BioAesthetics Plans Additional Clinical Study for Regenerative Nipple Graft
Research Triangle Park-based BioAesthetics Corp., a biomaterials company that received early funding from the North Carolina Biotechnology Center, has announced an additional clinical trial of its lead product candidate, a biologically derived allograft for patients needing nipple reconstruction.
The new study will investigate the use of the company’s NACgraft in male and female patients, breast cancer survivors with or without radiation treatment, and patients who have not had breast cancer.
“There are several patient populations who could benefit from the NACgraft in addition to female breast cancer survivors who have received autologous reconstructions,” said Nicholas C. Pashos, Ph.D., founder and chief executive officer of BioAesthetics. “We are excited make the NACgraft available for these patients as well.”
The new study will follow, over a 12-month period, about 36 patients who receive nipple reconstruction with the NACgraft. The main goal is to evaluate healing time, and secondary objectives are to assess patients’ satisfaction, well-being, self-esteem, body image, psychological well-being, nipple dimensions and sensitivity.
The study will be conducted by Scott Sullivan, M.D., at the Center for Restorative Breast Surgery in New Orleans and Beverly Hills, and Karen Horton, M.D., at San Francisco Plastic Surgery.
The study follows a previously announced study of NACgraft at Stanford Medicine focused on female breast cancer survivors who have undergone an autologous reconstruction without receiving radiation.
NACgraft is a tissue-engineered collagen scaffold in the shape of the human nipple-areolar complex (NAC) intended to replace the NAC when lost due to mastectomy or other procedure or incident. The patient’s body integrates the decellularized NACgraft as a building frame to regenerate his or her own nipple-areolar complex.
Currently available nipple reconstruction options such as prostheses, tattoos and skin flap reconstructions often have unsatisfactory results, according to BioAesthetics. The company hopes the NACgraft will improve the quality of life — including body image and other positive psychological impacts — of those choosing to undergo breast reconstruction.
Supported by NCBiotech
BioAesthetics was founded in 2015 as a spin-out of Tulane University in New Orleans and relocated to Research Triangle Park three years later.
In 2019 the Biotech Center provided the company a $100,000 Small Business Research Loan to establish quality systems and a manufacturing process for NACgraft. A year later the company received a $3,000 grant from NCBiotech’s Industrial Internship Program to host a biomedical engineering student from North Carolina State University for summer project work.
BioAesthetics subsequently raised $2.5 million in Series A venture capital funding and then doubled the fundraising goal to $5 million. The Series A round was co-led by FemHealth Ventures and personally by BioAesthetics’ Director Sandra Coufal, M.D., of Sibling Capital Ventures.