Pluris Research, Inc.

A contract research organization CRO specialized in providing pre-clinical studies for consumer, medical, and surgical product research and development.

Pluris Research, Inc. was established in 2001 and is located in Franklin, TN.

We are an independent, private, state of the art surgical research laboratory specialized in providing pre-clinical studies for consumer-medical-surgical product research and development. We are dedicated to our Sponsors providing the best preclinical research support services possible designed for clinical relevance with direct communication with the Study Director throughout the study.

We have many models and years of experience, both clinical and preclinical, in studies for wound healing (dressings, debridement, topicals, collagen, etc.), infection potentiation (antibacterial sutures, dressings, barrier-sealants), implantable devices, bone healing (including fusion), pharmacology (pk and dose response) of pharmaceuticals, systemic toxicity studies, and more. We provide histology, quantitative microbiology, in-vivo biomechanical testing (BTC-2000™ ), clinical chemistry … and more.

Our models are pre-approved so we can initiate studies without delay. We perform pilot and definitive studies, both non-GLP and GLP. Studies are scientifically designed to evaluate the safety, efficacy, and product performance to support regulatory claims substantiation and FDA submission.

Wound healing:

• Acute surgical induced wounds (incisional, excisional, and partial thickness) for testing wound care products and dressings.
• Burn wounds (full and partial thickness) for testing wound care products and dressings.
• Burn wound eschar debridement model.
• Ischemic delayed compromised full thickness wounds for testing products that improve chronic wound healing and hypertrophic scar.
• Infected wounds, for products that treat or prevent wound infection, with quantitative microbiology.
• Bio-mechanical incisional wound model to test the strength of wound closures (sutures, surgical adhesives) or the effects of products on the wound healing process.

In-vitro Skin testing for Skin Barriers and Cleansers:

• In-vitro skin model to test products for skin barrier protection.
• In-vitro skin model to test products for skin cleansing.

In-vivo Skin Testing, Topical or Technology:

• In-vivo skin model for testing bio-mechanical properties of skin (softness, firmness, elasticity) and the effects of treatments.
• Skin erythema model (test products for reduced redness).

Antibacterial and Antimicrobial Sutures, Surgical Tissue Adhesives, BioFilms, IVs and Dressings:

• In-vivo and In-vitro Quantitative Microbiology assay to test the growth response of antibacterial and antimicrobial sutures (colonization and zone of inhibition).
• In-vivo and In-vitro Quantitative Microbiology assay to test the barrier protection of surgical adhesives.
• In-vivo and In-vitro Antimicrobial efficacy testing for dressings and biofilms.

Wound Hemostasis:

• Splenic wound model to assess product performance for hemostasis.
• Partial thickness skin wound model to assess product performance for hemostasis.

Dressing Adherence Strength:

• Partial thickness wound model to test dressing-wound adherence strength for non-adherent dressings-gauze.

Bone Allograft, Fillers, and Osteoinductivity:

• Femur defect surgical model to assess products in bone healing.
• Spinal fusion surgical model assess products in bone healing.
• In-vivo sub muscular model (muscle pouch) to assess osteoinductivity.

Implantable Materials, Injectables, Including Local Tolerance and Systemic Toxicity:

• In-vivo models for surgical implantation, injection, with clinical observations, and specimens collected for histopathology.
• In-vivo models for evaluation of injectables, dermal graft and mesh materials.

Breast Implants, Silicone Cohesive Gel, and Tissue Expanders:

• In-vivo sub muscular implantation and evaluation (capsular contracture, histology of textured surface interface).
• In-vivo subQ model for histological evaluation of implant material interface.
• In-vitro testing for cohesive silicone gel material properties.
• In-vitro morphological analysis of implant and expander shape using a computerized simulated human model.

These established models have been used extensively for preclinical evaluation of product performance and are well documented in the literature. Additional models, including custom models, may be considered as required by the Sponsor.