXAMPLE APPLICATIONS

Sensor 2 (Avg Rad) Sensor 3 (Avg Rad)

6/24/2013

14:30 15:00 15:30

0

0.5

1

Re

lativ

e O

2

Tumor Metabolism

7

Gut Microbiome O2

Stroke/TBI ResearchFlaps/Reconstruction

`

Re

lative

O

2

Hypoxia in PigsPasted Series Pasted Series

11/26/2013

10:30 11:00 11:30

0

0.5

1

0

0.2

0.4

0.6

0.8

Re

lative

se

nso

r si

gn

al

Critical Limb Ischemia

Oxyg

en

(u

M)

0.5

0.7

0.9

1.1

1.3

3 2

1

Montero-Baker, et al. 2015. J Vasc Surg

Wisniewski, et al. 2017. Adv Exp Med Biol

PROFUSA OVERVIEW

8

• Background:

• Incorporated 2009 in Silicon Valley

• Multiple academic partners

• Milestones:

• First funded by DARPA (2011)

• 4 year human biosensor performance (landmark!)

• CE Mark in Europe; currently going thru FDA

• Multi-analyte sensors (O2, glucose, lactate, pH, alcohol, etc.)

• 1000s tested in animals and 100s in humans with NO SAFETY ISSUES

• Funding:

• DARPA and NIH grants ($29M)

• Investor backed ($21M)

INNOVATIONS: Tissue-integrating sensors, fluorescent dye chemistry, skin optics,

wearable electronics, digital health

PROFUSA SITES AND COLLABORATORS TODAY

9

• Synthetic chemistry

• Hydrogel development

• Optics instrumentation

• Clinical testing

• Quality and manufacturing

• All business functions

SF

Well utilized dye synthesis

hoods

6 lab bays

TX• Pre-clinical testing

• Oxidase sensor development

Chem lab space within animal facility

Dr. Mike Conte

• Critical limb ischemia clinical trials

Dr. Bruce Klitzman

• Physiology

• Long-term rat studies

Dr. Kevin Akers

• Pre-clinical test models

• Burn/smoke inhalation

• REBOA

• Skin grafts

Dr. Michael Daniele

• Flexible electronics

• Conformal optics

Dr. Klearchos Papas

• Immuno-isolation devices

TOTAL PROFUSA GRANTS BREAKDOWN PER YEAR

$0

$5,000,000

$10,000,000

$15,000,000

$20,000,000

$25,000,000

$30,000,000

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

BaseWashington Research Foundation ($50k)UW Commercialization Award ($42k)DARPA Seedling ($735k)NIH SBIR ($127k)NIH SBIR AP ($1M)NIH SBIR AP (Admin Suppl) ($70k)DARPA STTR ($100k)DARPA Subcontract ($782k)TRA R01 ($4.3M)TRA R01 (Admin Suppl) ($550k)NIH Phase I SBIR ($225k)NIH Phase I SBIR (Admin Suppl) ($27k)Dasman Grant ($144k)NIH STTR Fast Track ($2.3M)NIH SBIR Fast Track ($1.7M)DARPA BAA ($7.5M)STAB P2 ($1.5M)PAD STTR P2 ($1.7M)D2P2 w/ NC State ($1.5M)Beta Cell ($225k)DiaComp ($20k?)DARPA LOX base ($2.5M)DARPA LOX option ($2.6M)

FREEMIND ENGAGEMENT HELPED DRIVE SUCCESS

$0

$5,000,000

$10,000,000

$15,000,000

$20,000,000

$25,000,000

$30,000,000

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018


Short strategic

assessment

Fully engaged

INVESTOR MONEY STARTED FLOWING AFTER GRANTS ARE AWARDED

$0

$5,000,000

$10,000,000

$15,000,000

$20,000,000

$25,000,000

$30,000,000

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018


Angels

A-round

B-round

LESSONS LEARNED ON OUR GRANTS JOURNEY

1. Persistence/Patience

2. Learn from mistakes (or misconceptions)

3. Align yourself with those who will make you successful

4. Tell a story

5. Make your story “marketable”

LESSONS LEARNED – PART 2

6. Build an internal grants management function

7. Be strategic about when and where you apply for grants

8. Quantity AND quality (with NIH)

9. Balance IP and publishing to build successful pipeline

10. Deliver, Deliver, DELIVER! to keep success going

WHAT HAS/IS CHANGING AS PROFUSA GROWS?

1. Budgeted small %s of many FTEs

2. Will try for any grant

3. Use grants to get scientific work done

4. Balancing act of writing grants and

investor pitches

5. Hire outside consultants for accounting

1. Try to budgeted 100% FTEs

2. Focus on success areas/agencies

3. Use grants strategically

4. Balancing act of writing grants, managing grants and building a commercial organization

5. Take on most accounting ourselves with oversight from outside consultants

When we started Now

THANK YOU FROM THE PROFUSA TEAM

• NHLBI

• NIBIB

• NIDDK

• Common Fund

WITH SPECIAL THANKS TO:

ALWAYS HAVE A PIPELINE

Topic Amount Comments

PAD Clinical SBIR Fast Track with UCSF – O2 (NIH) $1.75 M Awarded 3/17/2016

Soldier Health Multi-analyte sensors BAA – lactate focus (DARPA) $7.5 M Awarded 6/27/2016

Diabetes Phase II Artificial Pancreas SBIR – BA Glucose Sensor (NIH) $1.5 M Awarded

Thin Film Wearable Electronics Phase II SBIR with NC State (NIH) $1.5 M Awarded 9/3/2016

B-Cell STTR for Immunoisolation with UA (NIH) $0.25 M Awarded 3/10/2017

Diabetic Foot – UA (DiaComp/NIDDK) $20k? Awarded 6/20/2017 – subaward still

being calculated

DARPA LOX $2.5M base

$2.7M option

Likely to be awarded

Glucose CRP (NIH) $1 M Submitted April 2017

Home Monitoring R01 (NIH) $3.5 M Submitted June 2017

Awarded – In

Progress

Awarded – to begin

soon

Submitted

17

PAD Soldier Health

(LACTATE)Home MonitoringDiabetes Wearables B-cell Culture

LATE

STAGE (in grant develop-ment)

EARLY

STAGE

CO2

Increase CO2Decrease CO2

Baseline Recovery-2.0

-4.0

-6.0

-8.0

-12

-16

-18 Se

nso

r R

esp

on

se

x108

MULTIPLE CHEMISTRIES DEVELOPED/DEMONSTRATED

– FROM SENSOR TO PANELS

CONFIDENTIAL

18

Oxygen

Lactate pH

Glucose

Alcohol

CO2

TECHNICAL HURDLE:

19CONFIDENTIAL

Solution: tissue-integrating sensors

Problem: How to get sensors to function in the body for years?

Nanosensors are

cleared from the

tissue or taken up by

cells if injected as

nanoparticles

Solid, hard, sensor

platforms are

encapsulated by collagen

and “walled-off” from

surrounding tissue and

function poorly

SQ

Tissue-Integrating Sensor

Flexible, tissue

integrating sensors

become part of the

tissue they are sensing

for long-term

monitoring.

SQ

Tissue-Integrating Sensor

20

Reader illuminates sensor1 Reader acquires signal Sensor phosphoresces

HOW DOES IT WORK? – ENGINEERED NIR PHOSPHORESCENCE

2 3

CONFIDENTIAL

CO2

Increase

CO2 Decrease CO2

Baseline Recovery

-2.0

-4.0

-6.0

-8.0

-12

-16

-18 Sen

sor

Re

spo

nse

x108

MULTI-ANALYTE PANELS EXPAND APPLICATIONS – PROOF OF CONCEPT

21

Oxygen Lactate

pHGlucose

Alcohol CO2

CONFIDENTIAL

Menu of analytes to create

multi-plexed panels

Metabolism Training optimization Fatigue detection Trauma and sepsis

Blood Gases COPD Surgical trauma ICU monitoring

Training optimization

Dehydration Renal Disease Hydratation

monitoring CHF Training optimization

+

New

chemistries…1) potassium

2) sodium

3) chloride

4) calcium

5) urea

6) creatinine

7) others…

+

profusa’s non-dilutive funding journey - freemind group · training optimization fatigue...

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