Profusa’s non-dilutive funding journey - FreeMind Group · Training optimization Fatigue...
Transcript of Profusa’s non-dilutive funding journey - FreeMind Group · Training optimization Fatigue...
PROFUSA’S NON-DILUTIVE FUNDING JOURNEYTISSUE-INTEGRATING SENSORS
Founder & CTO
Jan 2018
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
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2
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6
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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
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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
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Re
lativ
e O
2
Tumor Metabolism
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Gut Microbiome O2
Stroke/TBI ResearchFlaps/Reconstruction
`
Re
lative
O
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Hypoxia in PigsPasted Series Pasted Series
11/26/2013
10:30 11:00 11:30
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0.5
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Re
lative
se
nso
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gn
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Critical Limb Ischemia
Oxyg
en
(u
M)
0.5
0.7
0.9
1.1
1.3
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1
Montero-Baker, et al. 2015. J Vasc Surg
Wisniewski, et al. 2017. Adv Exp Med Biol
PROFUSA OVERVIEW
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• 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
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• 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
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)
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
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)
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
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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
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-16
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nso
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esp
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se
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MULTIPLE CHEMISTRIES DEVELOPED/DEMONSTRATED
– FROM SENSOR TO PANELS
CONFIDENTIAL
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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
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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
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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…
+