Proposed Abstract for the IIR - Orthopaedic Research Society

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Gabriele G. Niederauer, Ph.D.
Since May 2007, Dr. Niederauer has been leading Research and Development at
ENTrigue Surgical, Inc.
As Senior Vice-President of Technology and
Development, she is one of the founding officers of the company. She is
directing biomaterials and instrument product design to develop novel instruments
and implants for the ENT operating room and office, with an initial focus on
enhancing surgical access for increased functionality and precision. She
supervises the regulatory, quality, preclinical and clinical activities resulting in
FDA clearance of two device implants, conduct of several clinical trials, CE mark
and Canadian licensing of numerous products as well as ISO 13485 certification. She is also
responsible for management of ENTrigue’s intellectual property portfolio and Director of ENTrigue’s
Tissue Bank. Dr. Niederauer has more than 25 years of experience in the study, development and
commercialization of biomaterials for orthopedic, dental and ENT tissue repair.
Previously, Dr. Niederauer was Vice President of Research and Development at C2M (Concept to
Market) Medical, a consultant group to medical device companies and investors. From 1995 to 2006,
Dr. Niederauer was with OsteoBiologics, Inc. (OBI), where she served as Director of Research and
Development. Her responsibilities included coordination of experimental, preclinical, and clinical
studies, planning and submission of regulatory filings, and management of OBI's intellectual property
portfolio. She also led development of 12 new products / product line extensions and worked with key
opinion leading surgeons in arthroscopy and cartilage repair to gain exposure and assure constant flow
of new product ideas. Dr. Niederauer was engaged in new business expansion to leverage the OBI
technologies into other medical specialties and assisted in raising $20 million of venture capital (three
rounds) to fund development, manufacture and commercialization of novel implants and instruments to
fuel the company’s growth. OBI was acquired by Smith&Nephew, Inc. in July 2006 for $72.3 million,
following 2005 revenues of $3.3 million.
Dr. Niederauer completed a Post-Doctoral Fellowship at the Orthopaedic Biomechanics Laboratory at
the University of Texas Health Science Center at San Antonio. Dr. Niederauer earned a Doctor of
Philosophy degree in Biomedical Engineering from Iowa State University, a Masters of Science degree
in Materials Science and Biomedical Engineering from Iowa State University, and a Bachelor of
Science degree in Ceramic Engineering from Clemson University. Her research has led to over 20
peer-reviewed articles, 50 presentations, numerous abstracts and honors. Dr. Niederauer is also a coinventor of nine patents and seven applications for devices and methods used in orthopedic surgery,
tissue engineering and ENT procedures. Nationally, she is a member for the Society for Biomaterials,
ASTM and the Orthopedic Research Society. She has served on Council of the Society for
Biomaterials, where she chaired the Devices and Materials Committee. She has previously served on
the Board of Directors for the Orthopedic Research Society as well as the Biomedical Engineering
Society. Dr. Niederauer also serves of the Scientific Board of Bio2 Technologies, Inc., the Advisory
Board of Speer Medical, Inc., Panthera Global, a Healthcare-Focused Investment Bank and
StemBioSys, Inc. She is a Fellow of the American Institute for Medical and Biological Engineering.
Locally, she was the 2011 President of the San Antonio Chapter of the Healthcare Businesswomen’s
Association, which during her term received the Chapter of the Year Award and she was recognized as
exemplary Chapter President. In 2012, she was appointed as an honorary commander of the Air Force
59th Medical Wing's Honorary Commanders Program and serves on the Seton Home Board of
Directors. She is also a member of the UTSA College of Engineering Advisory Board and mentors
student teams applying to entrepreneur competitions.
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