{"id":46946,"date":"2022-08-04T16:01:52","date_gmt":"2022-08-04T14:01:52","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/bioaesthetics-announces-additional-clinical-study-for-nacgraft\/"},"modified":"2022-08-04T16:01:52","modified_gmt":"2022-08-04T14:01:52","slug":"bioaesthetics-announces-additional-clinical-study-for-nacgraft","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/bioaesthetics-announces-additional-clinical-study-for-nacgraft\/","title":{"rendered":"BioAesthetics Announces Additional Clinical Study for NACgraft"},"content":{"rendered":"
\n

\nNACgraft Aims to Improve Quality-of-Life for Breast Cancer Patients<\/i>\n<\/p>\n

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–BioAesthetics Corporation<\/a> today announced an additional clinical study for the BioAesthetics\u00ae<\/i> NACgraft<\/i>\u2122 Acellular Allograft that will investigate its performance in subpopulations of breast cancer survivors and other individuals needing nipple reconstruction. The previously announced study<\/a> at Stanford Medicine focuses on female breast cancer survivors who have undergone an autologous reconstruction without receiving radiation. This new study will investigate the use of the NACgraft<\/i> in male and female patients, breast cancer survivors with or without radiation treatment, and patients who have not had breast cancer.\n<\/p>\n

<\/a><\/p>\n

\nThe NACgraft<\/i> 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. Currently available nipple reconstruction options such as prostheses, tattoos, and skin flap reconstructions often have unsatisfactory results. BioAesthetics hopes the NACgraft <\/i>will improve the quality-of-life \u2014 including body-image and other positive psychological impacts \u2014 of those choosing to undergo breast reconstruction.\n<\/p>\n

\nThis new clinical study will be conducted by Dr. Scott Sullivan at the Center for Restorative Breast Surgery<\/a>, in New Orleans, LA and Beverly Hills, CA and by Dr. Karen Horton at San Francisco Plastic Surgery<\/a>. The study will follow, over a 12-month period, approximately 36 patients who receive nipple reconstruction with the NACgraft<\/i>. The primary objective of the study is to evaluate healing time, with the secondary objectives being to assess patients\u2019 satisfaction, well-being, self-esteem, body image, psychological well-being, nipple dimensions and sensitivity. The study is listed on clinicaltrials.gov<\/a> under \u201cInvestigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft.\u201d\n<\/p>\n

\n\u201cWe are looking forward to working with Drs. Horton and Sullivan for this study,\u201d says Nicholas C. Pashos, Ph.D., Founder and CEO of BioAesthetics. \u201cThere are several patient populations who could benefit from the NACgraft<\/i> in addition to female breast cancer survivors who have received autologous reconstructions. We are excited make the NACgraft<\/i> available for these patients as well.\u201d\n<\/p>\n

\nThe NACgraft<\/i>, 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.\n<\/p>\n

\n\u201cThe unsatisfactory results of current nipple reconstruction techniques is the primary hindrance to achieving \u2018complete\u2019 breast reconstruction,\u201d 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\u2019 Scientific Advisory Board. \u201cThis study is the next step in advancing the NACgraft<\/i> to broad-use and we are excited to welcome new patients to the research.\u201d\n<\/p>\n

\n\u201cAs a breast cancer survivor myself, I know the challenges that cancer patients have with body image,\u201d says Dr. Sandra Coufal, BioAesthetics\u2019 Board member and Series A co-lead. \u201cHelping 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 study.\u201d\n<\/p>\n

\nFor more information on BioAesthetics, visit https:\/\/bio-aesthetics.com\/.<\/a>\n<\/p>\n

\nAbout BioAesthetics:<\/span><\/i><\/b>\n<\/p>\n

\nBioAesthetics 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\u2122 Acellular Allograft) 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.<\/i>\n<\/p>\n

Contacts<\/b> <\/p>\n

\ninfo@bio-aesthetics.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

NACgraft Aims to Improve Quality-of-Life for Breast Cancer Patients RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–BioAesthetics Corporation today announced an additional clinical study for the BioAesthetics\u00ae NACgraft\u2122 Acellular Allograft that will investigate its performance in subpopulations of breast cancer survivors and other individuals needing nipple reconstruction. The previously announced study at Stanford Medicine focuses on female breast … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-46946","6":"format-standard","7":"category-industry"},"yoast_head":"\nBioAesthetics Announces Additional Clinical Study for NACgraft - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/bioaesthetics-announces-additional-clinical-study-for-nacgraft\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioAesthetics Announces Additional Clinical Study for NACgraft - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"NACgraft Aims to Improve Quality-of-Life for Breast Cancer Patients RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–BioAesthetics Corporation today announced an additional clinical study for the BioAesthetics\u00ae NACgraft\u2122 Acellular Allograft that will investigate its performance in subpopulations of breast cancer survivors and other individuals needing nipple reconstruction. 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