Working toward a dramatic shift in the treatment of peripheral blockages

PQ Bypass, Inc. is a Silicon Valley-based medical device company working to transform the treatment of long-segment peripheral artery disease with minimally-invasive endovascular solutions.

PQ Bypass is a former Company-In-Residence at the Fogarty Institute for Innovation and is operated by recognized leaders in the medical device industry. Our executive team members have held senior leadership positions at companies including Medtronic, Abbott, Johnson & Johnson, Covidien, and Stryker and also have extensive experience developing medical devices for venture-backed startups such as Evalve, AccessClosure, and DVI.

Our goal is to reduce patient hardship along with the morbidity and mortality associated with more invasive procedures and to ultimately improve the quality-of-life for patients with peripheral artery disease

The underlying technology and technique used in the percutaneous PQ Bypass procedure was co-developed by two world-renowned cardiologists and innovators, Dr. James Joye (El Camino Hospital, Mountain View, California) and Dr. Richard Heuser (St. Luke’s Hospital, Phoenix, Arizona), who are internationally recognized experts in peripheral artery disease (PAD).

Management Team

Heather Simonsen – Vice President, Global Therapy Development

Heather has over 25 years of experience in the healthcare industry. She has served in senior roles for venture-funded medtech startups and Fortune 500 companies such as Abbott and Johnson & Johnson. Heather completed the Executive Program at Dartmouth’s Tuck School of Business and holds an MBA from Chicago’s DePaul School of Business. She has held board positions with the Medical Marketing Association, Healthcare Businesswomen’s Association, and is on the founders board of advisors for the Stanford University-affiliated StartX Accelerator. Heather currently serves on the Board of Directors for Sanarus Technologies, Inc., a commercial-stage company pioneering a minimally invasive cryoablation treatment for breast tumors.

Steven Tyler – Vice President, Research & Development

Steve has over 20 years of experience in the medical device industry leading Research & Development teams.  He has held management positions at Stryker, Guidant, Abbott Vascular (Evalve) and Avinger. Steve holds a Master’s Degree in Mechanical Engineering from Stanford University and is a licensed Professional Engineer.

 

Scott Hosaka – Vice President, Quality & Operations

Scott has over 25 years experience in the medical industry at venture-funded start-ups and Fortune 500 corporations like DVI, Guidant, Johnson & Johnson, and Eli Lilly. He has served as Vice President of Operations and Quality for multiple medical start-ups and as Principal Consultant for medical and cleantech companies. Scott holds a Biomedical Engineering degree from Northwestern University.

Bradley Brown – Acting Vice President, Clinical Operations

Bradley has over 15 years of experience in academic and international research within the medical device and biotechnology industries.  He co-founded Global Genomics Group in 2012, a precision medicine-based biopharmaceutical company and ABio Clinical Research Partners in 2016, a full-service clinical strategy and operational consulting firm to the medical device industry.  Bradley has held management positions at Abbott Vascular, SquareOne, CardioDx Novate Medical and Keystone Heart. Bradley holds a B.S. degree in Exercise Science from the University of New England, a M.S. degree in Cardiac Rehabilitation & Exercise Science from East Stroudsburg University and a MBA from Virginia Commonwealth University.

 

Michael J. Billig – Acting Vice President, Regulatory Affairs

Mike has 40+ years of experience in regulatory affairs, quality systems, clinical research, and general management for medical device companies. He co-founded Experien Group in 2003, a full-service regulatory consulting firm exclusive to the medical device industry. He has secured regulatory approval for hundreds of medical device products across the U.S., Europe, Canada, Central and South America, and Asia. Mike held executive-level positions for over 20 years at early stage start-up companies, including Converge Medical, CardioThoracic Systems, Cardiometrics, and Timi3 Systems where he was President and CEO.  Mike earned his B.S. degree in Microbiology from the University of Minnesota.

Board of Directors

Richard Ferrari / DeNovo Ventures
Kenneth Hayes / Ascent Biomedical Ventures
James D. Joye, DO / Founder and Chief Medical Officer
David Neustaedter / Medtronic
Daniel O’Mahony / Seroba Life Sciences
Chris Owens / President & CEO, Gynesonics

 

Investors

Ascent Biomedical Ventures
Seroba Life Sciences