of Phase II programs advanced to Phase III in the BIO/Informa/QLS 2011–2020 benchmark.
Translational infrastructure for cardio-renal R&D
Make better preclinical decisions where current systems fail.
Corelia Bio is developing HETS™—a focused Human Engineered Tissue System for CKD-driven cardiac injury and fibrosis. It connects disease context, engineered tissues, decision-relevant readouts, and a live partner question.
Current phase: customer discovery, validation design, and two written design-partner agreements before the full experimental build.
The broken decision
Translation fails when the model cannot support the decision.
Cardio-renal programs often reach critical decisions with incomplete human-relevant evidence. HETS™ is designed to connect the partner question to a transparent prioritization or go/no-go output.
FDA is advancing validated human-relevant approaches, including organ chips, computational methods, and advanced in-vitro systems.
HETS™ decision workflow
From one live R&D question to a decision-ready evidence package.
Disease context, model design, readouts, and acceptance criteria are defined around the partner question.
Live R&D decision
Target, mechanism, biomarker, compound, or go/no-go question.
Disease context
CKD stress biology, cardiac remodeling, and acceptance criteria.
Human tissue system
Proposed renal and engineered myocardial modules with controlled exposure.
Readout package
Function, morphology, secreted factors, molecular profiles, and response.
Partner decision
Prioritize, refine, advance, stop, or define the next experiment.
Proposed workflow. Corelia Bio’s intended advantage is the full decision architecture—not a single isolated tool.
Measure what the tissue does.
Contractility, relaxation, calcium handling, and intervention response.
See how disease remodels tissue.
Fibrosis, matrix organization, morphology, integrity, and stiffness.
Connect phenotype to mechanism.
Secreted factors, focused molecular panels, and response signatures.
Turn evidence into action.
Prespecified criteria to prioritize, refine, advance, or stop.
First proof point
Start with one high-value wedge: CKD-driven cardiac injury and fibrosis.
Corelia Bio’s first evidence package will test whether CKD stress can reproduce cardiac fibrosis, stiffness, and HFpEF-relevant dysfunction with prespecified functional and molecular readouts.
Status: validation design and design-partner phase · first physical evidence package targeted for Q1 2027
CKD stress biology
Uremic, inflammatory, metabolic, and endothelial signals.
Cardiac remodeling
Fibrosis, stiffness, stress response, and HFpEF-relevant dysfunction.
Decision-grade readouts
Function, biomarkers, structural biology, and molecular response.
Partner value
Prioritize targets and mechanisms, refine biomarkers, or differentiate compounds.
What partners can decide
Does the candidate pathway modify CKD-driven cardiac remodeling?
Which signatures track with functional rescue?
Which candidate produces the strongest rescue profile?
Differentiation
Existing tools answer part of the question. HETS™ is designed around the complete decision.
The proposed advantage is human tissue context, heart–kidney crosstalk, and partner-defined decision utility.
| Approach | Human context | Organ crosstalk | Typical decision value |
|---|---|---|---|
| 2D cell assays | Reductionist | Minimal | High-throughput screening and focused mechanism tests |
| Animal models | Indirect | Systemic but species-dependent | Integrated biology with translation risk |
| Single-organ chips | Human-relevant | Limited to one organ or interface | Focused tissue response and safety questions |
| Proposed HETS™ workflow | Human engineered tissues | Cardio-renal interaction by design | Target, mechanism, biomarker, compound, and go/no-go evidence |
Positioning statement, not comparative performance data. HETS™ remains in validation-design phase.
Partner with us
A strong design partnership begins with one decision your team must make.
Best fit: translational R&D teams with an active CKD–HFpEF, fibrosis, or cardio-renal program and a near-term decision.
Co-design
Define the decision, inputs, endpoints, acceptance criteria, and scientific champion.
Written scope
Agree the workflow, controls, outputs, limitations, and decision rule.
Scoped paid pilot
Generate the evidence package and agree the follow-on—or stop.
Partners bring
- One live R&D decision
- Scientific champion and relevant inputs
Corelia Bio brings
- Fit-for-purpose study design
- Integrated evidence strategy
Success looks like
- Written design scope
- Clear pilot, follow-on, or stop decision
Validation gates
Build the evidence in stages. Make each gate measurable.
HETS™ is a TRL 2 concept without integrated experimental proof-of-concept data. Public claims distinguish rationale, proposed design, and future Corelia-generated evidence.
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Current gate
Design-partner discovery
15–20 interviews, two written scopes, one live decision.
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Gate 1
Baseline robustness
Stable modules and predefined variability thresholds.
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Gate 2
Disease phenotype and specificity
Reproducible remodeling beyond nonspecific toxicity.
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Gate 3
Responsiveness
A reference intervention partially normalizes the phenotype.
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Gate 4
Translational mapping and pilot conversion
Map signatures to clinical or partner data and convert to a paid pilot.
Investor brief
A focused pre-seed plan with explicit conversion gates.
Capital will fund one partner-ready HETS™ proof package and at least one structured paid pilot.
Pre-seed validation capital.
Interviews → scopes → proof → paid pilot.
Active CKD–HFpEF/fibrosis programs.
Technical gates, buyer commitment, and repeat demand.
Founder and traction
Built from firsthand experience with the translation gap.
Ronald St-Louis, PhD, brings 12+ years across diabetic kidney disease, CKD, cardiometabolic disease, fibrosis, target validation, and cross-functional drug discovery.
Evidence architecture
Publish evidence as the platform earns it.
Current materials define the context of use, validation gates, and partner decision.
HETS™ context of use
Model boundary, endpoints, acceptance criteria, and limitations.
Request the briefWhy CKD-driven cardiac fibrosis?
A focused wedge linking stress biology, remodeling, and functional rescue.
Review the first use caseWhat makes a readout useful?
It must be reproducible, interpretable, and linked to a concrete decision.
See the workflowBring us one live decision
Bring one live R&D decision.
Corelia Bio is opening conversations with design partners, strategic investors, and biotech/pharma advisors.
Context sources
BIO / Informa Pharma Intelligence / QLS Advisors — Clinical Development Success Rates 2011–2020
U.S. FDA — New Approach Methodologies (NAMs)
External statistics describe industry context. HETS™ is currently a proposed workflow in validation-design phase and is not presented as experimentally validated.