SBIR Phase I: Novel Scaffold for Nipple Areolar Regeneration

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be the ability to regenerate the nipple areolar complex after mastectomy. Breast cancer affects 1 in 8 women and many must undergo mastectomy, which results in the loss of the breast including the nipple. Patients report not feeling whole or complete after the loss of their nipples and this can have a devastating psychological impact on quality of life. Current nipple areolar reconstructive techniques use a surgical skin flap, where skin on the reconstructed breast is cut and sutured together to recreate the appearance of a nipple, and then tattooed for desired pigmentation. After reconstruction, only 13% of patients report being totally satisfied with their nipple reconstruction, flattening being the most common reason for dissatisfaction. Instead of just recreating the appearance of a nipple, this project enables patients to regenerate the nipple areolar complex using an acellular nipple areolar graft. The broader impact of this project would be transforming the clinical standard of care, resulting in improved outcomes and quality of life for women during their cancer survivorship. Additionally, this project further advances the understanding of extracellular matrix grafts for complex soft tissue reconstruction. This Small Business Innovation Research (SBIR) Phase I project will focus on investigating cellular ingrowth into the acellular nipple areolar graft through in vivo studies. The graft is created through a patented technique, in which the DNA and cellular components are removed from donor nipple areolar tissue, leaving behind an acellular extracellular matrix scaffold. The key challenges in bringing this technology to market center on demonstrating feasibility of cellular infiltration to the entirety of the graft and maintained nipple projection. The experiments proposed in this project investigate the graft cellular infiltration, biocompatibility, nipple projection, and pigmentation in vivo. The successful completion of the proposed studies in this project will facilitate advancement of this research and support studies for clinical application. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.