Xelios.ai Scope RUO pilot

Reproducible 3D cell culture infrastructure

The biology control layer for reproducible 3D cell culture.

Xelios.ai standardizes the biology interface and defines pilot qualification criteria for automation endpoints, combining hydrogels, automation-ready protocols, image-based QA, run monitoring, and reviewable run records for oncology research labs and CROs.

RUO research pilots only. Not for diagnostic, treatment, or clinical decision-making use.

Current stage

Design-partner research pilots for oncology and CRO labs, focused on repeatability, image QA, and complete run records.

Scope a 90-day RUO pilot Explore the system Investor diligence
Synthetic QA preview XEL-048
State
Review
Viability
95.2%
Record
Ready
RUO-first pilot evidence
Reviewable run records
Image QA plus review loop
Workstation-agnostic fit

Built for disciplined launch with CROs, oncology research labs, translational research units, and automation partners.

Run-record sample Pilot scorecard RUO boundary memo Data-use terms
The operating gap

Move 3D culture from fragile runs to repeatable biological infrastructure.

Xelios connects the fragile parts of 3D culture, matrix, protocol, imaging, and records, so each run can be repeated, reviewed, and improved.

01 / Drift

Powerful biology loses value when every run is a special case.

Manual handoffs make the source of variation hard to isolate. A failed or non-comparable run can be a biology issue, a protocol issue, or a record issue.

Biology drift Matrix, batch, and handling changes shift assay output. Protocol drift Technician-dependent execution makes runs hard to compare. Data drift Images, thresholds, and records scatter across tools.
02 / Control

One biology standard. Multiple machine endpoints under pilot qualification.

Xelios standardizes the wetware interface and defines workstation qualification criteria, so automation expands reproducibility instead of adding another variable.

Xelios wetware standard

Biology layer

  • Hydrogel and batch controls
  • Automation-ready protocol
  • Image QA thresholds
  • Run-record schema
X
Pilot qualification

Machine layer

  • Workstation agnostic
  • Instrument fit criteria
  • Environment monitoring
  • Data synchronization

Biology is the product standard. Machines become endpoints through pilot qualification criteria.

03 / Evidence

Every accepted run becomes a comparable biological record.

Once matrix, handling, optics, thresholds, and records move together, the dataset becomes more useful for diligence, model improvement, and IP.

Capture Morphology, run status, review notes, and environmental context. Compare Accepted runs against shared protocol and QA thresholds. Compound Cleaner datasets for diligence, model improvement, and defensible IP.
Platform thesis

The wedge is automation. The company is standardized biology and data.

Xelios controls protocols, hydrogels, vision thresholds, and run records while evaluating multiple automation platforms against the same biological interface.

Every standardized run can become a cleaner monitoring, benchmarking, and model-improvement event because matrix, protocol, optics, and handling conditions are designed together.

Operating loop

Each run becomes a controlled biological record.

Xelios turns a 3D culture workflow into a monitored cycle: prepare the matrix, execute the protocol, capture images, review anomalies, and preserve the run record.

See the data layer
01 Prepare

Standardized hydrogel matrix, batch controls, and setup conditions.

02 Execute

Automation-ready protocol with monitored handling and environmental checks.

03 Review

Image-based QA, human review, and clear acceptance thresholds.

04 Record

Structured run evidence for comparability, diligence, and model improvement.

Why now

Human-relevant models need stronger operating evidence.

FDA momentum does not remove validation requirements. It increases demand for reproducible, scientifically validated advanced in vitro systems with context-of-use evidence for RUO, preclinical, CRO, and translational research workflows.

FDA NAMs roadmap Validated methods still need context

Organoids, organ-on-chip systems, computational models, and advanced in vitro assays are moving into the policy conversation.

Source: FDA NAMs roadmap, April 10, 2025.

Research team reviewing a plate beside automated lab equipment
First SKU

A repeatable 3D culture environment for oncology research and CRO labs.

The first SKU combines selected hardware access, Xelios hydrogel consumables, automation-ready protocols, image-based QA, run monitoring, support, and structured run records.

Sold as a repeatable biological run environment, not a one-time instrument sale.
Automated cell culture workstation in a modern research lab
Workstation environment, selected movements, monitored runs, and structured biological evidence.
The investable boundary

Xelios is building the repeatable biology layer. Partners supply motion.

The moat is not a proprietary robot. The moat is a biological standard under review that can travel across selected machine layers.

Xelios wetware standard

Biology layer

  • Standardized hydrogels
  • Automation-ready protocols
  • Image-based QA thresholds
  • Run-record templates
X
Partner fit layer

Machine layer

  • Workstation agnostic criteria
  • Instrument fit criteria
  • Environmental control
  • Service and support obligations
Data moat

Cleaner wetware creates cleaner biological data.

When matrix, handling, optics, thresholds, and run records are standardized together, each experiment becomes more comparable, more reviewable, and more useful for future models.

Morphology monitoring Run status Review workflow Traceability log
Run-record schema XEL-048
Matrix
oxiHA-ADH batch, lot controls, stability window.
Protocol
Dispense parameters, timing, handling exceptions.
Images
Morphology frames, confidence threshold, review notes.
QA state
Accepted run, exception, or human review required.
Capture Review Lock Compare
Computer vision monitoring dashboard for 3D cell culture
Launch wedge

CRO and oncology research labs can evaluate the system before buying infrastructure.

The first sale is a 90-day RUO pilot with success criteria tied to run consistency, technician time, contamination events, utilization, and data capture.

What the pilot proves
  • Repeatability across accepted runs and review thresholds.
  • Technician time, contamination events, utilization, and service load.
  • Run-record completeness for QA, diligence, and data-use review.
Pilot package

Protocol fit Assay context, sample constraints, and automation readiness.

Data terms Run-record scope, de-identified RUO research data, no-PHI boundaries, review rights, and data-use language.

QA cadence Exception review, acceptance thresholds, and decision rhythm.

01

Interview

Map workflow pain, budget owner, timing, and pilot constraints.

02

Scope

Define protocol, success criteria, data-use language, and review cadence.

03

Run

Operate a 90-day RUO pilot with run records and human-in-the-loop QA.

04

Decide

Convert measured run economics into placement criteria, pilot renewal logic, and the next proof package.

Scope a 90-day RUO pilot See proof ledger
Diligence documents and charts on a conference table
Seed proof milestones

Seed capital funds the proof milestones that matter before Series A.

Hardware optionality and FTO

Output: two candidate automation options, integration terms, uptime requirements, service model, and FTO scope.

Computer vision models

Output: labeled image set, confidence threshold report, human review workflow, and traceability log.

Hydrogel evidence

Output: batch controls, stability evidence, extractables and leachables testing plan, and robot-dispensing data.

Commercial desirability

Output: 20 buyer interviews, 3 to 5 target LOIs, beta agreements, pilot pricing, and data-use language.

Current evidence ledger

What exists now.
What must be proven next.

Serious buyers and seed investors need to see the gap between current assets and the next milestone. Xelios makes the remaining evidence work explicit.

Proof area Current asset Next milestone Decision value
Biology standard In review oxiHA-ADH hydrogel thesis and batch-control plan. Robot-dispensing data, stability window, and accepted-run criteria. Confirms biology can transfer across selected automation endpoints.
Run records Schema ready Structured schema for protocol, image, threshold, and review evidence. Complete records across pilot runs with review state and traceability log. Turns lab execution into comparable diligence evidence.
Vision QA Concept Image-based monitoring concept and human review workflow. Labeled image set, confidence thresholds, and exception review rules. Shows whether automation improves decisions, not just throughput.
Quality boundary Defined RUO-first positioning and evidence discipline. RUO memo, pilot-quality checklist, data-use language, and support process. Keeps pilots credible without implying clinical readiness.
Artifact 01 Run-record sample Available in diligence
Fields
Protocol, images, thresholds
Status
Review state and lock state
Artifact 02 Mobile QA snapshot Pilot deliverable
View
Run state and exception status
Use
Pilot review cadence
Artifact 03 Pilot scorecard Seed proof milestone
Measures
Accepted runs, time, events
Decision
Renew, expand, or pause
Artifact 04 RUO boundary memo Quality boundary
Scope
Research-use positioning
Terms
Data use and support process
Business model

Recurring run infrastructure, not bespoke lab automation.

The subscription covers hardware access, hydrogel consumables, monitoring, analytics, support, and run records. Modeled economics require beta measurement before becoming operating claims.

Subscription $8k to $12k / mo

Target workstation subscription per placement.

CapEx target $40k to $45k

Beta workstation capital target, with scale target below $35k after partner hardware review.

Validation status Beta required

Utilization, uptime, service labor, and consumables must be measured.

Team

A cross-border team with scientific depth and venture formation experience.

Xelios combines Seattle biotech operations, Brazil-side deep-tech venture networks, and biomaterials expertise anchored in oxiHA-ADH hydrogel science.

CEO, automation and 3D culture

Daniel Lih, M.S.

Seattle biotech operator focused on robotic cell culture, 3D tissue workflows, and lab-to-product translation.

Founder, NanoBioPlus

Guilherme Santana

Serial founder and venture builder with Brazil-side deep-tech networks and capital-formation experience.

Scientific Director

Prof. Maria Helena Santana

Biopolymer authority and member of Brazil's National Academy of Engineering, anchoring hydrogel science.

Seed plan includes formal quality, regulatory, data governance, and life science finance advisors as part of the first proof milestone.

Investor close

$1M SAFE to convert technical promise into a Series A data package.

Xelios is raising seed capital to test the biological standard, evaluate the automation layer, and secure beta design partners.

Seed capital turns into
  • Hydrogel stability and robot-dispensing data.
  • Vision QA thresholds, run records, and traceability workflow.
  • RUO memo, pilot-quality checklist, and data-use language.
  • Buyer discovery with target LOIs and beta design partners.
Capital

Lead or co-lead interest in the $1M seed SAFE.

Customers

Introductions to CROs, oncology research centers, and translational labs.

Partners

Automation, equipment leasing, regulatory, and quality advisors.

Materials are available to qualified investors through an appropriate diligence process. This website is not an offer to sell securities.

Request diligence materials Discuss investor fit
Contact

Start a focused pilot, diligence, or partner conversation.

Choose the conversation that matches the decision in front of you. Each option opens a direct email with context already framed.

Labs and CROs

Share workflow constraints, sample type, automation status, and timing for a 90-day RUO research pilot.

Scope RUO pilot
Partners

Open a partner-fit conversation for robotics, leasing, quality, data, or regulatory support.

Discuss partnership
Operating boundary
  1. Research-use only

    No diagnostic, treatment, or clinical decision-making use.

  2. Data boundary

    De-identified RUO research data only. No PHI and no patient reporting.

  3. Rights

    Customers retain underlying sample and study rights unless separate written terms say otherwise.