Injectable Products

With an injectable formulation of the Humacyte product, there are several different markets that can be addressed. For instance, an injectable filler can be used for soft tissue repair and augmentation or as a bulking agent in the urological markets.

Minimally invasive dermal procedures have increased 70% with nearly 17 million total procedures performed in 2007. Within this number are more than 1.5 million procedures using a soft tissue filler. Notably, sales of new filler products increased over 35% from 2006-2007. These numbers indicate the tremendous opportunity for a novel dermal filler that meets the needs of patients and their physicians. The Humacyte filler will be more durable than most products on the market, yet not permanent. The Humacyte product will fit nicely into this market space, given the unique characteristics, longer lasting yet not permanent, and novel composition of the product.

Bulking agents have been used for the management of stress urinary incontinence for more than a decade, but their application has been limited by durability and antigenicity or compatibility issues. Periurethral injection therapy has excellent short-term results as a minimally invasive procedure. In 2004, approximately 84,000 bulking agent procedures were performed in the United States. Long-term success is possible, but multiple re-injections are typically necessary. Substance composition should ensure lack of migration, lack of local inflammation and chronic tissue changes, facility of agent use, and an optimized host environment. Humacyte's product used as a bulking agent would be biocompatible, hypoallergenic, and stable on injection.