HepQuant Appoints Sean Bundy Director of Regulatory & Quality Affairs
Bringing 20 Years in Medical Device and Diagnostics Regulatory and Quality Experience
DENVER (Aug. 2, 2018) — HepQuant, LLC, a Greenwood Village, Colo.-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced the appointment of Sean Bundy, RAC, as Director of Regulatory and Quality Affairs. In this role, Mr. Bundy will proactively develop, lead and drive the execution of a global regulatory and quality strategy with a focus on efficient, rapid and timely approval of the HepQuant liver test product suite. He brings to HepQuant two decades of experience as a skilled leader in the management of regulatory, clinical and quality processes for large life sciences organizations.
“Sean’s depth of credentials and experience will be invaluable as we advance HepQuant’s regulatory and clinical strategies,” said Gregory T. Everson, MD, CEO and Chief Medical Officer of HepQuant. “Over the course of his career with Precision Biopsy and Cochlear Americas, Sean has an accomplished track record of working closely with the FDA and other regulatory bodies to achieve successes for a number of medical devices. His significant expertise in the medical device and diagnostic space will be pivotal as we work to bring HepQuant to market as a potential tool to address enormous unmet needs for cost-effective, minimally invasive liver testing.”
“I am impressed with the breadth and depth of the clinical evidence that has been generated in support of this product,” noted Bundy. “I am also excited to work alongside the forward-thinking staff that HepQuant has assembled and the opportunity to bring this product to market and to improve the lives of our patients.”
Most recently, Bundy served as Vice President Regulatory and Quality at Precision Biopsy, where he defined regulatory and quality strategy for an early-stage prostate cancer diagnostic tool. In this role he successfully negotiated a De Novo submission approach for an assumed Class III device. Prior to Precision Biopsy, he held a variety of quality and regulatory affairs roles over 12 years at Cochlear Americas. As Director of Regulatory and Quality, at Cochlear Americas, he managed the approval of over 100 PMA supplements, 510(k) clearances and IDE submissions. In his most recent position as Director of Regulatory Strategy at Cochlear Americas, he drove global strategy for marketing authorizations for Class II and Class III medical devices. He led the submission of a Novel PMA for a first-of-kind device, including FDA Panel review.
Mr. Bundy earned a postgraduate diploma in Medical Technology Regulatory Affairs from Cranfield University in Cranfield, England and a postgraduate certificate in Clinical Trials Management from the University of Chicago.
Headquartered in Greenwood Village, Colorado, HepQuant, LLC, is a privately-held, early-stage combination drug and in-vitro diagnostic company. HepQuant’s products are investigational combination drug and in-vitro diagnostic devices and have not yet been evaluated or reviewed by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process. For additional information, visit www.hepquant.com.
Tom Kennedy, Corporate Communications
[email protected] (720) 507-4164