Pre-Clinical Evaluation

Pre-Clinical Evaluation

Pre-Clinical In Vivo Evaluation Completed

Our initial in vivo study, executed to evaluate the scientific foundations and proof of concept of our bioelectrical modulation principles, was successfully completed on a sepsis model by independent investigators.

To ensure investigator blinding and absolute objectivity, this study was designed utilizing a hypothesis-agnostic approach based on the independent researchers' own mechanistic perspectives. Conducted on a rigorous model induced with a high-density bacterial load of  CFU under controlled laboratory conditions representing an acute mortality risk , this independent research evaluated over 100 parameters across multiple medical disciplines.

The objective data derived from this study are evaluated as translational evidence substantiating the "Bioelectrical Epigenetic Programming (BEP)" hypothesis and cellular restoration capability developed by AVB Biotechnology. Detailed evaluations of blood and tissue samples revealed no adverse effects, verifying the biocompatibility of the administered dosimetry model and exposure levels within the organism
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FINDINGS (In Vivo Data Summaries)

Antibacterial Activity (Pathogen Clearance): The method was observed to achieve a statistically highly significant reduction in circulating high-density bacterial load (bacteremia), contributing to robust pathogen clearance. Furthermore, biomarker evaluations and tissue examinations demonstrated the absence of systemic toxic effects and secondary tissue damages that typically arise from toxic components and cellular byproducts released during massive bacterial lysis.

Anti-inflammatory and Immunomodulatory Activity (Immune System): The application demonstrated a regulatory profile that balanced the immune response by suppressing systemic inflammatory processes and unchecked cytokine release (cytokine storm) triggered by sepsis. It was observed to support the preservation of immune homeostasis by optimizing the leukocyte profile at the cellular level.

Cytoprotective and Antiapoptotic Activity (Tissue and Organ Systems):

  • Circulatory System (Heart): The method was observed to contribute to preserving myocardial tissue integrity by mitigating myocardial fiber degeneration and necrotic processes.

  • Respiratory System (Lung): The application was determined to minimize severe inflammatory cell infiltration and associated tissue damage within the lung parenchyma induced by the septic state.

  • Digestive System (Liver): The mechanism suppressed the formation of pathological necrotic zones in liver tissues secondary to sepsis.

  • Cellular Level: By attenuating programmed cell death (apoptosis) across the evaluated target organs, the method exerted direct tissue and cell-protective (cytoprotective) activity.

Antioxidant Activity (Cellular Defense): The modality restored the disrupted oxidant/antioxidant equilibrium at the cellular level, effectively alleviating tissue oxidative stress and lipid peroxidation.

Systemic and Rheological Regulation (Blood Gases and Microcirculation): Contributing to the stabilization of metabolic/respiratory acidosis and hypoxic states secondary to sepsis, the approach normalized blood pH and blood gas parameters (, ) back to physiological baselines. Furthermore, it assisted in preserving microcirculatory fluid dynamics by regulating blood viscosity and shear stress.

The study has been published. You can access the full Turkish and English texts of this research in our Scientific Publications section.

Disclaimer: The pre-clinical (animal model) R&D data presented in this section are derived from findings published in peer-reviewed international scientific literature (PLOS ONE, 2021). This information is intended solely for scientific informational purposes and does not constitute a commercial therapeutic claim, medical advice, or diagnostic/treatment recommendation. The global regulatory clearance and clinical registration pathways for the method are currently ongoing.