ArcadiaMedicine in partnership with
A trial observation brief for Arcadia Medicine

Non-racemic MDMA needs more than chemistry to win. It needs comparison data.

Single-enantiomer MDMA can deliver a different therapeutic and side-effect profile. Videra Health is the multimodal observation platform that captures the behavioral differences in trial data — turning 'we removed the bad enantiomer' into a measured, defensible claim.

See how we'd observe AM1002

The Asset

AM1002

Single-enantiomer MDMA for PTSD, designed to retain therapeutic benefit while reducing the side effects of racemic MDMA.

IndicationPost-Traumatic Stress Disorder
PhasePreclinical / Phase 1
ClassNon-racemic MDMA
MechanismSelective 5-HT release
DifferentiatorReduced side effect profile vs racemic MDMA
Comparison targetRacemic MDMA / Lykos MDMA-AT
Why we're paying attention

Non-racemic MDMA needs comparative behavioral data, not just chemistry slides.

The single-enantiomer story

AM1002 is single-enantiomer MDMA — designed to retain the therapeutic benefit of MDMA-assisted therapy while reducing the side effects that come from the unwanted enantiomer.

The therapeutic case is grounded in 20 years of MDMA research. The differentiation case lives in the trial data: which symptoms improve faster, which side effects truly diminish, and what happens to therapeutic alliance under a different subjective profile.

The case lives in observation

Comparative behavioral data — vocal patterns, facial affect, somatic response, linguistic content — surfaces the differences between AM1002 and racemic MDMA at the session level. MADRS at Day 28 cannot.

The story matters to the FDA, to payers, and to clinicians who watched the Lykos approval cycle.

Single-Ent
Single enantiomer MDMA reducing side effect profile
PTSD
Lead indication with documented MDMA-class efficacy
vs Racemic
Comparison story is the entire commercial wedge
In the News

We've followed Arcadia Medicine through preclinical development.

Building the case for single-enantiomer MDMA in PTSD.

The observation problem

Single-enantiomer MDMA needs comparison data.

'We removed the bad enantiomer' is a chemistry claim. The four observation gaps below convert it into clinical evidence.

Gap 1: Comparative Behavioral Data

Subtle differences live in vocal and facial signal.

How AM1002's session feels different from racemic MDMA's session is a question PRO scales were not designed to answer. Vocal affect, facial expressivity, and linguistic patterns can.

Gap 2: Side-Effect Quantification

'Reduced side effects' is a claim. Proving it requires measurement.

Anxiety, sympathetic activation, post-session fatigue — all measurable in continuous behavioral observation. The data Arcadia needs to substantiate the differentiation case.

Gap 3: Therapeutic Alliance Capture

A different subjective profile shifts the therapy dynamic.

How patient-therapist alliance evolves with AM1002 vs racemic MDMA is observable in session interaction patterns — and informs both label claims and clinician training.

Gap 4: FDA-Defensible Comparison

The FDA will ask: what does AM1002 do that MDMA does not?

The answer lives in head-to-head behavioral data, captured under directly comparable conditions. Videra delivers the framework.

How we partner

Capture, Analyze, Co-Develop — pick the entry point.

Bring us a question and we'll capture the data. Bring us your data and we'll run it through our models. Or start from a hypothesis and we'll co-develop a novel endpoint with you, end-to-end.

Capture

Trial or study data capture

We bring the hardware, software, and AI to your site. Behavioral signal collected the same way at every visit, every site, every time.

Analyze

Behavioral insight & analytics

Bring us your existing video, voice, or trial data. Our multimodal models surface vocal, facial, and linguistic biomarkers you couldn't see in PRO data alone.

Co-Develop

Digital models & endpoints

Start from a clinical hypothesis. We build the digital endpoint, the screener, or the response model end-to-end — from study design through peer review.

Three ways Videra observes AM1002

Purpose-built for single-enantiomer MDMA comparison trials.

Our platform pairs in-clinic AI hardware with multimodal behavioral analytics and a custom algorithm engine, already proven in TDScreen and Check on Mom. Here's how each maps to AM1002.

01 · Ambient Monitoring

An AI-powered video cart that captures AM1002 sessions head-to-head with MDMA.

A clinical-grade camera and directional audio rig that drops into any AM1002 site in minutes. Same framing, same fidelity, same conditions as MDMA comparison sessions. The basis for any 'AM1002 vs racemic' claim.

  • Verifies dosing protocol adherence and consistent administration across sites
  • Standardizes facilitator language and post-dose check-ins
  • Generates a defensible session record for regulators, monitors, and post-hoc review
  • HIPAA-compliant, end-to-end encrypted; data never leaves the secure pipeline
See it in action. Videra Monitoring Stand reference →
PRODUCT 01 ROOMVIEW

Ambient room & patient observation

Broad, continuous observation of the full room and the patient during the AM1002 session. Videra algorithms run on captured video, voice, and movement signal — triggering alerts on abnormalities, acute findings, and protocol-defined events.

  • Cart built for full-room and patient capture
  • AI analysis on the captured signal
  • Real-time alerts on acute findings
PRODUCT 02 FIDELITYVIEW

High-fidelity encounter monitoring

Multi-view cameras and high-fidelity audio focused on close-contact patient–provider interactions. Purpose-built to monitor protocol adherence remotely and protect the fidelity of the trial.

  • Cart built for close-contact capture
  • Multi-view cameras + hi-fi audio
  • Remote protocol-adherence monitoring
PRODUCT 03 LIVEVIEW

Centralized live oversight

Stream Videra carts from one or many rooms to a single central observation point, scaling oversight across AM1002 sites — in clinic and at commercial launch.

VoiceVitals · Live capture● Recording
00:00T+18 min00:60
Vocal affect tone↑ 32% vs. baseline
Speech rate variabilityNormalized at T+45
Facial expressivity (FACS)Peak T+22 min
Linguistic sentiment+1.8σ shift sustained
02 · Multimodal AI Endpoints

ASSESS turns AM1002 sessions into comparable, measurable endpoints.

Multimodal analysis of voice, video, and language across AM1002 and comparator sessions. The behavioral differentiation data that turns chemistry into clinical evidence.

  • Objectively capture onset, peak, and resolution of the psychoactive window
  • Augment MADRS and HAM-D with continuous, between-visit behavioral data
  • Built on 1M+ patient interactions across 300+ behavioral health facilities
  • Designed for 21 CFR Part 11, HIPAA, and SOC 2 Type II environments
Proof point: Check on Mom. Live AI video screener for postpartum depression →
03 · Custom Algorithms

Custom biomarkers for the AM1002 vs racemic MDMA story.

For AM1002, a proprietary single-enantiomer differentiation framework — capturing the specific behavioral and physiological signatures that distinguish AM1002 from racemic MDMA.

  • Capture comparative behavioral signal between AM1002 and racemic MDMA
  • Stratify likely responders vs. non-responders earlier in treatment
  • Feed regulatory submissions, label expansion, and payer dossiers
  • Live algorithms today: TDScreen (AUC 0.89, J Clin Psychiatry) and Check on Mom
Proof point: TDScreen. AI that outperforms trained clinician raters, in production →
LIVE · IN MARKET

TDScreen

AI-powered tardive dyskinesia screening built on the AIMS standard. A short, video-based assessment that quantifies involuntary movements, reducing reliance on subjective rating. AUC 0.89 vs. trained raters, peer-reviewed in J Clin Psychiatry.

  • Early & objective detection
  • Scalable, remote, device-agnostic
  • Geographic, demographic, prevalence RWE
  • Supports post-market & HEOR strategies

tdscreen.ai →

LIVE · IN MARKET

Check on Mom

Consumer-friendly video assessment for perinatal & postpartum depression. Surfaces postpartum risk earlier than standard EPDS administration, and routes to care with rich signal.

  • Multi-touch perinatal monitoring
  • Routes to provider with rich signal
  • Built for advocacy + commercial channels
  • Pharma-sponsored deployment model

checkonmom.ai →

PROPOSED · AM1002

A "AM1002 Differentiation Framework"

Multimodal AI model trained on AM1002 vs racemic MDMA data, surfacing the behavioral, somatic, and linguistic signatures that distinguish the single-enantiomer profile.

Co-developed with your team, the same way we built TDScreen and Check on Mom for our existing pharma partners.

Strategic Alignment

Where Arcadia Medicine is headed, and how Videra fits.

Your differentiation strategy, mapped to Videra capabilities in production.

Arcadia Medicine's Priority
How Videra Accelerates
Build the AM1002 vs racemic MDMA comparison case
ePRO+ with VoiceVitals captures head-to-head behavioral signal
Quantify the reduced side-effect profile
ASSESS multimodal analysis measures anxiety, fatigue, sympathetic load
Generate PTSD durability data for payer access
Behavioral-health network captures between-session functional outcomes
Position AM1002 as the next-gen MDMA standard
Custom differentiation biomarkers anchor the regulatory and commercial case
Build launch-ready infrastructure
EngageEntry for screening, SignalSort for response monitoring, InsightTranscribe for KOL sentiment
Built on real-world data

Not a pitch. A platform.

Videra's network isn't our customer base. It's the living dataset that powers every algorithm we build. For Arcadia Medicine, that means real clinical depth and peer-reviewed validation.

300+
Behavioral health facilities
1M+
Patient interactions analyzed
0.89
AUC for TDScreen (J Clin Psychiatry, 2025)
94%
Patient program completion rate
HIPAA Compliant SOC 2 Type II 21 CFR Part 11 ready End-to-End Encrypted

Let's explore what this could look like for AM1002.

We'd welcome a 30-minute session to walk Arcadia Medicine through a tailored, protocol-by-protocol proposal for AM1002's PTSD program.

Your Videra contact
Ryan Roberts
Videra Health
ryan@viderahealth.com viderahealth.com →