DuraSorb®

Instructions for Use (US)

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DuraSorb®

Instructions for Use – EU

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DuraSorb® 19-004

Instructions for Use
Clinical study investigational product

Access the clinical study IFU using your login credentials, or request your password

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  1. Requirements for eIFU download: internet connection and Adobe Acrobat version X, Adobe Reader version X, or OSX Preview version X. Other PDF readers may work but have not been verified.
  2. To request a physical copy of the IFU or to resolve issue related to eIFU access, please contact SIA at info@sia.health or +1 (872) 870-0520
  3. Previous revisions of the DuraSorb Instructions for Use are available upon request or for download here. Revision 1, 2, 3, 4, 5

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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Merritt H. Spelina - Director of Customer Experience, Sales Analytics

Merritt leads customer experience and sales analytics at SIA following two decades thriving in roles that allow her to ethically serve companies and key corporate stakeholders. Merritt manages customer-facing sales operations and is working to establish best-in-class loyalty, customer engagement and internal reporting to drive business growth. With roles at Sientra (NYSE: SIEN), CBRE, Inc. and Lord Abbett & Co., LLC, Merritt has thrived within heavily-regulated fields while continuing to drive customer acquisition, retention, and revenue generation.

Nolan Karp, MD, FACS

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.

Todd Cruikshank, MBA - Chief Operating Officer

Todd has served as COO of SIA since 2016 and has nearly 15 years of experience developing and implementing operational strategies for healthcare companies. Todd previously operated at Baxalta within the Office of the CEO (acquired by Shire) and Baxter Healthcare (NYSE:BAX) holding positions of increasing responsibility in marketing, business intelligence and analytics within the Bioscience division focused on plasma-derived therapies for rare and orphan diseases. Todd has a B.A. degree in English from Illinois Wesleyan University and an M.B.A. from Northwestern Kellogg School of Management where he was a distinguished Zell Fellow.

John Slump, Chief Financial Officer

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.

Nelson Torres, PhD Director, Regulatory and Quality Affairs

Nelson is responsible for maintaining SIA’s Quality Management System and authoring regulatory submissions. He previously led regulatory and quality efforts at SA Scientific supporting diagnostic devices for infectious diseases and supporting the organization’s ISO 13485 compliant Quality Management System. Most recently, he led regulatory efforts for the pre-market notification of Fresenius Kabi’s DXT Data Management System. Nelson graduated with a BS in Biology and a PhD in Biomedical Engineering from the University of Texas at San Antonio.

Michele Hilmer Director, Clinical Affairs

Michele brings over thirty years of diverse pharmaceutical and device clinical trial expertise to SIA and oversees both ongoing global post-market studies and a first-in-class U.S.-based Investigational Device Exemption (IDE) study of breast reconstruction. Her previous work includes positions with the DOD, research sites, CROs, and sponsor companies. She is spearheading the planning and development of upcoming clinical trials and will oversee operations to ensure trial conduct adheres to GCP guidelines and FDA regulations.

Jason O’Hearn, Chief Commercialization Officer

Jason has 27 years of experience and a proven track record of developing and leading successful commercial organizations in plastic surgery, and he is now focused on taking SIA from a best-in-class clinical company to a first-in-class commercial company. He previously held executive roles of increasing responsibility within Sientra (NYSE: SIEN) and Mentor Corporation WW LLC, a division of Johnson & Johnson (NYSE: JNJ). During his tenure at these companies he led the Sales, Marketing, Professional Education, KOL Management and Clinical groups. He held these responsibilities globally – including both the introduction of new brands and the growth of market-leading devices in reconstructive and aesthetic surgery.

Hilton Becker, MD, FACS, FRCS

Dr. Becker is a renowned voice in plastic surgery, having invented multiple marketed products, lectured all over the world on his surgical techniques, and published more than 50 articles in medical literature. He primarily operates at his private practice in Boca Raton, FL, while also serving as Affiliate Associate Professor at FAU College of Medicine and Volunteer Faculty at Cleveland Clinic, Florida, Department of Plastic Surgery. His primary clinical and research interests lie in cosmetic and reconstructive breast surgery.

John Kim, MD, FACS

Dr. Kim is the Clinical Director of the Northwestern University Feinberg School of Medicine’s Division of Plastic Surgery and a nationally recognized leader in innovations in plastic and breast surgery. He sits on the Editorial Board for the Annals of Plastic Surgery and his work has been featured in national media outlets, including ABC News and the Chicago Sun-Times. Dr. Kim has given over 100 lectures and Grand Rounds presentations on new techniques in plastic surgery and has published more than 100 articles and chapters in the plastic surgery literature and holds several patents on novel medical devices.

Josh Vose, MD, MBA - CEO

Josh is responsible for the strategic direction of SIA, leading the team, and many things in between. His career in medtech began as an undergrad at Georgia Tech and continued through medical training at the Medical College of Georgia, general surgery training at Beth Israel Deaconess Medical Center, and the Sloan School of Management at MIT. Professionally, Josh has spent much of his career in early-stage, scaling ventures, and particularly in breast oncology and reconstruction, first at PEAK Surgical (creators of the PlasmaBlade family of devices) and then at Medtronic, following PEAK’s acquisition. He has authored numerous peer-reviewed publications, led key engagements with FDA, and tirelessly endeavors to raise the standard of care in healthcare and surgery through innovation.

Mark Kuzycz, MD, FACS

Dr. Kuzycz is Chairman of the Department of Surgery and Trauma Surgery at Aurora Medical Center. He joined Aurora when they acquired the multidisciplinary group that he built from a solo practice in general surgery. His practice focuses on hernia surgery ranging from uncomplicated repairs to complex abdominal wall reconstruction, and he is consistently in the 95th percentile for surgical volume in the country. He has served as consultant and advisor to companies from start-up to Fortune 500 level, and has lectured to +1,000 peers on national and international stages.

Albert Losken, MD, FACS

Dr. Losken is a Professor of Plastic Surgery at Emory University Hospital and has a busy clinical practice with a focus on breast reconstruction and abdominal wall hernia repair. He is devoted to patient care and to advancing techniques and technology to improve outcomes. His contributions to the field include over 170 scientific articles and numerous book chapters focusing on reconstructive and aesthetic surgery.

Mark Sicso, MD, FACS

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.

Ryan Egeland, MD, PhD

Dr. Egeland is a multidisciplinary medical device executive who recently joined Cardiovascular Systems, Inc (Nasdaq: CSII) as Vice President of Medical Affairs after roles in marketing, medical affairs, and business development at Medtronic. Prior to this, he trained as a plastic/reconstructive surgeon at Northwestern Memorial Hospital after receiving an MD with honors from Harvard Medical School. He also holds a PhD in biochemistry and engineering from the University of Oxford, where he also got his MBA as a Rhodes Scholar.

Robert Hombach

Robert Hombach is a global financial and operations executive with extensive experience in biopharma and medical devices. He recently retired after a 27-year career at Baxter and Baxalta, where he served as EVP CFO/COO. Bob is now on the Board of several public companies, including BioMarin and Aptinyx, and serves on the Board of several private start-up companies in the healthcare space.

John Vacha

John is the Managing Partner of MVC Advisors, LLC which is focused on providing C-Level consulting services. He has 20+ years of med-tech CEO & CFO experience, including both VC-backed startup and publicly traded companies. His last full-time CEO role was with Intact Medical, a breast-focused diagnostic device company that was successfully sold to Medtronic in late 2016.

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