OUR TECHNOLOGY

Two AI platforms driving cell therapy and biologics to market.

Oracle and Delfi — our proprietary AI platforms — are the operating system for how we develop new medicines. They orchestrate every high-risk decision across the lifecycle of our cell therapy modalities and biologics programs, from candidate selection through clinical execution.

AI PLATFORMS

Oracle and Delfi — the operating system for AI-native drug development.

Two proprietary AI platforms, purpose-built for the modalities we develop — cell therapies and biologics — with every module tuned to the decisions that determine whether new medicines reach patients.

PLATFORM ONE · CELL THERAPY INTELLIGENCE

Oracle

From disease to stem cell to manufacturing — Oracle selects the right cell type, designs the QC framework, and builds the bioreactor blueprint.

Disease-to-cell matching with biological rationale and clinical precedent
Marker panels, release criteria, and AI scoring frameworks for QC
Bioreactor selection, media formulation, feed schedules, DO/pH setpoints
Research-to-commercial scale-up paths for every validated cell type

PLATFORM TWO · PHARMA R&D INTELLIGENCE

Delfi

Disease to target to candidates to trials to go/no-go — Delfi drives the decisions that determine whether a program advances or dies.

Candidate identification with competitive landscape (10+ programs per area)
Trial recruitment, eligibility screeners, and regulatory-ready AE reports
Toxicity, tolerability, and efficacy forecasts with confidence levels
GO / CONDITIONAL / NO-GO decision reports with full rationale

CELL THERAPY MODALITIES

Live, GMP-grade stem cells — advanced through Oracle's manufacturing intelligence.

Oracle orchestrates the development and manufacturing of two complementary stem cell modalities — patient-derived (autologous) and off-the-shelf (allogeneic) — engineered to specifically target and regenerate damaged tissue in osteoarthritis, degenerative disc disease, and beyond.

MODALITY ONE

ChondroStem™ — Autologous Therapy

Our advanced ChondroStem™ modality is based on the patient's own bone marrow stem cells. Using autologous sourcing, ChondroStem™ has shown to be a successful treatment for osteoarthritis and degenerative disc disease, with no risk of immune rejection and a strong clinical safety profile across more than a decade of published research.

Patient's own bone marrow as source material

Closed-loop manufacturing with multiple QC checkpoints

Intra-articular or intradiscal delivery at the point of care

Phase 3 clinical program in knee osteoarthritis

MODALITY TWO

Allogeneic Therapy

Utilizing our proprietary technology, we bring live, resilient stem cells directly to the bedside through our allogeneic modality. This off-the-shelf approach addresses the manufacturing scalability challenges that have hindered cell therapy adoption, while facilitating the same targeted tissue regeneration — a transformative solution for medical needs at scale.

Off-the-shelf, ready-to-use stem cell product

Master cell bank approach for consistency and scale

CD146+ release specifications enforced by Oracle's QC framework

Allogeneic platform in active development

SCIENTIFIC FOUNDATION

CD146 — the biomarker that defines effective stem cell therapy.

A decade of research has demonstrated that CD146 expression identifies the mesenchymal stromal cell subpopulation with superior immunosuppressive and regenerative capacity. Our platform enforces CD146+ ≥95% at release — a first-principles specification that other MSC products lack.

Why CD146 matters

Mesenchymal stromal cells (MSCs) are a heterogeneous population — and most cell therapy failures happen not because of biological inadequacy, but because the wrong subpopulation gets manufactured at scale. CD146+ MSCs show markedly higher immunosuppressive and regenerative capacity than CD146-low populations.

By engineering our manufacturing process to enforce a CD146+ ≥95% release specification — backed by Oracle's QC framework — we ensure that every dose delivered to a patient contains the cells capable of generating therapeutic outcomes.

40%

Survival advantage in Kaplan-Meier analysis

CD146-enriched MSCs delivered 40% survival at 48 days vs 0% for wild-type, CD146-depleted, and control populations — establishing CD146 as a functional, not just phenotypic, marker.

Bikorimana et al. Cells, 2022. PMID 35892560

PEER-REVIEWED PUBLICATIONS

Our science, validated.

Our clinical and translational findings have been published in peer-reviewed journals over more than a decade of research.

[01]

CD146 Defines a Mesenchymal Stromal Cell Subpopulation with Enhanced Suppressive Properties.

Bikorimana JP, Saad W, Abusarah J, et al. Cells · 2022; 11(15):2263 · DOI 10.3390/cells11152263 · PMID 35892560 ↗

[02]

Bone marrow aspirate concentrate versus platelet-rich plasma for treating knee osteoarthritis: a one-year non-randomized retrospective comparative study.

El-Kadiry AE, Lumbao C, Salame N, Rafei M, Shammaa R. BMC Musculoskeletal Disorders · 2022; 23(1):23 · DOI 10.1186/s12891-021-04910-5 · PMID 34980045 ↗

[03]

Engineering immunoproteasome-expressing mesenchymal stromal cells: A potent cellular vaccine for lymphoma and melanoma in mice.

Abusarah J, Khodayarian F, El-Hachem N, et al. Cell Reports Medicine · 2021; 2(12):100455 · DOI 10.1016/j.xcrm.2021.100455

[04]

Thymoproteasome-Expressing Mesenchymal Stromal Cells Confer Protective Anti-Tumor Immunity via Cross-Priming of Endogenous Dendritic Cells.

Bikorimana JP, El-Hachem N, El-Kadiry AE, et al. Frontiers in Immunology · 2021; 11:596303 · DOI 10.3389/fimmu.2020.596303

[05]

Autologous BMAC Therapy Improves Spinal Degenerative Joint Disease in Lower Back Pain Patients.

El-Kadiry AE, Lumbao C, Rafei M, Shammaa R. Frontiers in Medicine (Lausanne) · 2021; 8:622573 · DOI 10.3389/fmed.2021.622573 · PMID 33816523 ↗

[06]

Intralesional Injection of Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Knee Secondary to Systemic Lupus Erythematosus: A Case Report.

Kouroupis D, Ahari AF, Correa D, Shammaa R. Frontiers in Bioengineering & Biotechnology · 2020; 8:202 · DOI 10.3389/fbioe.2020.00202