SBIR-STTR Award

Using 3D Bioprinting for Nipple Areola Complex (NAC) Reconstruction
Award last edited on: 2/17/15

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$150,000
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Scott F Collins

Company Information

TeVido BioDevices LLC

10931 Jollyville Road Building 100
Austin, TX 78759
   (512) 828-2596
   info@tevidobiodevices.com
   www.tevidobiodevices.com
Location: Single
Congr. District: 10
County: Travis

Phase I

Contract Number: 1R43CA186666-01
Start Date: 9/30/14    Completed: 6/30/15
Phase I year
2014
Phase I Amount
$150,000
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 Statement:


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.

Project Terms:
3D Print; Address; Adipocytes; Adipose tissue; Affect; analog; Animal Model; Animals; Appearance; Area; Areola; authority; Autologous; Award; base; Biomedical Engineering; Blood Vessels; Body Image; Breast; Businesses; Cancer Survivor; Cell Shape; Cells; Cellular Structures; Client satisfaction; Collaborations; Color; Complex; Custom; Data; Development; Diagnosis; digital imaging; Dimensions; Drug Formulations; Emotional; Endothelial Cells; Engineering; Excision; experience; Fatty acid glycerol esters; Fibrin; Goals; Grant; Hispanics; Hypersensitivity skin testing; Image Analysis; Implant; implantation; improved; In Vitro; in vivo; Incidence; Infusion procedures; Investigation; malignant breast neoplasm; Malignant Neoplasms; Mammaplasty; Mastectomy; Measures; melanocyte; Methods; Minor; Molds; mouse model; Nipples; Nude Mice; Operative Surgical Procedures; Output; Patients; Pattern; Phase; Pigment Epithelium; Pigmentation physiologic function; Pigments; Plastic Surgeon; pre-clinical; Procedures; Process; psychological distress; public health relevance; Quality of life; Reaction; reconstruction; Recreation; Regenerative Medicine; Repeat Surgery; Research; Research Personnel; research study; Running; Sepharose; Shapes; Skin; Small Business Innovation Research Grant; soft tissue; Solutions; Specific qualifier value; Structure; subcutaneous; Surgical Flaps; Survivors; Tattooing; Techniques; Technology; Texas; Texture; Time; Tissue Engineering; tool; Universities; Vascularization; Woman; Work

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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