Miniaturized, Multiplex, Point-of-Care Diagnostic Solutions
July 2018
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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
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Management & AdvisorsManagement
� 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 – CTOMultidisciplinary 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.
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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
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Current Diagnostic Needs � Autoimmune diagnosis is a cumbersome
multi-step / multi-day testing - reporting diagnosis – treatment cycle� Multiple rounds of office visits, blood tests
= time� Constantly waiting for results = anxiety � Weeks to Months and $100s to $1000s� Disease progression waiting for tests
� Lack of sensitive and specific testing equipment at Point of Care (POC). No financially feasible screening.
� No multiplex POC solutions available for MD office / desktop
Central Lab Draws or Office Draws Sample &Sends to Central Lab,
Physician & Patient Initiate Dx Request
df
Central Lab Processes Sample; Results Sent
To MD
Current Paradigm
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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
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Polaron Platform Stage of Development
� Optical hardware and analytical software algorithms optimized, 6+ generations of readers
� Sensor and content sourcing industrialized
� Validated with manual and flow assays: nucleic acids, immunoassays, drug tests, cells
� Pilot autoimmune assays show excellent 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
Types TestingCompleted
DNA Yes
RNA Yes
Proteins Yes
Cells Yes
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Maven LFIRE Proprietary Technology Platform
“LFIRE" - Label Free Internal Reflection EllipsometryReal-Time Polarimetric Imaging
Live Cell TestingProteins, DNA, etc.
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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
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*
Protein Array Immunoassay Amplification Principle
Maven Confidential
YAdd amplifying substrate
Immobilized antigens in spots on the microarray surface already have patient’s specific Disease antibodies, and confirming enzyme-labeled Antibodies as well
The substrate precipitates at the spot, amplifying the thickness by 100-fold.
Concept: Third Step “Amplify” signal for greater sensitivity
Y*
YYYY
Precipitate
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INOVA (Werfen) Pilot #1Sm (lupus) Ag Only, 13 samples, IgG ELISA vs LFIRE Serum Screen
All 5 positive and 8 negatives agreed, ~proportional, semi-quantitative
6.5
6.0
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0.5
0.0
Abso
rban
ce (O
D)
110
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90
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0
Phase Change (mRad)
N1 N3
SM1
SM2
SM3
SM4N4 N5
SM5
ELISA Signal LFIRE Signal
N6
RNP1
RNP2N2
SM2D
LowC
Low ControlELISA
LFIRE ControlSM2 - 15 fold Dilution
(Amplified)
(Label-free)
(Add references)
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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
+ -+ 26 1- 0 123
ELISA
Concordance > 99%
Analytical Sensitivity 96%
Analytical Specificity 100%
INOVA (Werfen) Pilot #2 ENA-5 Clinical Utility Summary
Economics:ELISA: ~$375 kit and 3+ hours, no screen, 5 tests x 9 stepsLFIRE: ~$45 materials and 45 minutes, 15+ tests, 5 steps only
Expandable to a >80 test full AID panel for pennies/test
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SSB IgG
SNR ~675/nM
INOVA Pilot #2 ENA-5 Comparison of Maven’s Lfire, Elisa and Luminex
Cutofffor
positive>
Patient Serum ID Numbers
Note: SSB also had a surprising dynamic range.
Maven Confidential
Real Time Microarray Assay
IgM and IgG React at different rates
INOVA (Werfen) Pilot #2 ENA-5 Sm IgG, Serum 8171
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� Flu Chip – QC – Label-Free View taken from drop of blood
Infectious Disease Model System
IgG low control
Patient SerumTotal IgGMeter
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)
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Clinical Needs vs Technologies Maven is Multiplexing
Sensitivity Multiplexing
1.E-181.E-121.E-061.E+00
Classic Biochem
Maven LFIRE POC
Genalyte
Luminex
ELISA
Electrochemiluminescence (MSD)
0 100 200 300 400 500
g/mL of plasma tests per sample
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Diagnostics: BiomarkersInterleukin 6Workflow matches traditional ELISA for simple adoption, ease of use.
VS
Print Slides
Blocking
Analyte
Detection Antibody
Streptavidin-HRP
DAB Substrate
Maven LFIRE Standard ELISA
Time Resolved Analysis
Coat Plates
Blocking
Analyte
Detection Antibody
Streptavidin-HRP
TMB Substrate
End Point Analysis
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Polaron 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(Maverick)
Athelas Orphidia
POC Site √ X √ √Low Cost √ XHigh Accuracy √ XRheumatology √ √ X XSmall Sample √ √ √ √Rapid Result √ √ √ √
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Maven Cassette
<$$
Chip and Assay Content
Microfluidics
Instrument
<$$$$
Hardware Software
Maven Strategy� File as FDA Class 2 device via the 510(k) pathway
� Predicates to be used: Biorad 15-18 plex autoimmune profile
� Commercialize to large AID practices, integrated health systems� Enter consumer Health Service Account (HSA) market where patient
makes decision on blood testing expenditures: Expected ~$500B by 2020� Offer blood testing through pharmacies such as Walgreens, CVS, etc..
• Provider (M.D., Lab) $$$ panel• Consumer $$ / panel• Patient, Third Party Payor $-$$ / test
Revenue – 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 markets
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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 5. 162965 Apparatus and Method for Imaging Israel Jan 10, 2003 6. 6,859,280 Imaging Apparatus and Method US June 23, 2003 7. 6,882,420 Apparatus and Method for Imaging US May 7, 2004 8. 7,126,688 Microarray Scanning US May 17, 2004 9. 7,002,686 Apparatus and Method for Imaging US December 22, 2004 10. 7,193,711* Imaging Method and Apparatus US May 17, 2004 11. 7,518,724 Image Acquisition, Processing, & Display US December 29, 2005 12. 7,838,285 Imaging Electrophoresis System US April 24, 2006 Abandoned 13. 4219689 Imaging Apparatus and Method (Surface) Japan January 27, 2007 14. 7,867,783 Apparatus and Method for Performing US February 22, 2007
Ligand Binding Assays on Microarrays In Multiwell Plates (1st Vertical Wall Patent, Sidewall)
15. 7,863,037 Ligand Binding Assays on Microarrays US April 4, 2007 In Closed Multiwell Plates (2nd Vertical Wall, Single Post)
16. 7,799,558 Ligand Binding Assays on Microarrays US May 22, 2007 In Closed Multiwell Plates (2nd Vertical Wall, Arrayed Posts)
17. 8,039,270 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
Strong Patent Portfolio
� 21 issued patents
� Maven holds trade secrets to maximize sensitivity
� New patent applications pending
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Fundraising 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
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Investment 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
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Competitive OverviewMaven (Polaron)
Genalyte(Maverick)
Athelas Orphidia Karius
Platform Microfluidic chip/reader
Complex array of 12 chips [?]
Paper strip tests
Microfluidic chip
Infectious Disease focus Not POC
Site of Use POC – Exam Room
Office Laboratory
At home / POC POC Laboratory
No. of Tests 24 (?) – what is in 510(k) app (up to 220)
32 test (up to 128)
40 common tests
1,000 inf. Diseases
Focus Autoimmune Diseases
Rheumatology Cancer / Sepsis Infectious Disease
Stage Development Clin testing RA / SLE
Under FDA review
Development(Vapor, lol)
Development
Collection Amount
Finger prick Finger prick Finger prick Finger prick Full blood draw
Output Electronic
Speed < 15 min < 15 min 60 sec to result 24+ hours
Accuracy Robust Inconsistent
Cost / test [WHOSE?]
$12 / use [?][COGs, transfer, distrib, User,
~$200 / use
Must develop differentiated positioning vis a vis competition
Project Plan Overview, AskQ3 Q4 Q5 Q6 Q7 Q8 Q9
Product Launch – 2021
Concept, Planning
Alpha Prototyping
Prelim Assay Development
Beta Prototyping
Assay Transfer
Design for Manufacturing
Pilot Manufacturing
Verification and Validation
Equivalency Data Gen’n
Regulatory Package Prep’n
FDA Submission
Assay Dev: ID,Allergy, Hem, other
$2MM
$6MM
Maven Confidential
$12MM
Q1 Q2 Q3 Q4 Q52 Q6 Q7 Q8 Q9
$1.5MM
$2.5MM
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Detailed Product Development Timeline2018 2019 2020 2021
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William R. Rassman, M.D. [email protected] cell
David [email protected]
626-429-0632 cell
Maven Technologies, LLC2265 East Foothill Boulevard
Pasadena CA 91107