Surgical Innovation Associates (SIA) is committed to bringing better outcomes to patients and lowering cost to the system through “for surgeon, by surgeon” innovation in reconstructive and cosmetic surgery. SIA was originally founded in 2016 by affiliates of Northwestern University Feinberg School of Medicine and Kellogg School of Business in order to develop and commercialize an alternative to certain problematic, cadaver-derived, biologic implants that are being used today.
The company’s first product, DuraSorb™, was developed over the course of 2016-2017, and received FDA clearance for temporary soft tissue support in 2018. SIA has multiple devices in development to improve pre-pectoral breast reconstruction, minimally-invasive facelift, and other techniques.
Headquartered in Chicago, IL, SIA is situated in an active corridor of innovation in the Midwest United States. The company’s proximity to industry, academia and world-leading healthcare institutions is reflected in its strong team and advisory board. This ecosystem is ideal for the rapid translation of concepts into novel devices that incorporate the voice of key stakeholders – regulators, insurers, providers, physicians, and, most importantly, patients.
Alexei Mlodinow, MBA
Alexei is responsible for setting the strategic direction of SIA, brewing coffee for its meetings, and everything in between. He co-founded the company during dual MD-MBA programming at Northwestern’s Kellogg School of Management and Feinberg School of Medicine, where he also authored 25+ peer-reviewed publications, presentations, and abstracts in plastic and reconstructive surgery. Prior to that he graduated at the top of a 5,000+ person class from the University of California, Santa Barbara, with dual degrees in Economics and Japanese.
Todd Cruikshank, MBA
Chief Operating Officer
Todd brings extensive interdisciplinary business and academic training to SIA. He began his career in healthcare with Baxter, supporting the development of plasma-derived portfolio products for rare and orphan diseases. While there, he spent nearly a decade in business intelligence, operations and corporate strategy positions. He is currently focused on the development and commercialization of the SIA product portfolio. He graduated with a BA in English from Illinois Wesleyan University and an MBA from Northwestern’s Kellogg School of Management.
John Vacha, MS, CPA
Chief Financial Officer
John stepped into a part-time CFO role with SIA after an initial year of service as board advisor. He concurrently serves as a Board Member & part-time CFO of Imagin Medical (IMEXF). Prior to that he served as President, CEO and Board Member of Intact Medical Corporation for 7 years before successfully leading it to an acquisition by Medtronic. Mr. Vacha also serves as a member of the Board of Directors at the South Boston Health Center and holds two patents in electrosurgical instrumentation.
VP, Finance & Accounting
John is a serial entrepreneur and brings significant industry, finance and leadership expertise to the SIA team. He previously co-founded and held senior finance positioning in three Medtech start-ups, two of which he helped lead from concept to FDA 510(k) clearance and scaling sales, fueled by >$50MM of financing. The third medical device startup is pioneering a Class III device, is in the clinic, and is progressing towards a PMA approval, with funding support from Boston Scientific (NYSE: BSX) and several reputable VC’s. John holds several patents and was educated at University of Iowa, graduating with a BA in Finance.
Director Quality and Manufacturing
Michele is responsible for maintaining SIA’s MDSAP-, ISO-13485-, and 21-CFR-compliant Quality Management System, including manufacturing control and supplier management. Michele is concurrently the Vice President, Quality & Regulatory with Accumedix, Inc. She is also the President of Vantage Consulting International, Ltd, and has over 30 years of quality, regulatory and customer service and project management experience within the medical device industry.
Brian Young, RA, MBA
Director, Regulatory and Clinical Affairs
Brian guides regulatory and clinical strategy for SIA’s marketed and pipeline products. He is concurrently VP of Regulatory and Clinical Affairs for Health Policy Associates (HPA) and EVP of Quality and Regulatory for Prytime Medical. He brings over 30 years of diversified, professional experience in regulatory, quality and clinical affairs for medical device manufacturers, including a previous role as VP, Global Regulatory and Clinical affairs for KCI/Acelity.
Michelle Hasse, MS
Regulatory / Clinical Scientist
Michelle is responsible for regulatory and clinical affairs. Michelle has prior experience working with the FDA, EC, and clinicians on behalf of medical device manufacturers in both the pre and post market phases. She received her Bachelor of Science in Biomolecular Engineering from the Milwaukee School of Engineering and her Master of Science in Biotechnology from Northwestern University.
Director, Clinical Affairs
Michele brings over thirty years of diverse pharmaceutical and device clinical trial expertise to SIA. Her portfolio 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.
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.
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.
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.
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
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.
Bruce Krattenmaker is a Global Regulatory and Quality Assurance Executive with over 40 years in the medical industry, and currently the Vice President of Regulatory Affairs and Quality at Evolus, Inc. Prior to this recent engagement Bruce was Vice President of Global Regulatory Affairs for Allergan where he led worldwide regulatory affairs for the company’s entire medical device franchise. Prior experience included senior management positions at Johnson & Johnson, eV3, Boston Scientific, Edwards Lifesciences and Baxter International.
Ryan Egeland, MD, PhD
Dr. Egeland is a multidisciplinary medical device executive who recently joined CSI 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.
Paul Serio is the President of Accumedix, Inc., which provides a unique hybrid of contract manufacturing and Quality/Regulatory representation in the medical device industry. He has deep experience in general management, operations, and medical device development, including 25+ year career at Baxter in divisional and corporate roles, during which he served as a member of the senior management committee.
Matthew Tucker has extensive experience leading commercialization efforts across functional areas. He draws from his portfolio and team leadership experiences at Baxter and Mylan and has advised numerous startups through the launch and relaunch phase. Over the course of his career he has led the growth efforts of over 20 brands in medical devices and pharmaceuticals.