NACgraft Aims to Improve Quality-of-Life for Breast Cancer Patients
August 04, 2022
RESEARCH TRIANGLE PARK, NC –(BUSINESS WIRE)– BioAesthetics Corporation today announced an additional clinical study for the NACgraft to include additional subpopulations of breast cancer survivors and other individuals who may need a nipple reconstruction. The previously announced study at Stanford Medicine focuses on female breast cancer survivors who have undergone an autologous reconstruction without receiving radiation. This newly announced study will investigate the use of the NACgraft in male and female patients, breast cancer survivors with or without radiation treatment, and patients who have not had breast cancer.
The BioAesthetics® NACgraft™ Acellular Allograft is a biologically-derived allograft of the human nipple-areolar complex (NAC) intended to replace the NAC when lost due to mastectomy or other procedure or incident. BioAesthetics hopes the NACgraft will improve the quality-of-life — including body-image and other positive psychological impacts — of those choosing to undergo breast reconstruction, as current available nipple reconstruction options such as prostheses, tattoos, and skin flap reconstructions often have unsatisfactory results.
This new clinical study will be conducted by Dr. Scott Sullivan at the Center for Restorative Breast Surgery, in New Orleans, LA and Beverly Hills, CA, and by Dr. Karen Horton at San Francisco Plastic Surgery. This clinical study will follow, over a 12-month period, approximately 36 patients who receive nipple reconstruction with the BioAesthetics NACgraft. The primary goal of the study is to evaluate healing time, with the secondary objectives of assessing patients’ satisfaction, well-being, self-esteem, body image, psychological well-being, nipple dimensions and sensitivity. The study is listed on clinicaltrials.govunder “Open Label Case Reports Investigating Wound Healing, Aesthetic Outcomes and Patient Satisfaction Following Nipple-Areolar Complex Reconstruction Using a Decellularized Donor NACgraft.”
“We are looking forward to working with Drs. Horton and Sullivan for this study,” says Nicholas C. Pashos, Ph.D., Founder and CEO of BioAesthetics. “There are several patient populations who could benefit from the NACgraft in addition to female breast cancer survivors who have received autologous reconstructions. We are excited make the NACgraft available for these patients as well.”
The NACgraft, like other decellularized human tissues, is regulated as a human cell, tissue and cellular and tissue-based product (HCT/P) under section 361 of the Public Health Service (PHS) Act and 21 CFR Part 1271. Establishments engaged in manufacture of HCT/Ps are required to register with Food and Drug Administration, which BioAesthetics has done.
“Nipple reconstruction has been one of the areas lacking most in complete breast reconstruction,” says Scott K. Sullivan, M.D., Founding Partner of the Center for Restorative Breast Surgery and the St. Charles Surgical Hospital and a member of BioAesthetics’ Scientific Advisory Board. “This study is the next step in advancing the NACgraft progress and we are excited to welcome new patients to the research.”
“As a breast cancer survivor myself I know the challenges that cancer patients have with body image,” says Dr. Sandra Coufal, Board member BioAesthetics’ and Series A co-lead. “Helping women (and men) to restore their bodies with complete breast reconstruction is an exciting step and I look forward to the outcomes of this new trial.”
For more information on BioAesthetics, visit https://bio-aesthetics.com/.
BioAesthetics Corporation is a biotechnology company focused on transforming lives through advancements in biomaterials. Its inaugural product is a tissue-engineered nipple-areolar complex graft (NACgraft™ biologic matrix) for patients who are undergoing breast reconstruction generally following breast cancer and mastectomy. In addition, it has a product pipeline focused on acellular regenerative grafts for advanced wound and reconstructive care. BioAesthetics was founded as a spin-out of Tulane University in New Orleans, LA and is now located in Durham, NC.