Trending...
- Financial Solutions Inc. Receives the 2020 Best of Sheridan Wyoming Award
- Jim Taylor appointed Chairman of the Board Emeritus of Piedmont Advantage Credit Union
- North Carolina: Governor Cooper Sworn in for Second Term
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--BioAesthetics Corporation today announced 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."
More on ncarol.com
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," said 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. "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."
"We are excited to collaborate with Stanford for this clinical study and look forward to offering the BioAesthetics NACgraft to all patients in 2021," said Nicholas C. Pashos, Ph.D., Founder and CEO of BioAesthetics. "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."
More on ncarol.com
BioAesthetics recently announced that it surpassed its Series A funding goal with participating investors and previous seed investors including its Director Sandra Coufal, MD of Sibling Capital Ventures, IndieBio/SOSV, The Launch Place, FemHealth Ventures, NO/LA Angel Network, The Pelican Fund, New Orleans BioFund, Arizona Technology Investors, New Orleans Startup Fund, Hemi VC, and numerous individual angel investors.
For more information on BioAesthetics, visit https://bio-aesthetics.com/.
About BioAesthetics:
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; the company is currently validating its clinical manufacturing process in preparation for clinical launch of NACgraft. 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 Research Triangle Park, NC.
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."
More on ncarol.com
- Former CEO & Founder of Five Star Custom Foods, Acquired by Cargill, Joins CEO Coaching International
- Thiel College names Terry Eddy to Board of Trustees
- Carolina Ballet and LeithCars.com Now Dancing Across Your Television Screen
- Target RWE Acquires NoviSci Inc., Adding Significant Analytical Capabilities to Leading Real-World Evidence Platform
- Kuester Management Group Highlights Benefits of HOA Management for Small Associations
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," said 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. "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."
"We are excited to collaborate with Stanford for this clinical study and look forward to offering the BioAesthetics NACgraft to all patients in 2021," said Nicholas C. Pashos, Ph.D., Founder and CEO of BioAesthetics. "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."
More on ncarol.com
- "Diamond Fuji" to be Seen from TOKYO SKYTREE in February
- TransEnterix Announces Closing of $31.25 Million Registered Direct Offering of Common Stock
- Honda Aircraft Company Opens New Wing Production Facility
- Texpak Offers Environmentally-Friendly Ecotach™ Fasteners to Address Sustainability Needs
- Morningstar names Quantified STF Fund top-performing tactical-allocation fund in 2020
BioAesthetics recently announced that it surpassed its Series A funding goal with participating investors and previous seed investors including its Director Sandra Coufal, MD of Sibling Capital Ventures, IndieBio/SOSV, The Launch Place, FemHealth Ventures, NO/LA Angel Network, The Pelican Fund, New Orleans BioFund, Arizona Technology Investors, New Orleans Startup Fund, Hemi VC, and numerous individual angel investors.
For more information on BioAesthetics, visit https://bio-aesthetics.com/.
About BioAesthetics:
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; the company is currently validating its clinical manufacturing process in preparation for clinical launch of NACgraft. 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 Research Triangle Park, NC.
Filed Under: Business
0 Comments
Latest on ncarol.com
- North Carolina Central University Division of Student Affairs Presents Ready to Soar Conference
- Great Business Schools Releases National Rankings of Environmental Sustainability Master's Programs
- AI.Reverie Awarded $950 Million IDIQ Contract for U.S. Air Force Advanced Battle Management System (ABMS)
- Updated ASI Book Helps Association Executives Improve Organizational Performance Now and Post-COVID
- MBK Senior Living Ranks 7th On Fortune Best Workplaces For Aging Services List
- National Board of Certified Counselors, Inc. - Notice of Data Security Event
- North Carolina to Consider Climate Change Solution as Communities Feel Impacts
- Maison Fauna To Release 'Funk Decision' by Foundless
- Fifth Gen Media announces Darlene Pope as Chairman of the Advisory Council
- Maison Fauna to Release Footrocket's What We Learned EP
- Phinge To Launch Netverse, a Rewards-Based Alternative to Apple and Google Using Innovative Proprietary Technology and Patented Mobile Devices
- Kohler Generators Joins Roush Fenway Racing as an Anchor Partner on No. 6
- Spivey Hall Children's Choir Looks To 2021 Through The Lens of Langston Hughes Poetry
- Wohler releases AoIP & Analog options for their iVAM1-1
- Capco Appoints Dee McDougal as U.S. Head of Diversity, Equity & Inclusion
- Four Seasons Plumbing advises residents to be aware of frozen pipes this winter
- Venn Law Group Attorneys Recognized as Business North Carolina Magazine 2021 Legal Elite
- While Supplies Last: Thermal Transfer Label Sale
- The Business Consultant behind The First Black-owned BP
- Overstock Promo: Thermal Transfer Labels On Sale Now