Development of the Biobreast

Biostruxs, Llc, Westlake Village CA

Investigators

Abstract

DESCRIPTION (provided by applicant): The most common malignancy in American women is breast cancer. Breast reconstruction for mastectomy currently involves two choices, implant or autologous tissue flap. Implant reconstruction is relatively simpler but is temporary, whereas flap reconstruction is permanent but much more complex. We propose here a novel method for breast reconstruction by implanting a novel three dimensional biodegradable scaffold. This scaffold is designed to accommodate the patient's own omentum and fat tissues. Over time, the scaffold would be completely resorbed, leaving the patient's autologous tissue in the form of a new breast. This new method would offer a third choice for breast reconstruction that may potentially be superior to the current options. The goals of this proposal are to perform necessary pre-clinical tests on the Biobreast scaffold device to enable a pre-IDE application to the FDA for approval of initiation of a future Phase 1 human clinical trial. Our specific aims are as follows: Aim #1: To carry out bench performance tests of the scaffold. Aim #2: To complete animal and toxicity studies of the scaffold. Aim #3: To submit a pre-IDE application to the FDA.