Born out of an academic-industry collaboration, Amicidins are synthetic proteins engineered to combine beneficial phys. properties (e.g., barrier to block, surfactant to cleanse) with broad, non-antibiotic microbicidal activity. Their dual mode of action (MOA) - phys. and microbicidal - replaces and augments our natural defenses in order to prevent and treat infection. Amicidin-based products are being developed to address infections, whether caused by bacteria, fungi, or viruses, before they progress to life-threatening sepsis.<br/><br/><b>Amicidin-α Surgical Gel to prevent infection.</b> Amicidin-α synthetic protein has been engineered to mimic the dual protective elements of human skin: phys. barrier (like collagens and keratins) and non-antibiotic microbicidal activity (like defensins). Amicidin-α Surgical Gel will be applied intraoperatively to exposed tissues, reducing risk of infection by blocking microbial contamination and killing microbes that are already present. Preclin. proof-of-concept has been achieved in multiple studies using three animal models. GLP toxicol. studies have begun and feedback has been received from the FDA in a pre-IND face-to-face meeting. Phase 1 clin. trials are planned.<br/><br/><b>Amicidin-β Solution to treat contamination and infection.</b> Amicidin-β synthetic protein combines surfactant (detergent-like) properties with broad, non-antibiotic microbicidal activity. Its dual MOA enables enhanced performance on contaminated or infected tissues. Tissue cleansing / debridement, microbial killing, and anti-biofilm effects are all part of the process. A high clin. priority is the use of Amicidin-β Solution as an adjunct to surgical management of life-threatening orthopedic hardware related infections, including prosthetic joint infections. Amicidin-β is in late-stage preclin. development; feedback has been received from the FDA in a pre-IND face-to-face meeting. Phase 1 clin. trials are planned.<br/><br/>As part of the presentation, we hope to provide insights into lessons learned regarding intellectual property, manufacturing, and approaches to regulatory bodies.