SBIR Phase II: Bioprinted fat grafts for improved nipple reconstruction after breast cancer

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the delivery of a custom-made nipple made from a patient's own cells for women who have had a mastectomy due to breast cancer. In the US about 300,000 women are diagnosed with breast cancer annually and nearly 40% will undergo mastectomies, full removal of the breast. A third of them will opt for breast reconstruction, most of whom will desire a nipple. Patients with loss of the nipple areola complex (NAC) from cancer treatments continue to experience psychological distress long after breast mound reconstruction has taken place, yet currently available options for nipple reconstruction are vulnerable to an unpredictable degree of loss of nipple projection, symmetry, color and possible need for reoperation. The technology can be evolved to treat other unmet needs in reconstruction and the cosmetic surgery field. The technology in this project can contribute to the scientific knowledge fundamental to the fields of Tissue Engineering and Regenerative Medicine. The results of this research will help the field move towards larger, clinically relevant tissues and potentially the creation of whole organs. This project will investigate, develop tools and techniques, and select best formulation for the ultimate delivery of a graft that has been tissue engineered to address the lack of reconstructive solutions for women that have undergone mastectomies and desire nipple reconstruction. The research aims of the Phase II project will demonstrate further viability of the scientific concepts proposed, such as impact of vascularization on volume retention, and develop tools/techniques for engineering shaped adipose tissue constructs (relevant to nipple projection). The project will test and select best formulation for adipose constructs as measured by in vivo volume retention, host reaction and vascular infusion. The research proposes to further optimize size and projection parameters and develop methods to assess and characterize incoming materials to reproducibly fabricate constructs with the correct size and desired volume retention.