From Technology Development to Patient Treatment
We believe that collaboration is key to developing products that enable physicians to help patients lead healthier lives. Working with our physician partners, our professional team continues to produce innovative medical devices used in practices every day.
Cardiovascular Disease: Finding Solutions for Unmet Clinical Needs
Reflow Medical, Inc. is a privately held company founded in 2011 and headquartered in San Clemente, California.
The Reflow Medical “Innovation Algorithm” is an iterative approach to device development that partners physicians and engineers in a continuous feedback loop as they discover solutions backed by verifiable clinical data.
Together, our goal is to continually improve patient outcomes.
Reflow Medical supports various organizations through sponsorships and scholarships.
“Innovation starts with understanding the unmet clinical need, then imagining and developing, simple, effective solutions.”
– Isa Rizk
Co-Founder and Chief Executive Officer
Isa co-founded Reflow Medical Inc. and is Chief Executive Officer for the Company. Prior to founding ReFlow Medical, Isa served at Intersect Partners, a medical device incubator, where he helped found and manage several companies including Altura Medical, Mindframe Inc., and Reshape Medical. Isa was Director of Research and Development at Edwards Lifesciences Aortic Heart Valve Division, developing the Magna Ease heart valve. Earlier in his career, Isa was involved in Research and Development at Intraluminal Therapeutics, working on their peripheral and coronary chronic total occlusion system. He held R&D positions with Baxter Cardiovascular and Intramed Laboratories.
Isa earned an MBA from USC Marshall School of Business and a Bachelor of Science degree in Mechanical Engineering from San Diego State University. He is the co-founder and vice president of SD BACKed, a San Diego-based non-profit benefit and aid organization dedicated to underprivileged and at-risk children.
“The clinical involvement of the physicians and an iterative approach with our team drives the growth of our product families.”
– John Fulkerson
Co-Founder and Chief Operating Officer
John co-founded Reflow Medical Inc. and serves as Chief Operating Officer for the Company. Prior to founding Reflow Medical, John was affiliated with, Intersect Partners, a medical device incubator, where he helped found and manage several companies including Altura Medical, Mindframe Inc., and Reshape Medical. John was Sr. Director of Research and Development at Edwards Lifesciences Peripheral Vascular Division, developing the LifeStent Peripheral Stent, which was acquired by C.R. Bard in 2007. Earlier in his career, John was Manager of New Product Development at Cordis J&J developing and commercializing their Hepacoat coronary stent system. He also held management positions with Syntheon, Baxter Cardiovascular and Intramed Laboratories. John has been awarded with numerous US patents, with several pending. He received his Bachelor of Science degree in Mechanical Engineering from San Diego State University.
“Our mission is to design and engineer products that give physicians maximum control and efficiency in treating patients.”
– Teo Jimenez
Senior Vice President of Research and Development
Teo has over 20 years of R&D experience developing market leading medical devices for treatment of vascular and cardiac diseases. With this experience, he has led engineering teams to develop strategically aligned technologies from concept, clinical application and into commercialization to treat and save patient lives. His many contributions include the design and development of devices to treat abdominal aortic aneurysms, atrial fibrillation, peripheral stenting and various cardiac valve technologies from a surgical and transcatheter perspective.
“Reflow implements systems and procedures that ensure our products comply with all regulatory requirements and meet or exceed quality standards.”
– Jeff Vander Hoek
Sr. Director of Quality/Regulatory
Jeff Vander Hoek joined us in May 2021 as our Director of Regulatory Affairs/Quality Assurance. Jeff brings over 20 years experience in RA/QA for medical device companies.
“The best solutions are created when clinical needs intersect with novel engineering.”
VP of Engineering
Outhit Bouasaysy has served as Reflow Medical’s Vice President of Engineering since February 2022. Previously Senior Director of R&D at Reflow, Outhit developed the CoraCatheters™ product line, taking it from concept to 510k approval and commercialization. Prior to joining Reflow, Outhit was the Technical Leader for the early-stage research and development of Reshape™ Medical’s dual gastric balloon implant, and was responsible for obtaining CE mark, US IDE/PMA approval and early-stage commercialization. Outhit has demonstrated engineering leadership throughout his 20-plus years in the medical device industry, holding an engineering management position at Endologix and various engineering positions at ev3, Inc., Avail Medical and Specialty Silicone Fabricators.
Outhit received his undergraduate degree in Mechanical Engineering from the Henry Samueli School Engineering at the University of California, Irvine.
“Innovation doesn’t stop with our products, it continues with our stakeholders including patients, physicians, and regulatory bodies we work with.”
Senior Director, Regulatory Affairs
Lori has over 25 years of experience in analytical, quality control, and regulatory affairs for combination products. Her background includes working with Biologics License Applications (BLA), Premarket Approvals (PMA), New Drug Applications (NDA), and global registrations of novel ophthalmological and cardiovascular technologies.
“Doctors expect to see real data on devices used in life-saving procedures, and Reflow delivers. “
– Jose Marques
VP US Commercialization
Jose serves as Vice President of US Commercialization and Market Development for ReFlow Medical. Jose has been an accomplished sales and marketing executive with a passion to help patients for over 36 years. Prior to joining ReFlow Medical, Jose served as a Board Member of Lutonix and Director with the responsibility for the successful OUS Strategic Marketing and Commercialization of the Lutonix DEB technology. He has extensive knowledge in a medical device market that rapidly changes, requiring constant learning and adaptation keeping up with new algorithms of clinical treatment. Jose joined Bard, as a Regional Market Development Manager, to ensure the success of the acquisition, integration, training and execution of the Crosser CTO sales strategy in the peripheral market. Jose was involved in developing the CTO crossing catheter coronary and peripheral market with FlowCardia, a successful start-up, as Regional Director of Sales which was acquired by C.R. Bard in 2010. Prior, Jose served as Director of Sales for Edwards Lifesciences in the Peripheral Vascular Division, successfully commercializing the LifeStent which was acquired by C.R. Bard in 2007. Previously, Jose had a successful career in Cardiology Sales and Marketing where he was responsible for launching numerous coronary medical devices which significantly improved patient care. Jose held various executive management positions spanning over 24 years with Cordis J&J and Cordis, prior to the Johnson and Johnson acquisition, where he demonstrated a strong track record of significant achievement, including several US patents, with increasing responsibility and leadership. Prior to entering the medical device industry, Jose held key management roles in the Financial market arena. He holds an MSM, specialties in Finance and Marketing from Florida International University Graduate School of Business and a Bachelor of Science in Criminal Justice from Florida International University.
Andrej Schmidt, MD
Cardiologist, Angiologist – Leipzig, Germany
Dr. Schmidt serves as Deputy Director at University Hospital, in Leipzig Germany, where he is also Senior Interventionalist in the Division of Interventional Angiology. He previously held the position of Chief Senior Physician in the Department of Angiology, Park Hospital in Leipzig, Germany. He has published more than 75 research papers.
Prof Dierk Scheinert, MD
Professor – Leipzig, Saxony
Prof. Scheinert is the Medical Director at University Hospital Leipzig and Head of the Center for Vascular Medicine, Angiology and Vascular Surgery. He is recognized internationally for his expertise in both coronary and peripheral vascular interventions. Prof. Scheinert’s special interest areas are treatment of critical limb ischemia, endovascular repair of aneurysms and dissections of the thoracic and abdominal aorta. He has written numerous articles and abstracts, and is actively involved in clinical research to evaluate new technologies. Prof. Scheinert is the Director of LINC (Leipzig Interventional Course) and is also a Board Member of Euro PCR.
Gary M. Ansel, MD
Interventional Cardiologist – Columbus, Ohio
Dr. Ansel specializes in Interventional Cardiology and Cardiology in Columbus, Ohio, where he is a Practicing Partner of MidOhio Cardiology and Vascular Consultants Inc. He serves as Clinical Director of Peripheral-Vascular Interventionists in the Division of Cardiology of Riverside Methodist Hospital, and as Director of the Center for Critical Limb Care at Riverside Methodist Hospital, Columbus, Ohio. Dr. Ansel is an Assistant Clinical Professor of Medicine in the Department of Internal Medicine of the Medical University of Ohio in Toledo Medical Center and Associate Director of Ohio Health Research Institute.
Dr. Ansel is a Founding Board Member of the VIVA Conference. He also serves on the Peripheral Vascular Committee for the American College of Cardiology.
S. Jay Mathews, MD, MS, FACC, FSCAI
Interventional Cardiologist – Bradenton, Florida
Dr. Mathews is an interventional cardiologist and endovascular specialist at Bradenton Cardiology Center in Bradenton, FL specializing in complex coronary interventions, structural heart procedures, endovascular therapies, and novel device research. He did his undergraduate training at Rensselaer Polytechnic Institute in Troy, NY receiving a degree in Biology and Electronic Media Arts & Communication and subsequently working in the multimedia technology sector. He later went on to graduate and professional training at Tufts University in Boston, MA where he received his MD and Master’s in Health Communication at the Sackler School of Biomedical Sciences focusing on telemedicine and interactive education. He completed residency training and fellowship training in Cardiovascular Disease, Advanced Cardiac Imaging, and Interventional Cardiology at the Washington University School of Medicine in St. Louis, MO. He is currently in an investigator in several trials and is actively involved in endovascular research.
Jihad A. Mustapha, MD, FACC, FSCAI
Interventional Cardiologist – Grand Rapids, Michigan
Dr. Mustapha is an Interventional Cardiologist specializing in endovascular revascularization of peripheral artery disease (PAD), specifically critical limb ischemia, or CLI. He is an internationally recognized leader in the field and a co-founder of the first Advanced Cardiac & Vascular Amputation Prevention Centers Michigan State University College of Osteopathic Medicine Grand Rapids, Michigan. In addition to his practice, Dr. Mustapha serves on the editorial boards of several scientific publications. He has also authored or co-authored numerous articles and abstracts and is highly sought-after as a teacher and trainer for physicians throughout the world.
Dr. Mustapha is Clinical Associate Professor of Medicine at Michigan State University of Osteophathic Medicine. He is the Founder and Director of the AMPutation Prevention Symposium, and a Founding Board Member of the CLI Global Society.
Mahmood K Razavi, MD
Interventional Radiologist – Orange, California
Dr. Razavi specializes in image-guided therapy for cancer and endovascular treatment of vascular diseases. He serves as the Editor-in-Chief for Techniques in Vascular & Interventional Radiology and is a member of Council on Cardiovascular Radiology and Intervention, American Heart Association. He is a member of the Editorial Board of the Journal of Endovascular Specialists and is a reviewer for several other journals. Dr. Razavi co-founded Boston Scientific Santa Rosa Corp. in 1998.
Dr. Razavi chairs the Scientific Program for the Society of Interventional Radiology. He has held faculty positions at UCLA and Stanford University, and was the Director of Special Procedures at the West Los Angeles VA Medical Center. He serves on various committees of national organizations such as the Food & Drug Administration/SIR Device Forum. His scientific work is featured in national and international media programs, and he has authored or co-authored numerous scientific publications, abstracts and book chapters.
Michael Lichtenberg, MD, FESC
Interventional Cardiologist/Angiologist – Arnsberg, Germany
Dr Michael Lichtenberg is the Chief Medical Officer of the Angiology Department at Vascular Centre Clinic Arnsberg, Germany. He is an interventional cardiologist and angiologist with more than 15 years of experience in the field of endovascular interventions. While he values his day-to-day experiences in interventional care, his main interest is the evaluation of new devices, techniques and procedures for intervention of peripheral artery disease. Dr Lichtenberg has performed a series of studies in this area and conducted many clinical trials. He presents his research at conferences around the world. In 2011, Dr Lichtenberg was awarded the Fellowship of the European Board of Cardiology. In 2017 he was elected for the executive secretary of the Germany Angiology Society (DGA).Since January 2020 he is the President of the German Angiology Society.
William L. Lombardi, MD, FACC, FSCAI
Interventional Cardiologist – Seattle, Washington
Dr. Lombardi is a board-certified cardiologist at the University of Washington Medical Center and Northwest Hospital; Clinical Professor of Medicine, Division of Cardiology; and the Director of Complex Coronary Artery Disease Therapies at the University of Washington Medical Center in Seattle. He is a well-known expert in complex coronary intervention and complete chronic total occlusion therapies.
Lorenzo Azzalini, MD, PhD, MSC, FACC, FSCAI
Interventional Cardiologist – Seattle, Washington
Dr. Azzalini is the Director of Interventional Cardiology Research and an Associate Professor of Medicine at the Heart Institute at the University of Washington Medical Center. His background includes medical training across four countries and two continents. Dr. Azzalini provides unique approaches to treating complex heart conditions, including PCI, CTO and CHIP populations. His clinical research includes co-authoring 196 peer-reviewed articles, and he has participated in four clinical trials over the past 15 years.