PQ Bypass, Inc.
PQ Bypass, Inc. is a rapidly advancing medical technology company pioneering a first-of-its-kind technology to address the complexity of treatment for severe peripheral arterial disease. Its proprietary Detour platform for percutaneous femoral-popliteal bypass–designated by the FDA as a Breakthrough Device–is designed to be a significant technological advancement enabling novel, transformational interventions in outpatient settings. PQ Bypass is a former Company-In-Residence at the renowned Fogarty Institute for Innovation and is operated by recognized leaders in the medical device industry, including veterans from Boston Scientific, Phillips, Medtronic, Abbott and Johnson & Johnson.
PQ Bypass is recognized by MedTech Outlook magazine as one of the Top 10 Cardiovascular Companies of 2019 and earned Frost and Sullivan’s European Technology Innovation award in 2017. The Detour System and the TORUS Stent Graft are limited by federal law to investigational use only and are not available for sale
Richard Ferrari – Chairman of the Board and CEO
Rich is a Co-Founder of De Novo Ventures which has $650 million under management and which is one of the premier firms dedicated to Medical Devices and Bio-Technology. Rich has been a successful CEO of two publicly traded medical technology companies, Cardiovascular Imaging Systems, the first and leading developer of ultrasound imaging catheters, and CardioThoracic Systems (CTS) , which pioneered off-pump bypass surgery. He also co-founded the Medical Technology Group which spun-out Integrated Vascular Systems. Previously Mr. Ferrari held the positions of Executive Vice President and General Manager of ADAC Laboratories. In 1996 he founded Saratoga Ventures, a venture capital partnership that has provided seed financing to startup medical technology companies. Rich is the recipient of the Mallinckrodt Award for Excellence in Medicine and has been a finalist for the Entrepreneur of the Year Award. Rich holds a BS degree from Ashland University and an MBA from the University of South Florida.
Heather Simonsen – President
Heather has almost 30 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.
Pharoah Garma- Vice President, Regulatory Affairs
Pharoah is an expert regulatory strategist with a specialized focus on cardiovascular medical devices and combination products. With regulatory leadership experience at companies including Medtronic and Biotronik, most recently Pharoah presided over the regulatory team at Philips Image Guided Therapy Devices where she led the group to a significant number of approvals, and successfully completed PMA and CE Mark trials. She spent the first half of her career as Senior Lead FDA Reviewer in the Interventional Cardiology Devices Branch. Pharoah holds BS and MEng degrees in Biomedical Engineering from Syracuse University.
Colleen Holthe- Vice President, Clinical Affairs
Colleen has spent almost 20 years focused exclusively on driving clinical research for Class III peripheral vascular innovations. A recognized expert in global clinical operations and extremely complex PMAs, Colleen boasts clinical wins across multi-national drug coated balloon (DCB) and peripheral stent pivotal trials. Many of the products Colleen has helped bring to market are actively used across the world by peripheral interventionists and vascular surgeons. While also holding her day job, Colleen worked evenings and weekends to earn her Masters in Public Health from the prestigious University of Minnesota School of Public Health, ranked as one of the top-10 schools for public health in the United States.
Marion Larrea- Vice President, Operations
Marion is a seasoned veteran in operations excellence and an expert in lean manufacturing. Marion has been responsible for transforming the manufacturing and supply-chain organization at PQ Bypass. Prior to joining PQ, Marion was VP of Operations Iridex, and has held multiple leadership roles across operations, supply-chain, logistics, and materials at Genturadex, Solta Medical, and Reliant Technologies.
Steve Van Dick – Consulting Chief Financial Officer
Steve Van Dick is a strategic financial and accounting executive with a winning record of transitioning early stage companies to commercialization through astute financial management. Respected in the medical device startup community as financial startup subject matter expert, he develops and leads comprehensive, world-class financial and accounting groups credited for propelling startup companies forward. Across his career Steve has played a key role on the Executive Leadership Teams that successfully completed three separate Initial Public Offering (IPOs) and three mergers/integrations.
Ron Steckel – Special Advisor
Ron’s extensive experience with start-ups encompasses a broad range of corporate strategies, novel and disruptive technologies, diverse management teams and changes in the clinical, regulatory and reimbursement landscape.
He has the unique ability to rapidly assess strengths and weaknesses in the business model and provide actionable and implementable solutions to problems. His experience comprises over 35 years of domestic and international positions in the medical device, diagnostics and pharmaceutical industries including major corporations and private companies.
Richard Ferrari / PQ Bypass
Stanton Rowe / NXT Biomedical
Seroba Life Sciences
Seroba Life Sciences