Globally, in 2010, there were slightly more than 1 million incidences of breast cancer. In the US ~200,000 women are diagnosed with breast cancer annually and nearly 40% will undergo mastectomies, full removal of the breast. In the US in 2010, more than 93,000 breast reconstructions were performed due to cancer. Patients with loss of the nipple areola complex (NAC) from cancer excision continue to experience psychological distress long after breast mound reconstruction has taken place, yet currently available options are vulnerable to an unpredictable degree of loss of nipple projection, color and possible need for reoperation while issues with symmetry and breast-contour changes are common. The ultimate goal of this research is the delivery of an autologous NAC graft that has been tissue engineered to address these common issues, it will have a skin layer with pigmentation to match the existing nipple and a projection built of volume-stable adipose (fat) grafts layered into a single product for a plastic surgeon to apply in one setting. Plastic surgeons have indicated to TeVido that there is a significant need for a better solution.
The research aims of the Phase I award will demonstrate viability of the scientific concepts proposed and develop tools and techniques for engineering custom pigmented skin (relevant to the areola) and custom shaped adipose tissue constructs (relevant to nipple projection). TeVido will investigate and select best formulation for adipose constructs as measured by in vivo volume retention, host reaction and vascular infusion. Concurrently and independently, TeVido's bioprinting processes will be modified to produce a pigmented epidermal layer and the pattern of pigmentation of the formation will be assessed in vitro. Combined, these aims are the basis for addressing the two primary problems in NAC reconstruction in one minor surgical intervention. In Phase II, TeVido proposes to further optimize size and projection parameters and develop methods to assess and reproducibly fabricate constructs with the correct size, color and texture. Should Phase I be successful, Phase II work should result in pre-clinical animal studies. TeVido has a strong collaboration with and promotes research at the only Hispanic-Serving, Carnegie classified Research University, the University of Texas at El Paso, and will perform the work leveraging UTEP's new BioMedical Engineering facilities. The researchers have experience and expertise in tissue engineering, fibrin based neo-vascularization, bioprinted skin tested on a mouse model;and a leading authority on bioprinting for tissue engineering. Finally, TeVido is a women-founded and led technology business.

Public Health Relevance

This research will improve the quality of life for survivors of breast cancer who undergo breast reconstruction;in the US in 2010, more than 93,000 reconstructions were performed. Patients with loss of the nipple areola complex (NAC) from cancer excision continue to experience psychological distress long after breast mound reconstruction has taken place, yet currently available options are vulnerable to an unpredictable degree of loss of projection, color and possible need for reoperation while issues with symmetry and breast-contour changes are common. The ultimate goal of this research is the delivery of an autologous NAC graft that has been tissue engineered to address these common issues, it will have a skin layer with pigmentation to match the existing nipple and a projection built of volume-stable adipose (fat) grafts layered into a single product for a plastic surgeon to apply in one setting.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43CA186666-01
Application #
8715986
Study Section
Special Emphasis Panel (ZRG1-SBIB-Y (12))
Program Officer
Narayanan, Deepa
Project Start
2014-09-30
Project End
2015-06-30
Budget Start
2014-09-30
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
$150,000
Indirect Cost
Name
Tevido Biodevices, LLC
Department
Type
DUNS #
967853248
City
Austin
State
TX
Country
United States
Zip Code
78727