Market Overview

HepQuant Appoints Sean Bundy Director of Regulatory & Quality Affairs


, 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.

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Sean Bundy, RAC - HepQuant Director of Regulatory and Quality Affairs (Photo: Business Wire)

Sean Bundy, RAC - HepQuant Director of Regulatory and Quality Affairs (Photo: Business Wire)

"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.

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.

About HepQuant

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

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