Miniaturized, Multiplex, Point-of-Care Diagnostic Solutions - July 2018
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Miniaturized, Multiplex, Point-of-Care
Diagnostic Solutions
July 2018
Overview
Disruptive Point of Care (POC) diagnostic technology
positioned to replace central lab testing
Targeting the $5 Billion autoimmune disease Market
Strong IP position with 21 issued patents
Multiple prototypes completed and multiple sample tests
conducted
510(k) filing planned in two years
Currently seeking $2M for an integrated prototype,
preclinical studies
2
Management & Advisors
Management
William R. Rassman, M.D. – CEO
Holds dozens of patents in medical devices, surgical technologies, and other fields. Built multiple
business in medical, software and energy.
David Ralin – CTO
Multidisciplinary medical device and diagnostic assay developer. Built Maven’s technology to
date.
Advisors
Scott Mortimer, MBA - Business & Strategy Advisor
Principal with Mirsona Consulting. Scott has held positions in portfolio business strategy,
marketing and sales with Impax Labs, PDL BioPharma, MedImmune and Merck & Co.
Dmitry Karayev, M.D., M.D. F.A.C.P., F.A.C.R. - Medical Director
Center for Rheumatology Medical Group. Board certified Rheumatologist completed fellowship
in Rheumatology and residency in Internal Medicine from Cedars-Sinai Medical Center and
graduated medical school from Tufts University School of Medicine.
3
Diagnostic Opportunity
$54 billion global diagnostic
market
$3.8 billion global autoimmune
diagnostic market
US autoimmune assay panel
market: $633 million
Point of care market is already
27% of the laboratory market
and is growing at a rate of 9.3%
Ø Most current POC are simple strip
tests
Other significant market
opportunities: infectious disease,
veterinary ($3 billion), ex-US
Update #s
4
Current Diagnostic Needs
Autoimmune diagnosis is a cumbersome Current Paradigm
multi-step / multi-day testing - reporting
diagnosis – treatment cycle
Multiple rounds of office visits, blood tests Physician & Patient
= time Initiate Dx Request
Constantly waiting for results = anxiety
Weeks to Months and $100s to $1000s
Disease progression waiting for tests Central Lab Draws or
Office Draws Sample &
Sends to Central Lab,
Lack of sensitive and specific testing
equipment at Point of Care (POC). No d
f
financially feasible screening. Central Lab Processes
Sample; Results Sent
No multiplex POC solutions available for To MD
MD office / desktop
5
Current Autoimmune Testing Needs
Significant need for improved testing paradigm
enabling earlier, faster, lower cost and more
frequent diagnostic testing
Autoimmune Diseases represent a significant
medical and financial burden
Estimated 10-35 million under-diagnosed – not
tested
Autoimmune disease costs more than cancer care
These underdiagnosed Americans – need
monitoring which will produce multiple yearly tests
> 80 possible syndromes, > 90 specific auto-
antigen tests
Late diagnosis and treatment = acute syndromes =
decreased mobility, destruction of thyroid,
pancreas, myocardium, celiac function, kidneys,
stroke, cascade to other organ systems
RA, + Citations 6
Polaron Platform Stage of Development
Optical hardware and analytical software
algorithms optimized, 6+ generations of readers
Types Testing
Sensor and content sourcing industrialized Completed
DNA Yes
Validated with manual and flow assays: nucleic
acids, immunoassays, drug tests, cells RNA Yes
Proteins Yes
Pilot autoimmune assays show excellent
Cells Yes
sensitivity, specificity, radical time and cost
savings
POC final form factor design pending
Microfluidic immune assay cartridge will use
commercial off-the-shelf micro-fluidic cassettes
8
Maven LFIRE Proprietary Technology
Platform
“LFIRE" - Label Free Internal Reflection Ellipsometry
Real-Time Polarimetric Imaging
Proteins, DNA, etc. Live Cell Testing
9
Polaron Using LFIRE Diagnostic Technology
Maven’s sensor is a glass
surface that has a printed
microarray with spots of protein
molecules (antibodies or
antigens)
When a serum sample passes
over this sensor surface,
disease-specific antibodies
binds to disease specific
antigens.
Maven’s technology reads the
molecular thickness of the spots
before, during, and after binding
Because our technology can
read the microarray, it can read
the microarray for printing
defects before the tests are run
10
Protein Array Immunoassay Amplification Principle
Precipitate
Concept: Third Step “Amplify”
*
signal for greater sensitivity
Y Y
Y Add amplifying
* Y Y
substrate
Y
The substrate
Immobilized antigens in spots on the
precipitates at the
microarray surface already have
spot, amplifying the
patient’s specific Disease antibodies,
thickness by 100-
and confirming enzyme-labeled
fold.
Antibodies as well
12INOVA (Werfen) Pilot #1
Sm (lupus) Ag Only, 13 samples, IgG ELISA vs LFIRE Serum Screen
All 5 positive and 8 negatives agreed, ~proportional, semi-quantitative
6.5 (Amplified)
110
6.0 (Label-free)
5.5 ELISA Signal 100
LFIRE Signal 90
5.0
Phase Change (mRad)
4.5 80
Absorbance (OD)
4.0 70
3.5 60
3.0
50
2.5 LFIRE Control
Low Control
SM2 - 15 fold 40
2.0 ELISA
Dilution
30
1.5
1.0 20
0.5 10
0.0 0
RNP1
RNP2
SM2D
LowC
N1
N2
N3
N4
SM5
N5
N6
SM1
SM4
SM2
SM3
13
(Add references)INOVA (Werfen) Pilot #2
ENA-5 Clinical Utility Summary
Comparing Commercial ENA Profile 5 ELISAs and LFIRETM
Semi-Blind. Tested 30 patient samples and compared Maven’s LFIRE
results against a commercial ENA-5 ELISA IgG kit and Luminex
LFIRETM
Concordance > 99%
+ -
+ 26 1 Analytical Sensitivity 96%
ELISA
- 0 123
Analytical Specificity 100%
Economics:
ELISA: ~$375 kit and 3+ hours, no screen, 5 tests x 9 steps
LFIRE: ~$45 materials and 45 minutes, 15+ tests, 5 steps only
Expandable to a >80 test full AID panel for pennies/test
14INOVA Pilot #2
ENA-5 Comparison of Maven’s Lfire, Elisa and Luminex
SSB IgG
Cutoff
for
positive>
SNR ~675/nM Patient Serum ID Numbers
Note: SSB also had a surprising dynamic range. 15INOVA (Werfen) Pilot #2
ENA-5 Sm IgG, Serum 8171
IgM and IgG
React at
different rates
Real Time Microarray Assay
Maven ConfidentialInfectious Disease Model System
Flu Chip – QC – Label-Free View taken from drop of blood
Patient
Serum
IgG low control Total IgG
Meter
HARA
T0 before sample T5 “difference” after sample
Note: The array is made to fit within a 3.5mm footprint and is laid out in a way that is geometrically distinct.
The qc image of the array is on the left, an example of response to serum on the right. The sample’s serum
metering spots are quite active while it appears there is some human anti-rabbit IgG antibody present.
Microfluidics can perform such a test on 50 nl of serum (there are 50,000 nl in a drop of blood) 17Clinical Needs vs Technologies
Maven is Multiplexing
Sensitivity Multiplexing
Electrochemiluminescenc
e (MSD)
ELISA
Luminex
Genalyte
Maven LFIRE POC
Classic Biochem
0 100 200 300 400 500
1.E+00 1.E-06 1.E-12 1.E-18
g/mL of plasma tests per sample
18Diagnostics: Biomarkers
Interleukin 6
Workflow matches traditional ELISA for simple adoption, ease of use.
Maven LFIRE Standard ELISA
Print Slides Coat Plates
Blocking Blocking
Analyte Analyte
VS
Detection Antibody Detection Antibody
Streptavidin-HRP Streptavidin-HRP
DAB Substrate TMB Substrate
Time Resolved Analysis End Point Analysis
19Polaron Positioning & Differentiation
The LFIRE system is the first and only desktop testing system to help
diagnose and manage critical autoimmune disorders in minutes
Flexible and simple system for MD or office staff to operate at low cost
and high accuracy
While other systems require multiple chips or changing chips between
tests, only Maven’s single chip reader enables low-cost and accurate
reading of up to 220 tests with a single chip
Maven (Polaron) Genalyte Athelas Orphidia
(Maverick)
POC Site √ X √ √
Low Cost √ X
High Accuracy √ X
Rheumatology √ √ X X
Small Sample √ √ √ √
Rapid Result √ √ √ √
20Maven Strategy
File as FDA Class 2 device via the 510(k) pathway
Predicates to be used: Biorad 15-18 plex autoimmune profile
Commercialize to large AID practices, integrated health systems
Enter consumer Health Service Account (HSA) market where patient
makes decision on blood testing expenditures: Expected ~$500B by 2020
Offer blood testing through pharmacies such as Walgreens, CVS, etc..
Chip and Assay Microfluidics
Hardware Software Content
Instrumen
t Maven CassetteRevenue – Autoimmune Market
• Instruments have 30-60% Gross Margin
• Consumables have huge Gross Margins on $125 Million (2.5% of market) annual sales (@ year 3)
• Develop and enter other beach-head markets such as allergy, hematology, infectious disease, tropical
disease, drug testing, cancer markers, brain injury markers, and specialty ‘assay’ markets and many
other marketsStrong Patent Portfolio
Maven Patent Portfolio
Patent Title Country & Filing Date
1. 6,594,011 Imaging Apparatus and Method US Jul 11, 2000
2. 6,587,617 Micro Lens Array for Bioassay US Feb 22, 2001
3. 7,023,547 Apparatus Including A Biochip For US Apr 19, 2001
Imaging of Biological Samples….
4. 6,833,920 Apparatus and Method for Imaging US Jan 12, 2002
21 issued patents 5. 162965
6. 6,859,280
7. 6,882,420
Apparatus and Method for Imaging
Imaging Apparatus and Method
Apparatus and Method for Imaging
Israel Jan 10, 2003
US June 23, 2003
US May 7, 2004
8. 7,126,688 Microarray Scanning US May 17, 2004
Maven holds trade 9. 7,002,686 Apparatus and Method for Imaging
10. 7,193,711* Imaging Method and Apparatus
11. 7,518,724 Image Acquisition, Processing, & Display
US December 22, 2004
US May 17, 2004
US December 29, 2005
secrets to maximize 12. 7,838,285
13. 4219689
Imaging Electrophoresis System US April 24, 2006 Abandoned
Imaging Apparatus and Method (Surface) Japan January 27, 2007
sensitivity 14. 7,867,783 Apparatus and Method for Performing
Ligand Binding Assays on Microarrays
US February 22, 2007
In Multiwell Plates (1st Vertical Wall
Patent, Sidewall)
New patent 15. 7,863,037 Ligand Binding Assays on Microarrays
In Closed Multiwell Plates (2nd Vertical
US April 4, 2007
applications
Wall, Single Post)
16. 7,799,558 Ligand Binding Assays on Microarrays US May 22, 2007
In Closed Multiwell Plates (2nd Vertical
pending 17. 8,039,270
Wall, Arrayed Posts)
Apparatus and Method for Performing US May 22, 2008
Ligand Binding Assays on Microarrays
In Multiwell Plates (Microprisms)
18. 7,981,664 Apparatus and Method for Performing US May 22, 2008
igand Binding Assays on Microarrays
In Multiwell Plates (3rd Vertical Wall)
19. 8,355,133 Biological Testing with Sawtooth--‐ US December 30, 2009
Shaped Prisms…..
20. 9,063,072 B1 Birefringence Correction System….. US June 23, 2015
21. * ZL200580024159.6 Imaging Apparatus and Method China
The related US patient is US Patent No. 7,193,711 issued on March 20, 2007
23Fundraising History
$10M funding to date
Significant founder funding
NIH grant of $1.9M September 2010 (2 year grant)
William Rassman: $6.5 million
Other friends and family investors early in development
Company has no debt
Currently Seeking $7-10M
$2M for development of robust prototype and validation in
Auto Immune Disease
Funds > $5-8M for FDA and CLIA waived status application
plus enable more rapid development of other disease
testing platforms in parallel
24Investment Summary
Game-changing POC multiplex diagnostic system aiming to meet significant Dx
market needs
Initial target ~$5B market for Autoimmune disease diagnostics
Develop other lab applications: Cancer markers (>100), Infectious disease (>100),
Drug testing, Toxicology, Allergy, Tropical Diseases (third world applicatinos), Lipid
Profiles for Consumers and other consumer focused tests, Battlefield & Space
applications, etc….)
Attractive razor/ razor blade model with low COGs
Enable strong economics for large integrated health systems to utilize and even single
specialty practices
Consumable priced at $15, each test priced at ~$0.05
Significant development and de-risking undertaken to date in multiple successful
platforms developed
Raising $2M for prototype for validation (9 months)
510(k) filing planned by end 2020
25Must develop dif
Competitive Overview
positioning vis a
Maven Genalyte Athelas Orphidia Karius
(Polaron) (Maverick)
Platform Microfluidic Complex array Paper strip Microfluidic Infectious
chip/reader of 12 chips [?] tests chip Disease focus
Not POC
Site of Use POC – Exam Office At home / POC POC Laboratory
Room Laboratory
No. of Tests 24 (?) – what is 32 test (up to 40 common 1,000 inf.
in 510(k) app 128) tests Diseases
(up to 220)
Focus Autoimmune Rheumatology Cancer / Sepsis Infectious
Diseases Disease
Stage Development Clin testing RA Under FDA Development Development
/ SLE review (Vapor, lol)
Collection Finger prick Finger prick Finger prick Finger prick Full blood draw
Amount
Output Electronic
Speed < 15 min < 15 min 60 sec to result 24+ hours
Accuracy Robust Inconsistent
Cost / test $12 / use [?] ~$200 / use
[WHOSE?] [COGs,
transfer, 26Project Plan Overview, Ask
Q1 Q2 Q3
Q3 Q4
Q4 Q5
Q52 Q6
Q6 Q7
Q7 Q8
Q8 Q9
Q9
Concept, Planning
Alpha Prototyping $2MM
Prelim Assay Development
Beta Prototyping
Assay Transfer
Design for Manufacturing
Pilot Manufacturing $6MM
Verification and Validation
Equivalency Data Gen’n
Regulatory Package Prep’n
FDA Submission $1.5MM
Assay Dev: ID,Allergy, Hem, other $2.5MM
Product Launch – 2021 $12MM
Maven ConfidentialDetailed Product Development Timeline
2018 2019 2020 2021
28William R. Rassman, M.D. williamrassman@gmail.com
310-505-5383 cell
David Ralin
david.ralin@mavenbiotech.com
626-429-0632 cell
Maven Technologies, LLC
2265 East Foothill Boulevard
Pasadena CA 91107
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