10 Dec. 2024
An Innovative Solution to
Curb the Fentanyl Crisis
1 Speakers and Agenda
Kevin Gordon
Field Operations
Kamni Vijay Ph.D
Board Advisor
Junaid Mohiuddin
Co-Founder/CFO
Ahmad Hussain
Co-Founder/CEO
2 • Problem Statement
• Fentanyl Deaths in
Oakland – Impacts
All of Us
• DefentTM ONE
Fentanyl Detection
Device
Agenda
• Traditional Test
Strip Limitations
• Settlement Funds
• Awareness and
Deployment Plan
• Call to Action
• Recommended
Distribution Methods
• Q&A
Fentanyl testing hasn’t been widely adopted while this crisis grows, but covid yielded many best practices toward improving testing adoption… • Defense Diagnostics Inc. (DDI) was borne out of the COVID pandemic: founders led an EUA-approved, CLIA-certified
COVID testing lab and applied the learnings to create DDI • Consumer driven, at-home testing market has evolved
significantly post-pandemic
• Traditional test strips alone are neither sufficient nor effective for widespread adoption
• DefentTM ONE is a simple, more sensitive, lipstick-sized device for on-the-go, discreet testing
• Defent ONE is an FDA exempt Class 1 medical device
available OTC that meets all requirements for similarly regulated FDA Class 1 medical devices
The problem: fentanyl testing status quo isn’t working
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Limitations of traditional fentanyl test strips (FTS)
1. Requires multiple supplies such as clean water and
proper measuring components creating usage
barriers and increased risk of inaccurate results
2. Limited portability due to fragile construction, needs to be used in a stationary and sterile environment
3. Poor design, relying heavily on user
comprehension of directions
4. Field studies suggest only 10-20% of traditional
FTS distributed are typically used, indicating usage
challenges and wasted resources
Step 1: 81% did not shake drug bag as required
Step 2: 94% had difficulties gathering supplies
Step 3: 75% failed to retrieve correct sample quantity
Step 4: 73% struggled with proper test activation
0% preferred FTS vs Defent ONE
100% preferred Defent ONE vs FTS
3rd party usability study findings for each
step of using an FTS (% failure)
Randomized field study indicated users struggle to
follow directions and use test strips correctly
Traditional FTS are impractical to use, limiting market adoption 4Source: Randomized trial, single-blind, side-by-side study of FTS vs Defent 1 Fentanyl deaths occur in all Oakland districts
Fentanyl represents >80% of opioid deaths1, and is likely underreported 1) CalMatters Fentanyl Statistics 3) Approximation based on Oakland redistricting tool 2022 2) Oakland CDC Data
5 Any-Opioid Related Overdose Deaths
Alameda County, Prelim. 20233
Opioid Overdose Deaths, All Years
Oakland, CA 2022
Age-Adjusted rate per 100k residents2
Fatal and non-fatal overdose is a risk to all of us
• Males faced ~5x higher risk of fatal opioid
overdose than females
• Black/African-Americans had >2x the
opioid overdose mortality of Whites and 3x
of Hispanics/Latinos
• In 2020 alone, 70% of overdose cases
involved housed individuals
• This crisis is NOT just about those
experiencing homelessness
Age-adjusted overdose rate in 2020 by
occupation in the United States2:
2) Washington Post
This crisis impacts all ages, genders, races, occupations, and socioeconomic statuses, but some populations are at significantly higher risk of fatality Between 2019-2021 in Alameda County1:
1) Alameda County Public Health
6 Introducing DefentTM ONE Fentanyl Detection Device
* Optional: Report a positive result via QR code
Collect sample with
integrated scoop
Open lid, insert scoop
into device, close lid
Pull the pin to
engage test
Wait 3 mins
for result *
Simple, easy-to-use handheld device ensures broader adoption 7 • Integrated supplies built-in; no additional resources are required • Ensures consistent ratio, yielding highly accurate result w/o false positives • Usable in all settings with lowest detection concentration of 15 ng/mL • Detects 150+ fentanyl analogs w/o cross-reactivity to MDMA, diphenhydramine, etc.
• Study participants preferred Defent ONE’s ease of use over traditional FTS in a randomized user trial conducted in San Francisco, 2024 • Unique anonymous opt-in data collection via QR code allows for reporting of positive fentanyl detection for incident heat mapping
Benefits of DefentTM ONE
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Oakland has opioid settlement funds for this program
Schedule of Oakland Opioid Settlement Funds1
● Settlement funds received to date 2024: ~$2.3 million ● Settlement funds spent on prevention: $0.0
● Settlement funds forthcoming thru 2038: ~$6.5 million ● Total settlement funds thru 20381: ~$8.8 million Oakland's current funding has been used primarily on the unhoused2. These funds should also be used for overdose prevention and abatement for the broader population in
Oakland, (e.g. fentanyl testing devices) as part of overall opioid intervention efforts3.
Designated funds have yet to be deployed for abatement and prevention 1) KFF Settlement Tracker 2) Oakland Housing Project 3) Alameda County Health Report 9 Year Received ($K) Forthcoming ($K)
2022 1,094
2023 510
2024 709
2025 744
2026 448
2027 448
2028 533
2029 551
2030 551
2031 478
2032 393
2033 393
2034 393
2035 393
2036 393
2037 393
2038 393
Subtotal 2,313 6,504
1 Call to action: Oakland deployment plan
Recommended Distribution
Annual Units
Supplied Description
Centralized Pickup
Locations 7,500 DDI will stock and replenish devices for pickup at public and private sites across Oakland
Direct Street Distribution 4,500 DDI will distribute devices directly to the unhoused populations in Oakland
Online Ordering
(USPS Mail Delivery) 3,000
DDI will offer a website for ordering devices to
be delivered, inclusive of shipping and handling
costs
Subtotal 15,000 Annual units of Defent One supplied
Contract
Years
Devices / 1k
Population
Annual Units
Supplied Annual Cost 3-Year Cost 3-Year Units
Purchased
CY ‘25 – ‘28 34 15,000 $200,000 $600,000 45,000
3-Year Cost Includes:
• Defent ONE devices
• Project expenses
(operational distribution,
insurance, etc.)
• Training and education
• Awareness campaigns
(social media, digital,
targeted outreach)
• DDI’s existing
manufacturing capability
can accommodate
additional demand
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Awareness plan for Oakland’s program success
Examples of where and how this will work:
● Community outreach events and demonstrations (food banks, health clinics, farmers’ markets, non-profits)
● Drug rehab centers, detox clinics, MAT providers etc. ● Collaborations with local businesses (bars, clubs, dispensaries) ● Youth-focused educational programs in schools and colleges ● Social media-driven awareness campaigns
● Public transportation advertising (BART, AC Transit)
● Geo-targeted digital marketing
● Etc.
We will drive awareness through multiple channels to reach our audience 11 Call to action: Oakland’s distribution plan
Get devices into people’s hands ASAP!
In-Person Distribution
• 7,500 annual devices available
o Public pick-up sites (e.g., health
departments, community centers)
o Private pick-up sites (e.g., bars, music
venues, liquor stores)
• 4,500 annual devices allocated toward
unhoused communities
• Trained staff provide educational
materials on the use of Defent ONE and
fentanyl awareness
Online Distribution
• 3,000 annual devices allocated
• Our Oakland-specific platform will
enable at-home delivery
• 5 devices will be the maximum
available per person to ensure
equitable distribution
• The platform features a mobile-
friendly design and multi-language
support
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