Investment Opportunity — TraumaShield
Confidential · Qualified investors only

A multi-billion dollar opportunity.

Institutional buyers who bear the cost of PTSD. A consumable with a mandatory replacement cycle. A regulatory pathway that skips Phase 1 risk. Below: the model, the traction, and the road to market.

The business model

Sold to the people
who pay for PTSD.

Institutional buyers positioned to administer inside the window — and carrying the long-term cost of not doing so.

01

Psychiatric
Clinics

Urgent psychiatric networks already seeing post-trauma patients within days of the event — the fastest route to real-world evidence and repeat volume.

Insurers Provider budgets Self-pay
02

EMS & Trauma
Centers

The first clinicians to reach the patient, and the only people on earth positioned to administer inside the golden hours.

Provider budgets Insurers
03

Defense &
Government

Stockpile procurement for forces that both generate and absorb trauma at scale — and already fund preventive readiness.

Gov contracts
Market build-up
37–52M Addressable traumatic events
9.5M Potential PTSD cohort (US)
×
$300 One-time intervention
=
Serviceable market $2.85B
The cost arbitrage

Annual cost of one untreated PTSD patient, against a single $300 intervention.

Private insurance {{ arbPrivateVal }}
37× the cost of prevention
Average {{ arbAvgVal }}
63× the cost of prevention
Military / VA {{ arbMilVal }}
86× the cost of prevention
TraumaShield {{ arbTsVal }}
One-time prevention
24 months
Mandatory safety-driven replacement cycle — recurring revenue regardless of usage.
~88.6%
Gross margin on a single-use consumable at contract price.
1:65
ROI for insurers — every kit administered is replenished at full price.
Market valuation
PTSD treatment market versus preventive healthcare market size, 2026 to 2035

Market sizing per Future Market Insights (PTSD treatment market) and Precedence Research (preventive healthcare technologies & services market).

The proven playbook

Innovative science.
Old-fashioned business model.

The mechanism is new. The commercial structure is not. Take a known compound, pair it with a device that puts it where it has never been able to go, and own the combination. It has produced multi-billion-dollar franchises three times over.

EpiPen 1987
Mylan / Viatris

Epinephrine — known since 1901

Auto-injector for untrained hands

~$1B
ARR
Narcan 2015
Emergent BioSolutions

Naloxone — approved 1971

Nasal spray for bystander rescue

Exit
Acquired
Spravato 2019
Johnson & Johnson

Esketamine — a known anaesthetic

Metered nasal device, in-clinic protocol

~$1.8B
ARR
TraumaShield · next
The same structure, applied to the one window nobody has reached.

Repurposed compound — an FDA-approved agent with a characterised safety profile.

Proprietary device — field-ready delivery inside the 0–6 hour window.

Owned combination — 505(b)(2) pathway and a 20-year method-of-use patent.

Revenue and exit figures are publicly reported outcomes, shown as commercial precedent for the drug-device repurposing model — not as a forecast of TraumaShield performance.

The economics

Treating the fire,
not the smoke.

Reactive care compounds for decades. Prevention resolves in a single administration — and the cost curves are not close.

Reactive symptom management

High cost: Years of therapy, SSRIs, and lost productivity.

Low recovery: Treating the "smoke" after the fire has settled.

Chronic: Lifelong struggle with PTSD symptoms.

Proactive prevention (TraumaShield)

Low cost: Single-use, immediate intervention.

High resilience: Treating the "fire" during the Golden Hour.

Preventative: Blocks fear memory consolidation entirely.

Economic burden: reactive vs. preventive care
Reactive care ($19,630/pt)
TraumaShield ($300/pt)
$1000M $750M $500M $250M $0 0 10k 20k 30k 40k 50k PATIENTS TREATED
1:65
ROI for insurers

$19,600/yr chronic PTSD care cost vs. $300 one-time TraumaShield intervention.

Traction

"From concept to clinical. Every milestone de-risks your investment."

Phase 2 Protocol CompletedPI + pilot centers secured and ready
FDA Pre-IND Meeting Package PreparedDirect engagement with FDA regulatory pathway
Israeli Ministry of Health MeetingRegulatory relationship established at national level
IP Strategy FinalizedPatentability research and analysis completed. Patent submitted.
Regulatory Strategy Confirmed505(b)(2) + combination-product pathway locked
World-Class Advisory Board AssembledPsychiatry, neuroscience, and regulatory experts
Independent Clinical Validation47% PTSD reduction confirmed by external review
Full Scientific Package AssembledComplete regulatory and clinical documentation ready
Economic & Commercial RoadmapDetailed path to $3B SAM mapped and validated
DDR&D Strategic RelationshipStrategic partnership in progress

Next milestone: Generate real-world evidence with DDR&D, hospitals, and EMS — toward FDA approval.

Strategic roadmap

Path to commercialization

Five years from Phase 2 to standard of care.

2027
Validation
Phase 2 clinical trial
Medical device development
2028
Expansion
Phase 2 primary endpoint
Strategic partnerships
Fund raise
2029
Growth
Pivotal trial launch
Defence contracts
NDA preparation
2030
Commercialization
Pivotal trials end goals
FDA approval
U.S. Market Entry
Scale & marketing
2031
Preventive Care
Standard of care established
Development expansion
The honest view

What has to
be true.

This is a hard problem and a long road. We would rather you hear the risks from us than find them yourselves — and we have a plan for each one.

Risk 01 · Clinical
Phase 2 must hit its endpoint

Human efficacy has been shown in an independent surgical-trauma study, not yet in our own controlled trial.

How we de-risk it

Protocol complete, PI and pilot centres secured, and the effect reproduced preclinically across SEFL models before we spend a dollar of trial budget.

Risk 02 · Engineering
The device must work in the field

A combination product has to survive a real trauma scene — no power, no training, no second chance.

How we de-risk it

Deliberately simple architecture — four passive components, no electronics — led by an advisor with deep medical-device development experience.

Risk 03 · Regulatory
A combination product is a harder filing

Drug-plus-device review is more complex than either alone, and prevention indications are new ground for psychiatry.

How we de-risk it

505(b)(2) pathway confirmed on an already-approved agent, pre-IND package prepared, and a former FDA medical officer on the board.

Risk 04 · Adoption
Trauma protocols change slowly

Getting into every ambulance and IFAK means changing standard of care, which takes institutional will.

How we de-risk it

A 37–86× cost argument aimed directly at the budget holder, plus defence and psychiatric-network partnerships already in motion.

It is a hard challenge and a hard road ahead of us. We are going to do it anyway — and you can do it with us.

Use of funds

What this
round buys.

Four outcomes. Each one moves TraumaShield from a validated hypothesis to a company positioned for pivotal trials.

01
Two Phase 2 clinical trials

Executed to primary endpoint — the data package that unlocks everything after it.

02
A device ready for clinical use

Engineering completed to a unit that can be deployed in real clinical settings, not a prototype.

03
Position for pivotal trials

Regulatory groundwork and clinical infrastructure in place to move straight into the pivotal stage.

04
Crucial partnerships

Defence, EMS and psychiatric networks converted from conversations into signed programmes.

Investor materials

Access the full scientific and commercial package.

Backed, accelerated and partnered with
Mindful Care SouthUp D.Tech HaMitbah Mamram Association Israel Innovation Authority Next October
Qualified investors only · Stealth stage

Limited joining opportunity for this round.

TraumaShield is raising to execute its Phase 2 clinical trial and complete device engineering. Join us in making trauma a memory, not a disorder.

Round size, valuation and minimum ticket are shared directly with qualified investors on request.

Pre-Disclosure · Limited Access · Qualified Investors Only

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