IDE study
19-004 is an ongoing clinical study conducted in some of the top medical centers in the U.S. The study investigates the use of DuraSorb® to support a tissue expander in two-stage breast reconstruction using both dual plane and pre-pectoral techniques.
The study is supported by a grant from the National Cancer Institute and is the first-of-its-kind to be approved by the U.S. FDA under an Investigational Device Exemption (IDE).
On-label observational study
SIA 19-002 is an ongoing post-market registry study of DuraSorb in various soft tissue support procedures in general and plastic surgery. Over a dozen academic and private-practice surgeons using DuraSorb across the U.S. are building a database of real-world evidence for this next-generation bioabsorbable mesh. Presented at the American Society of Plastic Surgeons’ PSTM in 2019
Preclinical study
Biomechanical and Histologic Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair. Presented at Plastic Surgery Research Council 2019
The information contained in this website is intended for Health Care Professionals in the U.S. Patients should contact their physicians for additional information.
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Dr. Sisco is Chief of Plastic Surgery at NorthShore University HealthSystem in Evanston, IL and Clinical Associate Professor of Surgery at University of Chicago. His practice focuses on breast reconstruction and aesthetic surgery of the face and body. As an avid researcher, he has produced over 40 peer-reviewed articles and presentations, and performed pioneering laboratory research on scar formation and healing.
Dr. Karp is a Professor of Plastic Surgery at NYU School of Medicine, Vice Chair of Clinical Operations at Hansjörg Wyss Department of Plastic Surgery, and Chief of Plastic Surgery and Director of the Breast Service at NYU-Tisch Hospital. He specializes in breast and body contouring plastic surgery and has extensive experience in all areas of breast surgery. He has authored over 10 chapters and 100 peer-reviewed papers, with particular focus on 3D scanning to plan and follow plastic surgery of the breast, and internal support for aesthetic and reconstructive breast surgery.
John is a serial entrepreneur who co-founded three medical device companies and brings 15 years of operating CFO experience to SIA. John was most recently CFO/Co-Founder of Attune Medical, manufacturer of a novel patient temperature management device with scaling global sales. Prior to that, John co-founded Farapulse (formerly known as Iowa Approach), a company pioneering a disruptive atrial fibrillation ablation technology funded by Boston Scientific (NYSE: BSX) and several venture capitalists. Previously, John was CFO/Co-Founder of Corvida Medical, a device he invented and commercialized to enable safer delivery of chemotherapy medications. John holds multiple patents and received a Bachelor’s Degree in Finance from University of Iowa.