Research Foundation

Science & Evidence

Scientific Research Approach

AriaNova Bio's research programs are built on systematic laboratory validation. The King Skin wound-care program is currently in the in vitro validation stage, with six studies underway at CIC St. Louis — a leading life sciences research and incubation center in Missouri. Each study is designed to generate mechanistic and safety evidence aligned with FDA guidance for topical wound-care therapeutics.

The program draws on historical case observations from documented clinical use in Iran, which inform the research design and support the scientific rationale for formal validation. These observations are not controlled clinical trials and do not constitute regulatory evidence; they serve as the motivating foundation for the current laboratory program.

King Skin Program Publications

Evidence-First Development

Every therapeutic claim is supported by reproducible laboratory data before advancing to the next regulatory stage.

Rigorous In Vitro Methodology

Studies follow standardized protocols aligned with FDA guidance for topical wound-care therapeutics.

Natural Compound Formulation

Herbal-based active ingredients selected for documented traditional use and favorable safety profiles.

Transparent Publication

Completed study results will be submitted for peer review and published in indexed biomedical journals.

AriaNova Bio laboratory research for King Skin wound-care program

About the Program

King Skin is a research-stage herbal ointment formulated to support the healing of chronic and acute wounds. The product has been used clinically in Iran with documented outcomes across Many patients, demonstrating a healing timeline of one to three weeks.

AriaNova Bio is now conducting systematic in vitro validation at CIC St. Louis to generate the scientific evidence required for an FDA regulatory submission. This work is supported by a $10,000 USTAAR Venture Catalyst grant from the University of Miami.

Herbal-based, natural compound formulation
Clinically used in Iran with documented outcomes
In vitro validation underway at CIC St. Louis
FDA regulatory pathway in progress

In Vitro Research Program

Six validated laboratory tests form the scientific foundation of the King Skin regulatory submission.

Wound Scratch Assay

Measures the rate of cell migration to close a simulated wound gap, directly modeling wound closure kinetics.

Cell Viability

Assesses whether the formulation supports or inhibits the survival of skin and wound-relevant cell lines.

Cell Proliferation

Quantifies the ability of the formulation to stimulate new cell growth essential for tissue regeneration.

Cytotoxicity

Evaluates the safety profile of the herbal compounds at therapeutic concentrations.

Antimicrobial Activity

Tests efficacy against common wound-associated bacterial pathogens to support infection control claims.

Anti-Inflammatory Testing

Measures reduction of inflammatory markers relevant to chronic wound environments.

Experimental Methodology

Each study is designed to isolate a specific mechanism of action — cell migration, proliferation, viability, cytotoxicity, antimicrobial activity, and inflammation — providing a multi-dimensional evidence package for the regulatory dossier.

Standardized cell-line models for reproducibility across assays
Dose-response characterization at therapeutically relevant concentrations
Positive and negative controls included in all study designs
GLP-aligned documentation and data integrity protocols
Independent scientific oversight at CIC St. Louis

Study Site

All in vitro studies are conducted at CIC St. Louis, a leading life sciences research and incubation center providing access to certified laboratory infrastructure and expert scientific oversight.

Funding

The in vitro validation program is supported by a $10,000 USTAAR Venture Catalyst grant from the University of Miami, awarded to advance the King Skin formulation toward U.S. regulatory submission.

Current Evidence Status

AriaNova Bio distinguishes clearly between completed historical observations, ongoing laboratory studies, and future regulatory milestones.

Historical Observations

Completed

Documented case observations from clinical use in Iran across chronic wounds, diabetic foot ulcers, and severe burns. These are observational records, not controlled clinical trials, and do not constitute regulatory evidence.

In Vitro Validation

In Progress

Six laboratory studies currently underway at CIC St. Louis. Results are pending. No study outcomes have been published or submitted for peer review at this time.

Regulatory Submission

Planned

Compilation of in vitro data, safety documentation, and manufacturing information for FDA pre-submission consultation. The applicable regulatory pathway will be determined based on final product classification.

Explore the Research

Learn more about the King Skin program, review our publications, or get in touch with the AriaNova Bio research team.

King Skin Program Publications Contact Us