Our Technology
Ansella Therapeutics’ scientific team utilizes its expertise in materials science and biomedical engineering to create unique, “outside-the-box” therapeutic approaches inspired by inherent anatomy, physiology, biochemistry, and endocrinology.
UNIQUE COMBINATION OF GRAS INGREDIENTS
Our platform formulation technology comprises the development of an emulsified cream that uniquely combines specific combinations of well-known, generally recognized as safe (GRAS) ingredients that manifest a range of physicochemical properties to mimic the dynamic surface of the vaginal mucosa without the need for active ingredients. This emulsified cream formulation will serve as the base formulation across all our pipeline products, as this base formulation is designed to easily incorporate active ingredients to create a pipeline of over-the-counter (OTC) and prescription products across a number of vaginal health-based pathologies.
REDUCED COST, FASTER DEVELOPENT
We expect that our selection and transformation of solely GRAS ingredients will allow us to proceed along the 510(K) regulatory pathway through the CDRH, as our initial OTC product, ATX-001, is expected to be a Class II medical device with non-significant risk (NSR). The 510(K) regulatory pathway significantly reduces the costs and drastically expedites the development timeline toward FDA approval and registration.
