BioAesthetics Corporation announces a clinical study of its nipple reconstruction graft will be performed at Stanford Medicine beginning in 2021.
The BioAesthetics NACgraft biologic matrix is a decellularized skin allograft of the human nipple-areolar complex (NAC) intended to replace the NAC when lost due to mastectomy or other procedure. BioAesthetics hopes the NACgraft will improve the quality-of-life — including improved 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 have often-unsatisfactory results.
The clinical study will follow, over a 12-month period, 15 patients who receive nipple reconstruction with the BioAesthetics NACgraft and previously underwent autologous breast reconstruction as part of treatment for breast cancer. 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.gov under “Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts.”
Geoffrey C. Gurtner, MD, Professor of Surgery and Inaugural Vice Chairman of Surgery for Innovation at Stanford Medicine, is the principal investigator for the study. Also participating in the clinical study are Arash Momeni, MD, Assistant Professor of Surgery in the Division of Plastic and Reconstructive Surgery at Stanford Health Care, and Dung Nguyen, MD, Director of Breast Reconstruction at the Stanford Women’s Cancer Center and the Director of Adult Plastics Clinic at Stanford Health Care.
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 FDA, which BioAesthetics has done. BioAesthetics expects to begin offering its NACgraft to all patients, not just those enrolled in the clinical study, in 2021.
“I have been following BioAesthetics from the early days when the NACgraft was just an idea. Nipple reconstruction has been the limiting factor for a complete breast reconstruction. I’m excited to see this product become available to patients and look forward to offering it to mine.”
— Scott K. Sullivan, MD, Founding Partner of the Center for Restorative Breast Surgery and the St. Charles Surgical Hospital and a member of BioAesthetics’ Scientific Advisory Board
“We are excited to collaborate with Stanford for this clinical study and look forward to offering the BioAesthetics NACgraft to all patients in 2021. I can hardly believe that what was just a late-night idea in graduate school is now ready for patients and hopefully will make a positive impact on their quality-of-life. I am proud of all of the hard work the BioAesthetics team has done and grateful for the support of our investors without whom this could not happen.”
— Nicholas C. Pashos, PhD, Founder and CEO of BioAesthetics
[Source(s): BioAesthetics Corporation, Business Wire]