Our regenerative efficacy testing platforms enable sponsors to evaluate next-generation therapies across ocular, musculoskeletal, and systemic disease models in NHPs, providing translational insights into safety, durability, and functional restoration. We design studies that integrate quantitative imaging (MRI, OCT, CT, PET), tissue histology, immunohistochemistry, and biomarker profiling to assess regenerative processes at multiple levels—structural, cellular, and functional. These models support testing of stem cell therapies, gene-modified constructs, scaffold-based implants, and advanced biologics, with endpoints tailored to therapeutic class and target tissue. Functional recovery is evaluated through behavioral assays, biomechanical testing, electrophysiology, and quantitative scoring systems, while long-term efficacy is measured through serial imaging and histological endpoints that map tissue integration and durability.

 

Our platforms also incorporate immunological profiling to evaluate adaptive and innate immune responses, ensuring that regenerative candidates are tested for both efficacy and tolerability under clinically relevant conditions. All studies are conducted in AAALAC-accredited facilities with GLP compliance, aligning outputs with FDA and EMA expectations for IND or CTA submission. By combining rigorous methodology, regulatory alignment, and translational expertise, our regenerative testing programs deliver the reproducible data packages required to accelerate novel therapies into clinical practice, reducing developmental risk while maximizing clinical impact.