HepQuant Promotes Sean Bundy, RAC, to Chief Operating Officer
Denver, CO – June 10, 2020 – 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 promotion of Sean Bundy, RAC, to the role of Chief Operating Officer. Mr. Bundy has served as HepQuant’s Director of Regulatory and Quality Affairs since July 2018.
“We are delighted to promote Sean to this important role,” said Dr. Gregory T. Everson, Founder and Chief Executive Officer of HepQuant. “As a results-driven leader, he is equipped with a deep understanding of every aspect of our business and will continue to be instrumental as we advance through our developmental pathway.”
Mr. Bundy will maintain his focus on the execution of the pivotal SHUNT-V study, as well as ensuring that operational processes related to manufacturing, supply chain, distribution, and laboratory throughput, are ready for commercial-scale volumes. He will continue to act as head of Regulatory and Quality until a replacement is found.
“HepQuant remains at the forefront of one of the most exciting areas in liver health diagnostics,” Mr. Bundy noted. “I am looking forward to building on our operational and regulatory progress to date, including the important milestones accomplished in our pivotal study of the SHUNT-V liver diagnostic kit.”
The HepQuant SHUNT-V Liver Diagnostic Kit is being studied as an aid in the determination of the likelihood of large esophageal varices in patients with Chronic Liver Disease (CLD). As of May 20th, the company has enrolled over 170 subjects at 23 U.S. research sites. Results of the study are expected to support a Pre-Market Application (PMA) submission to the U.S. Food and Drug Administration (FDA) later this year.
“HepQuant has a solid foundation in place with a compelling vision, deep science and research, and backed by great people,” Mr. Bundy added.
Mr. Bundy has more than 25 years of experience in the management of regulatory, clinical and quality processes for large life sciences organizations. Prior to HepQuant, he 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.
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 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 guidelines for investigational device exemptions (IDEs). For additional information, visit www.hepquant.com.
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