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EU/Bulgaria · Software-as-a-Medical-Device

Health, assessed in 10 seconds — through the eyes.

SENTHORIS turns any camera into a non-invasive screening layer for early neuro-metabolic, psychoactive, and cognitive risk — powered by Dynamic Pupil Light Response and AI/ML. No samples. No pain. No delay.

DPLR · 10s AI/ML

Validated through industry partners and global stages

Thermo Fisher Scientific
Strategic CRO partnership · MOU signed at Global Health Exhibition, Riyadh, Oct 2025 — joint clinical validation programme
LUKOIL Neftochim Burgas
First commercial deployment, oil & gas (EU). Daily operational use since May 2025.
Global Health Exhibition 2025
Riyadh Exhibition & Convention Centre · Booth 27 · 27–30 October 2025. Under the patronage of KSA Ministry of Health.
EU / Bulgaria HQ
Headquartered in the European Union. Built and governed under EU privacy and medical device frameworks (GDPR, MDR-track).

Health assessed in 10 seconds — through the eyes.
No samples. No pain. No delay.

What SENTHORIS is.

A software-first medical screening platform. Our IP lives in the algorithms and the proprietary clinical dataset — not in the sensor. The same AI/ML engine runs across mobile, kiosk, embedded automotive, and clinical-grade camera infrastructure.

SENTHORIS extracts a proprietary clinical signal from Dynamic Pupil Light Response (DPLR) — the microscopic, brain-mediated reaction of the pupil to a calibrated light stimulus. From that signal, AI/ML models infer early markers of metabolic dysregulation, psychoactive influence, and neuro-cognitive change. The screen takes under ten seconds.

The platform ships through three asset-light channels: embedded SDK for consumer and automotive OEMs, API for pharma and CRO data services, and SaaS for healthcare and government screening programmes. One AI engine, three go-to-markets, software-grade unit economics — designed for FDA SaMD certification as the regulatory anchor.

Why now.

Three converging shifts — regulatory, market, and technical — have turned camera-based screening from a research curiosity into a defensible medical-software category.

01

Urinalysis is breaking under cannabis legalisation.

With recreational cannabis legal across 24 US states, traditional drug-of-abuse testing has become legally and operationally fragile for employers, transportation, and oil & gas. Workplaces need an objective, real-time, non-invasive alternative.

02

FDA opened the digital biomarker pathway.

Apple Watch ECG (510(k)), KardiaMobile, and the FDA's Digital Health Center of Excellence have already paved the route. Camera-derived physiological signals are now a recognised regulatory category for Software-as-a-Medical-Device.

03

Camera AI hit clinical resolution.

Modern smartphone optics and AI/ML pipelines now resolve sub-millisecond pupil dynamics that previously required laboratory pupillometers. The measurement floor moved — and with it, the size of the addressable screening market.

From pilot to global validation.

Real-world engineering. Real customers. Real data. The validation chain compresses years of clinical insight into a credible path to FDA SaMD readiness.

2022 – 2023 · Foundation

Engineering and data groundwork.

Years of clinical pupillometry research transformed into AI/ML-ready data architecture and the first functional prototypes.

2023 – 2024 · Industrial pilots

Field validation across transport applications.

The signal pipeline confirmed under real-world operational conditions, outside laboratory settings.

May 2025 → · LUKOIL Neftochim Burgas

First commercial deployment, oil & gas (EU).

Daily operational use at a major refinery checkpoint. Paying industrial customer. The deployment moved SENTHORIS from "validated technology" to "proven in production with real customers and real data".

29 October 2025 · Riyadh, KSA

Strategic CRO partnership with Thermo Fisher Scientific.

Memorandum of Understanding signed at the Global Health Exhibition with Thermo Fisher's PPD Clinical Research business — establishing strategic intent to collaborate on the international clinical validation of SENTHORIS as Software-as-a-Medical-Device. A Tier-1 CRO has reviewed the project and committed to taking it forward.

2026 – 2027 · In preparation

Multi-country clinical validation.

Joint clinical programme across US and APAC sites in design with Thermo Fisher. Target: regulatory readiness for the FDA SaMD pathway, with parallel international certifications.

How it ships.

One AI/ML engine. Three asset-light go-to-market channels. Software-grade unit economics. The same proprietary dataset compounds across all of them.

SDK

Embedded

Big Tech health platforms (Apple Health-class, Samsung Health-class), automotive driver-monitoring (DMS) for OEM and Tier-1 suppliers, and consumer wearables. Our software embeds into their devices and ships at their scale.

API

Data & clinical services

Pharma BD endpoints, CRO digital biomarker pipelines, occupational health TPAs. Direct integration into clinical, safety, and screening workflows.

SaaS

Enterprise & public

Healthcare systems, government screening programmes, smart-city public-safety infrastructure. Subscription delivery — activated post-FDA SaMD certification.

The team behind it.

Asset-light core team focused on AI/ML, mobile, and platform engineering. Clinical and regulatory delivery extends through Thermo Fisher rather than duplicated in-house — a deliberate choice that keeps unit economics software-grade.

Denis Zalynskiy

Engineering Heart of the company · EU

A leading researcher and technology innovator with extensive experience in project leadership, manufacturing facility development, and product improvement. Dedicated to driving innovation through a scientific approach.

Maxim Zagryadskiy

Head of IT Development

An experienced IT leader with 8+ years in .NET/C# development, system integration, and backend architecture. Skilled in building high-load services and digital platforms for industrial and medical sectors. Focused on turning complex technical challenges into reliable solutions that support business growth and digital transformation.

Artem Karavatyi

Strategy, operations, implementation management · EU

A seasoned international advisor guiding top-level executives across diverse enterprises. Strong strategic vision combined with a pragmatic approach to problem-solving, from initial concept development through successful implementation.

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