NASALCART™ · RESEARCH USE ONLY

The output is not a tissue. It is a decision-ready evidence package.

A tri-layer human nasal-tissue construct — epithelium, stroma and cartilage — with every layer linked to a release criterion, a biological identity check or a downstream decision readout.

FORMULATION/EXCIPIENT/DEVICE/REPEAT EXPOSURE/ONE DECISION

THE PROBLEM

Intranasal teams don't lack models. They lack one that ends in a decision.

01

Barrier signal only

Epithelial models are strong for transport and cilia, but can miss deeper stromal and cartilage injury.

02

Deep tissue, unstandardized

Cartilage and matrix response matter to local tolerability, yet are rarely standardized in routine screens.

03

Decision friction

Every new comparison becomes a bespoke study, so results never line up across programs.

THE PAID QUESTION

“Which formulation and device combination creates the lowest local human-tissue injury signal — and deserves to advance?”

THE CONSTRUCT

A specification stack, not a pretty tissue picture.

Geometry

Locked, version-controlled design with defined dimensional tolerance and repeatable handling.

Mechanics

A target mechanical window benchmarked against published comparators.

Viability

Tracked at 24 hours, 72 hours and day 7 against pre-specified thresholds.

Cell distribution

Layer retention, morphology and interface continuity across all three layers.

Phenotype

Cartilage identity confirmed and monitored for fibrotic or hypertrophic drift.

Traceability

Every construct tied to its lot, cell source, run record and QC history.

ASSAY STACK

Separate damage, inflammation, phenotype drift and matrix degradation.

Each readout is interpreted against untreated, vehicle, non-damaging and damaging controls — so a signal means something before it reaches your program team.

Survival

Viability and cytotoxicity

24 h · 72 h · 7 d

Inflammation

Response versus negative and positive controls

IL-6 · IL-8 · TNF-α

Cartilage identity

Phenotype retention

SOX9 · ACAN · COL2A1

Stability

Fibrotic and hypertrophic drift

COL1A1 · COL10A1

Matrix

Matrix formation and retention

GAG · histochemical staining

Degradation

Catabolic injury response

MMP-13 · ADAMTS5

Epithelial barrier metrics are added where the construct format supports a validated barrier measurement.

HOW A PILOT WORKS

One pilot. One question. One documented decision.

01 · INPUT

Formulation, dose, excipient, concentration, device and exposure pattern.

02 · EXPOSE

Standardized acute or repeat-exposure protocol on a lot-controlled construct.

03 · READ OUT

Barrier, inflammation, cartilage phenotype and matrix degradation.

04 · COMPARE

Candidates scored against pre-specified controls and acceptance logic.

05 · DECIDE

Rank, reformulate, advance, escalate — or stop.

WHAT A PILOT LETS YOU DECIDE

Every result maps to a permitted next step.

Your question Evidence delivered Decision it supports
Which lead formulation should advance? Comparative, control-referenced response profile Rank candidates and select a lead
Is an excipient or concentration driving injury? Component or dose comparison Reformulate or reduce concentration
Does repeat exposure amplify injury? Acute versus repeated exposure response Alter the schedule or stop
Do we need an epithelial or in vivo study? Tissue-response signal with stated limitations Escalate to the next fit-for-purpose model

THE DECISION PACKET

Compact, auditable — not a raw-data dump.

The packet sharpens your next experiment and makes uncertainty visible. It does not certify clinical safety.

Protocol and deviations Construct lot and metadata Exposure map Control performance Normalized assay results Image evidence Statistical analysis and limitations A clear recommendation

WHO IT'S FOR

Teams developing intranasal products.

Formulation and CMC, translational sciences, preclinical safety and innovation groups at pharma and biotech companies — and CROs building sponsor-facing study packages.

CNS delivery Rescue therapies Anti-infectives Allergy products Peptides and biologics Vaccines Nasal devices NAM-focused groups

ROADMAP

Own the decision system — not a single printer.

NOW

NasalCart™ Core

Tri-layer epithelium, stroma and cartilage with a documented QC standard.

NEXT

Core+

Mature air-liquid interface features and advanced barrier readouts.

EXPAND

Program modules

Donor variants, device-specific protocols, nose-to-brain interfaces.

COMPOUND

Decision data

Versioned benchmarks and cross-program response signatures.

LIVE INTERACTIVE SIMULATION

Explore the NasalCart roadmap in a live simulation.

Step through all six platform stages, adjust dose, barrier and targeting, and see how each delivery route resolves. Illustrative design indices, not experimental data.

Launch the live simulation →

Scope a research-use pilot.

Bring 2–5 candidate formulations or device conditions and one local-tissue question.

Discuss a pilot